Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).

Timeline

Start

2015-03-27

Primary completion

2016-05-31

Completion

2017-01-17

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Guselkumab; p <0.001; Percent difference 39.7 (95% CI 25.3 to 54.1); Cochran-Mantel-Haenszel NCT02319759 ↗

Publications

• Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.
• Rahman P, Boehncke WH, Mease PJ, Gottlieb AB, McInnes IB, Shawi M, Wang Y, Sheng S, Kollmeier AP, Theander E, Yu J, Leibowitz E, Marrache AM, Coates LC. Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. J Rheumatol. 2023 Jun;50(6):769-780. doi: 10.3899/jrheum.220928. Epub 2023 Jan 15.
• Mease PJ, Gladman DD, Deodhar A, McGonagle DG, Nash P, Boehncke WH, Gottlieb A, Xu XL, Xu S, Hsia EC, Karyekar CS, Helliwell PS. Impact of guselkumab, an interleukin-23 p19 subunit inhibitor, on enthesitis and dactylitis in patients with moderate to severe psoriatic arthritis: results from a randomised, placebo-controlled, phase II study. RMD Open. 2020 Jul;6(2):e001217. doi: 10.1136/rmdopen-2020-001217.
• Helliwell PS, Deodhar A, Gottlieb AB, Boehncke WH, Xu XL, Xu S, Wang Y, Hsia EC, Gladman DD, Ritchlin CT. Composite Measures of Disease Activity in Psoriatic Arthritis: Comparative Instrument Performance Based on the Efficacy of Guselkumab in an Interventional Phase II Trial. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1579-1588. doi: 10.1002/acr.24046.
• Deodhar A, Gottlieb AB, Boehncke WH, Dong B, Wang Y, Zhuang Y, Barchuk W, Xu XL, Hsia EC; CNTO1959PSA2001 Study Group. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2018 Jun 2;391(10136):2213-2224. doi: 10.1016/S0140-6736(18)30952-8. Epub 2018 Jun 1.

Drugs

Indications