OP0238 WORK PRODUCTIVITY AND ACTIVITY IMPAIRMENT AMONG PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS/RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS AND TREATED WITH IXEKIZUMAB FOR 16 WEEKS: RESULTS FROM COAST-V AND COAST-W

Abstract

Background Axial spondyloarthritis (axSpA) negatively impacts work productivity and IL-17A antagonists, such as ixekizumab (IXE), may improve paid and unpaid work productivity.1,2 Also, it is unknown if improvements with IXE differ between biologic-naive and TNF inhibitor (TNFi) experienced patients. Objectives We investigated the effect of IXE treatment for 16-weeks on work productivity and activity impairment among patients with radiographic axSpA (r-axSpA) using data from the biologic-naive and TNFi-experienced patients receiving either placebo (PBO), IXE, or adalimumab (ADA; if biologic-naive). Methods Both COAST-V and COAST-W investigated the efficacy and safety of IXE among patients with r-axSpA that either were biologic-naive patients (COAST-V, NCT02696785) or TNFi-experienced patients (COAST-W, NCT02696798), as defined by prior inadequate response or intolerance to 1 or 2 TNFi. Patients were required to have a diagnosis of axSpA. Patients fulfilled ASAS criteria for r-axSpA and mNY criteria for ankylosing spondylitis. Active disease was defined by BASDAI ≥4 and back pain ≥4 on a numeric ratings scale (NRS).1,2 Full eligibility criteria were previously reported.1,2Patients were treated with placebo (PBO), 40-mg adalimumab (ADA) every 2 weeks (Q2W; COAST-V only), 80-mg IXE Q2W (IXEQ2W) or every 4 weeks (IXEQ4W) for 16 weeks. Work productivity was investigated using the Work Productivity and Activity Impairment Questionnaire for Ankylosing Spondylitis (WPAI:SpA). Individual and integrated study data were analyzed using analysis of covariance models. Results reported as least squares mean (LSM) change from baseline±standard error (SE). Integrated data of COAST-V and -W were analyzed for inferential statistics due to small sample sizes in the individual studies. ADA was included in COAST-V as an active reference arm only, and the study was not powered to allow comparisons between the IXE and ADA arms. Results Overall, 365 (64.5%) PBO- and IXE-treated patients reported paid work (part-time or full-time) at baseline in COAST-V and COAST-W. Based on integrated data, Absenteeism was significantly lower in IXEQ2W treated patients than PBO and Presenteeism, Work Productivity Loss, and Activity Impairment were significantly reduced in IXEQ2W and IXEQ4W treated patients versus PBO (Table 1). WPAI-SpA outcomes for biologic-naive and TNFi-experienced were similar with some exceptions (Table 2). The active reference arm (ADA) exhibited numerical improvements for presenteeism, work productivity, and activity impairment versus PBO. Conclusion In this integrated analysis of patients with active r-axSpA, IXE treatment for 16 weeks yielded significant improvements in work productivity and activity impairment versus PBO. The effect is similar in biologic-naive and TNFi-experienced patients. A limitation for evaluations of work productivity in the individual studies was the relatively low number of employed patients.