FRI0421 IXEKIZUMAB SIGNIFICANTLY REDUCED PAIN, INFLAMMATION, AND FATIGUE IN PATIENTS WITH RADIOGRAPHIC AXIAL SPONDYLARTHRITIS (R-AXSPA)/ANKYLOSING SPONDYLITIS (AS)
Authors: James Cheng-Chung Wei, Xenofon Baraliakos, Theresa Hunter, Baojin Zhu, Rebecca Bolce, Fangyi Zhao, Philip J. Mease
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Chronic pain, inflammation, and fatigue are among the most common symptoms of radiographic axial spondyloarthritis (r-axSpA)/ankylosing spondylitis (AS).<sup>1,2</sup> Efficacy data for ixekizumab (IXE), a high affinity monoclonal antibody that selectively targets interleukin-17A,compared to placebo (PBO) in patients with r-axSpA have been reported.<sup>3,4</sup> <h3>Objectives</h3> The purpose of this analysis was to evaluate the impact of IXE on pain, inflammation, and fatigue in patients with r-axSpA treated with IXE versus PBO over 16 weeks. <h3>Methods</h3> This was a prespecified analysis from two Phase 3, multicenter, randomized, placebo-controlled studies comparing the efficacy and safety of IXE 80 mg every 2 weeks (Q2W) or every 4 weeks (Q4W) to PBO or reference, adalimumab (ADA), over 16 weeks in biologic-naive (COAST-V; NCT02696785) and to PBO in tumor necrosis factor inhibitor (TNFi)-experienced (COAST-W; NCT02696798) patients with active r-axSpA per Assessment of Spondyloarthritis (SpA) international Society (ASAS) criteria (sacroillitis modified New York criteria and ≥1 SpA feature). Patient global, spinal pain, spinal pain at night, and inflammation (average of BASDAI Q5&amp;6) data were collected at baseline and Weeks 1, 2, 4, 8, 12, and 16. Fatigue Numeric Rating Scale data were collected at baseline, Week 8, and Week 16. Changes from baseline were analyzed using mixed-effects model of repeated measures. <h3>Results</h3> In biologic-naive (COAST-V) and TNFi-experienced (COAST-W) patients, significant improvements from baseline in patient global, spinal pain, spinal pain at night, and inflammation were observed as early as Week 1 (Table 1, Figure 1). Significant reductions in fatigue as early as Week 8 (first measurement) were seen in patients receiving IXE Q2W and Q4W and maintained up to Week 16 (Table 1; <i>P</i>&lt;.05). <h3>Conclusion</h3> IXE significantly improved pain, inflammation, and fatigue in patients with r-axSpA. <h3>References</h3> [1] Sieper J, et al. Lancet. 2017;390:73–84. [2] Stebbings SM, et al. Clin Rheumatol. 2014:33:1467–74. [3] Van der Heijde D, et al. Lancet. 2018;392:2411–51. [4] Deodhar A, et al. Arthritis Rheumatol. 2018Oct20. Doi:10.1002/art.40753. <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, Xenofon Baraliakos Grant/research support from: AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Centocor, Chugai, Janssen, MSD, Novartis, Pfizer Inc, Roche and UCB, Grant/research support from: AbbVie, Pfizer, Merck Sharp &amp; Dohme, UCB Pharma, Novartis, Consultant for: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai, Janssen Biologics, Novartis, Pfizer, UCB Pharma, Galapagos, Speakers bureau: AbbVie, Chugai, Janssen, Novartis, Pfizer, UCB Pharma, Theresa Hunter Employee of: Eli Lilly and Company, Baojin Zhu Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Rebecca Bolce Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Fangyi Zhao Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Philip J Mease Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Sun and UCB., Consultant for: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun, UCB., Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer, and UCB.