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Conference Roundup
Highlights From Spring 2021 Virtual Medical Meetings
American Academy of Dermatology, American Association of Neurology, ACC, ENDO 2021, and NAPNAP 2021
Understanding the characteristics and prevalence of adverse reactions to penicillin in the pediatric population is crucial to optimizing patient outcomes and limiting cost of care, reported Trisha Wendling, DNP, APRN, CPNP-PC, during a presentation at the National Association of Pediatric Nurse Practitioners Annual Meeting (NAPNAP 2021), held March 24 to March 27, 2021.
Penicillin allergy is the most commonly reported drug allergy, noted Dr Wendling. Although penicillin allergy is reported in 10% to 20% of hospitalized patients, the true prevalence is estimated to be approximately 4% to 5%.
Most children (95%) who develop a rash when given amoxicillin are not truly allergic to the drug when re-exposed. In those cases, noted Dr Wendling, the rash is likely in response to a virus or an interaction between a virus and the antibiotic. Even in cases when the rash is caused by an allergic reaction, 50% of these children will tolerate amoxicillin after 5 years and 80% will tolerate amoxicillin after 10 years.
Out of all reported reactions to penicillin, just 5% are anaphylaxis; 38% are rashes, 18% are hives, 9% are angioedema, 6% are gastrointestinal upset, and 5% are itching. Just over one-quarter (26%) of reactions are “unknown.” Approximately 10% to 15% of all adverse drug reactions are drug hypersensitivity reactions (DHRs; Table). The majority (85% to 90%) of adverse drug reactions are predictable based upon the pharmacologic properties of the medicine and the dose given to the patient.
Some patients indicate that they can not be given penicillin due to a “family history of penicillin allergy,” but having relatives with a penicillin allergy (without confirmation) is not a valid contraindication, Dr Wendling said.
The drug provocation test (DPT) is the gold standard for penicillin allergy testing, although in cases when a clinician is concerned about anaphylaxis, skin testing may be done first. During DPT the patient is given an age-appropriate dose of amoxicillin and observed for 60 minutes. The test is designed to rule out an IgE-mediated immediate reaction, Dr Wendling said.
An extended challenge can help identify a T-cell-mediated DHR, she noted. An extended challenge may also help increase confidence in removing penicillin allergy from the patient’s record so that penicillin can be prescribed for future infections.
Since penicillin is the treatment of choice for several common infections, understanding whether or not a patient has a true allergy to the medication is crucial to optimizing patient outcomes. Neither side effects nor family history should be used as a reason to not prescribe penicillin if the patient has an infection that warrants treatment with antibiotics, Dr Wendling said. Diagnostic testing can confirm whether or not the patient has a life-threatening allergy to penicillin.
Using second-line antibiotics to avoid prescribing penicillin is associated with increased hospitalization, morbidity, antibiotic resistance, and cost of care.
Public health and patient outcomes are dependent on decreasing the number of patients who are not truly allergic to penicillin but receive second-line therapies to avoid the medication, Dr Wendling concluded.
TABLE. Types of Drug Hypersensitivity Reactions
Type I Type II Type III Type IV
Mechanism IgE-mediated IgG-mediated and complement formation IgG or IgM and complement activation with immune complex deposition T-cell mediated
Onset Immediate Delayed Delayed Delayed
Outcome Anaphylaxis Cytopenia Serum sickness-like reaction Maculopapular rash
Ig, immunoglobulin
GUSELKUMAB IMPROVES SYMPTOMS OF PSORIASIS AND PSORIATIC ARTHRITIS
Guselkumab treatment was associated with durable, complete skin clearance through 5 years in patients with moderate to severe plaque psoriasis (PsO) and improved disease activity and axial symptoms through 1 year in adults with active psoriatic arthritis (PsA), according to findings presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held April 23 to April 25, 2021.
In the VOYAGE 2 trial, approximately 55.5% of patients who received guselkumab had complete skin clearance, as determined by an Investigator’s Global Assessment (IGA) score of 0, by week 252. Approximately 53% of patients had a Psoriasis Area Severity Index (PASI) 100 skin clearance response (PASI 100) by week 252. Up to 82% of patients achieved a PASI 90 skin clearance response and 85% had an IGA score of 0/1. Efficacy rates were maintained at 5 years.
In the DISCOVER-1 and -2 trials, patients with active PsA received either placebo or 100-mg guselkumab every 4 weeks and every 8 weeks. Treatment with guselkumab improved disease activity in the joints as well as across several different domains through 52 weeks. Differences in response rates between the active treatment and placebo groups were observed at 8 weeks of treatment.
In the VOYAGE 2 trial, a significantly greater percentage of patients who received guselkumab vs placebo for 16 weeks had an IGA 0/1 response (84% vs 9%, respectively; P <.001).
Safety data from the VOYAGE 1 and 2 trials showed that 78.3% of patients who received guselkumab continued treatment through week 252. Low rates of adverse events due to treatment discontinuation were reported.
INTRANASAL KETAMINE REDUCES PAIN IN REFRACTORY HEADACHE
Patients with refractory headache may benefit from treatment with intranasal ketamine spray, according to findings from a single-center retrospective study presented at the American Academy of Neurology 2021 Virtual Annual Meeting, held April 17 to April 22, 2021.
Patients (N=245) prescribed intranasal ketamine from January 2019 to February 2020 were identified by electronic medical records. A total of 168 of these patients participated in the telephone survey.
The patients had a mean age of 44.5 (±13.8) years and the majority (n=134) were women. The most frequently documented diagnosis was chronic migraine (83.9%; n=141) and most of the patients were currently using intranasal ketamine (63.7%; n=107).
The average usage of intranasal ketamine was 11.8 (±8.9) days per month. On each usage day, patients administered a mean of 7.9 (±6.9) sprays of ketamine. Average headache intensity was reported to be 7.6 (±1.7) on a 10-point scale prior to taking ketamine and 4.7 (±2.2) after administration (P <.01). Headache relief after spray occurred after an average of 74.1 minutes.
The patients indicated headache relief due to ketamine was successful 70.8% of the time and 71.4% (n=120) reported they used fewer additional acute medications for headache relief while using intranasal ketamine.
Adverse effects included fatigue (20.8%), blurred vision or diplopia (20.8%), nausea (15.5%), vivid dreams (10.1%), hallucinations (7.7%), vomiting (3%), tremor (2.4%), extreme fear (1.8%), and myoclonus (1.2%).
Study limitations included the singlecenter, retrospective design, and selfreported responses.
SPINAL CORD STIMULATION RELIEVES PAINFUL DIABETIC NEUROPATHY
Spinal cord stimulation (SCS) was associated with reduced pain intensity among patients with painful diabetic neuropathy, according to findings from a prospective, multicenter, randomized controlled trial presented at the American Academy of Neurology 2021 Virtual Annual Meeting, held April 17 to April 22, 2021.
Researchers recruited patients (N=216) with diabetes who were diagnosed with neuropathy at least 12 months previously, were refractory to medications, had lower limb pain intensity of 5 cm or more on a 0 to 10 cm visual analog scale, little upper limb pain (<3 cm), did not use more than 120-mg morphine equivalents per day, and had controlled hemoglobin A1c (≤10%).
Study participants were randomly assigned in a 1:1 ratio to receive 10 kHz SCS with conventional therapy (n=113) or usual therapy alone (n=103).
The average pain intensity was 7.6 and 7.0 cm at baseline in the treatment and control cohorts, respectively. At 6 months, pain intensity was 1.7 cm
Ketamine relieved headache pain 70.8% of the time, according to patient report.
Conference Roundup
among patients in the treatment group, 85% had at least 50% pain relief, and 2.3% had worsening pain (P <.001); in contrast, the pain intensity was 6.9 cm among patients in the control group, 6.3% had at least 50% pain relief, and 52% had worsening pain symptoms.
Improvements in neurologic examination results were found in 65.9% of patients who received SCS and 8.5% of patients in the control group (P <.001). Two patients who had been randomly assigned to the treatment group required device explants due to infection.
This study was limited by low sample size and short study duration.
DUPILUMAB AND TOPICAL CORTICOSTEROIDS IMPROVE ATOPIC DERMATITIS SYMPTOMS
A combination of dupilumab and medium- potency topical corticosteroids significantly improved signs and symptoms of atopic dermatitis (AD) and quality of life in children with severe AD, according to study results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held April 23 to April 25, 2021.
The LIBERTY AD PEDS phase 3 trial enrolled children from 6 to 11 years of age with severe AD. Participants were randomly assigned to receive 300 mg dupilumab every 4 weeks (n=61), 100 mg/200 mg every 2 weeks (baseline weight ≥30 kg: n=59), or placebo (baseline weight <30 kg: n=61; baseline weight ≥30 kg: n=62). Each treatment group also received concomitant medium- potency topical corticosteroids.
Study investigators assessed the percentage of patients who reached the 16-week composite endpoint comprising achievement of 50% or greater improvement in Eczema Area and Severity Index (EASI-50), 3-point or greater improvement in Peak Pruritus Numerical Rating Scale (PP-NRS) score, and 6-point or greater improvement in Children’s Dermatology Life Quality Index (CDLQI).
Nearly half of patients in the 300-mg (49.2%) and 200-mg (47.5%) dupilumab arms achieved all 3 clinically meaningful endpoints compared with 8.1% to 9.8% of patients in the placebo groups (P <.0001).
The safety profile of dupilumab was consistent with its known safety reported in adult and adolescent patient populations.
CAN VITAMIN D LOWER DIABETES RISK AND REDUCE CA PROGRESSION, MORTALITY?
New findings on the impact of vitamin D supplementation on type 2 diabetes risk, cancer mortality, and progressionfree cancer survival were presented at the annual meeting of the Endocrine Society (ENDO 2021), held virtually March 20 to March 23, 2021.
Anastassios G. Pittas, MD, from Tufts Medical Center in Boston, Massachusetts, found that vitamin D supplementation decreased the risk for progression to diabetes in people with prediabetes by approximately 13% in an analysis of 3 large trials.
Dr Pittas also found that the protective effect of supplementation may be higher among individuals with prediabetes who have low baseline 25-hydroxyvitamin D levels (<12 ng/mL) and that risk reduction was proportional to serum levels of 25-hydroxyvitamin D achieved.
Vitamin D Reduces Cancer Mortality Another study was designed to evaluate whether daily supplementation with vitamin D3 (2000 IU) and marine omega-3 fatty acids (1 g) can be used in the primary prevention of cancer and cardiovascular disease. The study was based on results of the nationwide, randomized, placebo-controlled, 2×2 factorial VITamin D and OmegA-3 TriaL (VITAL). The findings were presented by JoAnn E. Manson, MD, DrPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, Massachusetts.
The total study cohort included 25,871 men and women (men aged ≥50 years, women aged ≥55 years; 5106 Black individuals) over a median treatment period of 5.3 years. Although vitamin D supplementation did not significantly reduce the total incidence of invasive cancer, it was associated with a reduction in total cancer mortality. The association between supplementation and total cancer mortality was more pronounced when the analysis excluded years 1 and 2 to account for latency.
This data was not as promising for the other coprimary endpoints of major cardiovascular events (HR, 0.97), other cardiovascular endpoints (no HR available), and all-cause mortality (HR, 0.99).
“Additional research is needed to determine which individuals may be most likely to have a net benefit from vitamin D supplementation,” Dr Manson concluded.
Nearly half of patients in the dupilumab arms achieved all 3 clinically meaningful endpoints.
