16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis

Summary

The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy

Timeline

Start

2015-05-29

Primary completion

2016-02-16

Completion

2017-12-19

Outcome

Met primary endpoint

registry analysis (superiority test); Secukinumab 150 mg No Load vs Placebo; p = 0.0002; Odds Ratio (OR) 3.07 (95% CI 1.66 to 5.66); Chi-squared NCT02294227 ↗

registry analysis (superiority test); Secukinumab 150 mg vs Placebo; p = 0.0003; Odds Ratio (OR) 3.24 (95% CI 1.76 to 5.97); Chi-squared, Corrected NCT02294227 ↗

paper The primary end point was met; PMID 31228101 ↗

Publications

• Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Secukinumab in Patients with Psoriatic Arthritis at 52 Weeks Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):817-828. doi: 10.1007/s40744-024-00652-7. Epub 2024 Mar 6.
• Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.
• Kivitz AJ, Nash P, Tahir H, Everding A, Mann H, Kaszuba A, Pellet P, Widmer A, Pricop L, Abrams K. Efficacy and Safety of Subcutaneous Secukinumab 150 mg with or Without Loading Regimen in Psoriatic Arthritis: Results from the FUTURE 4 Study. Rheumatol Ther. 2019 Sep;6(3):393-407. doi: 10.1007/s40744-019-0163-5. Epub 2019 Jun 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Secukinumab	Monoclonal antibody	150 mg	Subcutaneous
Subject	Secukinumab	Monoclonal antibody	300 mg	Subcutaneous

Indications