Abrocitinib Is a Safe, Effective Treatment for Patients With Atopic Dermatitis

Abrocitinib met efficacy and safety endpoints in a post hoc analysis of the phase 3 JADE COMPARE trial, supporting its use as a treatment for severe and/or difficult-to-treat atopic dermatitis, according to authors of a study published in the American Journal of Clinical Dermatology.

Through this analysis, researchers hoped to assess the efficacy and safety of once-daily oral abrocitinib administered at a dose of 200 mg or 100 mg vs subcutaneous injections of dupilumab 300 mg every 2 weeks or placebo in a subset of patients with severe and/or difficult-to-treat atopic dermatitis. All patients received concomitant medicated topical therapy.

The JADE COMPARE was a multicenter, randomized, double-blind, double-dummy, placebo-controlled, phase 3 trial evaluating the efficacy and safety of abrocitinib and of dupliumab vs placebo in adult patients with moderate-to-severe atopic dermatitis. The researchers categorized subgroups of patients with atopic dermatitis as having severe or hard-to-treat disease based on certain characteristics identified at the beginning of the study. These included Investigator’s Global Assessment (IGA) score of 4; Eczema Area and Severity Index (EASI) score greater than 21; failure of or intolerance to previous systemic agents (excluding patients who received only corticosteroids); percentage of body surface area (% BSA) greater than 50; upper quartile of EASI (EASI score >38) and % BSA (% BSA >65); and a combined subgroup of IGA 4, EASI score over 21, % BSA greater than 50, and failure of previous systemic agents or patient intolerance to them (excluding patients treated just with corticosteroids).

During the study, patients were evaluated using various instruments, including the IGA score of 0 (clear) or 1 (almost clear) and an improvement of 2 or more points from baseline, 75% or greater and 90% or greater improvement from baseline in EASI (EASI-75 and EASI-90), improvement of 4 or more points from baseline in the Peak Pruritus-Numerical Rating Scale (PP-NRS4), time to PP-NRS4, least squares mean (LSM) change from baseline in 14-day PP-NRS (days 2–15), Patient-Oriented Eczema Measure (POEM), and Dermatology Life Quality Index (DLQI) up to week 16.

More patients achieved an IGA score of 0/1, EASI-75, and EASI-90 responses with abrocitinib at 200 mg compared with placebo (P <.05) across all subgroups with severe and/or difficult-to-treat atopic dermatitis.

In all subgroups, abrocitinib at 200 mg was also associated with a significant increase in patients achieving an IGA 0/1 response (clear or almost clear) compared with placebo (nominal P <.05). Among those treated with abrocitinib at 100 mg, there was also a significant increase in the number of patients achieving an IGA 0/1 response compared with placebo, with the exception of the EASI greater than 38 and combined groups. The patients treated with dupilumab also showed a significant increase in IGA 0/1 response compared with placebo in all subgroups, except for the combined group, based on 95% confidence intervals for estimated differences. A significant difference was observed between abrocitinib 200 mg and dupilumab in those with an IGA score of 4 (severe AD), with an estimated difference of 16.4% (P <.03).

Across most subgroups, the Peak Pruritus-Numerical Rating Scale (PP-NRS4) response was larger with abrocitinib 200 mg than with abrocitinib 100 mg, dupilumab, and placebo. The treatment duration upon which patients achieved these responses ranged from 4.5 to 6 days with abrocitinib 200 mg, to 5 to 17 days with abrocitinib 100 mg, to 8 to 11 days with dupilumab, and 3 to 11.5 days with placebo.

The LSM change in POEM and DLQI from baseline was notably higher with abrocitinib 200 mg than with placebo (with a nominal P <.001) across all subgroups.

Abrocitinib was associated with a higher rate of treatment-emergent adverse events (TEAEs) — 65.9% for the 200-mg dose and 49.7% for the 100-mg dose — compared with placebo at 55.6% and dupilumab at 51.9%. Nausea and nasopharyngitis were the most common TEAEs among patients treated with abrocitinib, whereas the percentage of patients with conjunctivitis was higher with dupilumab (7.1%) than with abrocitinib 200 mg (1.7%), abrocitinib 100 mg (0.0%), or placebo (2.0%).

The post hoc assessment and short treatment duration are the main limitations of this study.

The authors concluded, “Abrocitinib 200 mg provided rapid and substantially greater improvements in itch, skin clearance, and quality of life compared with placebo and dupilumab in patients with severe and/or difficult-to-treat atopic dermatitis, including those who had failed or were intolerant to previous systemic therapy.”

Disclosure: This research was supported by Pfizer. Please see the original reference for a full list of disclosures.

This article originally appeared on Dermatology Advisor