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Upadacitinib Safe, Effective Therapy for Patients With AD in Comparator Trial
Upadacitinib demonstrated better efficacy in patients with moderate to severe atopic dermatitis (AD) compared with dupilumab and is a safe treatment option, according to a study by Blauvelt et al in JAMA Dermatology.
Researchers performed a 24-week, head-to-head, phase 3b, multicenter, randomized, double-blinded, double-dummy, active-controlled clinical trial (Heads Up) that compared the safety and efficacy of upadacitinib with dupilumab among 692 adults with moderate to severe AD who were candidates for systemic therapy. Patients were randomized to receive oral upadacitinib (30 mg once daily) or subcutaneous dupilumab (300 mg every other week). The primary end point was 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16, and secondary endpoints were percentage change in pruritus and proportion of patients achieving improvements in EASI (100, 90, and 75).
The trial included 348 patients in the upadacitinib arm and 344 patients in the dupliumab arm. Patients who achieved EASI 75 at week 16 was significantly greater for patients receiving upadacitinib than those receiving dupilumab (247 [71.0%] vs 210 [61.1%]). All ranked secondary endpoints (ie, pruritus and EASI) showed superiority for upadacitinib, including 27.9% of patients achieving EASI 100 at week 16 receiving upadacitinib vs only 7.6% receiving dupliumab.
In addition, upadacitinib was observed to be safe. Serious treatment-emergent adverse events (AEs) and AEs leading to drug discontinuation were 2.9% and 2.0% for upadacitinib and 1.2% and 1.2% for dupilumab, respectively.
“During 16 weeks of treatment, upadacitinib demonstrated superior efficacy vs dupilumab in patients with moderate-to-severe AD, with no new safety signals,” concluded the study authors.
Reference
Blauvelt A, Teixeira HD, Simpson EL, et al. Efficacy and safety of upadacitinib vs dupilumab in adults with moderate-to-severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol. Published online August 4, 2021. doi:10.1001/jamadermatol.2021.3023
