Ixekizumab, with or without concomitant methotrexate, improves the signs and symptoms of psa for up to 52 weeks of treatment

Abstract

Background Ixekizumab (IXE) is a high affinity monoclonal antibody selectively targeting interleukin (IL)-17A. It was previously demonstrated that IXE, with or without concomitant methotrexate (MTX), was superior to placebo (PBO) in improving the signs and symptoms of patients with psoriatic arthritis (PsA) for up to 24 weeks1 ,2.

Objectives To evaluate the efficacy of IXE, with or without continuous concomitant MTX, for up to 52 weeks of treatment in patients with active PsA.

Methods Patients with active PsA who were biologic naïve (SPIRIT-P1, NCT01695239) or had prior inadequate response or intolerance to tumour necrosis factor inhibitors (SPIRIT-P2; NCT02349295) were randomised to PBO (N=224), 80 mg IXE every 4 weeks (IXEQ4W, N=229) or every 2 weeks (IXEQ2W, N=226), after a 160 mg starting dose. In this post-hoc analysis, efficacy was assessed up to Week 52 for the following two subgroups: (i) patients who were treated with IXE as monotherapy i.e. no concomitant conventional disease-modifying anti-rheumatic drugs and (ii) patients who received constant dose of MTX from Weeks 0 to 52. Patients who had MTX dose change were excluded. Efficacy outcome measurements included American College of Rheumatology (ACR) 20/50/70 responses, minimal disease activity (MDA), and disease activity in psoriatic arthritis (DAPSA) low disease activity (LDA) (score ≤ 14). Patients who discontinued from treatment before Week 52 were included in the analysis. Missing values were imputed using non-responder imputation. All analyses were done post-hoc.

Results Among patients randomised to IXE at Week 0, 177 (38.9%) patients were treated with IXE monotherapy while 183 (40.2%) patients received constant dose of MTX up to Week 52. The average MTX dose was 15.7 mg/week and 16.0 mg/week for IXEQ4W and IXEQ2W, respectively. Week 52 results are presented in Table 1. At Week 52, similar results were observed between the two groups of patients for the different disease activity measures (ACR, MDA, and DAPSA LDA) and there was also a trend for a numerical higher proportion of patients achieving ACR responses with IXE monotherapy compared to patients with concomitant MTX use. Over time (Weeks 0-52), ACR 20, 50, and 70 response rates increased from baseline and were largely similar between the two subgroups (data not shown).

Conclusion In this post-hoc analysis, IXE treatment showed sustained efficacy in patients with PsA up to one year of treatment, with or without concomitant MTX therapy.