Objective To conduct subset analyses of SPIRIT-P2 (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, or none.
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, Disease Activity Index for PsA (DAPSA), 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP), Health Assessment Questionnaire-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 cDMARDs with subgroup safety profiles that were consistent with that observed in the overall SPIRIT-P2 population.
- DMARDs (biologic)
- DMARDs (synthetic)
- psoriatic arthritis
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Presented at The results of this study were previously presented, in part, at EULAR (European League Against Rheumatism) 2018.
Correction notice The article has been corrected since it first published online. The authors noticed some copyediting errors which have been rectified now.
Contributors PN, OB, DHA were involved in the conception and design of the clinical study; PN, A-MO, OB, DHA, AD were involved in the acquisition of the data. All authors were involved in the analysis and interpretation of the data. All authors were involved in the drafting and revision of the manuscript. SSR was involved in the statistical analyses.
Funding This study was funded and sponsored by Eli Lilly and Company.
Competing interests PN: Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, UCB; Consultant for: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, UCB; Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Hospira, Janssen, MSD, Novartis, Pfizer, Roche, Sanofi, UCB. FB: Grant/research support from: Abbvie, Pfizer, Roche, Chugai, Prophylix, Novartis, Iron4U; Consultant for: Abbvie, Pfizer, Roche, Chugai, UCB, BMS, Celgene, MSD, Novartis, Biotest, Janssen, Genzyme, Sanofi, Eli Lilly and Company, Sandoz; Speakers bureau: Abbvie, Pfizer, Roche, Chugai, UCB, BMS, Celgene, MSD, Novartis, Biotest, Janssen, Genzyme, Sanofi, Eli Lilly and Company, Sandoz. A-MO: Grant/research support from: Abbvie, Celgene, Eli Lilly and Company, Horizon, Janssen, Novartis, Pfizer; Consultant for: Eli Lilly and Company, Janssen, Novartis, Pfizer, UCB. SSR, DHA, OB: All employees and shareholders of Eli Lilly and Company. AD: Grant/research support from: Pfizer; Consultant for: Pfizer.
Patient consent Patient consent was obtained.
Ethics approval The protocol was approved by each site’s institutional review board or ethics committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Eli Lilly provides access to relevant anonymised patient level data from studies on approved medicines and indications as defined by the sponsor-specific information on www.clinicalstudydatarequest.com. For details on submitting a request, see the instructions provided at www.clinicalstudydatarequest.com.
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