Overview

• At week 52, the 30 mg dose achieved a mean Total Improvement Score of 46.5 versus 31.2 for placebo (p=0.0006), meeting the primary endpoint.
• Brepocitinib showed benefit across all nine key secondary measures with a dose‑response favoring 30 mg, with differences detectable as early as week 4.
• Among participants on background steroids, 62% on 30 mg tapered to ≤2.5 mg/day and 42% stopped steroids, compared with 34% and 23% on placebo.
• Investigators described a safety profile consistent with prior studies, noting more infections but no cardiovascular events from blood clots in the trial.
• The 241‑patient, three‑arm, 52‑week study underpins what the companies call the first positive registrational result for a targeted therapy in dermatomyositis, with an NDA planned for the first half of 2026.