AB0471 PATIENTS WITH RADIOGRAPHIC axSpA WHO PROGRESSED FROM ASAS20 AT WEEK 16 TO ASAS40 AT WEEK 52: RESULTS FROM COAST-W
Authors: X. Baraliakos, A. Deodhar, S. Liu Leage, Y. Schymura, R. Bolce, D. Sandoval, J. A. Walsh, J. Sieper
Journal: Annals of the Rheumatic Diseases (2021)

Background: The timeframe for maximum treatment response varies across patients with radiographic axial spondyloarthritis (r-axSpA). Understanding which patients may benefit from additional time on treatment could influence treatment decisions. Objectives: This post-hoc analysis aims to determine the percentage of patients, previously exposed to TNFi, who progressed from ASAS20 at week 16 to ASAS40 response at week 52 with ixekizumab (IXE) treatment and to explore factors that may associate with additional improvement after 16 weeks. Methods: Patients who achieved Assessment of SpondyloArthritis International Society (ASAS)20 at week 16 from COAST-W ( NCT02696798 ), a Phase 3, randomized, double-blind, placebo-controlled trial, in tumour necrosis factor inhibitor (TNFi)-experienced patients who fulfilled the ASAS criteria for r-axSpA, were analysed. Patients treated with IXE 80 mg Q4W were categorized according to their ASAS response at week 52: sustaining ASAS20 but not reaching an ASAS40 response or achieving ASAS40. Patient demographics and disease characteristics at baseline were analysed by descriptive statistics, and the individual components determining ASAS response at baseline and at week 52 are provided. Results: At week 16, 22.8% (n=26/114) of patients achieved ASAS20 but not ASAS40; of these, 2 patients discontinued the study before week 52. Amongst the patients who continued through week 52, 50% (12/24) of patients achieved ASAS40; the other 50% sustained their ASAS20 response. Patients who achieved ASAS40 at week 52 were older, had longer disease duration, were less likely to be HLA-B27 positive, and had worse BASDAI and BASFI scores at baseline (Table 1, part a). Achieving ASAS40 appeared to depend most on the Patient Global Assessment of Disease Activity and spinal pain score over time (Table 1, part b). Table 1. a) Demographics and Characteristics at Baseline (week 0) and b) Descriptive observed data for the individual components of the ASAS response criteria at week 52, mean (SD) a) IXEQ4W Patients sustaining an ASAS20 but not reaching an ASAS40 response at week 52 (n=12) Patients achieving an ASAS40 response at week 52 (n=12) Age, years 47.3 (13.3) 49.6 (12.3) Duration of symptoms since axSpA onset, years 16.4 (9.2) 18.6 (12.6) HLA B27 positive, n (%) 12 (100) 9 (75) Current tobacco use, n (%) 4 (33.3) 1 (8.3) ASDAS Score 4.0 (1.0) 4.2 (1.1) BASDAI Score 7.4 (1.2) 7.8 (1.7) Serum CRP concentration (mg/L) 23.0 (47.1) 28.0 (66.0) Spinal Pain due to Ankylosing Spondylitis (NRS) 8.2 (0.8) 8.5 (1.6) Patient Global Assessment of Disease Activity (NRS) 7.8 (1.3) 8.6 (1.2) BASFI 7.1 (1.4) 7.4 (2.3) BASDAI stiffness score 7.1 (1.5) 7.6 (2.2) b ) IXEQ4W Patient Global Assessment of Disease Activity (NRS) 5.5 (1) 3.2 (1.3) Spinal Pain due to Ankylosing Spondylitis (NRS) 5.6 (1) 3 (1.9) BASFI 5.0 (1.5) 3.7 (2.1) BASDAI stiffness score 4.1 (1.4) 3.4 (2.3) Values are mean (SD) unless stated otherwise ASAS= Assessment of SpondyloArthritis International Society; ASDAS= Ankylosing Spondylitis Disease Activity Score; axSpa = axial spondyloarthritis; BASDAI= Bath Ankylosing Spondylitis Disease Activity Index; BASFI= Bath Ankylosing Spondylitis Functional Index; CRP= C-reactive protein; HLA= human leucocyte antigen; NRS = numeric rating scale; SD= standard deviation Conclusion: For patients with r-axSpA previously exposed to TNFis and showing modest response to IXE over 16 weeks, longer exposure to IXE may be required to achieve ASAS40. Acknowledgements: The authors would like to acknowledge Philana Fernandes, an employee of Eli Lilly, for her editorial and writing support. Disclosure of Interests: Xenofon Baraliakos Speakers bureau: Abbvie, BMS, Chugai, Celgene, Eli Lilly, Pfizer, Galapagos, UCB, MSD, Consultant of: Abbvie, BMS, Chugai, Celgene, Eli Lilly, Pfizer, Galapagos, UCB, MSD, Grant/research support from: Abbvie, Celgene, MSD, Atul Deodhar Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Giliad, GlaxoSmith &amp; Kline, Janssen, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Boehringer Ingelheim, Eli Lilly, GlaxoSmith &amp; Kline, Novartis, Pfizer, UCB, Soyi Liu Leage Employee of: Eli Lilly, Yves Schymura Employee of: Eli Lilly, Rebecca Bolce Shareholder of: Eli Lilly, Employee of: Eli Lilly, David Sandoval Shareholder of: Eli Lilly, Employee of: Eli Lilly, Jessica A. Walsh Consultant of: AbbVie, Novartis, Eli Lilly, UCB, Amgen &amp; Pfizer, Grant/research support from: AbbVie, Pfizer, Merck, Joachim Sieper Speakers bureau: Abbvie, Janssen, Eli Lilly and Novartis, Consultant of: Abbvie, Janssen, Eli Lilly and Novartis.