Spondyloarthritis & psoriatic arthritis
Brodalumab, an anti–interleukin-17 receptor A monoclonal antibody, in axial spondyloarthritis: 68-week results from a phase 3 study
Authors' conclusion
Brodalumab demonstrated sustained efficacy and a consistent safety profile in patients with axSpA over 68 weeks.
Study context
- Population
- Patients with axial spondyloarthritis (axSpA), Japan, Korea and Taiwanreceived brodalumab in open-label extension
- Participants
- 145 patients
- Comparison
- Continued brodalumab 210 mg vs placebo switched to brodalumab 210 mg at week 16
- Brodalumabn = 77
- Placebon = 68reference
Methodological detailsmulticentre, phase 3, 16-week double-blind period, 52-week open-label extension
- Multicentre
- Phase 3
- 16-week double-blind period
- 52-week open-label extension
Primary result
As reported in the abstract
ASAS 40 response rate · week 68
Further findings
| Outcome | Brodalumab | Placebo |
|---|---|---|
| ASAS 20 response rate · week 68 | 71.3% (95% CI 60.0%–80.8%) | 78.7% (95% CI 66.3%–88.1%) |
| Change from baseline in ASDAS-CRP (least squares mean) · week 68Least squares mean change | −1.528 (95% CI −1.737–-1.319) | −1.586 (95% CI −1.815–-1.357) |
ASAS 20 response rate · week 68
- Similar in both treatment groups
Change from baseline in ASDAS-CRP (least squares mean) · week 68
- Clinically important improvement (change, ≥1.1) in both treatment groups
Safety
Exposure-adjusted event rates (per 100 patient-years), overall
- Treatment-emergent adverse events (TEAEs)
- 255.9
- Drug-related TEAEs
- 147.9
- Nasopharyngitis (most common TEAE)
- 35.6
- Upper respiratory tract infection
- 14.7
Original publication
Brodalumab, an anti–interleukin-17 receptor A monoclonal antibody, in axial spondyloarthritis: 68-week results from a phase 3 study. Rheumatology (Oxford). Published 21 September 2022. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →