Efficacy, safety, and target engagement of dazukibart, an IFNβ specific monoclonal antibody, in adults with dermatomyositis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial
Primary result · Mean change from baseline in CDASI-A, FAS stage 1Result — go to the resultPlacebo-adjusted difference −14.8 90% CI −20.3 to −9.4Authors' conclusion
Dazukibart resulted in a pronounced reduction in disease activity and was generally well tolerated
Study context
- Population
- Adults aged 18–80 years with moderate-to-severe DM: skin-predominant (CDASI-A ≥14, ≥1 unsuccessful systemic treatment) or muscle-predominant (active moderate muscle involvement); 25 sites in Germany, Hungary, Poland, Spain and the USArandomly assigned and treated
- Participants
- 75 adults
- Comparison
- Dazukibart 600 mg or 150 mg IV every 4 weeks vs placebo
- Dazukibart 600 mgn = 37
- Dazukibart 150 mgn = 15
- Placebon = 23reference
- Primary endpoint
- Skin-predominant cohorts: change from baseline in CDASI-A score (full analysis set (FAS) stage 1 and pooled skin FAS); muscle-predominant cohort: safety
- Follow-up
- Week 12
Methodological detailsphase 2, multicentre, double-blind, placebo-controlled, Stages 1, 2 and 2a (skin-predominant) and stage 3 (muscle-predominant); in stages 2a and 3 treatments switched at week 12
- Phase 2
- Multicentre
- Double-blind
- Placebo-controlled
- Stages 1, 2 and 2a (skin-predominant) and stage 3 (muscle-predominant); in stages 2a and 3 treatments switched at week 12
Primary result
As reported in the abstract
Mean change from baseline in CDASI-A, FAS stage 1
Placebo-adjusted difference
−14.8
90% CI −20.3 to −9.4
P < 0.0001
Change by group
Dazukibart 600 mg
−18.8
mean · 90% CI −21.8–-15.8
Dazukibart 600 mgvs Placebo
placebo-adjusted difference −14.8 (90% CI −20.3 to −9.4); P < 0.0001
Further findings
Mean
| Outcome | Dazukibart 600 mg | Dazukibart 150 mg | Placebo-adjusted difference (90% CI) | P value | |
|---|---|---|---|---|---|
| Mean change from baseline in CDASI-A, pooled skin FAS (co-primary) · week 12Dazukibart 600 mgvs Placebo | −19.2 (90% CI −21.5–-16.8) | −16.6 (90% CI −19.8–-13.4) | −16.3 (−20.4 to −12.1) | P < 0.0001 | |
| Mean change from baseline in CDASI-A, pooled skin FAS (co-primary) · week 12Dazukibart 150 mgvs Placebo | −13.7 (−18.3 to −9.0) | P < 0.0001 | |||
| −30−20−10010Difference (linear scale) |
Death
- One patient in stage 3 (dazukibart 600 mg then placebo) died during follow-up due to haemophagocytic lymphohistiocytosis and macrophage activation syndrome
- 1
Safety
Treatment-emergent adverse events
Infections and infestations (most common TEAE)
| Outcome | Dazukibart 600 mg | Dazukibart 150 mg | Placebo |
|---|---|---|---|
| Serious adverse events | — not stated in the abstract | 11% | 4% |
— not stated in the abstract
Original publication
Efficacy, safety, and target engagement of dazukibart, an IFNβ specific monoclonal antibody, in adults with dermatomyositis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. Lancet. Published 11 January 2025. doi:10.
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