Long-term Safety and Efficacy of Dazukibart in Dermatomyositis: Combined Phase 2 Results from Double-blind and Open-Label Extension Studies.

Authors

Ruth Ann Vleugels, Elena Peeva, Rohit Aggarwal, Myron Chu, Abigail Sloan, Natalie Rath, Emily Mangialardi, David Fiorentino

Published in

The Journal of rheumatology. Aug 01, 2026. Epub Aug 01, 2026.

Abstract

To evaluate long-term safety and efficacy of dazukibart, a novel anti-interferon beta monoclonal antibody, in adults with moderate-to-severe dermatomyositis (DM).
Participants from two cohorts of DM (skin-predominant, SP and muscle-predominant, MP), completing a 24-week phase 2, double-blind study, were enrolled into a 52-week phase 2b, open-label extension (OLE) study, with a 16-week follow-up post treatment (combined study: 92 weeks). Pooled skin-analysis set included all SP and MP DM (with baseline CDASI-A [Cutaneous Dermatomyositis Disease Area and Severity Index-Activity]≥ 14) participants. Primary endpoint was incidence of treatment-emergent adverse events (TEAEs; weeks 24-92). Key secondary endpoints were change in CDASI-A and Total Improvement Score (TIS) (weeks 0-92).
Participants who received ≥ 1 dose of dazukibart (600 mg) during the OLE study (n = 9 [SP], 15[MP], 16[pooled skin-analysis set]) were analyzed (median age- 49.5 years; 83% females; 96% White). Treatment-related TEAEs were mild (55%), moderate (38%), or severe (7%), with no treatment-related serious adverse events or treatment discontinuations. At week 76, CDASI-A scores improved, with median change from baseline of -24.0 (range -33 to -12; SP), -9.0 (range -32 to 1; MP), and -23.5 (range -33 to -12; pooled skin-analysis set). In the MP cohort, TIS (65.0 [range 2.5 to 9.5]) and associated core set measures (including patient-reported outcomes) improved at week 76. Overall, the observed improvements (slight reduction) in outcomes persisted during the 16-week post-treatment follow-up.
The safety and efficacy profiles of dazukibart observed at 24 weeks were sustained through 92 weeks.

PMID:
42542380
Bibliographic data and abstract were imported from PubMed on 02 Aug 2026.

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