Continuing versus withdrawing ixekizumab treatment in patients with axial spondyloarthritis who achieved remission: Efficacy and safety results from a placebo-controlled, randomised withdrawal study (COAST-Y)

Robert B. M. Landewé, Lianne S. Gensler, Denis Poddubnyy, Proton Rahman, Maja Hojnik, Xiaoqi Li, Soyi Liu Leage, David Adams, Hilde Carlier, Filip van den Bosch

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27 Citations (Scopus)

Abstract

Objectives: The objective of COAST-Y was to evaluate the effect of continuing versus withdrawing ixekizumab (IXE) in patients with axial spondyloarthritis (axSpA) who had achieved remission. Methods: COAST-Y is an ongoing, phase III, long-term extension study that included a double-blind, placebo (PBO)-controlled, randomised withdrawal-retreatment period (RWRP). Patients who completed the originating 52-week COAST-V, COAST-W or COAST-X studies entered a 24-week lead-in period and continued either 80 mg IXE every 2 (Q2W) or 4 weeks (Q4W). Patients who achieved remission (an Ankylosing Spondylitis Disease Activity Score (ASDAS)<1.3 at least once at week 16 or week 20, and <2.1 at both visits) were randomly assigned equally at week 24 to continue IXE Q4W, IXE Q2W or withdraw to PBO in a blinded fashion. The primary endpoint was the proportion of flare-free patients (flare: ASDAS≥2.1 at two consecutive visits or ASDAS>3.5 at any visit) after the 40-week RWRP, with time-to-flare as a major secondary endpoint. Results: Of 773 enrolled patients, 741 completed the 24-week lead-in period and 155 entered the RWRP. Forty weeks after randomised withdrawal, 83.3% of patients in the combined IXE (85/102, p<0.001), IXE Q4W (40/48, p=0.003) and IXE Q2W (45/54, p=0.001) groups remained flare-free versus 54.7% in the PBO group (29/53). Continuing IXE significantly delayed time-to-flare versus PBO, with most patients remaining flare-free for up to 20 weeks after IXE withdrawal. Conclusions: Patients with axSpA who continued treatment with IXE were significantly less likely to flare and had significantly delayed time-to-flare compared with patients who withdrew to PBO.

Original languageEnglish
Pages (from-to)1022-1030
Number of pages9
JournalAnnals of the rheumatic diseases
Volume80
Issue number8
Early online date2021
DOIs
Publication statusPublished - 1 Aug 2021

Keywords

  • ankylosing
  • antirheumatic agents
  • biological therapy
  • immune system diseases
  • spondylitis

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