Efficacy and Safety of Subcutaneous Abatacept Plus Standard Treatment for Active Idiopathic Inflammatory Myopathy: Phase 3 Randomized Controlled Trial
Authors' conclusion
The proportion of patients who met improvement criteria after 24 weeks was similar between abatacept and placebo groups.
Study context
- Population
- Patients with treatment-refractory idiopathic inflammatory myopathy (IIM)133 treated in open-label period
- Participants
- 148 patients
- Comparison
- SC abatacept 125 mg weekly plus standard of care (SOC) vs placebo plus SOC
- Primary endpoint
- IMACS definition of improvement (IMACS DOI)
- Follow-up
- Week 24
Methodological detailsdouble-blind, placebo-controlled, phase III, 24-week double-blind period followed by open-label period to 52 weeks
- Double-blind
- Placebo-controlled
- Phase III
- 24-week double-blind period followed by open-label period to 52 weeks
Primary result
As reported in the abstract
Improvement per IMACS DOI · 24 weeks
P = 0.083
Secondary outcomes
Improvement per IMACS DOI (open-label) · 52 weeks · continued abatacept vs placebo-to-abatacept switch
IMACS DOI rate, non-DM subtype (subgroup) · 24 weeks
P = 0.040
IMACS DOI rate, DM subtype (subgroup) · 24 weeks
P = 0.679
Safety
- Observed safety profile similar in both groups
Original publication
Efficacy and Safety of Subcutaneous Abatacept Plus Standard Treatment for Active Idiopathic Inflammatory Myopathy: Phase 3 Randomized Controlled Trial. Arthritis Rheumatol. Published 21 February 2025. doi:10.
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