POS0912 LONG-TERM TREATMENT WITH IXEKIZUMAB IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: TWO-YEAR RESULTS FROM COAST-Y
Authors: J. Braun, U. Kiltz, A. Deodhar, T. Tomita, M. Dougados, R. Bolce, D. Sandoval, D. Adams, C. Y. Lin, J. A. Walsh
Journal: Annals of the Rheumatic Diseases (2021)

Background: The efficacy and safety of the interleukin-17 inhibitor ixekizumab (IXE) for the treatment of radiographic (r-) and non-radiographic (nr-) axial spondyloarthritis (axSpA) has been shown for up to 52 weeks. 1-2 Objectives: To study the efficacy and safety of ixekizumab in the treatment of patients with r- and nr-axSpA for up to 116 weeks. Methods: COAST-Y ( NCT03129100 ) is the 2-year extension of the COAST-V, -W, and -X trials. Patients continued with the dose received at the end of the originating trial at Week 52, either with 80 mg IXE every 4 weeks (Q4W) or every 2 weeks (Q2W). Patients who had been assigned to adalimumab or placebo were re-randomized to IXE Q4W or Q2W at Week 16 in COAST-V and -W. Patients who had received placebo for 52 weeks in COAST-X were switched to IXE Q4W in COAST-Y. Patients who switched from placebo or adalimumab treatment to IXE (COAST-V, -W, or -X) or from IXE Q4W to open-label IXE Q2W (COAST-X) during the originating studies were analyzed separately from patients continuously treated with IXE. Standardized efficacy measures were used (Table 1). Missing data were handled by non-responder imputation for categorical data and modified baseline observation carried forward for continuous data. Safety data were analyzed for all patients who received ≥1 dose of IXE. Table 1. Demographic and efficacy results for patients continuously treated with IXE for 116 weeks IXE Q4W N=157 IXE Q2W N=195 Demographics Age 42.7 (13.0 ) 41.8 (11.2 ) Male (n, [%]) 124 (79.0 ) 132 (67.7 ) Baseline ASDAS 3.92 (0.80 ) 3.95 (0.76 ) Baseline BASDAI 7.07 (1.26 ) 7.18 (1.35 ) Baseline BASFI 6.57 (1.76 ) 6.74 (1.86 ) Baseline BASMI 4.08 (1.46 ) 3.97 (1.52 ) Baseline SF-36 PCS 33.90 (7.27 ) 33.26 (6.88 ) Outcome measure Response (n, [%]) Week 52 Week 116 Week 52 Week 116 ASDAS &lt;2.1 75 (47.8 ) 69 (43.9 ) 88 (45.1 ) 96 (49.2 ) ASAS partial remission 34 (21.7 ) 31 (19.7 ) 35 (17.9 ) 39 (20.0 ) ASAS40 82 (52.2 ) 89 (56.7 ) 99 (50.8 ) 108 (55.4 ) BASDAI50 78 (49.7 ) 75 (47.8 ) 83 (42.6 ) 99 (50.8 ) Change from baseline ASDAS -1.64 (1.05 ) -1.60 (1.15 ) -1.63 (1.03 ) -1.78 (1.04 ) BASFI -2.88 (2.31 ) -2.76 (2.39 ) -2.83 (2.38 ) -3.15 (2.34 ) BASMI -0.57 (0.95 ) -0.57 (0.93 ) -0.53 (0.92 ) -0.60 (1.00 ) SF-36 PCS 9.03 (8.62 ) 8.43 (8.70 ) 8.87 (7.57 ) 9.86 (8.45 ) Data are mean (SD) unless otherwise noted. Non-responder imputation was used for categorical variables, and modified baseline observation carried forward for continuous variables. Results: Of the 773 patients enrolled in COAST-Y, 86.0% completed Week 116 of treatment (52 weeks of one of the originating trials and 64 weeks of COAST-Y). Among the patients continuously treated with IXE for 116 weeks (IXE Q4W: N=157; IXE Q2W: N=195), 46.9% achieved low disease activity (ASDAS &lt;2.1), and 19.9% achieved ASAS partial remission at 116 weeks (Table 1; Figure 1). In comparison to baseline, 56.0% achieved ASAS40 (Table 1). The mean change from baseline at Week 116 was –1.70 for ASDAS, –2.98 for BASFI, and 9.22 for SF-36 Physical Component Summary (Table 1). Similar observed responses were achieved between the patients continuously treated with IXE and patients initially treated with placebo or adalimumab. For the 932 patients in the safety population, no new safety signals were identified. Conclusion: Ixekizumab treatment led to consistent and sustained long-term improvements in disease activity and quality of life in patients with r- and nr-axSpA, with no new safety signals after up to 2 years of treatment. References: [1]Dougados, et al. Ann Rheum Dis 2020;79:176-185. [2]Deodhar, et al. Lancet 2020; 395:53-64. Disclosure of Interests: Juergen Braun Speakers bureau: Abbvie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, Consultant of: Abbvie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, Grant/research support from: Abbvie, Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Eli Lilly and Company, Medac, MSD, Mundipharma, Novartis, Pfizer, Roche, Sanofi-Aventis, and UCB, Uta Kiltz Speakers bureau: AbbVie, Hexal, MSD, Novartis, Pfizer, Roche, and UCB, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Hexal, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Biogen, Hexal, Novartis, and Pfizer, Atul Deodhar Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Giliad, GlaxoSmith &amp; Kline, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Boehringer Ingelheim, Eli Lilly and Company, GlaxoSmith &amp; Kline, Novartis, Pfizer, and UCB, Tetsuya Tomita Speakers bureau: AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe, Novartis, Takeda, Pfizer, Consultant of: AbbVie, Astellas, Bristol-Myers Squibb, Eisai, Eli Lilly and Company, Janssen, Mitsubishi Tanabe, Novartis, Takeda, Pfizer, Maxime Dougados Consultant of: AbbVie, BMS, Eli Lilly and Company, Merck, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, BMS, Eli Lilly and Company, Merck, Novartis, Pfizer, Roche, and UCB, Rebecca Bolce 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, David Adams Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Chen-Yen Lin Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jessica A. Walsh Consultant of: AbbVie, Amgen, Eli Lilly and Company, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Merck, and Pfizer