A Phase 3 Trial of Brepocitinib in Dermatomyositis - PubMed
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- #dermatomyositis
- #brepocitinib
- #clinical trial
- A phase 3 trial of brepocitinib, an oral TYK2-JAK1 inhibitor, for dermatomyositis involved 241 adults randomized to 30 mg, 15 mg, or placebo for 52 weeks.
- At week 52, the mean Total Improvement Score was 46.5 for brepocitinib 30 mg, 37.5 for 15 mg, and 31.2 for placebo, with 30 mg showing superiority over placebo (difference 15.3, P<0.001).
- Brepocitinib 30 mg outperformed placebo on all key secondary endpoints, including skin disease activity, glucocorticoid tapering, and functional disability, with improvements seen as early as week 4.
- Serious infections were more frequent with brepocitinib 30 mg (10%) compared to placebo (1%), though no deaths occurred during the trial.
- Conclusions indicate brepocitinib 30 mg, but not 15 mg, provided significant benefits in composite myositis index, skin severity, glucocorticoid tapering, and functional disability for treatment-resistant dermatomyositis.