A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)
Summary
To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis \[AS\] and non-radiographic axial spondyloarthritis \[nr-axSpA\]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.
Timeline
- Start
- 2017-03-07
- Primary completion
- 2019-09-23
- Completion
- 2019-09-23
Outcome
Met primary endpoint
paper 43.8% (35/80; 32.7, 55.3) with brodalumab vs 24.1% (19/79; 15.1, 35.0) with placebo PMID 33827787 ↗
paper rate difference, 19.7% (5.3, 34.1); p=0.018 by stratified Cochran-Mantel-Haenszel test PMID 33827787 ↗
release “The percentage of axSpA subjects who achieved ASAS40 at Week 16 was 43.8% (n=35, 95%CI: 32.7, 55.3) in the brodalumab group and 24.1% (n=19, 95%CI: 15.1, 35.0) in the placebo group, and significantly higher in the brodalumab group than in the placebo group (p<0.05).” kyowakirin.com ↗
Publications
- Kim TH, Kishimoto M, Wei JC, Jeong H, Nozaki A, Kobayashi S. Brodalumab, an anti-interleukin-17 receptor A monoclonal antibody, in axial spondyloarthritis: 68-week results from a phase 3 study. Rheumatology (Oxford). 2023 May 2;62(5):1851-1859. doi: 10.1093/rheumatology/keac522.
- Wei JC, Kim TH, Kishimoto M, Ogusu N, Jeong H, Kobayashi S; 4827-006 study group. Efficacy and safety of brodalumab, an anti-IL17RA monoclonal antibody, in patients with axial spondyloarthritis: 16-week results from a randomised, placebo-controlled, phase 3 trial. Ann Rheum Dis. 2021 Aug;80(8):1014-1021. doi: 10.1136/annrheumdis-2020-219406. Epub 2021 Apr 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brodalumab | Monoclonal antibody | 210 mg | Subcutaneous |