FRI0420 IXEKIZUMAB SIGNIFICANTLY IMPROVES SELF-REPORTED OVERALL HEALTH IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS/RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS: SF-36 RESULTS OF TWO PHASE 3 TRIALS

Abstract

Background Using the Short Form-36 (SF-36) questionnaire, previous studies have determined that ankylosing spondylitis/radiographic axial spondyloarthritis (AS/r-axSpA) significantly impairs patients’ health-related quality of life (HRQoL).1 Ixekizumab (IXE), a humanized anti-interleukin-17A monoclonal antibody, improves disease signs and symptoms in patients with AS/r-axSpA.2,3 Week 16 SF-36 results from two clinical trials with IXE are presented here (NCT02696785 and NCT02696798). Objectives To evaluate the efficacy of IXE versus placebo (PBO) in improving HRQoL assessed by the SF-36 questionnaire in patients with active AS/r-axSpA who were either naive to biologic therapy or have failed or been intolerant of one or two TNF inhibitors (TNFi). Methods COAST-V and -W are randomized, double-blind, placebo-controlled clinical trials. Enrolled patients were adults with active AS/r-axSpA classified by ASAS criteria who fulfilled mNY of sacroiliitis (central reading), with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and back pain ≥4. In COAST-V, patients naive to biologic agents were randomized 1:1:1:1 to receive 80 mg IXE every 4 weeks (Q4W), 80 mg IXE every 2 weeks (Q2W), adalimumab 40 mg Q2W (ADA), or PBO. In COAST-W, patients who had failed on or were intolerant of one or two TNFi were randomized 1:1:1 to 80 mg IXE Q4W, 80 mg IXE Q2W, or PBO. In both studies, patients in the IXE arms were randomized to receive either 80 mg or 160 mg IXE as the starting dose. Comparisons of change from baseline to Week 16 in norm-based SF-36 scores between active groups and PBO were performed using mixed model for repeated measures. Results Biologic naive and TNFi-experienced patients treated with IXE reported significantly greater improvement than PBO patients in SF-36 Physical Component Summary and the physical functioning, bodily pain, general health, and vitality domains. No changes between treatments groups were reported in Mental Component Summary scores. The greatest numerical improvements with IXE were observed in the bodily pain domain. Similar improvements were reported in the IXE Q4W, IXE Q2W, and ADA groups. Conclusion IXE improved self-reported HRQoL, as measured by the SF-36 questionnaire, at Week 16 in patients with active AS/r-axSpA who were naive or experienced with biologic treatments.