Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies

Abstract

Background: The efficacy and safety of ixekizumab (IXE) with and without continuous concomitant methotrexate (MTX), for up to 52 weeks of treatment, were evaluated in patients with active psoriatic arthritis (PsA).

Methods: Patients with active PsA who were biologic-naive (SPIRIT-P1) or had prior inadequate response to tumor necrosis factor inhibitors (SPIRIT-P2) were randomized to 80 mg IXE every 4 (IXE Q4W) or 2 weeks (IXE Q2W), after a 160-mg initial dose. In this post hoc analysis, efficacy and safety were assessed up to week 52 in the subgroups of patients who received (i) IXE as monotherapy and (ii) IXE along with a stable dose of MTX (no dose tapering or increase). Efficacy outcomes included, but were not limited to, the percentage of patients achieving the American College of Rheumatology (ACR) responses.

Results: Out of 455 patients initially randomized to IXE, 177 (38.9%) received monotherapy, 230 (50.5%) had concomitant MTX use, and 48 (10.5%) had other concomitant medication. Overall, 183 (40.2%) received IXE with a stable dose of concomitant MTX for 1 year. At week 52, the percentage of patients achieving ACR20/50/70 responses in IXE Q4W monotherapy versus concomitant MTX groups were 66.3% versus 55.3%, 48.4% versus 38.8%, and 35.8% versus 27.1%, respectively; these responses were generally similar with IXE Q2W. The safety profiles were similar between patients receiving IXE with or without concomitant MTX.

Conclusions: In this post hoc analysis, treatment with IXE demonstrated sustained efficacy in patients with PsA up to 1 year of treatment, with or without concomitant MTX therapy.

Trial registration: ClinicalTrials.gov NCT01695239 and NCT02349295 .

Keywords: Ixekizumab; Methotrexate; Psoriatic arthritis; cDMARDs.

Conflict of interest statement

BC has received grant/research support and/or is on the speakers bureau for and/or is a consultant for AbbVie, BMS, Eli Lilly and Company, Gilead, Janssen, MSD, Novartis, Pfizer, Roche-Chugai, and UCB; T-FT is a consultant for and/or is on the speakers bureau for AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly and Company, GSK-Stiefel, Janssen-Cilag, Novartis, and Pfizer; JEH is a consultant for and/or is on the speakers bureau for Eli Lilly and Company, Genentech, Janssen, Pfizer, and Regeneron; ATS, C-YL, SYP, AK, and MMH are current employees and shareholders of Eli Lilly and Company; PN is a consultant for AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB; is on the speakers bureau of: AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB; and has received research funding from AbbVie, Amgen, BMS, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, and UCB.

Figures

Fig. 1

ACR20/50/70 responses with IXE with or without concomitant MTX after 52 weeks of treatment. Abbreviations: ACR20/50/70 American College of Rheumatology criteria 20%/50%/70% improvement, cDMARD conventional disease-modifying antirheumatic drug, IXE ixekizumab, IXE Q2W 80 mg ixekizumab every 2 weeks, IXE Q4W 80 mg ixekizumab every 4 weeks, and MTX methotrexate

Fig. 2

DAPSA LDAa and MDAb responses with IXE with or without concomitant MTX after 52 weeks of treatment. aDAPSA LDA requires DAPSA score ≤ 14. bMDA criteria requires improvement in ≥ 5 of 7 domains (TJC ≤ 1, SJC ≤ 1, PASI ≤ 1 or percentage of BSA affected ≤ 3, patient’s assessment of pain VAS ≤ 15, patient’s global assessment of disease activity VAS ≤ 20, HAQ-DI ≤ 0.5, and tender entheseal points ≤ 1