A Phase 3 Trial of Brepocitinib in Dermatomyositis
Authors' conclusion
In adults with dermatomyositis that was resistant to previous therapy, the use of brepocitinib at a dose of 30 mg (but not at a dose of 15 mg) resulted in significant benefits with respect to a composite myositis index, skin disease severity, glucocorticoid tapering, and functional disability.
Study context
- Population
- Adults with DM
- Participants
- 241 adults
- Comparison
- Once-daily oral brepocitinib 30 mg or 15 mg vs placebo for 52 weeks
- Brepocitinib 30 mgn = 81
- Brepocitinib 15 mgn = 81
- Placebon = 79reference
- Primary endpoint
- Total Improvement Score, a validated composite myositis index (0 to 100, higher scores indicating greater improvement)
- Follow-up
- Week 52
Methodological detailsphase 3, double-blind, placebo-controlled, 1:1:1 randomisation
- Phase 3
- Double-blind
- Placebo-controlled
- 1:1:1 randomisation
Primary result
As reported in the abstract
Total Improvement Score, mean
Brepocitinib 30 mg
46.5
mean
Brepocitinib 15 mg
37.5
mean
Placebo
31.2
mean
Each group vs placeboDifference (95% CI)P value
Brepocitinib 30 mg
15.3(6.7–24.0)
P < 0.001Brepocitinib 15 mg
6.3(−2.4 to 14.9)
Secondary outcomes
Nine key secondary end points (incl. skin disease activity, systemic GC tapering, functional disability), multiplicity-controlled
- Brepocitinib 30 mg superior to placebo across all nine key secondary end points, with improvements as early as week 4
Deaths
- No deaths occurred during the trial
Safety
| Outcome | Brepocitinib 30 mg | Placebo |
|---|---|---|
| Serious infections | 10% | 1% |
Original publication
A Phase 3 Trial of Brepocitinib in Dermatomyositis. N Engl J Med. Published 28 March 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →