Fibromyalgia & musculoskeletal pain
Efficacy and safety of rozanolixizumab in severe fibromyalgia: a phase 2A randomised, double-blind, placebo-controlled, multicentre trial
Primary result · BPI-SF interference score change from baselineResult — go to the resultLeast squares mean difference −0.5 80% one-sided CI −1.0 to −0.1Authors' conclusion
Rozanolixizumab did not demonstrate broad efficacy in this severe fibromyalgia population.
Study context
- Population
- Adults (18–70 years) with severe FM (BPI-SF interference score ≥6; 10-day mean daily Pain NRS ≥6 to <10), seven sites in north west England55 completed all phases
- Participants
- 63 adults
- Comparison
- Rozanolixizumab 560 mg sc once a week vs placebo
- Rozanolixizumab-rozanolixizumabn = 22
- Placebo-rozanolixizumabn = 20
- Placebo-placebon = 21reference
- Primary endpoint
- BPI-SF interference score mean change from baseline
- Follow-up
- 12 weeks
Methodological detailsphase 2A, multicentre, double-blind, placebo-controlled, single-blind placebo run-in and run-out, People with lived experience of fibromyalgia consulted on the study and reviewed study materials
- Phase 2A
- Multicentre
- Double-blind
- Placebo-controlled
- Single-blind placebo run-in and run-out
- People with lived experience of fibromyalgia consulted on the study and reviewed study materials
Primary result
BPI-SF interference score change from baseline
Least squares mean difference
−0.5
80% one-sided CI −1.0 to −0.1
P = 0.065
Rozanolixizumabvs Placebo
least squares mean difference −0.5 (80% one-sided CI −1.0 to −0.1); P = 0.065
As reported in the abstract
Safety
Headache (most common treatment-emergent adverse event) · First 12 weeks of double-blind treatment
Headache (most common treatment-emergent adverse event) · Second 12 weeks of double-blind treatment
- Headache (most common treatment-emergent adverse event): of 22 vs of 41 participants
- Headache (most common treatment-emergent adverse event): of 37 vs of 20 participants
Serious treatment-emergent adverse events with rozanolixizumab
- No serious treatment-emergent adverse events reported by participants receiving rozanolixizumab
Original publication
Efficacy and safety of rozanolixizumab in severe fibromyalgia: a phase 2A randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. Published 16 September 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →