POS0915 SUSTAINABILITY OF IXEKIZUMAB RESPONSE AT THE INDIVIDUAL PATIENT LEVEL OVER TIME IN RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS
Authors: S. Ramiro, R. Bolce, D. Sandoval, A. Kronbergs, S. Y. Park, B. Wu, J. A. Walsh
Journal: Annals of the Rheumatic Diseases (2021)

Background: Ixekizumab (IXE) has demonstrated efficacy in treating the signs and symptoms of radiographic axial spondyloarthritis (r-axSpA) in patients (pts) up to week (Wk) 52 [1]. Pts may experience fluctuations in the improvements of their symptoms, which may impact their overall quality of life [2]. Providing data at the pt level is important to support consistency and sustainability of efficacy. Objectives: To analyse IXE response for sustainability at the individual pt level, between Wks 16 and 52. Methods: COAST-V ( NCT02696785 ) and COAST-W ( NCT02696798 ) were two phase 3, multicentre, randomised, double-blind, placebo-controlled studies (adalimumab was the active control in COAST-V). Pts with active r-axSpA who were either biologic disease modifying anti-rheumatic drug (bDMARD) naïve (COAST-V) or, inadequate responders or intolerant to up to 2 TNF inhibitors (COAST-W) received IXE every 4 weeks (Q4W) or every 2 weeks (Q2W). Only IXE Q4W pts were included in the present analysis (approved dosage for the indication). Separate analyses were conducted on pts who achieved either endpoint; ASAS40 or ASDAS&lt;2.1. The proportion (%) of pts who achieved either ASAS40 or ASDAS&lt;2.1, at Wk 16 and at each visit out to Wk 52 (total of 8 visits) was assessed. Missing data were imputed as non-response. Heatmaps were used to depict the data analysed at the individual patient level across all visits. Results: In COAST-V, 81 pts enrolled in the trial were initially randomised to IXE Q4W. Of those, 48% (N=39) of pts achieved ASAS40 at Wk 16 (Figure 1), of which 59% (N=23) maintained ASAS40 at every visit afterwards. In total, 85% (N=33) of the ASAS40 achievers at Wk 16 maintained ASAS40 with some (26% (N=10)) fluctuations, between ASAS40 and ASAS20. In COAST-W, 114 pts enrolled in the trial were initially randomised to IXE Q4W. Of those, 25.4% (N=29) pts achieved ASAS40 at Wk 16, of which, 69% (N=20) maintained ASAS40 at every visit afterwards. In total, 83% (N=24), of the ASAS40 achievers at Wk 16 maintained ASAS40 with some (14% (N=4)) fluctuations, between ASAS40 and ASAS20. Of the 81 pts initially randomised to IXE Q4W in COAST-V, 35 pts achieved low disease activity (ASDAS&lt;2.1, LDA) at Wk 16. Of those, 54% (N=19) of pts maintained LDA at every visit afterwards. In total, 91% (N=32) of the ASDAS-LDA achievers at Wk 16 maintained LDA with some (37% (N=13)) fluctuations, between LDA and high disease activity (ASDAS 2.1-3.5, HDA). Of the 114 pts initially randomised to IXE Q4W in COAST-W, 20 pts achieved LDA at Wk 16. Of those, 50% (N=10) of pts maintained LDA at every visit afterwards. In total, 95% (N=19) of the ASDAS-LDA achievers at Wk 16 maintained LDA with some (45% (N=9)) fluctuations between LDA and HDA. Conclusion: This analysis demonstrates that pts with r-axSpA and treated with IXE Q4W who achieve ASAS40 or ASDAS-LDA at Wk 16 show a sustainable response, at the individual patient level, with similar levels of efficacy over time and at each visit out to week 52. References: [1]Dougados et al., Ann Rheum Dis. 2020; 79(2):176-185. [2]Essers et al., Rheumatology. 2016;55(11):2014-22. Figure 1. Heatmap diagram depicting the sustained effect of IXE over time at the pt level in pts with r-axSpA from COAST-V. Each row corresponds to an individual ASAS40 responder at Wk 16. Acknowledgements: Edel Hughes, an employee of Eli Lilly and Company, provided editorial and writing support. Disclosure of Interests: Sofia Ramiro Speakers bureau: AbbVie, Eli Lilly, MSD, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, MSD, Novartis, Sanofi, UCB, Grant/research support from: MSD, 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, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, So Young Park Shareholder of: Eli Lilly &amp; Company, Employee of: Eli Lilly &amp; Company, Beilei Wu: None declared, Jessica A. Walsh Consultant of: AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Merck, Pfizer