FRI0286 IXEKIZUMAB TREATMENT IMPROVES FATIGUE, SPINAL PAIN, STIFFNESS, AND SLEEP IN PATIENTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS
Authors: P. J. Mease, A. Deodhar, P. Rahman, H. Marzo-Ortega, V. Strand, T. Hunter, D. Adams, D. Sandoval, A. Kronbergs, B. Zhu, A. Leung, S. Liu Leage, V. Navarro-Compán
Journal: Annals of the Rheumatic Diseases (2020)

Background: Common symptoms of axial spondyloarthritis (axSpA) include fatigue, spinal pain, stiffness, and sleep problems, which can impair health-related quality of life. Ixekizumab (IXE) treatment shows efficacy in active non-radiographic axSpA (nr-axSpA). 1 Objectives: To assess fatigue, spinal pain, stiffness, and sleep with IXE treatment versus (vs) placebo (PBO) in patients (pts) with active nr-axSpA up to 16 and 52 weeks (wks). Methods: In COAST-X, pts with active nr-axSpA were randomized to 52 wks of double-blind IXE 80 mg once every 4 wks (Q4W) or 2 wks (Q2W), or PBO. Data were collected from baseline to Wk 52. Results: At Wk 16, IXE Q4W significantly improved fatigue, spinal pain, and stiffness, and IXE Q2W improved spinal pain, spinal pain at night, and stiffness vs PBO (Table). At Wk 52, IXE Q4W significantly improved stiffness, and IXE Q2W improved spinal pain, spinal pain at night, and stiffness vs PBO. Numeric improvements in sleep were not significant vs PBO. Wk 1, and up to Wk 16, IXE Q4W and Q2W significantly reduced spinal pain and stiffness vs PBO; stiffness was significantly reduced vs PBO up to Wk 52 (Figure). Least squares mean (standard error) change from BL-ITT population (mixed-effect model of repeated measures) Measure Timepoint PBO N=105 IXE Q4W N=96 IXE Q2W N=102 Spinal pain a Wk 16 -1.45 (0.244) -2.35 (0.248)* -2.59 (0.244) † Wk 52 -2.29 (0.350) -2.92 (0.305) -3.32 (0.304)* Spinal pain at night a Wk 16 -1.71 (0.262) -2.43 (0.267) -2.79 (0.263)* Wk 52 -2.25 (0.358) -3.04 (0.312) -3.58 (0.311)* BASDAI-stiffness b,c Wk 16 -1.44 (0.242) -2.44 (0.246)* -2.89 (0.242) † Wk 52 -1.94 (0.332) -3.15 (0.290)* -3.48 (0.289) † Fatigue severity NRS d Wk 16 -1.4 (0.24) -2.1 (0.24)* -1.9 (0.24) Wk 52 -2.1 (0.38) -2.6 (0.32) -2.7 (0.32) Sleep disturbance e Wk 16 -2.3 (0.45) -2.0 (0.45) -2.5 (0.45) Wk 52 -2.9 (0.63) -3.6 (0.52) -3.6 (0.53) Pt Global Assessment of Disease Activity f Wk 16 -1.30 (0.246) -2.32 (0.251)* -2.64 (0.247) † Wk 52 -1.81 (0.378) -2.77 (0.320) -3.30 (0.321)* *P&lt;.05 vs PBO; † P≤.001 vs PBO. ITT population: all randomized pts. Pts needing rescue treatment after Wk 16 per investigator could switch to open-label IXE Q2W; observations at visits thereafter not included in analyses. BL values similar across treatments. Numerical improvements in BASDAI-fatigue not significant vs PBO. a Scored 0 (no pain) to 10 (most severe pain) on NRS b Mean score BASDAI questions 5 (intensity) and 6 (duration) c Scored 1–10 on NRS d Scored 0 (no fatigue) to 10 (as bad as you can imagine) e Jenkins Sleep Evaluation Questionnaire scored 0 to 20: each of 4 items scored 0 (0 days) to 5 (22–30 days) f Scored 0 (not active) to 10 (very active) on NRS BASDAI =Bath Ankylosing Spondylitis Disease Activity Index BL =baseline ITT =intent-to-treat IXE =ixekizumab N =number of pts in ITT population NRS = numeric rating scale PBO =placebo pt =patient Q2W =every 2 wks Q4W =every 4 wks vs =versus wk =week Conclusion: IXE Q4W and/or Q2W significantly improved spinal pain, spinal pain at night, and stiffness vs PBO at 16 and 52 wks in pts with nr-axSpA. IXE Q4W also improved fatigue at 16 wks in these pts. Numerical improvements in sleep were not significant vs PBO. References: [1]Deodhar A, et al. Lancet. 2019 Disclosure of Interests: Philip J Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, Sun Pharma, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Galapagos, Gilead, Novartis, Pfizer, Sun Pharma, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer, UCB Pharma, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Proton Rahman Grant/research support from: Janssen and Novartis, Consultant of: Abbott, AbbVie, Amgen, BMS, Celgene, Lilly, Janssen, Novartis, and Pfizer., Speakers bureau: Abbott, AbbVie, Amgen, BMS, Celgene, Lilly, Janssen, Novartis, Pfizer, Helena Marzo-Ortega Grant/research support from: Janssen, Novartis, Consultant of: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Speakers bureau: Abbvie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, Takeda, UCB, Vibeke Strand Consultant of: AbbVie, Amgen, Biogen, Celltrion, Consortium of Rheumatology Researchers of North America, Crescendo Bioscience, Eli Lilly, Genentech/Roche, GlaxoSmithKline, Hospira, Janssen, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Inc., Sanofi, UCB, Theresa Hunter Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, David Sandoval Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Baojin Zhu Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Ann Leung: None declared, Soyi Liu Leage Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB