SAT0396 IMPROVEMENT IN THE SIGNS AND SYMPTOMS OF PSORIATIC ARTHRITIS WITH IXEKIZUMAB COMPARED TO PLACEBO IN PATIENT SUBGROUPS DEFINED BY BASELINE DISEASE CHARACTERISTICS

Abstract

Background Ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin-17A, was superior to placebo (PBO) in two randomized Phase 3 studies in patients (pts) with active psoriatic arthritis (PsA).1,2 Objectives To assess the consistency of response of IXE across subgroups of pts defined by specific baseline disease characteristics. Methods Data were analyzed from an integrated database of 2 randomized, double-blind, Phase 3 studies in pts who were either biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)-naive (SPIRIT-P1) or who had prior inadequate response or intolerance to TNF inhibitors (SPIRIT-P2). Analyses included pts randomly assigned to the approved dosing regimen of IXE (80 mg IXE every 4 wks [IXE Q4W] with a starting dose of 160 mg IXE) or to PBO through Wk 24. Efficacy was measured as the percentage of pts achieving ≥20%, 50%, or 70% improvement from baseline in the American College of Rheumatology criteria (ACR20/50/70) or minimal disease activity (MDA) in subgroups of pts defined by baseline presence of enthesitis, dactylitis, psoriasis body surface area (BSA) involvement ( 6 or ≤6 mg/L). Missing data were imputed by nonresponder imputation. Results Clinical response rates at Wk 24 in each subgroup are summarized (Table). Significantly (p Conclusion At Wk 24, IXE was superior to placebo for the treatment of PsA signs and symptoms regardless of baseline presence of dactylitis or enthesitis, BSA involvement, or CRP levels.