Abrocitinib, a selective JAK1 inhibitor, has shown sustained efficacy in treating moderate-to-severe atopic dermatitis (AD) in adolescents and adults, according to interim results from the JADE REAL study. The multicenter, open-label, expanded access protocol provided abrocitinib to patients for whom approved topical and systemic AD medications were inadequate. The study's findings, presented at the 2024 Revolutionizing Atopic Dermatitis Mid-Year Virtual Update, highlight the potential of abrocitinib in real-world clinical settings.
JADE REAL Study Design
The JADE REAL analysis (NCT04564755) was conducted across multiple countries, including the US, Austria, Australia, Canada, and the Netherlands. The study aimed to provide early access to abrocitinib, an oral, once-daily JAK1-selective inhibitor, for patients with moderate-to-severe AD who had not responded adequately to available treatments. Participants received either 100 mg or 200 mg of abrocitinib daily, with dosage adjustments permitted throughout the treatment period. Concomitant use of topical treatments for AD was also allowed.
The primary objective was to assess the efficacy and safety of abrocitinib over an extended period, with data collected until participants chose to leave the study, the drug became locally available, or the sponsor discontinued the study in their country. Efficacy evaluations included changes from baseline in Eczema Area and Severity Index (EASI) total scores, Peak Pruritus Numerical Rating Scale (PP-NRS), body surface area (BSA) involvement, and Patient-Oriented Eczema Measure (POEM) scores.
Key Findings at 72 Weeks
The interim analysis included data from 277 participants, excluding those from Australia and Belgium due to the expanded access program remaining active in those regions. The median age of participants was 34 years (range: 12-84 years), with 12.3% being 65 years or older. Among those who reported their racial categories, 70% were White and 15.5% were Black or African American. A significant proportion (56%) had previously used at least one systemic therapy, including dupilumab (23.8%), corticosteroids (25.6%), or cyclosporine (5.8%).
After 72 weeks, participants demonstrated substantial improvements across all measured efficacy endpoints. The average reduction in EASI total scores was 80.3%, indicating a significant decrease in overall eczema severity. Patients also experienced a 5.5-point reduction in PP-NRS, reflecting reduced itch intensity. Furthermore, there was a 76.1% reduction in %BSA involvement and a 13.3-point reduction in POEM scores, demonstrating improvements in the extent of affected skin and patient-reported outcomes, respectively.
Safety Profile
Treatment-emergent adverse events (TEAEs) were reported in approximately 78% of participants. More severe TEAEs were observed in 4.7% of cases, and serious adverse events occurred in 5.4%. A total of 7.9% of participants discontinued abrocitinib treatment due to adverse events but remained in the study, while 2.9% concluded the study entirely as a result of TEAEs. The most commonly reported TEAEs were COVID-19 (17.7%) and nausea (15.9%), with nearly all cases of nausea and all but one case of COVID-19 being mild or moderate in severity.
Clinical Implications
The JADE REAL study provides valuable insights into the long-term efficacy and safety of abrocitinib in a real-world setting. The observed improvements in disease severity and patient-reported outcomes highlight the potential of abrocitinib as a valuable treatment option for individuals with moderate-to-severe atopic dermatitis who have not responded adequately to other therapies. The study authors noted that the results may reflect real-world use of abrocitinib, with dose selection and adjustments made by individual healthcare professionals based on patient needs. They also observed that a higher proportion of patients initially receiving 200 mg of abrocitinib required dose adjustments compared to those receiving 100 mg.
