Vasculitis & polymyalgia rheumatica
Efficacy, Safety, Pharmacokinetics, and Immunogenicity of ABBV ‐154 in Adults With Glucocorticoid‐Dependent Polymyalgia Rheumatica: A Phase 2, Randomized, Double‐Blind, Placebo‐Controlled Trial
Authors' conclusion
Treatment effects were observed for ABBV-154 cohorts compared with placebo for time to flare. ABBV-154 was generally well tolerated.
Study context
- Population
- Adults with GC-dependent PMR: confirmed PMR, GC response and ≥2 unequivocal PMR flares while tapering GC and still on ≥5 mg daily prednisone equivalent67.4% completed study drug at week 24
- Participants
- 181 adults
- Comparison
- ABBV-154 40, 150 or 340 mg SC every other week vs placebo
- Primary endpoint
- Time to flare
Methodological detailsphase 2, double-blind, placebo-controlled, dose-ranging
- Phase 2
- Double-blind
- Placebo-controlled
- Dose-ranging
Primary result
As reported in the abstract
Hazard ratio (95% CI)P value
40 mgvs Placebo
0.49(0.27–0.88)
P = 0.017150 mgvs Placebo
0.44(0.25–0.79)
P = 0.006340 mgvs Placebo
0.20(0.09–0.42)
P < 0.001Safety
Treatment-emergent adverse events
- Most common TEAE across ABBV-154 cohorts: COVID-19
- 16.0%
- Incidences similar between groups
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Efficacy, Safety, Pharmacokinetics, and Immunogenicity of ABBV ‐154 in Adults With Glucocorticoid‐Dependent Polymyalgia Rheumatica: A Phase 2, Randomized, Double‐Blind, Placebo‐Controlled Trial. Arthritis Rheumatol. Published 2 April 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →