Study summary

The first pill for dermatomyositis improved muscle, skin and steroid use

VALOR trial (brepocitinib) · 241 people, phase 3 · Published March 2026, New England Journal of Medicine; FDA approved August 2026 (30 mg)

What was tested

Brepocitinib, a once-daily pill that blocks TYK2 and JAK1 (immune signaling enzymes), at 15 mg or 30 mg, against placebo, for adults with dermatomyositis that had resisted earlier treatment.

What they found

• Total Improvement Score at week 52: 46.5 with 30 mg vs 31.2 with placebo; the 15 mg dose was not significantly better.
• The 30 mg dose beat placebo on all nine secondary goals, including skin disease and steroid tapering.
• Serious infections were more common (10% vs 1%).

What it means

The first oral drug approved for dermatomyositis, after IVIg in 2021.