Journal Article

A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial

Helliwell, Philip S, Behrens, Frank, Li, Lingnan, Mease, Philip J, Liu-Seifert, Hong, Smolen, Josef S, Nash, Peter, Krishnan, Eswar, Gooderham, Melinda, Liu Leage, Soyi, Pillai, Sreekumar G, Tahir, Hasan, Emery, Paul

2020

Overview

ObjectivesTo compare efficacy and safety of ixekizumab (IXE) to adalimumab (ADA) in biological disease-modifying antirheumatic drug-naïve patients with both active psoriatic arthritis (PsA) and skin disease and inadequate response to conventional synthetic disease-modifying antirheumatic drug (csDMARDs).MethodsPatients with active PsA were randomised (1:1) to approved dosing of IXE or ADA in an open-label, head-to-head, blinded assessor clinical trial. The primary objective was to evaluate whether IXE was superior to ADA at week 24 for simultaneous achievement of a ≥50% improvement from baseline in the American College of Rheumatology criteria (ACR50) and a 100% improvement from baseline in the Psoriasis Area and Severity Index (PASI100). Major secondary objectives, also at week 24, were to evaluate whether IXE was: (1) non-inferior to ADA for achievement of ACR50 and (2) superior to ADA for PASI100 response. Additional PsA, skin, treat-to-target and quality-of-life outcome measures were assessed at week 24.ResultsThe primary efficacy endpoint was met (IXE: 36%, ADA: 28%; p=0.036). IXE was non-inferior for ACR50 response (IXE: 51%, ADA: 47%; treatment difference: 3.9%) and superior for PASI100 response (IXE: 60%, ADA: 47%; p=0.001). IXE had greater response versus ADA in additional PsA, skin, nail, treat-to-target and quality-of-life outcomes. Serious adverse events were reported in 8.5% (ADA) and 3.5% (IXE) of patients.ConclusionsIXE was superior to ADA in achievement of simultaneous improvement of joint and skin disease (ACR50 and PASI100) in patients with PsA and inadequate response to csDMARDs. Safety and tolerability for both biologicals were aligned with established safety profiles.

• Publisher: BMJ Publishing Group Ltd and European League Against Rheumatism,Elsevier Limited,BMJ Publishing Group
• Subject: adalimumab / Adalimumab - therapeutic use / Adult / Antibodies, Monoclonal, Humanized - therapeutic use / Antirheumatic Agents - therapeutic use / Arthritis / Arthritis, Psoriatic - drug therapy / clinical trial / Consortia / Dermatology / Drug dosages / Family medical history / Female / head-to-head / Humans / Immunotherapy / Inflammatory bowel disease / ixekizumab / Male / Middle Aged / Monoclonal antibodies / Patients / Psoriasis / Psoriasis - drug therapy / Psoriatic Arthritis / Quality of life / Rheumatology / Safety / Single-Blind Method / Skin / Skin diseases / Studies / TNF inhibitors / Treatment Outcome / Tumor necrosis factor-TNF