Ixekizumab improves patient-reported outcomes through 52 weeks in patients with active psoriatic arthritis and previous inadequate response to tumor necrosis factor-inhibitors

Abstract

Aim Up to 24 weeks, ixekizumab (IXE) was superior to placebo (PBO) in patients with active psoriatic arthritis (PsA) and inadequate response to TNF inhibitors (TNFi) (phase 3 trial; SPIRIT‐P2).1 We report Week 52 interim patient‐reported outcomes (PROs) of IXE, during the SPIRIT‐P2 Extension Period (EP).

Methods During Double‐Blind Treatment Period (DBTP; Weeks 0‐24), 363 patients with inadequate response or intolerance to TNFi were randomized 1:1:1 to subcutaneous administration of either 80 mg IXE every 4 weeks (Q4W; N=122) or 2 weeks (Q2W; N=123) following a 160 mg starting dose, or PBO (N=118). On completion of DBTP, 310 patients entered EP (Weeks 24‐156). Patients in IXE arms continued the same dose regimen in EP. PBO patients were re‐randomized (1:1) to IXE Q4W or Q2W at Week 16 (inadequate responders) or Week 24 after a 160 mg starting dose. At baseline and week 52 in EP, descriptive statistics were used to summarize PROs: Short Form‐36 Health Survey (SF‐36) Physical Component Summary (PCS) and Mental Component Summary (MCS), European Quality of Life 5 Dimensions Visual Analog Scale (EQ‐5D VAS; 0‐100 scale), Work Productivity and Activity Impairment‐Specific Health Problem (WPAI‐SHP), fatigue Numeric Rating Scale (NRS; unvalidated), and the itch NRS (in patients with baseline psoriatic lesion ≥3% body surface area (BSA; N=175)).

Results The EP population had impaired physical and mental function, QoL, and work productivity at baseline. Patients receiving IXE up to 52 weeks reported improvements in SF‐36 (PCS and MCS), EQ‐5D VAS, WPAI‐SHP (presenteeism, work‐productivity, and activity‐impairment), fatigue NRS and itch NRS.

Conclusions In patients with active PsA and previous inadequate response to TNF‐i, IXE provided sustained improvement up to 52 weeks in all measured PROs, including physical and mental function, QoL, work productivity, fatigue, and itch (≥3% BSA psoriasis).