AB0710 IXEKIZUMAB SIGNIFICANTLY IMPROVES SELF-REPORTED OVERALL HEALTH AS MEASURED BY SF-36 IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS/RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS NAIVE TO BIOLOGICAL THERAPY: 52 WEEK RESULTS OF A PHASE 3 TRIAL
Authors: James Cheng-Chung Wei, Filip van den Bosch, Jessica a. Walsh, Uta Kiltz, Theresa Hunter, Yan Dong, Ann Leung, David Sandoval, Luis Leon, Vibeke Strand
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> 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).<sup>1</sup> Ixekizumab (IXE), a humanized anti-interleukin-17A monoclonal antibody, improves disease signs and symptoms in patients with aS/r-axSpA.<sup>2</sup> <h3>Objectives</h3> To quantify the effect of 52 weeks of IXE treatment on self-reported HRQoL in patients with active aS/r-axSpA who are naïve to biologic therapy (NCT02696785). <h3>Methods</h3> COAST-V is a randomized, double-blind clinical trial that is active- and placebo-controlled in its first 16 weeks. Enrolled patients were adults with active aS/r-axSpA with aSAS criteria who fulfilled mNY of sacroiliitis (central reading), with a BASDAI and back pain ≥4, and with no prior treatment with biologic agents. Patients were initially randomized 1:1:1:1 to 80 mg IXE every 4 weeks (Q4W) or every 2 weeks (Q2W), adalimumab (ADA), or placebo (PBO) groups. Changes from baseline in SF-36 up to Week 16 were analyzed by mixed model for repeated measures. Changes from baseline in SF-36 for Weeks 36-52 had no model applied. Missing data were imputed by modified baseline observation carried forward (mBOCF). <h3>Results</h3> By Week 4, statistically significant differences in Physical Component Summary (PCS) were observed between PBO and both IXE Q4W and Q2W groups (Figure; p&lt;0.002). Further differences in PCS between PBO and IXE groups were observed up to 16 weeks (p&lt;0.001) and maintained through 52 weeks. The change in Mental Component Summary (MCS) was modest (Table). Improvements in all domains were reported at 52 weeks for both the Q4W and Q2W doses of IXE, with the largest improvements observed in the bodily pain domain (Table). <h3>Conclusion</h3> Improvement in self-reported HRQoL in patients with aS/r-axSpA as measured by SF-36 was observed as soon as Week 4 of IXE treatment and maintained for at least 52 weeks. <h3>References</h3> [1] Yang, et al. (2016). Qual Life Res. 25:2711-23. [2] van der Heijde, et al. (2018). Lancet. 392(10163):2441-51. <h3>Disclosure of interests</h3> James Cheng-Chung Wei Grant/research support from: abbvie, BMS, Celgene, Janssen, Novartis, Pfizer, and UCB pharma, Consultant for: TSH Taiwan, Speakers bureau: Janssen, Novartis, Pfizer and TSH, Filip van den Bosch Consultant for: abbVie, BMS, Galapagos, Janssen, Lilly, Merck, Novartis, Pfizer and UCB, Speakers bureau: abbVie, BMS, Janssen, Lilly, Merck, Novartis, Pfizer and UCB., Jessica a. Walsh Grant/research support from: abbvie, Pfizer, Consultant for: abbvie, Celgene, Lilly, Novartis, Uta Kiltz Grant/research support from: abbVie, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., Consultant for: abbVie, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB., theresa Hunter Employee of: Eli Lilly and Company, Yan Dong Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, ann Leung Employee of: Syneos Health, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Luis Leon Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vibeke Strand Consultant for: abbVie, amgen, Bayer, BMS, Boehringer ingelheim, Celgene, Celltrion, CORRONA, Crescendo, EMD Serono, Genentech/Roche, GSK, Horizon, inmedix, Janssen, Kezar, Lilly, Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Servier, UCB.