Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement
Summary
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).
Timeline
- Start
- 2016-10-03
- Primary completion
- 2019-06-26
- Completion
- 2019-06-26
Outcome
Met primary endpoint
paper Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). PMID 33334727 ↗
registry analysis (superiority test); AIN457 300mg vs Placebo AIN457; p <.0001; Odds Ratio (OR) 3.83 (95% CI 2.41 to 6.10); Regression, Logistic NCT02721966 ↗
registry analysis (superiority test); AIN457 150mg vs Placebo AIN457; p <.0001; Odds Ratio (OR) 4.37 (95% CI 2.72 to 7.01); Regression, Logistic NCT02721966 ↗
Publications
- Baraliakos X, Pournara E, Coates LC, Navarro-Compan V, Blanco R, O'Brien E, Schulz B, Landewe R. Magnetic resonance imaging characteristics in patients with psoriatic arthritis and axial manifestations from the MAXIMISE cohort. Rheumatology (Oxford). 2024 Jan 4;63(1):85-92. doi: 10.1093/rheumatology/kead162.
- Baraliakos X, Gossec L, Pournara E, Jeka S, Mera-Varela A, D'Angelo S, Schulz B, Rissler M, Nagar K, Perella C, Coates LC. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021 May;80(5):582-590. doi: 10.1136/annrheumdis-2020-218808. Epub 2020 Dec 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |