The effect of ixekizumab versus adalimumab on individual components of the acr composite score, with and without concomitant methotrexate or other conventional synthetic dmards at 52 weeks in patients with psoriatic arthritis.

Abstract

Aim: This analysis describes the effect of ixekizumab (IXE) and adalimumab (ADA) on individual ACR components at week (Wk)52, with and without concomitant methotrexate (MTX) and csDMARDs. Method(s): Patients from SPIRIT-H2H (NCT03151551, 52Wk randomized multicenter study) who met Classification Criteria for Psoriatic Arthritis (CASPAR) (N=566), were randomized 1:1 to IXE or ADA. Patients had active psoriatic arthritis (PsA), psoriasis (PsO), and were bDMARD-naive with inadequate response (IR) to csDMARDs. Patient's Global Assessment (PtGA) and Physicians Global Assessment (PGA), Health Assessment Questionnaire-Disability Index (HAQ-DI), and joint pain were assessed by visual analog scale, and TJC and SJC as well as C-reactive protein (CRP) were analyzed. Nine patients with active PsO and BSA>=3% were assessed as Psoriasis Area and Severity Index (PASI)=0 at baseline, a medical inconsistency that was resolved using medical judgment. These patients were considered PASI100 responders if PASI=0 and BSA=0 at post baseline visits. Result(s): Overall, 566 patients received either IXE (N=283) or ADA (N=283). Baseline values for individual ACR components were balanced between IXE and ADA. At Wk52, IXE demonstrated efficacy across individual ACR components in the ITT population, specifically in PGA, PtGA and Joint Pain. Improvements from baseline for IXE were observed across ACR components, with or without MTX or csDMARD. The effect of MTX (with or without) was notably different between IXE and ADA in TJC68, PGA, Joint Pain, and PtGA. Conclusion(s): In this analysis, there was improvement with IXE in all components of the ACR composite score at Wk52, irrespective of MTX or csDMARDuse (with or without). In the ITT population, IXE showed comparable efficacy to ADA at Wk52 in all components of ACR, demonstrating improvement across musculoskeletal domains. These results may provide further confidence of the clinical benefits of ixekizumab across musculoskeletal domains in patients with PsA, regardless ofMTXor csDMARDuse.