Value-Based Care in Rheumatology October 2014 by Value-Based Cancer Care

OCTOBER 2014 VOL 3 • NO 5

www.ValueBasedRheumatology.com

RHEUMATOLOGY CENTER PROFILE

THE Rheumatology NURSE™

A conversation with Clifton O. Bingham III, MD, Director, Johns Hopkins Arthritis Center

By Deanna L. Owens, MSN, RN, and Sheree C. Carter, PhD, RN Ms Owens is Director, Infusion and Clinical Services, Low Country Rheumatology, Charleston, SC; and Member, Board of Directors, Rheumatology Nurses Society

Joining the Race to Patient Care, Research, and Rheumatology: RNS Education Are the Pillars of Johns Hopkins Arthritis Center Conference Highlights Louisville, KY—Rheumatology nurses and healthcare providers gathered from across the United States, Canada, Puerto Rico, and Kenya to “Join the Race to Rheumatology” at the 7th Annual Rheumatology Nurses Soci-

ety (RNS) Conference. The conference —which had the largest attendance in the organization’s history—provided networking opportunities and inspired rheumatology nurses to achieve excellence in the care of the Continued on page 19

n a recent interview with ValueBased Care in Rheumatology, Clifton O. Bingham III, MD, Associate Professor of Medicine, Division of Rheumatology, and Director of

the Johns Hopkins Arthritis Center, discussed current trends in rheumatology and the pillars of care at Johns Hopkins. The Arthritis Center consists of Continued on page 17

Disease Activity Linked to Radiographic Progression in Ankylosing Spondylitis

Better Osteoporosis Screening Needed for Women Age 50-54 Years By Rosemary Frei, MSc Houston, TX—The US Preventive Services Task Force strategy captures less than 5% of postmenopausal women 50 to 54 years of age who will have a major osteoporotic fracture (MOF) within the next 10 years, according to an analysis presented at the American

Society for Bone and Mineral Research 2014 Annual Meeting. The US Task Force recommends that women younger than 65 years of age should be screened for osteoporosis if their Fracture Risk Assessment Tool (FRAX) score indicates Continued on page 8

By Leslie Wyatt

he association between inflammation and new bone formation in ankylosing spondylitis (AS)

has been widely studied and debated in recent years. However, the studies have resulted in inconclusive data

Continued on page 8

INSIDE VALUE PROPOSITIONS. . . . . . . . . . . Behavioral therapy cost-effective in patients with fibromyalgia HEALTH ECONOMICS. . . . . . . . . . . . . Shifts to value-based care and payment models improve quality of care

RHEUMATOLOGY UPDATE. . . . 19 Neurologic symptoms of rheumatologic conditions elucidated

RHEUMATOID ARTHRITIS . . . . 22 Concomitant use of statins does not significantly impact the efficacy of rituximab

GOUT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Febuxostat safe and effective in elderly women with hyperuricemia

PERSONALIZED MEDICINE in Rheumatology™. . . . . . . . . . . . . . . . . . . . 26 Autoantibodies in patients with RA could lead to more precise diagnosis, therapy

PSORIATIC ARTHRITIS. . . . . . . . . . . Brodalumab shows positive results in phase 2 trial

◆

Otezla was studied in 3 randomized, double-blind, placebocontrolled trials of similar design. 1493 adults with active psoriatic arthritis (≥3 swollen and ≥3 tender joints), despite prior or current DMARD† therapy, were randomized to placebo or Otezla 30 mg twice daily, after a titration period1 Patients who failed >3 small molecules or biologics or >1 biologic TNF blocker were excluded1

INDICATION ◆

Otezla® (apremilast) is indicated for the treatment of adult patients with active psoriatic arthritis

IMPORTANT SAFETY INFORMATION Contraindications ◆ Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation Warnings and Precautions ◆ Depression: Treatment with Otezla is associated with an

◆

Study 1 – ACR20 responders at week 16 (primary endpoint): Otezla, 38%; placebo, 19%; P = 0.00011,2 Significant ACR20 responses also seen with Otezla in Studies 2 and 31,2 *In patients with preexisting dactylitis and enthesitis. Disease-modifying antirheumatic drug.

†

increase in adverse reactions of depression. During clinical trials, 1.0% (10/998) of patients treated with Otezla reported depression or depressed mood compared to 0.8% (4/495) treated with placebo; 0.3% (4/1441) of patients treated with Otezla discontinued treatment due to depression or depressed mood compared with none in placebo treated patients (0/495). Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo treated patients (0/495). Suicidal ideation and behavior were observed in 0.2% (3/1441) of

patients on Otezla, compared to none on placebo (0/495). Two patients who received placebo committed suicide compared to none on Otezla - Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur

Weight Decrease: Body weight frequency at least 1 % higher be exercised when Otezla is administered to a nursing woman loss of 5-10% was reported in 10% than that observed in patients of patients taking Otezla and in taking placebo, for up to 16 weeks ◆ Renal Impairment: Otezla 3.3% of patients taking placebo. (after the initial 5-day titration), dosage should be reduced in Monitor body weight regularly; were (Otezla%, placebo%): patients with severe renal evaluate unexplained or clinically diarrhea (7.7, 1.6); nausea (8.9, 3.1); impairment (creatinine clearance significant weight loss, and headache (5.9, 2.2); upper less than 30 mL/min); for details, consider discontinuation of Otezla respiratory tract infection (3.9, see Dosage and Administration, 1.8); vomiting (3.2, 0.4); ◆ Drug Interactions: Apremilast Section 2, in the Full Prescribing nasopharyngitis (2.6, 1.6); upper Information exposure was decreased when abdominal pain (2.0, 0.2) Otezla was co-administered with Please see Brief Summary of rifampin, a strong CYP450 Use in Specific Populations Full Prescribing Information enzyme inducer; loss of Otezla ◆ Pregnancy and Nursing Mothers: on the following page. efficacy may occur. Concomitant Otezla is Pregnancy Category C; References: 1. Otezla [package insert]. Summit, use of Otezla with CYP450 NJ: Celgene Corporation; 2014. 2. Data on file, it has not been studied in enzyme inducers (eg, rifampin, Celgene Corporation. pregnant women. Use during phenobarbital, carbamazepine, pregnancy only if the potential phenytoin) is not recommended benefit justifies the potential Adverse Reactions risk to the fetus. It is not known ◆ Adverse reactions reported in whether apremilast or its metabolites are present in at least 2% of patients taking human milk. Caution should Otezla, that occurred at a ◆

Get the latest news at otezlapro.com

Rx Only OTEZLA® (apremilast) tablets, for oral use The following is a Brief Summary of the Prescribing Information; see Full Prescribing Information for complete product information. INDICATIONS AND USAGE OTEZLA® (apremilast) is indicated for the treatment of adult patients with active psoriatic arthritis. CONTRAINDICATIONS OTEZLA is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation [see Adverse Reactions (6.1)]. WARNINGS AND PRECAUTIONS Depression: Treatment with OTEZLA is associated with an increase in adverse reactions of depression. During the 0 to 16 weeks placebo-controlled period of the 3 controlled clinical trials, 1.0% (10/998) of patients treated with OTEZLA reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. During the clinical trials, 0.3% (4/1441) of patients treated with OTEZLA discontinued treatment due to depression or depressed mood compared with none in placebo treated patients (0/495). Depression was reported as serious in 0.2% (3/1441) of patients exposed to OTEZLA, compared to none in placebo treated patients (0/495). Instances of suicidal ideation and behavior have been observed in 0.2% (3/1441) of patients while receiving OTEZLA, compared to none in placebo treated patients (0/495). In the clinical trials, two patients who received placebo committed suicide compared to none in OTEZLA treated patients. Before using OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment with OTEZLA in such patients. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Prescribers should carefully evaluate the risks and benefits of continuing treatment with OTEZLA if such events occur. Weight Decrease: During the controlled period of the studies, weight decrease between 5-10% of body weight was reported in 10% (49/497) of patients treated with OTEZLA 30 mg twice daily compared to 3.3% (16/495) treated with placebo [see Adverse Reactions (6.1)]. Patients treated with OTEZLA should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of OTEZLA should be considered. Drug Interactions: Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of OTEZLA. Therefore, the use of cytochrome P450 enzyme inducers (e.g. rifampin, phenobarbital, carbamazepine, phenytoin) with OTEZLA is not recommended. [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. ADVERSE REACTIONS Clinical Trials Experience in Psoriatic Arthritis: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The majority of the most common adverse reactions presented in Table 2 occurred within the first two weeks of treatment and tended to resolve over time with continued dosing. Diarrhea, headache, and nausea were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for patients taking OTEZLA were nausea (1.8%), diarrhea (1.8%), and headache (1.2%). The proportion of patients with psoriatic arthritis who discontinued treatment due to any adverse reaction was 4.6% for patients taking OTEZLA 30 mg twice daily and 1.2% for placebo-treated patients.

Table 2: Adverse Reactions Reported in ≥ 2% of Patients on OTEZLA 30 mg Twice Daily and ≥ 1% Than That Observed in Patients on Placebo For Up To Day 112 ( Week 16) Placebo

Preferred Term

OTEZLA 30 mg BID

Day 1 to 5 Day 6 to Day 112 Day 1 to 5 Day 6 to Day 112 (N=495) (N=490) (N=497) (N=493) n (%)c n (%) n (%) n (%)

Diarrhea a

6 (1.2)

8 (1.6)

46 (9.3)

38 (7.7)

Nauseaa

7 (1.4)

15 (3.1)

37 (7.4)

44 (8.9)

Headachea

9 (1.8)

11 (2.2)

24 (4.8)

29 (5.9)

Upper respiratory tract infectionb

3 (0.6)

9 (1.8)

3 (0.6)

19 (3.9)

Vomitinga

2 (0.4)

4 (0.8)

16 (3.2)

Nasopharyngitisb

1 (0.2)

8 (1.6)

1 (0.2)

13 (2.6)

Abdominal pain upperb

0 (0.0)

1 (0.2)

3 (0.6)

10 (2.0)

Of the reported gastrointestinal adverse reactions, 1 subject experienced a serious adverse reaction of nausea and vomiting in OTEZLA 30 mg twice daily; 1 subject treated with OTEZLA 20 mg twice daily experienced a serious adverse reaction of diarrhea; 1 patient treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction of headache. b Of the reported adverse drug reactions none were serious. c n (%) indicates number of patients and percent.

Other adverse reactions reported in patients on OTEZLA were hypersensitivity, weight decrease, frequent bowel movement, gastroesophageal reflux disease, dyspepsia, decreased appetite*, migraine, cough, and rash. *1 patient treated with OTEZLA 30 mg twice daily experienced a serious adverse reaction. DRUG INTERACTIONS Strong CYP 450 Inducers: Apremilast exposure is decreased when OTEZLA is co-administered with strong CYP450 inducers (such as rifampin) and may result in loss of efficacy [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C : OTEZLA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to OTEZLA during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972. Nursing Mothers: It is not known whether OTEZLA or its metabolites are present in human milk. Because many drugs are present in human milk, caution should be exercised when OTEZLA is administered to a nursing woman. Pediatric use: The safety and effectiveness of OTEZLA in pediatric patients less than 18 years of age have not been established. Geriatric use: Of the 1493 patients who enrolled in Studies PsA-1, PsA-2, and PsA-3 a total of 146 psoriatic arthritis patients were 65 years of age and older, including 19 patients 75 years and older. No overall differences were observed in the safety profile of elderly patients ≥ 65 years of age and younger adult patients < 65 years of age in the clinical studies. Renal Impairment: OTEZLA pharmacokinetics were not characterized in subjects with mild (creatinine clearance of 60-89 mL per minute estimated by the Cockroft– Gault equation) or moderate (creatinine clearance of 30-59 mL per minute estimated by the Cockroft–Gault equation) renal impairment. The dose of OTEZLA should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft– Gault equation) [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]. Hepatic Impairment: Apremilast pharmacokinetics were characterized in subjects with moderate (Child Pugh B) and severe (Child Pugh C) hepatic impairment. No dose adjustment is necessary in these patients. OVERDOSAGE In case of overdose, patients should seek immediate medical help. Patients should be managed by symptomatic and supportive care should there be an overdose. Manufactured for: Celgene Corporation, Summit, NJ 07901 OTEZLA® is a registered trademarks of Celgene Corporation. Pat. www.celgene.com ©2014 Celgene Corporation, All Rights Reserved.

OTZPBS.001 03/14

In This Issue Value-Based Care in Integrating Rheumatologists, NPs/PAs, Practice Managers & Payers

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Director, Client Services Zach Ceretelle zceretelle@the-lynx-group.com Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Frederique H. Evans, MBS fevans@the-lynx-group.com Associate Editor Lara J. Lorton Copyeditor Hina Khaliq Editorial Assistant Cara Guglielmon Senior Production Manager Lynn Hamilton Production Manager Marie RS Borrelli THE LYNX GROUP President/CEO Brian Tyburski

VALUE PROPOSITIONS

RHEUMATOLOGY UPDATE

Behavioral therapy cost-effective in patients with fibromyalgia Kaiser Permanente implements value-based care/ payment model

HEALTH ECONOMICS

Neurologic symptoms of rheumatologic conditions elucidated Survey reveals drawbacks to participation in ACA exchanges Am I done clicking yet? Mourning the loss of the doctor–patient relationship

Shifts to value-based care and payment models improve quality of care

RHEUMATOID ARTHRITIS

PSORIATIC ARTHRITIS Psoriatic arthritis underdiagnosed, better screening needed Brodalumab shows positive results in phase 2 trial

Chief Operating Officer Pam Rattananont Ferris

GOUT

Vice President of Finance Andrea Kelly

Febuxostat safe and effective in elderly women with hyperuricemia

Human Resources Jennine Leale

ACR facilitates PQRS efforts Concomitant use of statins does not significantly impact the efficacy of rituximab RABBIT risk score a reliable tool for serious infections in patients with RA Sarilumab promising in patients with rheumatoid arthritis

PERSONALIZED MEDICINE in Rheumatology™

Autoantibodies in patients with RA could lead to more precise diagnosis, therapy

Associate Director, Content Strategy & Development John Welz Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs

VBCR Editorial Advisory Board

Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Alyson Bruni Jini Gopalaswamy Project Manager Deanna Martinez Project Coordinator Mike Kodada IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Administrative Coordinator Stephanie Ramadan Office Coordinator Robert Sorensen Engage Healthcare Communications, LLC 1249 South River Road, Ste 202A Cranbury, NJ 08512 Telephone: 732-992-1882 Fax: 732-992-1881

Value-Based Care in Rheumatology, ISSN (applied), is published 6 times a year by Engage Healthcare Com munications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2014 by Engage Health care Communications, LLC. All rights reserved. Value-Based Care in Rheumatology is a trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including pho tocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Print ed in the United States of America. The ideas and opinions expressed in Value-Based Care in Rheumatology do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an adver tisement or other product mentioned in Value-Based Care in Rheumatology should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication.

Howard B. Blumstein, MD Rheumatology Associates of Long Island, Smithtown, NY Scott Breidbart, MD Chief Medical Officer Empire BlueCross BlueShield New York, NY Sheree C. Carter, PhD, RN Assistant Clinical Professor The University of Alabama in Huntsville; President, Rheumatology Nurses Society

James T. Kenney, Jr, RPh, MBA Pharmacy Operations Manager Harvard Pilgrim Health Care Wellesley, MA

Lynn Nishida, RPh Director, Clinical Services Catamaran Center of Excellence Northwest Region, Portland, OR

Muhammad Asim Khan, MD Professor of Medicine Case Western Reserve University Cleveland, OH

Gary M. Owens, MD President, Gary Owens Associates Philadelphia, PA Kim A. Papp, MD, PhD Founder and President Probity Medical Research Waterloo, Ontario, Canada

John Kolstoe, MD Kolstoe Rheumatology Musculoskeletal Medicine East Lansing, MI

Gary R. Feldman, MD, FACR Private Practice, Pacific Rheumatology, Los Angeles, CA

Randall Krakauer, MD, FACP, FACR National Medical Director Medicare, Aetna, Princeton, NJ

Gary L. Johnson, MD, MS, MBA Regional Medical Director Humana, Inc, Madison, WI

Joel M. Kremer, MD Pfaff Family Professor of Medicine Albany Medical College Director of Research, Center for Rheumatology, Albany, NY

Atheer A. Kaddis, PharmD Vice President, Managed Markets Diplomat Specialty Pharmacy Swartz Creek, MI Shelly P. Kafka, MD, FACR Rheumatologist, Mountain State Rheumatology, Medical Director, Mountain State Clinical Research Clarksburg, WV Clinical Assistant Professor West Virginia University School of Medicine, Morgantown, WV

Jeffrey S. Peller, MD Practicing Rheumatologist Harbin Clinic/Rheumatology Rome, GA Edmund J. Pezalla, MD, MPH National Medical Director for Pharmacy Policy and Strategy Aetna, Hartford, CT

Alan Menter, MD Director, Baylor Psoriasis Research Center Dallas, TX Matthew Mitchell, PharmD, MBA Manager, Pharmacy Services SelectHealth, Murray, UT

William A. Sunshine, MD, FACR Rheumatology Practice Boca Raton & Delray Beach, FL Ronald van Vollenhoven, MD, PhD Associate Professor Karlinska University Hospital Solna Stockholm, Sweden F. Randy Vogenberg, RPh, PhD Principal, Institute of Integrated Healthcare, Greenville, SC

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Value-Based Care in Rheumatology provides a forum for payers, providers, and the entire rheumatology team to consider the cost-value issues particular to rheumatology treatments. This unique focus is achieved through news coverage from major rheumatology meetings and the rheumatic diseases literature, supplemented with commentaries and perspectives from those involved in evaluating therapies, treating patients, and paying for care. Contact Information: For subscription information please contact: Telephone: 732-992-1880 Fax: 732-992-1881. Permission requests to reprint all or part of any article published in this publication should be addressed to editorial@engagehc.com. Address all editorial queries to: editorial@engagehc.com. Telephone: 732-992-1882 Fax: 732-992-1881. POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Value-Based Care in Rheumatology, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

VOL. 3

NO. 5

OCTOBER 2014

www.ValueBasedRheumatology.com

Value Propositions Behavioral Therapy Cost-Effective in Patients with Fibromyalgia

Cognitive behavioral therapy may be beneficial for adult patients with fibromyalgia, according to recent findings. As part of a 6-month economic analysis that took place concurrently with a randomized controlled trial, investigators compared the cost-utility from the healthcare and societal perspectives of cognitive behavioral therapy versus recommended pharmacological treatments and usual care in patients with fibromyalgia. Overall, 168 patients with fibromyalgia from 41 general practices in Zaragoza, Spain, were included in the analysis: 57 patients were randomized to cognitive behavioral therapy, 56 patients to recommended pharmacological treatments, and 55 patients to usual care. The investigators found that the total costs per patient in the cognitive behavioral therapy group were significantly lower compared with patients in the recommended pharmacological treatments or the usual care groups. In addition, they observed that patients who received behavioral therapy had a higher quality of life based on quality-adjusted life-years and the EuroQoL visual analog scale. However, the difference between the groups was only significant for EuroQoL visual analog scores. “Due to lower costs, cognitive behavioral therapy is the most costeffective treatment for adult [fibromyalgia] patients,” according to the study authors. “Implementation in routine medical care would require policy makers to develop more widespread public access to trained and experienced therapists in group-based forms of cognitive behavioral therapy.” Luciano JV, et al. Arthritis Res Ther. 2014;16(5):451

Kaiser Permanente Implements Value-Based Care/ Payment Model

In an exclusive interview with FierceHealthPayer, Jack Cochran, MD, Executive Director of the Permanente Federation, discussed the benefits in implementing value-based care and a payment model at Kaiser Permanente, which represents a partnership between a healthcare delivery entity, hospitals, and the Kaiser health plan. “For our care to be value-based, we think of how many people we have to take care of, and then we figure how much it’ll cost….We think in terms of the entire package, the physicians and their staff, and decide how much we will need to expense them,” Dr Cochran said. The move toward value-based payment required an enhanced focus on data measurement across the entire health plan. Establishing tools to measure data and care transparency is crucial for improving outcomes, which, in turn, can reduce costs. “Doing the right thing will also be the best thing to make sure care is affordable,” he said. Kaiser has moved away from the fee-for-service model, in which providers are paid for each service rendered, and is moving to value-based payment (VBP). “At Kaiser Permanente, under a VBP model, we look at the process of care, which may not entail classically codeable events. We pay them [providers] for their intellect, not for what is just codeable,” Dr Cochran elaborated. He noted that avoiding misuse and errors will help to generate the savings in healthcare that everyone is concerned about. The quality of care must be the focus of healthcare for all, he said. “The entire industry needs to shift its focus on quality at a reasonable cost for families.” Dori Zweig, FierceHealthPayer; August 1, 2014 C

Health Economics

Shifts to Value-Based Care and Payment Models Are Improving Quality of Care

CMY

By Wayne Kuznar

lue Cross Blue Shield (BCBS) is implementing value-based care and payment models across the country to reward quality and improve outcomes, and these are amounting to billions of dollars in cost-savings and reduced hospitalizations. According to a company press release (“Blue Cross and Blue Shield companies direct more than $65 billion in medical spending to value-based care programs”; July 9, 2014), these programs “shift payment away from the fee-for-service model... to one that links reimbursement to the quality of care and improved patient outcomes.” These programs include accountable care organizations (ACOs), patientcentered medical homes (PCMHs), pay-for-performance programs, and episode-based payment programs. PCMHs Cut Healthcare Utilization According to 2013 data, practices participating in the BCBS PCMH program show a 19.1% lower hospital

admission rate; 8.8% and 17.7% lower emergency department visit rates for adults and children, respectively; and 7.3% lower use of high-tech radiology services. Data from 2012 from a PCMH program in New Jersey showed a 23% lower inpatient admissions rate, a 12% reduced emergency department visits rate, a 5% higher rate of improved control of diabetes, and a 3% higher rate of breast cancer screenings. In a PCMH pilot from Anthem, practices had 15% lower medical and pharmaceutical costs than in the control practices. In Connecticut, PCMH pilot practices had 18% and 29% fewer hospital admissions and readmissions, respectively, than nonparticipating practices. Similarly, in Colorado, 18% reduced hospital admissions and 15% fewer emergency department visits were reported compared with nonparticipant practices, according to a BCBS report (“Blue plans improving healthcare quality and affordability through innovative partnerships

VALUE-BASED CARE IN RHEUMATOLOGY

OCTOBER 2014

with clinicians”; February 13, 2014). ACOs Contribute to Cost-Savings BCBS’s ACO arrangements, which offer financial incentives for improvements in care, have seen similar success. BCBS of Illinois has a 4-year agreement with 10 hospitals in the Advocate Health Care. “This ACO is driving compelling quality and cost impact including a decline of 4.7 percent in the inpatient admission rate per 1000 for Advocate facilities versus an increase of 2.2 percent for the control facilities, a decline of 0.9 percent for length of stay for Advocate facilities versus an increase of 2.7 percent for the control facilities and better results for outpatient utilization,” according to BCBS. In Minnesota, BCBS has aligned with providers to transition from fee for service to performance incentives that are tied to measurable improvements in quality outcomes and to managing the total cost of care. In this “aligned incentive contracting,” BCBS

of Minnesota provides a riskadjusted per-member per-month payment along with an allowed trend for attributed members’ total cost of care. If the provider’s actual per-member per-month cost is below the target, the provider is eligible to receive a share of the savings. In 2011, 75% of the aligned incentive contracting providers earned incentives, and approximately $13 million in net savings against the expected claims costs were achieved. In Massachusetts, performance standards tied to nationally accepted quality standards are combined with a population-based global budget adjusted annually for health status and inflation in what is called an “alternative quality contract.” Practice pattern analyses are provided to participating physician groups to provide feedback to clinicians and to identify opportunities for improvement. An independent analysis showed that these contracts led to slower growth in medical spending—2% slower growth in 2009 and 3% slower growth in 2010. n VOL. 3

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Don’t Face the Maze of Changes in Rheumatology Alone

NORM Keeps You Informed National Organization of Rheumatology Managers

NORM’s mission is to provide rheumatology managers, administrators and managing physicians countless opportunities to network with colleagues through our listserv and annual conference. At NORM, our goals involve addressing, educating, distributing, and functioning as a conduit for rheumatologic practice management needs and expertise. “NORM, by far, surpasses the benefits of any other organization I have ever belonged to. Through the listserv, NORM members willingly assists each other by providing solutions to everyday issues that arise while managing a rheum practice. We share experiences, ideas, protocols and procedures specific to a rheumatology practice. The annual NORM conference in September is definitely the icing on the cake as we all come away with practical ideas and tools we can implement.” Mary Jo Wideman, RN, BSN, Practice Manager

Do you have questions about coding, biologics, insurance carrier denials or personnel issues? Join NORM to help find your answers. Are your questions state specific, MAC specific or national coverage issues? NORM offers rheumatology managers the opportunity to connect across the Nation. Through our listserv you receive expert advice from professionals in rheumatology! Join NORM and network with experienced managers through our listserv, gain access to our members only section which contains sample practice forms, job descriptions, and other documents that have been shared on this listserv, a list of our members, and in the future educational resources. NORM also hosts webinars throughout the year to continue supporting the education of our members. Membership is open to rheumatology professionals including physicians and those who hold a management position in a rheumatology practice.

Save the Date for our 2015 2014 Annual Conference September 12 18 & 13, 19, 2014 2015 ~ Louisville, Bellevue, WA KY

NORM ~ www.normgroup.org ~ info@normgroup.org

Ankylosing Spondylitis

Disease Activity Linked to Radiographic Progression... about the inhibition and progression of radiographic progression. In a recent study, researchers examined the long-term relationship between disease activity and radiographic spine progression in patients with AS and found that higher disease activity leads to more structural damage in the spine of these patients (Ramiro S, et al. Ann Rheum Dis. 2014;73:1455-1461). This is the first study to show that disease activity contributes longitudinally to the radiographic progression in the spine of patients with AS, according to Sofia Ramiro, MD, MSc, Department of

at a glance ➤ This is the first study to show that disease activity contributes longitudinally to radiographic progression in the spine of patients with AS ➤ ASDAS, which combines patient repeated outcomes and acute-phase response, offers a more ideal method to measure disease activity ➤ Disease activity had a stronger effect on radiographic progression in men than in women

Clinical Immunology & Rheumatology, Amsterdam Rheumatology Center, University of Amsterdam, the Netherlands, and colleagues. “The effect of disease activity on radiographic damage is stronger in men than in women, and in the earlier phases of the disease,” they added. Clinical and Radiographic Assessment Measurement of radiographic progression in patients with AS is a slow and difficult process that requires long-term patient follow-up and recurring assessments, according to the authors. Disease activity was measured with either acute-phase response or patient-reported outcomes, which have provided disparate results in previous studies. To circumvent these uncertain outcomes, Dr Ramiro and colleagues used a newly developed AS Disease Activity Index (ASDAS), which combines patient-reported outcomes and acute-phase response, and offers a more ideal method to measure disease activity. Using the Outcome in Ankylos ing Spondylitis International Study (OASIS)—a cohort study of patients with AS from the Netherlands, Belgium, and France—the study authors analyzed the clinical and radiographic assessments of 184 patients during the span of 12 years, at 2-year inter-

vals. Seventy percent of the patients were men, with a mean age of 43 years, and mean symptom duration of 20 years.

This is the first study to shown that disease activity is longitudinally associated with radiographic progression in AS. —Sofia Ramiro, MD, MSc, and colleagues

Investigators blinded to clinical and demographic data scored radiographs using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Disease activity measures included the Bath AS Disease Activity Index and ASDAS-C-reactive protein. On average, patients at baseline had an ASDAS of 2.6 with an increase of 1.9 mSASSS units every 2 years. For every ASDAS unit increase, a progression of 0.72 mSASSS units can be expected during the course of 2 years, the study authors found. Patients with very high activity disease states (ASDAS >3.5) had an additional 2-year progression of 2.3 mSASSS units compared with pa-

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tients with inactive disease states (ASDAS <1.3). Gender Disparity and Disease Duration Disease activity was shown to have a stronger effect on radiographic progression in men than in women. At each 2-year interval, approximately 1 mSASSS of additional progression was seen in male patients using the ASDAS. However, the authors note that less than a third of the patients included in the study were women, most of whom had little structural progression. Dr Ramiro and colleagues also found that disease activity had a stronger impact on radiographic progression in the earlier phases of AS (patients with <18 years of symptom duration). This may be attributed to the increased likelihood of patients doing vigorous exercises more often in the early phases of the disease compared with the later phases, although more data are needed, the authors noted. “The biggest challenge for the near future will…be to design a clinical study that takes all these different aspects into consideration,” Dr Ramiro and colleagues concluded. “The next question will be whether lower disease activity by drugs with various modes of action will result into less radiographic damage.” n

OSTEOPOROSIS

Better Osteoporosis Screening Needed... that their 10-year MOF risk is greater than 9.3%. However, the analysis of data from 62,492 participants aged 50

at a glance ➤ Women younger than 65 years should be screened for osteoporosis if their FRAX score shows that their 10-year MOF risk is greater than 9.3% ➤ Data demonstrated that the US Task Force screening strategy had a sensitivity of only 25.8% for identifying women with incident MOF ➤ Further research is warranted to analyze data from falls in the WHI study

to 64 years in the Women’s Health Initiative (WHI) Observational Study and Clinical Trial showed that this strategy had a sensitivity of only 25.8% for identifying women with incident MOFs. The sensitivity was lower still— 4.7%—among women in the 50 to 54 age-group. The sensitivity of the Osteoporosis Self-Assessment Tool (OST) and the Simple Calculated Osteoporosis Risk Estimation (SCORE) in women aged 50 to 54 years was also low (18.5% and 22.9%, respectively). “What that means is that for all 3 of these tools, in these younger women, they are no better than flipping a coin in identifying who is going to have a fracture in the next 10 years,” lead investigator Carolyn J. Crandall, MD, MS, told Value-Based Care in Rheumatology. “We can’t know for sure what

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those risk factors are that aren’t in the tools,” she added. “The FRAX tool contains almost all known fracture-risk factors. So one potential factor we thought of was maybe they’re very vigorous and they’re falling— FRAX doesn’t capture falls.” Dr Crandall, Professor of Medicine, David Geffen School of Medicine, University of California Los Angeles, and colleagues focused on data from the WHI between 1993 and 2008. The women included in their analysis were postmenopausal and were not taking osteoporosis medicine. Patients who were taking hormone replacement therapy were not excluded, according to the researchers. The results indicated that the sensitivity of the strategy of the US Task Force, OST, and SCORE using baseline values for predicting the 10-year

observed incidence of MOF of the spine, hip, forearm, and shoulder was relatively low. The overall sensitivity was 25.8% for the US Task Force strategy, 38.6% for SCORE, and 30.8% for OST. For women aged 50 to 54 years, it was 4.7%, 18.5%, and 22.9%, respectively. The specificity was relatively high for women overall, at 83.3% for the US Task Force, 65.8% for SCORE, and 66.7% for OST. When the researchers adjusted the positive-result thresholds for each of the 3 strategies they found that the sensitivity increased but the specificity decreased. “The next steps are going to be looking at the falls data from the WHI study,” Dr Crandall said. “We’re also going to try to think of what else may be increasing fracture risk. It could be something dietary, it’s possible.” n VOL. 3

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Psoriatic Arthritis

Psoriatic Arthritis Underdiagnosed, Better Screening Needed By Rosemary Frei, MSc

ixteen experts from across Europe and the United States have issued a series of recommendations based on a Psoriatic Arthritis Forum consensus meeting held in October 2013. They are intended to provide guidance on improving the accuracy and efficiency of diagnosis and overall patient care (Arthritis Care Res (Hoboken). 2014; July 21 [Epub ahead of print]). Treatment Algorithm Philip Helliwell, MD, PhD, National Institute for Health Research Leeds Musculoskeletal Biomedical Research Unit, University of Leeds, United Kingdom, was the lead author of the consensus document. He told Val-

at a glance ➤ Two of the most urgent issues are the need to improve screening for PsA and independently analyze current treatment algorithms ➤ The creation of multidisciplinary clinics where dermatologists and rheumatologists work together may significantly increase PsA detection and referral ➤ Several steps need to be taken to develop and validate an up-to-date PsA treatment algorithm

ue-Based Care in Rheumatology that the attendees agreed that 2 of the most urgent issues are the need to improve screening for psoriatic arthritis (PsA) and independently analyze current treatment algorithms. “There are algorithms on biologics and non-biologics now but there’s no evidence for any of it, especially the non-biologics,” Dr Helliwell said in a telephone interview. “And treatment sequencing and fitting treatment to phenotype—most of it—is based on grade D, poor-quality evidence.” He and his colleagues noted that most cases of PsA likely go undiagnosed; for example, a recent study undertaken in the United Kingdom showed that 13.8% of psoriasis patients had PsA and that two-thirds of these cases had not been previously diagnosed (Ibrahim G, et al. Arthritis Rheum. 2009;61:1373-1378). The forum members also observed that information was presented last year on a new screening tool that may be more accurate than any of the other currently used screening instruments (Coates LC, et al. EULAR 2013 Abstract #SA0265). The CONTEST questionnaire is composed of 13 yes/no questions. The creators of the tool determined that using a cutpoint of 4 positive responses has an 86% sensitivity and a 35.4% specificity while a cutpoint of 5 "yes" responses has an 82% sensitivity and a 52.3% specificity. The results in 2 validation cohorts produced mixed results: one in Dublin demonstrated 37.9% and 20.7%

“It’s a matter of trying to raise awareness.” —Philip Helliwell, MD, PhD

sensitivity, respectively, and 88.7% and 98.6% specificity, respectively. The other study, in Utah, had 70.2% and 54.8% sensitivity, respectively, and 61.7% and 77.8% specificity, respectively. Multidisciplinary Approach to Care The creation of multidisciplinary clinics in which dermatologists and rheumatologists work together may also significantly increase PsA detection and referral, the consensus group concluded. In addition, complementary approaches will likely be helpful, including developing more education programs on PsA for dermatologists and family physicians, and creating

clearer criteria for referral to dermatologists of people who are likely to have PsA. Increased education of psoriasis patients is also important, the group noted, including providing information on the potentially significant impact of PsA on patients’ quality of life. Moreover, communication can be improved between healthcare providers and patients to ensure they discuss and come to an agreement about the expectations from treatment. “It’s a matter of trying to raise awareness,” said Dr Helliwell. “[In addition] we don’t know who should be seen—we know people with PsA can become severely disabled, but we don’t know who those high-risk patients are.” Furthermore, he and his colleagues agreed that several steps need to be taken to develop and validate an upto-date PsA treatment algorithm, including defining accurate indicators of treatment response, remission and need for treatment change/titration, and clarifying what patients, physicians, and regulatory bodies define as treatment success. Another as yet unmet need is validating a composite index that integrates both physicianand patient-oriented outcomes. The forum members are now investigating several composite outcome measures, including the PsA Disease Activity Score, GRACE Index, PsA Joint Activity Index, Composite Psoriatic Arthritis Disease Activity Index, and the PsA Impact of Disease scale. n

Brodalumab Shows Positive Results in Phase 2 Trial By Phoebe Starr Paris, France—Brodalumab improved the signs and symptoms of psoriatic arthritis (PsA) at week 12, week 24, and week 52, according to results of a phase 2 trial and an open-label extension of that trial. The phase 2 results were presented at the 2014 European League Against Rheumatism Congress and published online in the New England Journal of Medicine (N Engl J Med. Mease PI, et al. 2014;370:2295-2306). Symptom Improvements Sustained The positive results for brodalu VOL. 3

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mab, an interleukin-17 receptor inhibitor, come on the heels of positive results from the AMAGINE-1, a phase 3 study showing significant improvement in moderate to severe plaque psoriasis. The phase 2 study presented focused on the joint symptoms of PsA. Overall, treatment with brodalu mab significantly improved tender and swollen joints at 12 weeks by at least 20% as measured by the American College of Rheumatology criteria (ACR20). Many patients continued to improve, and improvements were

sustained through the first 52 weeks of the study. “We are encouraged that treatment with brodalumab significantly reduced clinical signs and joint symptoms compared to placebo and that similar degrees of disease improvement were seen in biologic-treated and biologic-naïve patients with psoriatic arthritis,” stated lead author Philip J. Mease, MD, from the Swedish Medical Center and University of Washington in Seattle. The results of the phase 2 trial add to the growing body of evidence supporting the inOCTOBER 2014

terleukin-17 receptor as a promising target for the treatment of patients with PsA and other inflammatory diseases, he added. Adverse Events Similar Across Groups In this phase 2, randomized, double-blind, placebo-controlled trial, the investigators randomized 168 patients with active PsA (defined as ≥3 tender and ≥3 swollen joints) to 1 of 3 treatment arms: brodalumab 140 mg subcutaneously, brodalumab 280 mg subcutaneously, or placebo at day 1 and Continued on page 10

www.ValueBasedRheumatology.com

Gout

Febuxostat Safe and Effective in Elderly Women with Hyperuricemia By E. K. Charles

lthough the efficacy of febuxostat has been shown in el derly patients, its efficacy is unclear in elderly women with hyperuricemia. To ascertain the safety and efficacy of febuxostat in elderly women with hyperuricemia, Tomohiro Mizuno, Meijo University, Nagoya, Japan, and colleagues conducted a retrospective cohort of Japanese women 65 years and older treated with febuxostat between January 2012 and December 2013. The data originated from the electronic records of the Fujita Health University Hospital. Treatment goal was the primary

at a glance ➤ Mean time to achieving the treatment goal was 53 days in elderly women compared with 71 days in elderly men ➤ Approximately 9% of men and 17% of women had adverse events

end point of the study, which was defined as reaching a serum urate level of ≤6.0 mg/dL within 16 weeks. Secondary end points included the occurrence of adverse events with a focus on leukopenia hepatic disorder, thrombocytopenia, and anemia. Criteria for exclusion were patients on hemodialysis or peritoneal dialysis, patients on anticancer therapy or immunosuppressants, as well as patients with a baseline serum urate level <7.0 mg/dL, and patients who did not have their serum urate level measured within the study time frame. Overall, 82 patients were included in the analysis and divided into 2 groups based on sex (men, n = 53; women, n = 29). The mean ages of the patients were 75 years and 78 years, in men and women, respectively. The study authors noted that the mean body weight and body surface area of women in the study group were significantly lower than those of men. Among women, the investigators found that the mean time to achieving the treatment goal was 53 days, which

was significantly shorter than their male counterparts, who had a mean time to treatment goal of 71 days. In

These findings suggest that the efficacy of febuxostat in elderly female patients is superior to that in elderly male patients and that the safety is equivalent. —Tomohiro Mizuno, and colleagues

terms of adverse events, 9.4% of men and 17.2% of women had adverse events. In particular, 3.8% of men had leukemia, 3.8% hepatic disorder, 1.9% thrombocytopenia, and 5.7% anemia. Alternatively, 3.4% had leukopenia, 6.9% hepatic disorder, 3.4% thrombocytopenia, and 3.4% anemia. The occurrence of adverse events was not significantly higher in one group over the other.

“The dose of febuxostat commonly prescribed in Japan (10-20 mg/day) is lower than that prescribed in other countries, and there was a time lag preceding the drug’s introduction in Japan,” according to the study authors. “Although achievement of the treatment goal was difficult in patients with renal impairment, more than 70% of the female patients achieved serum urate levels of 6.0 mg/dL or less within 16 weeks.” Citing previous research, the investigators discuss other data indicating that age or sex did not have a clinically significant effect on the pharmacokinetics, pharmacodynamics, or safety of febuxostat, and noted that these data are not consistent with the results of their current study. However, according to their literature search, several reports support their finding that the efficacy of febuxostat increases in a dose-dependent manner. More data are needed to establish the pharmacodynamics of febuxostat in elderly patients, according to the study authors. n

Psoriatic Arthritis

Brodalumab Shows Positive... weeks 1, 2, 4, 6, 8, and 10. At week 12, all patients were offered open-label brodalumab 280 mg every 2 weeks; 156 patients entered the open-label phase. Fifty-one percent of patients were previously treated with biologics and 49% were biologic-naїve. At 12 weeks, ACR20 was achieved by 37%, 39%, versus 18% of patients treated with brodalumab 140 mg, brodalumab 180 mg, versus placebo, respectively (P = .03 and P = .02, respectively, compared with placebo). During the open-label phase of the study, improvements seen with brodalumab were sustained. At 24 weeks, ACR20 was achieved in 51% of patients treated with the 140-mg dose in the first 12 weeks, in 64% of patients who received the 280-mg dose in the first 12 weeks, and in 44% of patients randomized to placebo for the first 12 weeks. These responses were maintained through 52 weeks.

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Setting a higher bar, Dr Mease and colleagues evaluated at least a 50% response according to ACR50 and at

weeks were not significantly higher in brodalumab-treated patients. At week 24, ACR50 was reported in 33%

“We are encouraged that treatment with brodalumab significantly reduced clinical signs and joint symptoms compared to placebo.” —Philip J. Mease, MD

least a 70% response according to ACR70, and found that brodalumab was superior to placebo at 12 weeks. ACR50 was achieved by 14% in both brodalumab dosing groups compared with 4% of patients in the placebo group. ACR70 responses at 12

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of patients treated with both brodalumab doses during the first 12 weeks versus 20% of placebo patients switched to brodalumab 280 mg at 12 weeks. Adverse events were similar across all treatment groups. Adverse events

at a glance ➤ Brodalumab therapy led to significantly reduced clinical signs and joint symptoms compared with placebo ➤ Disease improvement was similar in biologic-treated and biologic-naïve patients with PsA ➤ The interleukin-17 receptor may be a promising target for the treatment of patients with PsA and other inflammatory diseases seen more frequently with brodalu mab included upper respiratory tract infections (12% vs 7% for placebo), diarrhea (6% vs 4%, respectively), and headache (6% vs 7%, respectively). Brodalumab is in phase 3 testing for PsA and in moderate to severe plaque psoriasis. The drug is in phase 2 testing for asthma. n VOL. 3

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Center Profile

Patient Care, Research, and Education Are the Pillars... 7 clinical faculty members who provide patient care. In addition, basic science faculty within the division work on translational research projects. There is a large staff of research coordinators and data managers, as well as Rheumatology fellows and residents in training from the Department of Medicine. The Arthritis Center is structured to follow the Johns Hopkins tripartite mission: clinical care, cutting-edge research, and education for patients and healthcare providers. The clinical focus is care for patients with inflammatory forms of arthritis, particularly rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankyl osing spondylitis and other spondyloarthropathies. The Arthritis Center is one of several disease-specific centers within the Johns Hopkins Division of Rheumatology. “It is a model that has been in existence since 1999,” Dr Bingham explained. “It has been very successful in facilitating patient care in integrated clinical and translation research activities that have allowed considerable discovery to take place in understanding the etiology and pathogenesis, advancing new treatments, and improving outcomes for patients with various rheumatic diseases.” Other specialty centers in the Division of Rheumatology include scleroderma, lupus, myositis, vasculitis, and Sjögren’s syndrome. Current research under way includes evaluating disease etiology and pathogenesis, and trying to develop both diagnostic and prognostic biomarkers. Advanced imaging methodologies and techniques to visualize rheumatic diseases are also being evaluated, as well as incorporating these techniques into patient assessment and clinical care decision-making. “We have considerable work, ongoing, related to patient-reported outcomes, how to improve the assessment of the patient’s experience of disease, and understanding the experience of people affected with these forms of arthritis, so that we can identify what aspects of disease we are not adequately treating with our current therapies,” Dr Bingham added. Other ongoing research is geared toward better informing other physicians of optimal treatment algorithms and strategies for care, as well as research on comorbidities related to rheumatic diseases. Another integral part of the Arthritis Center is the education of patients and healthcare providers. In particular, visiting fellows and medical residents are welcomed from other instiVOL. 3

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tutions and other departments. Johns Hopkins also works actively to inform other practitioners and healthcare providers on best practices for the treatment of rheumatic diseases. Patients are encouraged to participate in real shared decision-making. To that end, patients are provided with written materials, web-based information, as well as one-on-one instruction and counseling on rheumatic diseases. What services do you provide at the Johns Hopkins Arthritis Center? Clifton O. Bingham III (COB): As a tertiary center, we see a lot of referrals coming from other rheumatologists for people who may have more advanced or refractory disease. We also have a very large primary care network of referring physicians, for whom we are the primary rheumatol-

that we use and their potential consequences on our patients. What is the approach to care? COB: We review prior patient records at the time of the visit or, ideally, before the visit if they are available. We conduct comprehensive initial evaluations for all patients and order additional testing and referrals as may be required. One of the things that we’re very careful about is trying to capture accurate information regarding histories of immunization to prior infections and infection risk. These have considerable impact on potential treatment decisions that we may make. Also, we document the presence of, or risk factors for, comorbid conditions that may also affect risk or choices of therapy. An important part of our approach

One of the other services that we are able to provide as part of Johns Hopkins is referral to other specialists who have specific expertise in the treatment of people with rheumatic diseases. —Clifton O. Bingham III, MD

ogist and the first rheumatologist that they see. This mix of patients potentially leads to different approaches, but in general, we provide comprehensive evaluation and management for patients with inflammatory arthritis. In addition to comprehensive disease evaluation, we try to educate patients and avail them of resources regarding their disease and therapies. We also offer patients opportunities to participate in various research programs that we have going, which allows us to use their clinical data in registries and databases, and to collect blood from them so that we can better understand these diseases. One of the other services that we are able to provide as part of Johns Hopkins is referral to other specialists who have specific expertise in the treatment of people with rheumatic diseases. We specifically work, for instance, with pulmonologists, who only take care of patients with connective tissue disease–related lung disease. We are thus able to comanage our patients with multisystem manifestations with physicians who are very aware of the types of therapies

to care is the standardized collection of common clinical data at the time of every visit for all patients seen in the clinic, including those in our registries as well as those who are not participating in research. We believe that the systematic collection of clinical data is essential to providing optimal care. This type of information includes clinical variables, detailed counting of all joints that are swollen and tender, documentation of extraarticular manifestations of disease, and routine review of radiographic studies. In addition to the care provided by the physicians, we also actively integrate nursing within the care of patients. With newly diagnosed patients, we are able to provide additional visits to meet with one of our nurses for disease education. For patients who are starting any new type of immunomodulatory therapies, especially biologicals, we try to arrange for an educational nursing session as well to familiarize them with the medications prescribed, their potential side effects and necessary monitoring, and warning signs of infection so that patients are well informed before starting their medicines. OCTOBER 2014

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How does this approach to care translate to better outcomes? COB: The routine collection of data allows us to adhere to the treat-to-target approaches that have been advocated and recommended for people with rheumatic diseases. We do think that by increasing the education of patients and adequately answering their individual questions and concerns, we are able to optimize treat-to-target approaches. This additional education also improves our ability to engage patients in vigilant infection monitoring and communication regarding their medicines and monitoring back to their primary physicians. We also are very available for patients via both the electronic medical record system portal for communication related to specific concerns about disease. The proof of the impact of our approach to care is seen when we look at our patient population, in terms of those who participate in research. We’ve really seen a shift over time, to where most of our patients are at the target of therapy of low disease activity and in remission. That proportion continues to increase over time. These data confirm the underlying treat-totarget principle: when you use your collect clinical data to guide your decisions, in fact, people do better. What advice would you give to physicians considering referring a patient to your center? COB: We’re very happy to provide second opinions for patients and/or help other rheumatologists to manage their patients. Often we can confidently tell patients that their rheumatologists are doing the right thing and doing a great job. Sometimes patients just need that reassurance. We also get referred a lot of very tough cases of patients who did not respond to traditional management, and we also see many patients who present with unusual features that raise a diagnostic question where a referring doctor just wants our opinion on it. When we are seeing patients who come from other rheumatologists, we send back our recommendations based on what we’ve found. In some circumstances, this turns out to be a one-time visit; at other times we will comanage patients with their local rheumatologist. The most important thing for the physicians who are referring us is to provide us with as much information as possible, in terms of prior imaging, laboratories, and specific questions to be answered. Continued on page 18

www.ValueBasedRheumatology.com

Center Profile

Patient Care, Research, and Education Are the Pillars...

Continued from page 17

What is the biggest challenge you face in your profession? COB: As a specialty, rheumatologists face an ever-increasing body of information regarding pathogenesis of our diseases that has driven the availability of new therapeutic options targeting different mechanisms of disease. It can be a challenge to keep up with the pace of discovery and therapeutics, especially for people who are not as familiar with immunology. I think that is an area where, as a specialty, we will only see continued growth in that direction. The necessity of maintaining understanding of immunologic mechanisms will be critically important to informing doctors which medications to choose for individual patients. I think this is going to become even more important over time, as we try to understand better, based on molecular phenotyping, which patients are most likely to respond to a given therapy. Right now, a challenge for us in the care of RA and PsA is trying to figure out a way that we can identify early which patients will be a responder to a particular therapy or class of agents, such as a tumor necrosis factor inhibitor, an interleukin-6 inhibitor, a costimulatory blocker, a B-cell inhibitor, or a kinase blocker. If we could improve our ability to do that phenotyping, and understanding who would be a responder, or how we can look for those patients, it would save patients a lot of trial and error, which is still, unfortunately, what we’re left

with in the care of people with RA. I think that’s a scientific challenge, as new therapies move along. I do think that this issue of deciding what is best for individual patients and the lack of specific biomarkers is a great challenge for this specialty. Defining what are the optimal pathways or optimal strategies and combinations or sequences of treatment is also a great challenge, where again, we’re using trial and error now. Issues related to access and cost of biological therapies is a growing challenge for the care of people with rheumatic diseases. It is incontrovertible that biologics and the advent of more aggressive therapeutic strategies, earlier aggressive interventions, and the use of biological therapies have really revolutionized our specialty. It has completely changed the expectations for people and for physicians, especially in RA and PsA. Having the ability to use these medications in an appropriate manner and without challenge from payers is increasingly problematic for us to provide optimal care. One problem is that most treatment guidelines are based on data from clinical trials, but people who participate in clinical trials are not like the people who are seen in clinical practice in terms of disease severity and comorbidities that greatly influence treatment decisions. Issues related to access and cost continue to be problematic. The cost of biologics, unfortunately, has not come down over time. Newer oral agents have not come in at a lower price point, which is also problematic. There’s no doubt that we preserve physical function and keep people employed, but the cost can become prohibitive for patients, especially regarding copays. Tiered pricing on biological agents can result in the drug that the patient really needs being priced out of their possibility for use— those are certainly challenges that we will continue to face.

How has the specialty changed since you first joined the profession? COB: When I started in rheumatology, we had very few therapies and we were just beginning to use methotrexate as a primary therapy for people with RA. Our waiting rooms were filled with people in wheelchairs with severe disability. Our discussions were often centered around appropriate times for referral for patients for joint replacements and synovectomies. That’s not at all the case anymore. We’ve evolved to a point where methotrexate is the baseline therapy for patients, aggressively dosed, and rapidly supplemented with other agents. We had numerous mechanisms of action of drugs—all of which have improved outcomes for this disease or have afforded the opportunity for greatly improved outcomes and expectations for people—to the point that we just don’t see the type of disease that we did when I was a trainee. The types of extraarticular manifestations that we saw then are becoming so vanishingly rare that fellows could potentially leave the training programs having never seen severe rheumatoid vasculitis or severe RA ocular diseases such as scleromalacia. I think that is pretty good evidence that better control of inflammation with biological and more aggressive therapeutic regimens have made that possible. The availability of therapies that are mechanism-based treatments, and the fact that that’s moved beyond RA to PsA, spondylitis, and now into lupus and vasculitis, is really, I think, strong evidence of how far we’ve come in understanding the diseases that enable targeted therapies. What advice would you give to a rheumatologist just starting out today? COB: I see rheumatology as one of the most exciting specialties in medicine. Not only because of the spectrum of diseases that we take care of, but real-

ly, the fact that the bench-to-bedside approach is really yielding advances that are probably unlike those in any other specialty of medicine. Targeted therapies, based on specific mechanisms related to disease, are now the norm. Rheumatology is a great field with tremendous opportunity and reward now and for the future. As we have moved forward with real goals of achieving remission for more and more people with RA, I look forward to the time that this will be the expectation for many of our other diseases, as new therapies come along. What key opportunities lie ahead in the field of rheumatology? COB: I think we have a challenge, as well as an opportunity, in continuing to inform the general public of the potential, devastating consequences of rheumatic diseases and the importance of funding research into these diseases. While I look at RA as a disease where we have accomplished a tremendous amount, we still have conditions like osteoarthritis, where we have no treatment to slow down the progression of disease. As we look at the funding that goes into medical research in the United States, through the National Institutes of Health, the proportional amount that is spent on common musculoskeletal conditions is fractional in comparison to other diseases that are less common and that don’t have the same impact on our gross domestic product. There is a great opportunity for rheumatologists and people affected with rheumatic diseases to advocate for these conditions and their consequences and impact to increase research funding. Without increased funding the ability to make the types of advances that have been made in the RA arena with our other, less common rheumatic diseases, and even with the most common musculoskeletal conditions, like osteoarthritis, will remain limited. n

TAKE ACTION: Get Your Rheumatology Center Profiled We are interested in interviewing medical directors from rheumatology centers around the country. It is an easy process—a short phone interview and submit some photos of your center and staff.

VBCR_TakeAction101514

It’s also very important for us, if people are coming in with refractory disease, to understand what drugs they previously received, what dosages and for how long, and whether there were complications from these medications. The history that we obtain from patients is often inadequate in that regard, so providers can be very helpful in providing us with accurate information for that.

Contact Frederique Evans, Editorial Director, fevans@the-lynx-group.com, for more information.

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The Rheumatology Nurse

™

Joining the Race to Rheumatology: RNS Conference... rheumatology patient across the life span.1 The RNS identified 5 key elements serving as the basis of education, ensuring that session content was focused on the latest in the standards of care in rheumatology nursing. These 5 elements were: essentials, evaluations, efficiencies, evidences, and engagements.1 Essentials The essentials of rheumatology nursing include differentiating between rheumatic disease diagnoses, understanding common biologic and disease-modifying medications, and demonstrating comprehensive assessments of rheumatology patients during their life span. By taking it back to the basics of immunology and pharmacology, novice nurses and experienced practitioners alike gained exposure to new perspectives on delivery of care. Topics included rheumatology 101, pharmacology updates, intravenous techniques, basic immunology, rheumatic disease in the pediatric population, and coding with the International Classification of Diseases, Tenth Edition (ICD 10). In one session, Christine Stamatos, RN, DNP-C, Long Island Regional Arthritis and Osteoporosis Care, Inc, Babylon, NY, reviewed the latest staggering financial costs associated with

rheumatic diseases. Citing data from Ong and colleagues,2 and Aletaha and colleagues,3 she pointed to a 53% increase in the cost of treatment for rheumatic disease in the past decade.

Johns Hopkins Myositis Center, Baltimore, MD, discussed myositis and related inflammatory myopathies. Dermatomyositis, which was once thought of as polymyositis with a

Rheumatology nurses gained clinical exposure through case studies, diagnostic parameters, and explanation of current treatments. —Deanna L. Owens, MSN, RN

Since the time of these studies, this figure equates to $377 billion in direct and indirect costs for an average of 16 workdays missed for individuals suffering with rheumatic diseases. This rise in the cost of care for chronic rheumatic diseases is more than diabetes, heart disease, and cancer combined in the United States. Evaluations The evaluation sessions introduced recent developments in science and evidence-based research, which, along with essential rheumatology-specific skills, improve long-term outcomes for patients with rheumatic conditions. In particular, Lisa ChristopherStine, MD, MPH, Co-Director of The

rash, has very specific criteria for diagnosis, she explained during a presentation. Using Bohan and Peter Diagnostic Criteria for Polymyositis/ Dermatomyositis,4 the following 5 criteria can be used for diagnosis: • Symmetric proximal muscle weakness • Elevated muscle enzymes (ie, creatinine phosphokinase, aldolase, transaminases, lactate dehydrogenase) • Myopathic electromyography abnormalities • Typical changes on muscle biopsy • Rash typical of dermatomyositis Polymyositis is a definite diagnosis if patients meet 4 of 5 criteria; a probable diagnosis is given if a patient meets 3 of 5 criteria. Dermatomyositis

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is diagnosed as definite with a rash and 3/4 criteria; probable with a rash and 2/4 criteria. Dr Christopher-Stein further explained that skin lesions in dermatomyositis may precede myopathy or persist well after the myositis is quiescent. Furthermore, the course of skin lesions does not always parallel that of muscle disease. In addition, rheumatology nurses gained clinical exposure through case studies, diagnostic parameters, and explanation of current treatments. Efficiencies The Affordable Care Act (ACA) has been a hot topic of discussion among providers across the country anticipating the decisions it will lead to in healthcare facilities. Angela Golden, DNP, FNP-C, FAANP, mesmerized attendees in a presentation about the ACA and discussed the importance of the closing of the gap for Part D and how it will affect medications, especially biologic treatments, and lead to a potential decrease in outpatient diagnostic treatments, and rheumatology radiologic services. Nurses were also reminded of the Institute of Medicine’s 2010 report, "The Future of Nursing: Leading Change, Advancing Health,"5 where it is stated that nurses should work with all others to redesign healthcare in the United States. Continued on page 20

Rheumatology Update

Neurologic Symptoms of Rheumatologic Conditions Elucidated By Rosemary Frei, MSc

brief review of the neurologic al symptoms occurring in people with rheumatologic diagnoses seeks to assist clinicians in differentially diagnosing conditions (Curr Neurol Neurosci Rep. 2014;14:456469). In the article, Amre Nouh, MD, Department of Neurology, Loyola University Medical Center, Maywood, IL, and colleagues, also discuss ways to distinguish between neurotoxicity from medications used to treat rheumatic disease and neurologic manifestations of rheumatologic conditions. Rheumatologic diseases and some of their treatments can involve many

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parts of the nervous system ranging from the meninges to the peripheral nervous system, according to the study authors. Neurologic symptoms may even be the presenting feature of some rheumatologic conditions. “The neurologic manifestations of rheumatic disorders and their treatments are some of the most challenging conditions to diagnose,” Sean Ruland, DO, Associate Professor and Medical Director, Neuroscience Intensive Care Unit, Department of Neurology, Loyola University Chicago, Stritch School of Medicine, and senior author of the review, told Value-Based Care in Rheumatology.

Neurologic Signs and Symptoms Among the rheumatologic conditions that are frequently accompanied by neurologic symptoms is systemic lupus erythematosus (SLE), they explained. Central nervous symptom manifestations are the presenting feature in approximately one-quarter of SLE patients, according to one study they cited (Joseph FG, et al. Neurology. 2007;69:644-654). Moreover, more than half of SLE patients have headaches, up to 15% have recurrent seizures, and 10% to 20% have mood disorders. Dr Ruland and colleagues also described the neurologic symptoms that OCTOBER 2014

at a glance ➤ Rheumatologic diseases and some of their treatments can involve many parts of the nervous system ranging from the meninges to the their peripheral nervous system ➤ Serious neurologic complicat ions can result from the use of immunosuppressive therapies can be present in patients with rheumatoid arthritis, Sjögren’s syndrome, scleroderma, immunoglobulin-4–related disorders, idiopathic inflammaContinued on page 20

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The Rheumatology Nurse

™

Joining the Race to Rheumatology: RNS... Nurses were provided with additional resources for their role as patient advocates in response to changes in insurance plan benefits and limitations. Evidences Nurses also had the opportunity to attend a poster session focused on research projects specific to nursing. patient-focused topics, including interventions linking exercise efficacy and fatigue in the osteoarthritis population, to presentations centered on establishing the role of the rheumatology registered nurse. A study led by Iris Zink, NP, President-Elect and Conference Committee Chair, RNS, presented a case series evaluating oral versus subcutaneous methotrexate (MTX) in the treatment of patients with rheumatoid arthritis (RA) and a gastric bypass. Three patients in the study were successfully switched to subcutaneous MTX and 2 were given alternative treatments because they refused subcutaneous MTX. Five of 6 patients with RA in this case series needed to discontinue oral MTX associated with intolerance and inefficacy. More research is needed in this area of study. Engagements In addition to promoting research,

the conference took networking a step further this year by designating a section specifically to interaction, tying in the element of engagement. Rheumatology nurses from across the globe used this session as an opportunity for collegial exchanges and collaborations across specialties, including advanced practitioners, infusion nurses, and nurses beginning their career in rheumatology. In addition, a clinical skill-building session allowed nurses to observe and practice how to perform joint counts while other presentations encouraged promotion of self-management for pain. Ms Zink provided the attendees with some very frank talk about intimacy and chronic illness, an often overlooked and sometimes uncomfortable topic to approach in practice. Ms Zink reminded attendees that it is imperative for patients to maintain a healthy intimate relationship, especially when under the constraints of chronic rheumatic diseases. Specific exercises to recommend and knowledge of resources were highlighted in order to care for patients holistically and respectfully. Some areas of practice can benefit from referrals to the American Association of Sexuality Educators Counselors and Therapists6 or recommendation of books such as The Ultimate Guide to Sex and Disability: For All of Us Who Live with

Continued from the page 19

Disabilities, Chronic Pain, and Illness.7 Conclusion With rheumatology nursing first gaining recognition as a specialty in 2012 and the publication of the Scope and Standards of Practice in 2013, the RNS is gaining momentum. This year’s drive delivers the exciting announcement that the RNS has partnered with the American Nurses Credentialing Center (ANCC) to develop a certification process by portfolio. The credentialing process encourages nurses to build a compilation of their career accomplishments, knowledge, and abilities, leading to recognition as an expert in the field of rheu matology nursing. In addition to partnering with the ANCC, the RNS released a projected publication date for the Rheumatology Core Curriculum— the end of this year. This textbook is authored by expert rheumatology nurses expanding on the diagnosis and unique delivery of care to both pediatric and adult rheumatology patients. Furthermore, the publication of the Rheumatology Core Curriculum will serve as a valuable resource for nurses preparing for portfolio certification. The “Race to Rheumatology” came to a close with an exciting invitation to next year’s conference, which is being

held August 6-8 in Orlando, FL, and calls for all nurses to Dive Deep into Rheumatology in 2015.8 n Ms Owens is Director, Infusion and Clinical Services, Low Country Rheumatology, Charleston, SC; and Member, Board of Directors, Rheumatology Nurses Society; Dr Carter is Assistant Clinical Professor, The University of Alabama in Huntsville; and President, Rheumatology Nurses Society. References

1. Rheumatology Nurses Society. 2014 Annual Conference. http://rnsnurse.org/conference/2014annual-conference. Accessed October 15, 2014. 2. Ong KL, Wu BJ, Cheung B, et al. Arthritis: its prevalence, risk factors, and association with cardiovascular diseases in the United States, 1999 to 2008. Ann Epidemiol. 2013;23:80-86. 3. Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria. An American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62:2569-2581. 4. Bohan A, Peter JB, Bowman RL, et al. A computer-assisted analysis of 153 patients with polymyositis and dermatomyositis. Medicine (Baltimore). 1977;56:255-286. 5. Institute of Medicine of the National Academies. The Future of Nursing: Leading Change, Advancing Health. www.iom.edu/Reports/2010/The-Future-ofNursing-Leading-Change-Advancing-Health.aspx. Accessed October 15, 2014. 6. American Association of Sexuality Educators Counselors and Therapists. www.aasect.org/. Accessed October 15, 2014. 7. Kaufman M, Silverberg C, Odette F. The Ultimate Guide to Sex and Disability: For All of Us Who Live with Disabilities, Chronic Pain, and Illness. 2nd ed. Berkeley, CA: Cleis Press; 2007. 8. Rheumatology Nurses Society. Member Perspective: Running the Race of Rheumatology Nursing. http:// rnsnurse.org/blog/rns-newsrheum/member-per spective-running-race-rheumatology-nursing. Accessed October 15, 2014.

Rheumatology Update

Neurologic Symptoms of Rheumatologic Conditions... tory myositis, sarcoidosis, and spondyloarthropathies. For example, peripheral neuropathies occur in 22% to 27% of people with Sjögren’s syndrome and central nervous system manifestations in 0.3% to 48%. The former include length-dependent sensorimotor polyneuropathy, mononeuritis multiplex, small-fiber neuropathy, and a pure sensory neuronopathy, which is an asymmetric non–lengthdependent neuropathy usually affecting arms more than legs. The latter include aseptic meningitis, demyelination, vasculitis, acute cerebellitis, seizures, and cognitive impairment. In addition, 19% to 40% of patients with scleroderma have neurologic symptoms. Fifty-seven percent of those with neurologic involvement have distal axonal sensorimotor peripheral neuropathy, and respond poorly to treatment, the study authors noted; 15% to 17% of patients have

myositis. Other neurologic syndromes include brachial plexopathy and entrapment neuropathies.

“The neurologic manifestations of rheumatic disorders and their treatments are some of the most challenging conditions to diagnose.” —Sean Ruland, DO

They also describe in detail the neurologic symptoms that can accompany systemic vasculitis and idiopathic inflammatory myositis. There are

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many forms of vasculitis, including giant cell arteritis, Takayasu’s arteritis, polyarteritis nodosa, Kawasaki’s arteritis, microscopic polyangiitis, and granulomatosis with polyangiitis, each with distinct presentation, clinical signs and diagnosis, and treatment. Efficient Diagnosis and Treatment Possible The 4 types of idiopathic inflammatory myositis are polymyositis, dermatomyositis, immune-mediated necrotizing myopathy, and inclusion body myositis. Dr Ruland and co authors provided details on the dif ferences between these conditions, ranging from age—inclusion body myositis, for example, occurs in people 50 years and older, while dermatomyositis can have a juvenile or adult onset—to treatment, where inclusion body myositis is not responsive to treatment, for instance, but dermato-

Continued from page 19

myositis responds well to immu nosuppression and intravenous immunoglobulin. Furthermore, serious neurologic complications can result from the use of immunosuppressive therapies, they stated. Progressive multifocal leukoencephalopathy has received considerable attention in patients receiving natalizumab, rituximab, or efalizumab, or, in some cases, in patients not taking biologics. Some patients treated with intravenous immunoglobulins for the first time have had strokes, Dr Ruland and colleagues noted. Other neurotoxicities have been reported in a variety of other medications commonly used in rheumatology, from corticosteroids to colchicine. “Efficient diagnosis and treatment should be a multidisciplinary, collaborative effort that includes expertise in rheumatology and rehabilitation, among other fields,” they concluded. n VOL. 3

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Rheumatology Update

Survey Reveals Drawbacks to Participation in ACA Exchanges By Rosemary Frei, MSc These are roughly similar proportions to those from the more than 1000 physician practices that responded to a September 2013 survey by MGMA.2 The earlier survey was intended to determine how practice administrators viewed the impending start of patient purchase of ACA insurance exchange

Just 25.8% of respondents said that their practice’s patient numbers had increased under the ACA, and approximately one-tenth (10.8%) said that their patient numbers had fallen. Furthermore, approximately one-third of respondents reported that payment rates under the ACA exchanges were some-

"It is a transition for practices and patients and the insurance industry. So, some of these are going to get better over time.” —Allison Brennan, MPP

products. The April 2014 survey results indicate that 15.1% of respondents regard the ACA insurance exchanges as very unfavorable to their practices, and 44.3% view them as unfavorable. Approximately three-quarters (76.5%) of respondents said that their practices are participating with new health insurance plans under the ACA. The main reasons cited for participation are remaining competitive in the local market, replacing current charity care when uninsured patients obtain coverage, and providing care to underserved patient populations. The top reason cited for nonparticipation was the financial liability represented by the 90-day grace period for ACA exchange enrollees. Among respondents whose practices are participating, 84.8% offer coverage through 5 or fewer plans. Only 19.9% of respondents, however, said that their practices had been excluded from a network in which they would like to have been included.

what lower than or equal to average payment rates from all of their traditional commercial contracts, at 32% and 36.6%, respectively. Just less than half (41.8%) said that rates were equal to those from traditional commercial products offered by the same payers. The situation was somewhat better compared with traditional Medicare and Medicaid, with 30.1% and 46.4% of practices, respectively, reporting higher reimbursement with the new exchanges than with these government programs. When Ms Brennan and colleagues probed the practical aspects of the implementation, they found an abundance of pain for practices and patients. Approximately one-third (31.5%) of respondents said that it has been very or extremely difficult to distinguish between patients with ACA insurance coverage versus traditional, commercial health insurance not related to ACA exchanges, whereas 56.1% found it slightly or moderately difficult. Only 12.4% said it was not at all difficult. Furthermore, 63.2% have

found it more difficult to verify patient eligibility for coverage, 62.3% said it was more difficult to obtain cost-sharing information, and 58.6% have found obtaining information about the plan’s provider network to facilitate referrals to be more difficult than with traditional, commercial coverage. Fully 40.9% of those who completed the survey said that their practices had been unable to treat some patients, because their practices were not included in those patients’ insurance exchange networks. In addition, 94.8% of respondents said that it was likely that patients have high deductibles with the new products compared with traditional, commercial coverage. “We are consistently denied ‘out of network’ approvals for the very sick who truly need to continue their care with providers who have worked with the patient for years,” wrote a respondent; another indicated that “payer directories [of providers in the practices’ networks] are woefully inaccurate and impossible to rely on.” Ms Brennan said that she and her colleagues have heard these complaints from a number of providers, and that they represent significant problems for patients and physicians. However, she said that these difficulties, like most of the others associated with the early days of exchange network use, are being worked on, and should improve over time. n References

1. Medical Group Management Association. MGMA ACA exchange implementation survey report. May 2014. www.mgma.com/government-affairs/issues-over view/aca/aca-exchange-implementation-report/acasurveyreport_online_2?ext=.pdf. Accessed June 5, 2014. 2. Medical Group Management Association Legisla tive and Executive Advocacy Response Network (LEARN). ACA insurance exchange implementation, September 2013. www.mgma.com/Libraries/Assets/ Government%20Affairs/Advocacy/LEARN/ACAExchange-Implementation-LEARN.pdf. Accessed June 5, 2014.

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he challenges involved with the implementation of the Affordable Care Act (ACA)’s insurance exchange program are evident in the responses to an April 2014 survey by the Medical Group Management Association (MGMA).1 There were 728 respondents to the survey, representing more than 40,000 physicians. A majority (59.4%) of respondents viewed ACA insurance exchanges as being unfavorable to their practices, and most said that payment rates are no higher than those offered from traditional commercial products or traditional Medicare. Furthermore, 87.6% reported difficulty identifying whether patients had ACA exchange coverage. Most respondents also said that it is more difficult than with traditional insurance products to accomplish tasks such as verifying patient eligibility and obtaining information about patients’ provider networks to facilitate referrals. “Some of these things I think are growing pains,” said Allison Brennan, MPP, senior advocacy advisor, MGMA, Washington, DC. “This is the first year. It is a transition for practices and patients and the insurance industry. So, some of these are going to get better over time.” Ms Brennan and colleagues included the survey in an e-newsletter that they e-mailed to all 22,500 members of the MGMA. Although the response rate was only 3.2%, respondents hailed from all but 4 states and were from 42 specialties. Their practices included multispecialty practices with primary and specialty care (19.3%), orthopedic surgery practices (10%), family practices (8.3%), and obstetrics/gynecology practices (6.6%). Approximately three-quarters (75.1%) were independent medical practices, and the mean practice size was 55.7 full-time–equivalent physicians.

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Rheumatoid Arthritis

ACR Facilitates PQRS Compliance Efforts By Rosemary Frei, MSc

elissa Francisco of the American College of Rheumatology (ACR) does not mind taking time after regular working hours to help office managers who are confused about points of compliance with the Physician Quality Reporting System (PQRS). The head of registries at the ACR, Ms Francisco knows that part of her job means offering 24-hour support for the hundreds of ACR members’ practices who use the organization’s electronic PQRS reporting support. “I and my coworker Natalie Fisk keep very flexible hours. Physicians and their staff have crazy schedules and sometimes may need to talk to us outside of the regular workday,” Ms Francisco told Value-Based Care in Rheumatology. “Our role is to work with ACR members whenever they need us to help them figure out how to report and the best method for them to use to report, as well as any of the details of each reporting process.” Ms Francisco and Ms Fisk help ACR members navigate electronic reporting of PQRS data, because, as the Centers for Medicare & Medicaid Services (CMS) has documented, reporting the data electronically results in a higher compliance rate. CMS is working to ensure that providers get the message that accurate reporting is important: the incentive payment for

successful reporting in 2014 is 0.5%; the payment will be assessed in the fall of 2015. Beginning in 2015 there will also be a 1.5% payment adjustment for clinicians who do not satisfactorily report data on quality measures for covered professional services. This will increase to 2% in 2016.

The 6 RA measures that are required to be reported in PQRS are as follows: documentation of which adult patients with RA have been prescribed disease-modifying antirheumatic drugs (DMARDs), as well as date and dose prescribed; whether these patients had tuberculosis screenings before biologic

“Our role is to work with ACR members whenever they need us to help them figure out how to report and the best method for them to use to report, as well as any of the details of each reporting process.” —Melissa Francisco

In addition, a provision came into effect this year that measures for patients with rheumatoid arthritis (RA) can no longer be reported as a group in claims-based reporting. This will help nudge even more practices toward electronic PQRS reporting, said Ms Francisco: practices that use claims-based reporting have to report on 9 measures for 50% of patient encounters, rather than the 6 in the RA measures group that are required to be reported on by providers submitting data electronically.

DMARD initiation; whether patients with RA had a yearly assessment of disease activity, functional status, and disease prognosis; and which patients have been prescribed prednisone and whether, if they have been receiving doses of at least 10 mg daily with no change or improvement, there has been documentation of creation of a steroid management plan within 12 months. Ms Francisco gave Value-Based Care in Rheumatology a virtual tour of the ACR Rheumatology Clinical Registry (RCR), which was launched in

2009. The website is designed to help practice staff members easily and quickly record and correct or update annual patient information relating to the 6 RA measures. The website also automatically generates reports that show where each practice stands with respect to other rheumatology practices in reporting of the 6 measures. Ms Francisco and Ms Fisk also run 3 validation checks on each practice’s patient data, and send each practice a report that flags information that needs to be updated or corrected before the data are filed with the CMS. This service is available for a fee. ACR staff launched a new system they have dubbed RISE—Rheumatology Informatics System for Effectiveness—that pulls data for PQRS reporting directly out of electronic health records. This means the intermediary step of entering the data into the RCR will not be needed. The ACR recently attained Qualified Clinical Data Registry status for this system. “RISE is a single solution for meeting multiple reporting requirements, from filing for quality-based incentive programs to avoiding penalties,” said Ms Francisco. “The ACR is committed to providing products and services designed to streamline complex reporting processes, and ultimately advance the field of rheumatology.” n

Concomitant Use of Statins Does Not Significantly Impact Efficacy of Rituximab By Lianne Bennett

t is well recognized that patients with rheumatoid arthritis (RA) are at an increased risk for cardiovascular disease, and statins are used to lower that risk. However, the concomitant use of statins with rituximab is a topic of debate, according to an article published in Annals of Rheumatic Diseases, with some studies reporting that statins lower the antirheumatic effects of rituximab and other studies, reporting that statins do not influence the efficacy of rituximab (Lehane PB, et al. Ann Rheum Dis. 2014;73:1906-1908). Investigators sought to evaluate how statins affect the efficacy of ri tuximab in RA and conducted a ret rospective, pooled, observed-case

analysis using 4 placebo-controlled, randomized, clinical trials—DANCER, REFLEX, SERENE, and IMAGE— comprising 2238 patients with moderate to severe active RA. During a 24-week placebo-controlled period, all patients received methotrexate (10-25 mg weekly) and were allowed to receive background doses of oral corticosteroids and nonsteroidal antiinflammatory drugs throughout the study period. Patients were divided into 2 groups: those receiving concomitant statins for ≥8 weeks (ie, STY group) and those receiving concomitant statins for <8 weeks or not at all (ie, STN group). Overall, 104 of the 1460

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Table Difference in Outcome Measures Between STY and STN Groups Efficacy parameter

Response (95% CI)

P value

Placebo-adjusted change DAS28-ESR

–0.09 (–0.65 to 0.47)

.7640

Placebo-adjusted odds ratio ACR20

1.094 (0.49 to 2.45)

.8266

Placebo-adjusted odds ratio ACR50

0.775 (0.30 to 2.00)

.5977

ACR20 indicates American College of Rheumatology 20% response; ACR50, American College of Rheumatology 50% response; CI, confidence interval; DAS28-ESR, Disease Activity Score 28-erythrocyte sedimentation rate; STN, no statins; STY, with statins. Source: Lehane PB, et al. Ann Rheum Dis. 2014;73:1906-1908.

rituximab-treated patients and 57 of the 778 patients receiving placebo received concomitant statins.

The efficacy of rituximab was measured at 24 weeks using the Disease Activity Score 28-erythrocyte sedi-

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Rheumatology Update

RABBIT Risk Score Reliable to Identify Serious Infections in Patients with RA This tool may allow rheumatologists to align therapy to expected risk By Angelique Sunny

he RABBIT risk score may be a useful tool for rheumatologists to incorporate in daily practice to determine the risk for infection in patients with rheumatoid arthritis (RA), especially because serious infections are a concern in patients taking cytokine inhibitors or other biologic agents (Zink A, et al. Ann Rheum Dis. 2014;73:1673-1676). Determining Infection in the RABBIT Cohort The risk score was created in 2011 based on an analysis of patients with RA enrolled in the Rheumatoid Arthritis Observation of Biologic Therapy (RABBIT) German register between 2001 and 2007 (Strangfeld A, et al. Ann Rheum Dis. 2011;70:1914-1920). “This risk estimate allows rheumatologists to align their therapy to the expected risk of individual patients,” according to Prof Dr Angela Zink, Ein Leibniz Institut, Berlin, Germany, and colleagues. In this study, the investigators used data from patients enrolled in the RABBIT cohort between January 2009 and January 2012 to predict the likelihood of a serious infection based on individual risk profiles. Patients were enrolled at the initiation of therapy with a tumor necrosis factor (TNF)-α inhibitor or nonbiologic disease-modifying antirheumatic drug (DMARD). Overall, 1522 patients with RA tak-

ing TNF-α inhibitors and 1468 patients taking DMARDs were included in the evaluation sample and compared with the original data sample, which included 3271 and 1773 patients, respectively. Compared with

“This risk estimate allows rheumatologists to align their therapy to the expected risk of individual patients.” —Angela Zink, Prof Dr, and colleagues

patients in the evaluation sample, patients included in the original data set had higher disease activity, lower functional capacity, more previous DMARD failures, were more often rheumatoid factor positive, and more often treated with glucocorticoids ≥7.5 mg/day. The investigators found excellent agreement between observed and expected rates of serious infection. The evaluation cohort showed similar RABBIT risk scores as the original group based on the number of infections per 100 patient-years for patients

taking TNF-α inhibitors, at 69 and 69.6, respectively. Expected and observed risk for infection was 3.0 per 100 patient-years in patients taking TNF-α inhibitors, and 1.5 and 1.8 per 100 patient-years in patients taking nonbiologic DMARDs, respectively. Other Tools Available for RA The German group compared their research with RA risk score assessments in the United States. In one analysis, investigators used data from the Rochester cohort and showed that RA severity, functional status, and comorbidity were predictors of serious infection (Doran MF, et al. Arthritis Rheum. 2002;46:2294-2300). Risk factors for infection in RA were similar to the RABBIT data reported, and included age, previous infection, comorbidity, and glucocorticoid dose. In another study, Curtis and colleagues developed a risk score and reported predictors similar to those reported in the current study, including account for older age, comorbidities, higher glucocorticoid dosages, previous serious infection, and diabetes mellitus (Curtis JR, et al. Arthritis Care Res (Hoboken). 2012;64:1480-1489). “The RABBIT Risk Score is a reliable instrument which determines the risk of serious infection in individual patients based on clinical and treatment information,” Dr Zink and col-

leagues concluded. “It helps the rheumatologist to balance benefits and risk of treatment, to avoid high-risk treatment combinations and thus to make informed clinical decisions.” The strength of this risk score is that it encompasses time-varying parameters of disease activity and disability, which allows a more patient-specific approach, they added. RA risk scores may provide a reliable guide to reduce the risk for infection in patients with RA, but the different parameters included in each calculator should guide the rheumatologist in deciding the optimal medical approach. A calculator is available at www.biologika –register.de/en/home/risk-score/. n

at a glance ➤ Serious infections are a concern in patients with RA taking cytokine inhibitors or other biologic agents ➤ The RABBIT risk score was developed in 2011 as a tool to calculate the risk for infections in specific patient profiles ➤ A high level of agreement was seen between the observed and expected rates of serious infection in patients with RA

Rheumatoid Arthritis

Concomitant Use of Statins Does Not Significantly... mentation rate (DAS28-ESR), American College of Rheumatology 20% or 50% response (ACR20/50), and peripheral blood CD19+ B-cell counts. Differences in outcome measures between the 2 groups were evaluated using either an analysis of covariance model for continuous variables or logistic regression for categoric variables. In addition, placebo-adjusted means were also evaluated.

The investigators observed that ri tuximab-treated patients in the STN group had a greater mean decrease in DAS28-ESR compared with rituximabtreated patients in the STY group; the difference was not significant and similar results were reported in the placebo group. In addition, fewer patients in the STY group achieved ACR20/50 responses compared with patients in the STN group for ritux-

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OCTOBER 2014

imab-treated patients and those receiving placebo. Between the statin groups, placebo-adjusted mean decrease in DAS28ESR and placebo-adjusted odd ratios for ACR20/50 were not sufficiently significant to confirm the impact of statins on the efficacy of rituximab (Table). Furthermore, CD19 counts, although lower in the STY group compared with the STN group, did not

Continued from page 22

reach significance. This analysis was the first to use a large placebo-controlled data set to assess the impact of statins on the efficacy of rituximab. “These findings suggest that concomitant use of statins did not significantly alter patients’ response to rituximab treatment over a 24-week placebo-controlled period,” according to Patricia B. Lehane, PhD, Roche Products Ltd, and colleagues. n VOL. 3

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Rheumatoid Arthritis

Sarilumab Promising in Patients with Rheumatoid Arthritis This tool may allow rheumatologists to align therapy to expected risk By Phoebe Starr Paris, France—Sarilumab plus methotrexate (MTX) was significantly superior to placebo plus MTX in a phase 3 trial presented at the 2014 European League Against Rheumatism Congress. Sarilumab significantly improved clinical, radiographic, and functional response in patients with moderate to severe rheumatoid arthritis (RA), and a suboptimal response to MTX alone in the SARIL-RA-MOBILITY trial, one of 4 phase 3 trials in the registration program for this drug. Sarilumab is an interleukin-6 receptor inhibitor, similar to tocilizumab, a drug already approved for RA. Lead author Mark Genovese, MD, Professor at Stanford University Medical Center, CA, said that even though there are effective therapies for RA, not all patients respond well to currently available drugs. “There is a clear need for additional treatment options,” he said. “We look forward to the results of 3 other ongoing phase 3 trials in this comprehensive registration program.” As part of the trial, investigators enrolled 1197 patients from 30 different countries with active, moderate to severe RA and an inadequate response to MTX alone who were randomized to sarilumab 150 mg subcutaneously, sarilumab 200 mg subcutaneously, or placebo. All treatments were given in

combination with MTX. Both doses of sarilumab were statistically superior to placebo (P <.0001 for all comparisons) for the 3 primary end points. The first primary end point was improvement of at least 20% by week 24 in signs and symp-

Structural damage at week 52 was the third coprimary end point, as shown by change in the van der Heijde modified total Sharp score; results were 0.90, 0.25, and 2.78, respectively, for the 3 treatment arms. A secondary end point of the trial,

“We look forward to the results of 3 other ongoing phase 3 trials in this comprehensive registration program.” —Mark Genovese, MD

MTX groups compared with placebo: 12.5%, 13.9%, and 4.7% for the 3 treatment groups, respectively. Infection was the most frequently reported adverse event: 40.1%, 39.6%, and 31.1% in the saril umab 150-mg group, the sarilumab 200-mg group, and the placebo group, respectively (all in combination with MTX). Serious infections were reported in 2.6%, 4%, and 2.3% in the 3 treatment arms, respectively. As previously reported with sarilumab, mean low-density lipoprotein cholesterol and liver enzymes increased compared with patients in the placebo group. n

at a glance toms of RA measured by American College of Rheumatology criteria (ACR20); this end point was met by 58% of patients in the sarilumab 150mg group, 66% of patients in the sar ilumab 200-mg group, and 33% of patients in the placebo group. The second coprimary end point was improvement in physical function at week 16 as measured by the Health Assessment Questionnaire Disability Index; results were –0.53, –0.55, and –0.29, respectively, for the 3 treatment arms.

defined as an improvement of 70% or more according to ACR criteria for at least 24 consecutive weeks was achieved in 20%, 25%, and 7%, respectively, for the sarilumab 150-mg group, the sarilumab 200-mg group, and the placebo group. Improvements in ACR20 were sustained at 52 weeks as follows: 54%, 59%, and 32% for the sarilumab 150-mg group, the sarilu mab 200-mg group, and the placebo group, respectively. More patients withdrew from treatment because of adverse events in the sarilumab plus

➤ Although there are effective therapies for RA, not all patients respond well to currently available drugs ➤ Sarilumab significantly improved clinical, radiographic, and functional response in patients with moderate to severe RA and a suboptimal response to MTX alone ➤ Infection was the most frequently reported adverse event

Rheumatology Update

Am I Done Clicking Yet? Mourning the Loss of the Doctor–Patient Relationship By Kyle C. Harner, MD, Managing Partner, Carolina Arthritis Center, Greenville, NC

y first experience with documentation outside of a hospital was at a small internal medicine office in Richmond, VA. I was a fourth-year medical student, and the supervising internist ran a small, but very nice office near Stuart Circle. He spent a lot of time with each patient and very little time dictating a few sentences about each encounter

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for the patient’s medical record. When my supervising internist was done seeing patients for the day, he went home. I am sure he was getting paid by the prevailing insurance providers of the day. After all, he did have a nice office in a very nice part of Richmond. I often think of that month in Richmond as I spend my entire lunch hour, and up to several hours after

our office closes, typing and clicking boxes. This is to make sure my notes meet all the requirements for not only a Current Procedural Terminology code 99214 office visit, but also for Meaningful Use. This is also because we would like to keep our nice office in Greenville. This begs the question, what is all this clicking about? What is all the OCTOBER 2014

Meaningful Use data being used for at the Centers for Medicare & Medicaid Services (CMS)? For answers, I turned to the source that everyone uses: I Googled it. Using the search “How does CMS use Meaningful Use data?,” I was rewarded with hundreds of hits about how I can meet Meaningful Use specifications, but absolutely none about what the bean counters at CMS

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Autoantibodies in Patients with RA Could Lead to More Precise Diagnosis, Therapy By E. K. Charles

utoantibodies are a key feature of rheumatoid arthritis (RA) and a useful marker in the diagnosis and classification of the disease, as well as to determine its severity and development. Previous research indicates that they may play an important role in the pathophysiology of RA. In an effort to assess the relationships between antibodies against carbamylated protein (anti-CarP) antibodies, anticitrullinated protein antibodies (ACPA), genetic factors (HLA-DRB1 alleles and PTPN22), and smoking in RA, Xia Jiang, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, and colleagues determined the presence of antibodies to CarP–fetal calf serum (FCS) and fibrinogen (CarP-Fib) in 846 patients with RA from the Leiden Early Arthritis Clinic (EAC), and almost 2000 patients with RA from the Swedish Epidemiological Investigation of Rheumatoid Arthritis (EIRA). “The detection of autoantibodies in sera of RA patients has opened up possibilities of subgrouping the RA population to allow more precise

prognosis and possibly therapeutic management,” according to the investigators. Using enzyme-linked immunosorbent assays, Dr Jiang and colleagues evaluated the frequency of anti-CarP as it relates to anti–cyclic citrullinated protein (CCP) immunoglobulin G in patients with RA and found that antibodies to CarP-FCS and CarP-Fib existed in both cohorts. Anti-CarP antibody positivity was observed in 49% to 73% of patients with anti– CCP-positive RA, and in 8% to 14% of patients with anti–CCP-negative RA—the differences were statistically significant. In addition, the researchers further analyzed the impact of HLA-DRB1 alleles on disease risk in different types of RA and found a significant strong risk effect in anti–CCP-positive RA. This finding was observed regardless of anti-CarP antibody status, in both EIRA and EAC cohorts, as well as in the meta-analysis that was observed, the study authors noted. Taking a closer look at the association of different HLA-DRB1 alleles and disease risk in different RA sub-

sets, they found that several alleles, including HLA-DRB1*03 and HLADRB1*07, were associated with protection against anti–CCP-positive RA, especially in double-positive (CCP+/ CarP+) subgroups. These data were collected through unstratified analyses, however, and after stratification, only HLA-DRB1*13 alleles showed protective effects. The investigators also evaluated a subset of patients with ACPA-negative RA. No association was observed between anti-CarP antibodies and smoking, PTPN22 genotype variants, or HLA-DRB1 alleles; an association was, however, observed between anti–CarPFCS antibodies and HLA-DRB1*03. “These data suggest that anti-CarP antibody induction may be facilitated by different mechanisms than the ones involved in the induction of ACPA,” Dr Jiang and colleagues explained. No specific association between anti-CarP antibodies with other HLA-DRB1 alleles, PTPN22 genotypes, or smoking was seen after further analysis was performed. Overall, data by Dr Jiang and colleagues indicate that different biologi-

cal mechanisms may be associated with the formation of anti-CarP versus anti-CCP antibodies in patients with ACPA-positive and ACPA-negative RA. n

at a glance ➤ Autoantibodies are a useful marker in the diagnosis and classification of RA, as well as in the determination of disease severity and development ➤ Detection of autoantibodies in sera of RA patients has opened up possibilities of subgrouping the RA population to allow more precise prognosis and possibly therapeutic management ➤ In stratified analyses, HLADRB1*13 alleles showed protective effects against anti–CCP-positive RA, especially in double-positive (CCP+/CarP+) subgroups

Rheumatology Update

Am I Done Clicking Yet? Mourning the Loss... are doing with the data we are providing. I cannot say I was surprised by this, but some explanation would

In our quest to meet Meaningful Use standards, our office has gone through an initial electronic medical

I think we have come full circle on this issue, because in the end quality care takes place when a physician and patient get to spend more time together, not when a physician gets to spend more time clicking. Kyle C. Harner have been nice. I did not call CMS because I did not want to hear a vague answer about quality.

records transition, followed by multiple updates, the most recent of which is to accommodate changes stemming

VALUE-BASED CARE IN RHEUMATOLOGY

OCTOBER 2014

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from Meaningful Use Stage 2. Each update brings changes in workflow and more boxes to click. More boxes mean either less time with each patient or more time documenting after the clinic closes. I can only hope that electronic medical records evolve into systems that no longer hinder conversation between providers and patients, but I am not going to hold my breath waiting. Is there anything that the medical community and our patients can do about the loss of the doctor–patient relationship, or is it too late to turn back? I certainly do not have an easy answer to this question. Doctors are historically poor at advocating for themselves, but many states now have strong medical societies and

even rheumatology-specific societies that lobby for the interests of their membership. Organizations like the National Organization of Rheumatology Managers (NORM) are also vital. Through NORM, managers and physicians can work together to advocate for what we consider quality care. Finally, patients likely are the most powerful lobbyists. As consumers of medical care, patients have the most to win or lose when physicians look at computer screens rather than them. I think we have come full circle on this issue, because in the end quality care takes place when a physician and patient get to spend more time together, not when a physician gets to spend more time clicking. n VOL. 3

NO. 5

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If only it were this easy to spot SLE* organ damage

33% to 50% of SLE patients experience permanent organ damage within the ﬁrst 5 years of diagnosis.1,2

To learn more about SLE, visit

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SLE can affect nearly every major organ, including the skin, kidneys, joints, lungs, and heart.3 Even when minimal symptoms are present, organ damage can still occur. 2 *systemic lupus erythematosus

REFERENCES: 1. Chambers SA, Allen E, Rahman A, Isenberg D. Damage and mortality in a group of British patients with systemic lupus erythematosus followed up for over 10 years. Rheumatology (Oxford). 2009;48(6):673-675. 2. Urowitz MB, Gladman DD, Ibañez D, et al. Evolution of disease burden over five years in a multicenter inception systemic lupus erythematosus cohort. Arthritis Care Res (Hoboken). 2012;64(1):132-137. 3. Lopez R, Davidson JE, Beeby MD, Egger PJ, Isenberg DA. Lupus disease activity and the risk of subsequent organ damage and mortality in a large lupus cohort. Rheumatology (Oxford). 2012;51(3):491-498. ©2014 GSK group of companies. All rights reserved. Printed in USA. BN2670R0 April 2014