Abrocitinib Prevents AD Flare at Similar Rates Among Adolescents and Adults

Abrocitinib is effective for flare prevention among adolescents and adults with atopic dermatitis (AD), according to results of a post hoc analysis published in the Journal of Dermatological Treatment.

Researchers conducted a post hoc analysis of data from JADE REGIMEN (ClinicalTrials.gov Identifier: NCT03627767), a multicenter, responder-enriched, double-blind, placebo-controlled, randomized withdrawal, phase 3 trial. Participants (N=1233) aged 12 years and older with moderate to severe AD who responded to induction with abrocitinib 200 mg were randomly assigned to receive abrocitinib 100 mg, abrocitinib 200 mg, or placebo for 40 weeks. The outcome of interest was flare, defined as a 50% or greater decrease in Eczema Area and Severity Index (EASI) score from week 12 plus a new Investigator’s Global Assessment (IGA) score of 2 points or greater.

Adolescents (n=246) and adults (n=987) were a mean age of 15.1 (SD, 1.8) and 35.7 (SD, 13.8) years, 54.9% were boys and 55.6% were men, 72.8% and 76.2% were White, median EASI scores were 30.0 (IQR, 21.6-40.9) and 27.5 (IQR, 20.8-27.0) points, and 43.5% and 40.2% had an IGA score of 4 points, respectively.

Among adolescents and adults, 49 and 216 received abrocitinib 100 mg, 47 and 219 received abrocitinib 200 mg, and 49 and 218 received placebo, respectively.

The proportion of patients who had disease flare was similar among adolescents and adults who received low-dose (42.9% vs 38.9%) and high-dose (14.9% vs 16.9%) abrocitinib or placebo (75.5% vs 78.0%), respectively. The cumulative probability of flare at week 52 was similar among low-dose (47.2% vs 42.8%) and high-dose (15.3% vs 19.6%) abrocitinib or placebo (79.7% vs 81.2%) recipients, respectively.

The median time to flare was 285.9 days for adolescents and 323.0 days for adults who received low-dose abrocitinib and 28.0 days among those who received placebo. Time to flare could not be estimated in the high-dose abrocitinib treatment arms.

No significant differences in the risk for flare between adolescents and adults were observed for low-dose (hazard ratio [HR], 1.16; 95% CI, 0.72-1.87) or high-dose (HR, 0.85; 95% CI, 0.38-1.90) abrocitinib or placebo (HR, 1.01; 95% CI, 0.71-1.44).

More adolescents who received low-dose abrocitinib (49.0% vs 39.4%) and a similar proportion who received high-dose abrocitinib (14.9% vs 16.9%) or placebo (77.6% vs 78.0%) entered the rescue period compared with adults, respectively. After 12 weeks of rescue with abrocitinib 200 mg plus topical treatments, numerically fewer adolescents recaptured EASI response (25.0%-52.6% vs 33.7%-58.0%), but more recaptured IGA response (42.9%-73.5% vs 34.3%-74.1%) compared with adults, respectively.

Limitations of the study include the small sample size of the adolescent group and imbalances in previous treatment characteristics between adolescents and adults.

The study authors conclude, “These results reinforce that treatment with abrocitinib using either induction with abrocitinib 200 mg followed by maintenance with reduced-dose abrocitinib 100 mg, or continuous dosing with abrocitinib 200 mg is an effective therapeutic approach in adults and adolescents with moderate-to-severe AD.”

Disclosures: This research was supported by Pfizer Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.