A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis

Summary

The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.

Timeline

Start

2015-09-14

Primary completion

2018-10-30

Completion

2018-10-30

Outcome

Met primary endpoint

registry analysis (superiority test); Ixekizumab vs Placebo; p <0.001; Log Rank NCT02584855 ↗

paper Continued ixekizumab therapy is superior to ixekizumab withdrawal in maintaining low disease activity in biologic treatment-naive patients with PsA. PMID 33682378 ↗

Publications

• Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.
• Coates LC, Pillai SG, Tahir H, Valter I, Chandran V, Kameda H, Okada M, Kerr L, Alves D, Park SY, Adams DH, Gallo G, Hufford MM, Hojnik M, Mease PJ, Kavanaugh A; SPIRIT-P3 Study Group. Withdrawing Ixekizumab in Patients With Psoriatic Arthritis Who Achieved Minimal Disease Activity: Results From a Randomized, Double-Blind Withdrawal Study. Arthritis Rheumatol. 2021 Sep;73(9):1663-1672. doi: 10.1002/art.41716. Epub 2021 Aug 6.
• Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ixekizumab	Monoclonal antibody	80 mg	Subcutaneous

Indications