RT Journal Article
SR Electronic
T1 Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial Spondyloarthritis: Week 52 Results from 2 Pivotal Studies
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP jrheum.200093
DO 10.3899/jrheum.200093
A1 Uta Kiltz
A1 James Cheng-Chung  Wei
A1 Désirée van der Heijde
A1 Filip  van den Bosch
A1 Jessica A.  Walsh
A1 Annelies Boonen
A1 Lianne S.  Gensler
A1 Theresa Hunter
A1 Hilde Carlier
A1 Yan Dong
A1 Xiaoqi Li
A1 Rebecca Bolce
A1 Vibeke Strand
A1 Juergen Braun
YR 2020
UL http://www.jrheum.org/content/early/2020/12/10/jrheum.200093.abstract
AB Objective This study evaluated the effect of ixekizumab (IXE) on self-reported functioning and health in patients with radiographic axial spondyloarthritis (r-axSpA) who were either biological disease-modifying antirheumatic drug (bDMARD)–naïve or failed at least 1 tumor necrosis factor inhibitor (TNFi). Methods In 2 multicenter, randomized, double-blind, placebo-controlled, and active‑controlled (bDMARD-naïve only) trials, patients with r-axSpA were randomly assigned to receive 80 mg of IXE [every 2 weeks (Q2W) or every 4 weeks (Q4W)], placebo (PBO), or adalimumab (ADA; bDMARD-naïve only). After 16 weeks, patients who received PBO or ADA were rerandomized to receive IXE (Q2W or Q4W) up to Week 52. Functioning and health were measured by the generic 36-item Short Form Health Survey (SF‑36) and the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI). Societal health utility was assessed by the 5-level EuroQol-5 Dimension (EQ-5D-5L). Results At Week 16, both doses of IXE in bDMARD-naïve 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. A larger proportion of patients reaching improvement in ASAS HI ≥ 3 as well as an achievement of ASAS HI good health status was reported in patients treated with IXE. Improvements were maintained through Week 52. Conclusion IXE significantly improved functioning and health as assessed by both generic and disease-specific measures, as well as societal health utility values in patients with r-axSpA, as measured by SF-36, ASAS HI, and EQ-5D-5L at Week 16, and improvements were sustained through 52 weeks.