Ixekizumab is efficacious when used alone or when added to conventional synthetic disease-modifying antirheumatic drugs (cDMARDs) in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor inhibitors

Peter Nash; Frank Behrens; Ana-Maria Orbai; Suchitrita S Rathmann; David H Adams; Olivier Benichou; Atul Deodhar

doi:10.1136/rmdopen-2018-000692

Ixekizumab is efficacious when used alone or when added to conventional synthetic disease-modifying antirheumatic drugs (cDMARDs) in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor inhibitors

RMD Open. 2018 Sep 7;4(2):e000692. doi: 10.1136/rmdopen-2018-000692. eCollection 2018.

Authors

Peter Nash¹, Frank Behrens², Ana-Maria Orbai³, Suchitrita S Rathmann⁴, David H Adams⁴, Olivier Benichou⁴, Atul Deodhar⁵

Affiliations

¹ Department of Medicine, University of Queensland, Brisbane, Queensland, Australia.
² Center for Innovative Diagnostics and Therapy in Rheumatology/Immunology (CIRI), Goethe University Frankfurt and Fraunhofer IME Project Group Translational Medicine and Pharmacology TMP, Frankfurt, Germany.
³ Division of Rheumatology, John Hopkins University School of Medicine, Baltimore, Maryland, USA.
⁴ Eli Lilly and Company, Indianapolis, Indiana, USA.
⁵ Division of Arthritis and Rheumatic Diseases, Department of Medicine, Oregon Health and Science University, Portland, Oregon, USA.

Abstract

Objective: To conduct subset analyses of SPIRIT-P2 (Standard Protocol Items: Recommendations for Interventional Trials, NCT02349295) to investigate the efficacy and safety of ixekizumab versus placebo in three subgroups of patients with active psoriatic arthritis (PsA) according to the concomitant conventional synthetic disease-modifying antirheumatic drug (cDMARD) received: any background cDMARDs (including methotrexate), background methotrexate only.

Methods: Patients were randomised to receive placebo, ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W). Efficacy and safety were assessed when patients were subdivided according to cDMARD use at baseline. Efficacy was evaluated versus placebo at week 24 by the American College of Rheumatology criteria (ACR20/50), achievement of minimal disease activity (MDA) state, DiseaseActivityIndex for PsA (DAPSA), 28-joint DiseaseActivityScore using C reactive protein (DAS28-CRP), HealthAssessmentQuestionnaire-Disability Index and the 36-item Short-Form health survey physical functioning domain.

Results: Regardless of background cDMARD status, ACR20, ACR50 and MDA response rates were significantly higher than placebo with IXEQ4W or IXEQ2W treatment. Similarly, significant improvements were observed relative to placebo for DAS28-CRP and DAPSA across subgroups. Physical function also significantly improved relative to placebo with IXEQ4W treatment regardless of background cDMARD status and with IXEQ2W alone. Percentages of reported treatment emergent adverse events (AEs), serious AEs (including serious infections) and discontinuations due to AEs in each subgroup were comparable to the overall SPIRIT-P2 population.

Conclusion: Ixekizumab was efficacious in patients with active PsA and previous tumour necrosis factor inhibitor (TNFi)inadequate response or TNFi intolerance treated with ixekizumab alone or when added to cDMARDswith subgroup safety profiles that were consistent with that observed in the overall SPIRIT-P2 population.

Keywords: DMARDs (biologic); DMARDs (synthetic); methotrexate; psoriatic arthritis.