Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial Spondyloarthritis: Week 52 Results from 2 pivotal studies.

OBJECTIVE This study evaluated the effect of ixekizumab on self-reported functioning and health in patients with radiographic axial spondyloarthritis (r-axSpA) who were either biologic disease modifying antirheumatic drugs naive (bDMARD-naive) or failed at least 1 tumor necrosis factor inhibitor (TNFi). METHODS In 2 multicenter, randomized, double-blind, placebo-controlled, and active-controlled (bDMARD-naive only) trials, r-axSpA patients were randomly assigned to receive 80 mg of ixekizumab (every 2 weeks [Q2W] or every 4 weeks [Q4W]), placebo, or adalimumab (bDMARD-naive only). After 16 weeks, patients who received placebo or adalimumab were re-randomized to receive ixekizumab (Q2W or Q4W) up to Week 52. Functioning and health was measured by the generic Short Form Health Survey 36-item (SF-36) and the diseasespecific ASAS Health Index (ASAS HI). Societal health utility was assessed by the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L). RESULTS At week 16, both doses of ixekizumab in bDMARD-naive and TNFi-experienced patients resulted in larger improvement in SF-36, ASAS HI, and EQ-5D-5L versus placebo. For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical. Larger proportion of patients reaching improvement in ASAS HI ≥3, ASAS HI good health status were reported in patients treated with ixekizumab. Improvements were maintained through Week 52. CONCLUSION Ixekizumab significantly improved functioning and health as assessed by both generic and disease specific measures as well as societal health utility values in patients with raxSpA, as measured by SF-36, ASAS HI, and EQ-5D-5L at Week 16 and improvements were sustained through 52 weeks.