Improvement of Functioning and Health With Ixekizumab in the Treatment of Active Nonradiographic Axial Spondyloarthritis in a 52‐Week, Randomized, Controlled Trial

Abstract

Objective. To evaluate the effect of ixekizumab on self-reported functioning and health in patients with active nonradiographic axial spondyloarthritis (SpA).Methods. COAST-X was a randomized, controlled trial conducted in patients with nonradiographic axial SpA over 52 weeks. Participants were randomized at a ratio of 1:1:1 to receive 80 mg of ixekizumab subcutaneously every 4 weeks or 2 weeks or placebo for 52 weeks. Self-reported functioning and health end points included the Medical Outcomes Study Short Form 36 (SF-36) health survey, Assessment of Spondyloarthritis International Society (ASAS) health index, and European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) health-utility descriptive system.Results. Compared to placebo, ixekizumab treatment resulted in improvement of SF-36 physical component summary scores from baseline, with a score of 4.7 improving to 8.9 with ixekizumab therapy every 4 weeks (P < 0.05) and a score of 9.3 with ixekizumab therapy every 2 weeks (P < 0.01); the greatest improvements were observed in the domains of physical functioning, role-physical, and bodily pain at weeks 16 and 52. A higher proportion of patients receiving ixekizumab therapy every 2 weeks reported ≥3 improvements based on the ASAS health index from baseline to weeks 16 and 52 (P < 0.05). Significantly more patients receiving ixekizumab every 4 weeks reported improvements in "good health status" on the ASAS health index (ASAS score of ≤5) at weeks 16 and 52 (P < 0.05). Patients receiving ixekizumab reported improvements on the EQ-5D-5L compared to those who received placebo at week 16 (0.11 versus 0.17 for patients receiving treatment every 4 weeks and 0.19 for patients receiving treatment every 2 weeks; P < 0.05), which remained consistent at week 52. There were no clinical meaningful differences in responses based on the ixekizumab dosing regimen for patients who received ixekizumab therapy every 2 weeks or every 4 weeks.Conclusion. In patients with nonradiographic axial SpA, therapy with ixekizumab was superior to placebo in the improvement of self-reported functioning and health at weeks 16 and 52.

Effect of Upadacitinib on Quality of Life and Work Productivity in Active Non-radiographic Axial Spondyloarthritis: Results From Randomized Phase 3 Trial SELECT-AXIS 2

“…Furthermore, positive improvements in pain, as well as physical function and general HRQoL as measured by SF-36 PCS and ASAS HI, were consistent with previous studies with IL-17 inhibitors [ 28 , 29 ]. Results were also consistent with studies with TNFi treatments in nr-axSpA [ 30 – 32 ].…”

Axial spondyloarthritis: one year in review 2023

“…The response was higher in TNFi-naive patients and correlated with a better control of disease activity and with an improvement of the Working Productivity and Activity Impairment (WPAI) as well (68). Similarly, Walsh and colleagues observed an improvement in QoL of patients with a nr-axSpA during therapy with IXE (69).…”

Work participation in patients with axial spondyloarthritis: high prevalence of negative workplace experiences and long-term work impairment

“…This supports some previous findings 36 and highlights that the medical need remains high and requires urgent attention. Although other studies suggest biological treatment can lead to improvements in work disability and disease symptoms, [36][37][38][39] substantial unmet needs remain. 11 12 It may be that biological treatment improves outcomes for some domains of impairment but not all; for instance, Wallman and colleagues only found improved work disability after treatment, while disability pension levels remained similar.…”