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NEJM Publication Confirms Phase 3 Win for Brepocitinib in Dermatomyositis

The FDA is conducting a Priority Review with a decision expected in the third quarter of 2026.

Overview

  • VALOR’s Phase 3 results, published Saturday in NEJM and presented at the AAD meeting, showed the 30 mg dose improved the mean Total Improvement Score by 15.3 points over placebo at Week 52.
  • The 30 mg dose outperformed placebo on all nine key secondary endpoints, and nearly twice as many patients were able to taper background corticosteroids.
  • Skin symptoms eased quickly, with an 18.9% greater share achieving itch remission by Week 4 and higher cutaneous remission at Week 52 for those with more severe skin disease.
  • Safety trade-offs emerged, with serious infections reported in 10% on 30 mg versus 1% on placebo and more discontinuations on 30 mg, though most infections resolved with treatment.
  • The trial enrolled 241 adults across 90 global sites and tested 30 mg, 15 mg, and placebo, and an open-label extension is ongoing to gather longer-term safety and real-world tapering data.