Sharing A Breath by Integritas Communications

SHARING A BREATH Interdisciplinary Management of Patients With Severe Asthma

Educational Objectives Upon completion of this activity, participants will be better able to:  Identify patients with asthma who may be appropriate candidates for specialist follow‐up based on ongoing symptoms, exacerbation history, and treatment responses  Discuss biologic options that have been approved by the US Food and Drug Administration for the treatment of severe asthma  Coordinate the management of patients with severe asthma who require multidisciplinary care to maximize symptom control, reduce exacerbation risks, and minimize medication‐related toxicities  Educate patients with severe asthma about disease‐related risks, long‐term treatment options, and information related to adherence and self‐management

IDENTIFYING PATIENTS WITH SEVERE ASTHMA Nicola Hanania, MD, MS, FCCP

Severe Asthma Definition From the ATS and ERS4  Asthma in patients aged ≥6 years that would be uncontrolled if not for

Estimated Prevalence, 2015 Approximately 25 Million Americans Have Asthma1

 High‐dose ICS plus a LABA or leukotriene modifier/theophylline for the previous year

Severe Asthma2‐4

OR  Systemic corticosteroids for ≥50% of the year

Mild‐to‐Moderate Asthma

 Asthma that is uncontrolled despite these therapies

ATS, American Thoracic Society; ERS, European Respiratory Society; ICS, inhaled corticosteroid; LABA, long‐acting β2 ‐agonist. 1. American Lung Association. Asthma in adults fact sheet. www.lung.org/lung‐health‐and‐diseases/lung‐disease‐lookup/asthma/learn‐about‐ asthma/asthma‐adults‐facts‐sheet.html. Accessed February 10, 2019; 2. Busse WW, et al. J Allergy Clin Immunol. 2000;106(6):1033‐1042; 3. Lang DM. Allergy Asthma Proc. 2015;36(6):418‐424; 4. Chung KF, et al. Eur Respir J. 2014;43(2):343‐373.

Uncontrolled vs Severe Asthma  “Asthma may be considered uncontrolled either because of persistence of symptoms despite appropriate treatment, or due to poor adherence to therapy or use of inhaler devices.”1  “Severe asthma is asthma that is uncontrolled despite adherence with maximal optimized therapy and treatment of contributory factors, or that worsens when high‐ dose treatment is decreased.”2

GINA, Global Initiative for Asthma. 1. Skolnik NS, et al. Curr Med Res Opin. 2019 Mar 18:1. 2. [Epub ahead of print]. GINA. Difficult‐to‐treat and severe asthma in adolescents and adult patients. Diagnosis and Management. https://ginasthma.org/wp‐ content/uploads/2019/04/GINA‐Severe‐asthma‐Pocket‐Guide‐v2.0‐wms‐1.pdf. Accessed April 15, 2019.

Factors That Can Contribute to Uncontrolled Asthma Disease‐Related Factors

Environmental Factors • Passive smoking • Frequent exposure to traffic or air pollution • Outdoor and indoor allergens

• Cyclical nature of disease • Increased disease severity • Differing asthma phenotypes

Uncontrolled Asthma Physician‐Related Factors • Medication underprescribing • Failure to assess adherence • Failure to assess inhaler technique • Misdiagnosis • Lack of asthma action plan • Absence of specialty care

GERD, gastroesophageal reflux disease; NSAID, nonsteroidal anti‐inflammatory drug. Adapted from Wechsler ME. Am J Med. 2014;127(11):1049‐1059.

Patient‐Related Factors • Comorbidities (eg, GERD, rhinosinusitis, depression) • Smoking • Obesity • Age • Psychosocial issues (eg, lower income, poor health literacy) • Poor treatment adherence • Inadequate inhaler technique • Heterogeneity of treatment response • Failure to follow self‐ management plan • Side effects of other medications (eg, NSAIDs)

Factors That Can Contribute to Uncontrolled Asthma Disease‐Related Factors

Environmental Factors • Passive smoking • Frequent exposure to • Reduce exposure to traffic or air pollution allergic triggers • Outdoor and indoor allergens

Cyclical nature of disease • Assess phenotypes Increased disease severity • Match treatment to asthma • phenotype Differing asthma phenotypes

Controlled Asthma? Physician‐Related Factors • Medication under‐prescribing • Assess Failure to assess adherence and address adherence and • inhaler Failure to assess inhaler technique technique Misdiagnosis • Refer for specialty care Lack of asthma action plan •• Develop an asthma action plan • Absence of specialty care

Patient‐Related Factors • Comorbidities (eg, GERD rhinosinusitis, depression) Smokingcomorbid conditions •• Manage •– Obesity Depression •– Age GERD •– Psychosocial issues (eg, lower Rhinitis income, poor health literacy) – Sinusitis • Poor treatment adherence •• Encourage weight loss Inadequate inhaler technique •• Emphasize treatment adherence Heterogeneity of treatment • Educate about correct inhaler response • technique Failure to follow self‐ management plan • Smoking cessation • Side effects of other medications (eg, NSAIDs)

Adapted from Wechsler ME. Am J Med. 2014;127(11):1049‐1059.

Poor Adherence to Asthma Therapies Surprising Statistics

of medications prescribed for asthma are taken by patients1

of patients with asthma do not fill their ICS prescriptions2

of patients in clinical trials used less than 80% of their medications3

1. Bender B, et al. Ann Allergy Asthma Immunol. 1997;79(3):177‐185; 2. Williams LK, et al. J Allergy Clin Immunol. 2007;120(5):1153‐1159; 3. Bateman ED, et al. Am J Respir Crit Care Med. 2004;170(8):836‐844.

A Case Example  23‐year‐old man with diagnosed asthma  Controller treatment regimen includes daily high‐dose ICS plus a LABA that he refills monthly  Experienced 2 exacerbations requiring an OCS within the last year  Reports awakening 1 night/week owing to cough and chest tightness  Uses rescue albuterol for daily wheezing  Spirometry results; FEV1 <70% predicted  15% improvement after bronchodilator

Does this patient have uncontrolled or severe asthma? 9

FEV1, forced expiratory volume in 1 second; OCS, oral corticosteroid.

ASSESSMENT OF ASTHMA CONTROL Joel Heidelbaugh, MD, FAAP, FACG

Best Practices in Patient Evaluation a. Carefully consider other possible disorders in the differential diagnosis, and confirm asthma diagnosis with physiologic testing

Confirm asthma diagnosisa Assess disease severityb Evaluate triggers that affect asthma

b. Standardized questionnaires (including rescue inhaler use), exacerbation history, measurement of biomarkers

Evaluate comorbid states that affect asthma

c. Less than 50% of medication prescribed for asthma is taken by patients; poor inhaler technique in up to 75% of patients

Assess treatment adherence and inhaler techniquec

Aaron SD, et al. Respir Crit Care Med. 2018;198(8):1012‐1020; Bender B, et al. Ann Allergy Asthma Immunol. 1997;79(3):177‐185.

Under‐ and Overdiagnosis of Asthma Underdiagnosis of current asthma

Overdiagnosis of current asthma

No diagnosis made, or a disease or condition other A disease or condition other than asthma that than asthma that causes respiratory symptoms has causes respiratory symptoms (such as allergic been assigned to the patient rhinitis, GERD, or vocal cord dysfunction) OR Patient’s previous asthma is in sustained clinical remission (in the absence of controller treatment, or after controller treatment has been stopped)  People who have asthma that is undiagnosed suffer from poorer health‐related quality of life and more absenteeism from work and school  People with overdiagnosed asthma suffer from potential side effects related to unnecessary use of medications, the burden of increased drug costs, and a delay in identifying and addressing the true cause of their respiratory symptoms

Aaron SD, et al. Am J Respir Crit Care Med. 2018;198(8):1012‐1020.

Conditions Commonly Misdiagnosed as Asthma in Adults  Hypereosinophilic syndromes  Pulmonary embolus  Herpetic tracheobronchitis  Endobronchial lesion or foreign body

 COPD  Hyperventilation with panic attacks  Bronchiolitis  (Constrictive/proliferative)

 Congestive heart failure  Adverse drug reaction

 (eg, Amyloid, carcinoid, tracheal stricture)

 Allergic bronchopulmonary aspergillosis  Acquired tracheobronchomalacia  Churg‐Strauss syndrome

 (eg, ACE inhibitors, β‐blockers)

 Bronchiectasis, cystic fibrosis  Hypersensitivity pneumonitis

ACE, angiotensin‐converting enzyme; COPD, chronic obstructive pulmonary disease.

Determining Asthma Control Patients Aged ≥12 Years Components of Controla

Not Well Controlled

Very Poorly Controlled

>2 days/week

Throughout the day

1‐3×/week

≥4×/week

Some limitation

Extremely limited

>2 days/week

Several times/day

60%‐80% predicted/personal best

<60% predicted/personal best

Symptoms Nighttime awakenings Interference with normal activity Rescue inhaler use FEV1/peak flow Validated questionnaires • ATAQ • ACQ • ACT

• 1‐2 • ≥1.5 • 16‐19

• 3‐4 • N/A • ≤15

aLevel

of control determined by most severe impairment or risk category. ACQ, Asthma Control Questionnaire; ACT, Asthma Control Test; ATAQ, Asthma Therapy Assessment Questionnaire; N/A, not applicable. National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma – Full Report 2007. https://www.nhlbi.nih.gov/sites/default/files/media/docs/asthsumm.pdf. Accessed April 11, 2019.

Assessment Tools to Evaluate Asthma Symptom Control Asthma Control Test (ACT)1

Asthma Control Questionnaire (ACQ)2

Asthma APGAR PLUS Questionnaire4

Asthma Therapy Assessment Questionnaire (ATAQ)3

For links to these assessment tools and other resources, please visit: www.ExchangeCME.com/AsthmaResources19. 15

1. Nathan RA, et al. J Allergy Clin Immunol. 2004;113(1):59‐65; 2. Juniper EF, et al. Eur Respir J. 1999;14(4):902‐907; 3. Vollmer WM, et al. Am J Respir Crit Care Med. 1999;160(5 Pt 1):1647‐1652. 4. Yawn BP, et al. Ann Fam Med. 2018;16(2):100‐110.

Sample Follow‐up Questions Activities of Daily Living

Medication Regimen

What have you given up because of your asthma?

What do you think is the difference between your rescue and controller medications?

Disease Persistence

Treatment Response

Has the frequency or severity of your daytime symptoms remained relatively consistent over the last 2 months?

Why do you think your asthma therapy is not working well?

Consider the Role of Potential Asthma Triggers Irritants

Allergens

 Tobacco and wood smoke  Particulates, pollution  Gas or diesel fumes

 Pollens  Mold  Animal dander  Insects

Occupational factors

Concomitant medications

 Chemicals  Fumes

 NSAIDs, β‐blockers

NSAID, nonsteroidal anti‐inflammatory drug. Centers for Disease Control and Prevention. Environmental triggers of asthma. https://www.atsdr.cdc.gov/csem/csem.asp?csem=32&po=6. Accessed February 10, 2019; Wechsler ME. Am J Med. 2014;127(11):1049‐1059; Morales DR, et al. BMC Medicine. 2017;15(1):18; American Academy of Allergy, Asthma, and Immunology. Medications may trigger asthma symptoms. https://www.aaaai.org/conditions‐and‐treatments/library/asthma‐ library/medications‐that‐can‐trigger‐asthma‐symptoms. Accessed February 10, 2019.

Asthma Management Algorithm Severity Treatment

Asthma Control Management Modifications

• Impairment • Risk • Lung function

Inadequate Asthma Control Inadequate: Why? 18

• Nonadherence • Asthma triggers • Comorbidities • Psychosocial issues • Incorrect inhaler technique

Courtesy of Dr. Barbara Yawn.

Adequate

ADVANCED THERAPIES FOR SEVERE ASTHMA Nicola Hanania, MD, MS, FCCP

Unmet Needs in Patients With Asthma  Careful assessment of current adherence to asthma guideline recommendations is an important first step when considering an asthma biologic  28% of patients who had uncontrolled asthma failed to improve after 1 year of guideline‐ recommended care1

 Even after ensuring guideline/medication adherence, considering safety of these agents, and using available biomarkers to estimate treatment response, patient access to the biologic is needed2

Prescribers of biologics for asthma should consider how best to assess and improve medication adherence to ICS/LABA before considering the use of a biologic agent.2 20

LABA, long‐acting β‐agonist; ICS, inhaled corticosteroid. 1. Bateman ED, et al. Am J Respir Crit Care Med. 2004;170(8):836‐844; 2. Rank MA, Oppenheimer JJ. Ann Allergy Asthma Immunol. 2019;122(4);358‐359.

Kira, 4 Months Later  New regimen includes a combination ICS/LABA  Recent episode of “bronchitis” sent Kira her to an urgent care clinic while she was out of town, where she was prescribed a course of prednisone and an antibiotic  Continues to use her rescue inhaler 4 or 5 times weekly  Has canceled activities and plans arising from daytime and nighttime asthma symptoms  Kira and her physician confirm together that she is using her medications properly, and confirm that any asthma triggers are under control

Stepwise Approach to Asthma Management STEP 1 PREFERRED CONTROLLER OPTIONS

Other Controller Options Other Reliever Option

As‐needed low‐dose ICS‐ formoterol

STEP 2

STEP 3

Daily low‐dose ICS or as‐ needed low‐ dose ICS‐ formoterol

Low‐dose ICS +LABA

Low‐dose ICS LTRA, or low ‐ Medium‐dose taken dose ICS taken ICS, or low‐dose whenever whenever ICS+LTRA SABA taken SABA is taken

STEP 4

STEP 5

Medium/high‐dose ICS+LABA

High‐dose ICS+LABA Refer for phenotypic assessment ± add‐on therapy, eg, tiotropium, anti‐IgE, anti‐IL5/5R, anti‐IL4R

High‐dose ICS, add‐ on tiopropium, or add‐on LTRA

Add low‐dose OCS, but consider side effects

As-needed low-dose ICS-formoterol As-needed short-acting β2 -agonist (SABA) Each step requires Patient education and efforts to address modifiable risk factors and comorbidities.

IgE, immunoglobulin E; LTRA, leukotriene receptor antagonist; OCS, oral corticosteroid; SABA, short‐acting β2‐agonist. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2019. Available from: www.ginasthma.org.

Biomarkers Their Role in Asthma Phenotyping

Blood eosinophils

FeNO

IgE

FeNO, fractional exhaled nitric oxide. Kim MA, et al. Curr Opin Allergy Clin Immunol. 2014;14(1):49‐54; Chung KF, et al. Eur Respir J. 2014;43(2):343‐373; Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2018. www.ginasthma.org. Accessed February 10, 2019.

Basis for Biologic Therapies Type 2 Inflammation

Non–Type 2 Inflammation Irritants, pollutants, microbes, and viruses

Antigens

TSLP

CRTh2

IL-33

IL-13

Th2 cell

ILC2

IL-4, IL-5, IL-13

GATA3 IL-4

B cell

IL-25

GM-CSF Leukotrienes

GATA3 IL-5

CRTh2

Mast cell

Histamine IL-3, IL-4, IL-5, IL-9

CXCL8 GM-CSF

IL-23

Th17 cell

TNF

IL-17

CXCR2

IL-8 Lipoxin

Eosinophil

Th1 cell

IFN-γ

IL-6

CRTh2

PGD2

IgE

IL-6 TGF-β

Leukotrienes B4

BLT2 ALX

Neutrophil

ALX, lipoxin A4 receptor; BLT2, leukotriene B receptor 2; CRTh2, chemoattractant receptor homologue from Th2 cells; CXCL8, CXC motif chemokine ligand 8; CXCR2, CXC motif chemokine receptor 2; GATA3, GATA binding protein 3; GM‐CSF, granulocyte–macrophage colony‐stimulating factor; IFN‐γ, interferon gamma; IgE, immunoglobulin E; IL, interleukin; ILC2, innate lymphoid cells; PGD2, prostaglandin D2; TSLP, thymic stromal lymphopoietin; TGF‐β, transforming growth factor β; Th, T helper; TNF, tumor necrosis factor. Adapted from Israel E, Reddel HK. N Engl J Med. 2017;377(10):965‐976.

FDA‐Approved Biologic Agents for Severe Asthma Anti‐IgE Therapy

Anti‐IL‐5/IL‐5Rα Therapies

IgE

Mepolizumab Reslizumab

IL-5

B cell

Benralizumab

Omalizumab

IL-5Rα

Anti‐IL‐4Rα Therapy IL-4

IL-4Rα

Mast cell

IL-13

Dupilumab

c

IL-4

γc

IL-4Rα

IL-13Rα1

IL-4 mediates IgE production, Th2-cell differentiation, B-cell growth, and eosinophil recruitment

IL-5 regulates eosinophil proliferation, differentiation, migration, and survival

FDA, US Food and Drug Administration; IgE, immunoglobulin E; IL, interleukin; IL‐4Rα, interleukin‐4 receptor α; IL‐5Rα, interleukin‐5 receptor α; IL‐ 13Rα1, interleukin‐13 receptor α1; Th, T helper. Adapted from Darveaux J, et al. J Allergy Clin Immunol Pract. 2015;3(2):152‐161 and Gandhi NA, et al. Nat Rev Drug Discov. 2016;15(1):35‐50.

Omalizumab Anti‐IgE mAb

 Moderate‐to‐severe persistent asthma  A positive skin test or in vitro reactivity to a perennial aeroallergen  Inadequate control with ICS

 SQ administration1  Based on pretreatment serum IgE level and body weight1

1.6

Annual Exacerbation Rate2

 Approved for patients aged ≥6 years with1

1.47

1.4

38.3% RR vs placebo

1.2 1.0

0.91a

0.8 0.6 0.4 0.2 0.0 Control

Omalizumab

Pooled Clinical Study Data aP<0.0001.

mAb, monoclonal antibody; Q2W, every 2 weeks; Q4W, every 4 weeks; RR, relative reduction; SQ, subcutaneous. 1. Drugs@FDA. www.accessdata.fda.gov/scripts/cder/daf/; 2. D’Amato G, et al. Ther Clin Risk Manag. 2007;3(4):613‐619.

Mepolizumab Anti‐IL‐5 mAb

 ≥150 cells/μL at screening OR ≥300 cells/μL during the prior year

 Treated with high‐dose ICS plus another controller

2.0

Annual Exacerbation Rate1

 ≥2 exacerbations within the last year  High blood eosinophils

1.74

53% RR vs placebo

1.5

1.0

0.83a

0.5

0.0 Placebo (n=191)

Mepolizumab (n=194)

Approved as add‐on maintenance therapy for patients aged ≥12 years with severe eosinophilic asthma; SQ administration.2 aP<0.001 versus placebo.

Patients with severe asthma aged 12 to 82 years were randomly assigned to receive SQ mepolizumab 100 mg or placebo Q4W for 32 weeks. IL, interleukin. 1. Ortega HG, et al. N Engl J Med. 2014;371(13):1198‐1207; 2. Drugs@FDA. www.accessdata.fda.gov/scripts/cder/daf/.

Reslizumab  ≥1 exacerbation within the last year  High blood eosinophils  ≥400 cells/μL at screening

 Treated with medium‐ to high‐dose ICS and up to 1 other controller drug

Annual Exacerbation Rate1

Anti‐IL‐5 mAb 2.0

1.81

50%‐59% RR vs placebo

1.5

1.0

0.84a

0.5

0.0 Placebo (n=476)

Reslizumab (n=477)

Approved as add‐on maintenance therapy for patients aged ≥18 years with severe eosinophilic asthma; IV administration.2 aP<0.0001 versus placebo. IV, intravenous.

Patients with severe asthma aged 12 to 75 years were randomly assigned to IV reslizumab 3 mg/kg or placebo Q4W for 52 weeks. Data from 2 pooled phase 3 trials. 1. Castro M, et al. Lancet Respir Med. 2015;3(5):355‐366; 2. Drugs@FDA. www.accessdata.fda.gov/scripts/cder/daf/.

Benralizumab  ≥2 exacerbations within the last year  Treated with medium‐ to high‐ dose ICS plus LABA

Annual Exacerbation Rate1,2

Anti‐IL‐5Rα mAb 2.0

51%

1.5

RR vs placebo

1.33

Placebo Benralizumab

28% RR vs placebo

0.93

1.0

0.66b

0.65a 0.5 0.0 SIROCCO

CALIMA

≥300 Eosinophils/μL

Approved as add‐on maintenance therapy for patients aged ≥12 years with severe eosinophilic asthma; SQ administration.3 aP<0.0001 versus placebo; bP<0.02 versus placebo.

N=1205 (SIROCCO) or 1306 (CALIMA) patients aged 12 to 75 years with severe asthma randomly assigned to SQ benralizumab 30 mg Q8W (first 3 doses Q4W) or placebo. Q8W, every 8 weeks. 1. Bleecker ER, et al. Lancet. 2016;388(10056):2115‐2127; 2. FitzGerald JM, et al. Lancet. 2016;388(10056):2128‐2141; 3. Drugs@FDA. www.accessdata.fda.gov/scripts/cder/daf/.

Dupilumab Anti‐IL‐4Rα mAb

‐48%

1.2

Annual Exacerbation Rate1

 Treatment with a systemic steroid for worsening asthma at least once in the last year  Hospitalization or emergency medical care visit for worsening asthma

1.0

0.87

RR vs placebo

‐46%

0.97

RR vs placebo

0.8 0.6

0.52a

0.46a 0.4 0.2 0.0 Placebo

Dupilumab 200 mg

Placebo

Dupilumab 300 mg

Approved as add‐on maintenance therapy for patients aged ≥12 years with moderate‐to‐severe eosinophilic or OCS‐dependent asthma; SQ administration.2 aP<0.001 versus placebo.

N=1902 patients aged ≥12 years with moderate‐to‐severe asthma uncontrolled with medium‐ to‐high‐dose ICS plus 1 or 2 other controllers received SQ dupilumab or placebo Q2W for 52 weeks. 1. Castro M, et al. N Engl J Med. 2018;378(26):2486‐2496; 2. Drugs@FDA. www.accessdata.fda.gov/scripts/cder/daf/..

Emerging Agent: Tezepelumab Phase 2b Trial With an Anti‐TSLP mAb Tezepelumab

TSLP

TSLPR

IL-7Rα

TSLP regulates type 2 immune responses by activating dendritic cells, ILC2 cells, T cells, and B cells

Annual Exacerbation Rate

Anti‐TSLP Therapy

61%

71%

66%

RR vs placebo

0.19a

0.22a

Tezepelumab 210 mg Q4W

Tezepelumab 280 mg Q2W

1.0 0.8 0.67 0.6 0.4

0.26a 0.2 0.0 Placebo

Tezepelumab 70 mg Q4W

aP≤0.001 versus placebo.

N=584 patients aged 18 to 75 years with ≥2 exacerbations or 1 severe exacerbation requiring hospitalization in the last year despite medium‐ to high‐dose ICS plus LABA were randomly assigned to receive SQ tezepelumab for 52 weeks. IL‐7Rα, interleukin‐7 receptor α; TSLP, thymic stromal lymphopoietin; TSLPR, thymic stromal lymphopoietin receptor. Corren J, et al. N Engl J Med. 2017;377(10):936‐946.

Safety of Biologics in Asthma Biologic Agent

Most Commonly Reported Adverse Reactions in Clinical Trials

Benralizumab

Headache, pharyngitis

None

Dupilumab

Injection‐site reactions

None

Mepolizumab

Headache, injection‐site reaction, back pain, fatigue

None

Omalizumab

Arthralgia, pain (general)

Anaphylaxis

Reslizumab

Oropharyngeal pain

Anaphylaxis

Drugs@FDA: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/daf/.

Black Box Warning

What Patients Need to Know About Biologic Therapies for Severe Asthma Biologic agents —  Are used to treat uncontrolled moderate or severe asthma  Do not cure asthma  Are added to a patient’s current treatment regimen  Must be taken regularly, like all asthma medicines  Are injectable medications  Some biologics can be self‐administered at home, whereas others must be administered in a doctor’s office

MULTIDISCIPLINARY MANAGEMENT of SEVERE ASTHMA Joel Heidelbaugh, MD, FAAP, FACG

Asthma Action Plan

CDC. Asthma action plan. https://www.cdc.gov/asthma/actionplan.html. Accessed April 11, 2019.

Shared Decision Making/Goal Setting Focus on Choice, Rather Than Change “Healthcare professionals have a duty to inform people about the benefits and harms of proposed interventions… Shared decision making is defined by extending this duty to supporting people to arrive at informed preferences, eliciting and respecting those preferences by integrating them as decisions are made.”  Patients should be engaged in decisions to the extent that they wish  The process of shared decision making is not limited to the use of patient decision aids

Shared Decision‐Making Tool CHEST Foundation, Allergy and Asthma Network, ACAAI http://asthma.chestnet.org/sdm‐tool/ OR ExchangeCME.com/SAResources19 36

Elwyn G, et al. Implement Sci. 2016;11:114.

Reducing Oral Corticosteroid Burden in Patients With Asthma

32%‐45% of patients with severe asthma require frequent, and often daily, OCS1,2

DID YOU KNOW…

93%

of asthma registry patients with severe disease had ≥1 condition linked to OCS exposure3‐5    

T2DM Osteoporosis Cataracts Dyspeptic disorders

   

Weight gain Osteopenia Hypertension Obstructive sleep apnea

As recommended in the GINA Report, patients with asthma who require ≥2 courses of OCS within a year to control their asthma symptoms should be referred to a specialist for evaluation.6 37

T2DM, type 2 diabetes mellitus. 1. Moore WC, et al. J Allergy Clin Immunol. 2007;119(2):405‐413; 2. Shaw DE, et al. Eur Respir J. 2015;46(5):1308‐1321; 3. Sweeney J, et al. Thorax. 2016;71(4):339‐346; 4. Luskin AT, et al. Clinicoecon Outcomes Res. 2016;8:641‐648; 5. Sullivan PW, et al. J Allergy Clin Immunol. 2018;141(1):110‐116; 6. Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2018. Available from: www.ginasthma.org.

Oral Corticosteroid–Sparing Strategies Encouraging Results With Biologic Therapies  Benralizumab1

 Mepolizumab3

 Reduced OCS dose by 75% (vs 25% with placebo)

 Dupilumab2

 Reduced OCS dose by 50% (vs 0% with placebo)

 Omalizumab4

 Reduced OCS dose by 70% (vs 42% with placebo)

 79% of patients reduced OCS dose by ≥50% (vs 55% with placebo)

1. Nair P, et al. N Engl J Med. 2017;376(25):2448‐2458; 2. Rabe KF, et al. N Engl J Med. 2018;378(26):2475‐2485; 3. Bel EH, et al. N Engl J Med. 2014;371(25):1189‐1197; 4. Soler M, et al. Eur Respir J. 2001;18(2):254‐261.

Overcoming Challenges With Treatment Adherence  Assess for adherence

 Reasons for nonadherence

 Inspect medication dose counters

 Inadequate access to medication  Dissatisfaction with medication delivery  Perceived adverse effects  Lack of improvement with medication noted by patient

• Breath‐actuated devices are more accurate

 Check pharmacy refill records

Seek to understand and address reasons for low adherence, particularly defining the purpose of the medication and why it is essential to patient care. 39

If You Have Asthma A Poster

Conclusions  Identifying patients with poorly controlled, severe asthma is critical  Targeted biologic therapies can improve symptoms, decrease exacerbation risks, and improve QoL in certain patients who have severe asthma  An anti‐IgE biologic is FDA approved for patients with moderate‐to‐severe, persistent allergic asthma, a positive skin test or in vitro reactivity to a perennial aeroallergen, and age/body weight serum IgE levels  Three biologic therapies targeting IL‐5 signaling are now FDA approved for patients with severe eosinophilic asthma  A biologic agent targeting IL‐4Rα is now FDA approved for patients with moderate‐to‐ severe asthma aged ≥12 years who have an eosinophilic phenotype or OCS–dependent asthma  A biologic agent targeting TSLP is in late‐stage clinical development

QoL, quality of life.