Dados do Trabalho

Título

Efficacy and Safety Outcomes in Patients From Latin America With Moderate-to-Severe Atopic Dermatitis: A Post Hoc, Subgroup Analysis of the JADE REGIMEN Phase 3 Trial

Resumo

Rationale: Atopic dermatitis (AD) causes significant health care burden in Latin America (LATAM), a region with diverse populations. This post hoc analysis evaluated the maintenance of abrocitinib-induced response with uninterrupted treatment, dose reduction, or withdrawal and response to treatment reintroduction after flare in the LATAM subpopulation of the JADE REGIMEN trial (NCT03627767).
Methods: In JADE REGIMEN, patients with moderate-to-severe AD who responded to open-label abrocitinib 200 mg for 12 weeks (induction period) were randomized 1:1:1 to blinded abrocitinib (200 or 100 mg) or placebo for 40 weeks (maintenance period). Patients who had flare received rescue with abrocitinib 200 mg plus topical therapy. Analysis included data from the patient subset from LATAM (Argentina, Brazil, Chile, and Mexico) and evaluated the probability of flare (primary endpoint) and ≥75% improvement in Eczema Area and Severity Index (EASI-75) after rescue; safety was assessed by adverse event (AE) monitoring.
Results: Of 1233 patients treated in the induction period, 202 (16%) enrolled from LATAM (median age [interquartile range], 24 [18-33] years; moderate AD [Investigator’s Global Assessment=3], 59%); of those, 157 (78%) responded and were randomized to the maintenance period. The probability of flare by week 52 was 7% (95% CI, 2-20%), 28% (17-42%), and 72% (60-83%) for the abrocitinib 200-mg, abrocitinib 100-mg, and placebo arms, respectively. The proportions of patients who had flare in the abrocitinib 200-mg, abrocitinib 100-mg, and placebo arms, and recaptured EASI-75 at week 12 after rescue were 67% (95% CI, 13-100%), 93% (81-100%), and 94% (87-100%), respectively. In the maintenance period, 65% and 60% of patients experienced AEs in the abrocitinib 200- and 100-mg arms, respectively.
Conclusions: LATAM patients who participated in JADE REGIMEN had similar baseline characteristics and achieved similar efficacy with comparable safety with the overall enrolled population.