Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
Summary
The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
Timeline
- Start
- 2011-08-30
- Primary completion
- 2015-09-09
- Completion
- 2015-09-09
Outcome
Met primary endpoint
registry AIN457 10mg/Kg-75mg vs Placebo; p = 0.0004; Odds Ratio (OR) 2.21 (95% CI 1.4 to 3.4) NCT01377012 ↗
registry AIN457 10mg/Kg-150mg vs Placebo; p = 0.0004; Odds Ratio (OR) 2.21 (95% CI 1.4 to 3.4) NCT01377012 ↗
paper The primary efficacy endpoint was met with both secukinumab dose groups: PMID 29138986 ↗
paper ACR20 response rate at week 24 was 35.2% for both secukinumab dose groups (P = 0.0009) vs 19.6% for placebo. PMID 29138986 ↗
Publications
- Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.
- Tahir H, Deodhar A, Genovese M, Takeuchi T, Aelion J, Van den Bosch F, Haemmerle S, Richards HB. Secukinumab in Active Rheumatoid Arthritis after Anti-TNFalpha Therapy: A Randomized, Double-Blind Placebo-Controlled Phase 3 Study. Rheumatol Ther. 2017 Dec;4(2):475-488. doi: 10.1007/s40744-017-0086-y. Epub 2017 Nov 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Secukinumab | Monoclonal antibody | 75 mg | Intravenous |
| Subject | Secukinumab | Monoclonal antibody | 150 mg | Intravenous |