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). Issue 8 (6th May 2021)

• Record Type: Journal Article
• Authors: Landewé, Robert BM; Gensler, Lianne S; Poddubnyy, Denis; Rahman, Proton; Hojnik, Maja; Li, Xiaoqi; Liu Leage, Soyi; Adams, David; Carlier, Hilde; Van den Bosch, Filip
• Other Names: author non-byline.; Ariel Federico Javier author non-byline.; Berman Alberto author non-byline.; Carrio Judith author non-byline.; Lucero Eleonora Del Valle author non-byline.; Cocco Jose Maldonado author non-byline.; Velasco Benito Jorge author non-byline.; Resch Heinrich author non-byline.; Grisar Johannes author non-byline.; Azevedo Valderilio author non-byline.; Keiserman Mauro author non-byline.; Marcolino Flora author non-byline.; Xavier Ricardo author non-byline.; Ximenes Antonio author non-byline.; Melazzi Ana author non-byline.; Scotton Antonio author non-byline.; Bessette Louis author non-byline.; Maksymowych Walter author non-byline.; Morin Frederic author non-byline.; Dokoupilova Eva author non-byline.; Dvorak Zdenek author non-byline.; Racek Vlastimil author non-byline.; Moravcova Radka author non-byline.; Malcova Martina author non-byline.; Pavelka Karel author non-byline.; Eklund Kari K. author non-byline.; Jarvinen Pentti author non-byline.; Paimela Leena author non-byline.; Goupille Philippe author non-byline.; Lespessailles Eric author non-byline.; Combe Bernard author non-byline.; Neeck Gunther author non-byline.; Braun Jürgen author non-byline.; Everding Andrea author non-byline.; Cseuz Regina author non-byline.; Drescher Edit author non-byline.; Moscovici Yolanda Braun author non-byline.; Elkayam Ori author non-byline.; Molad Yair author non-byline.; Reitblat Tatiana author non-byline.; Salvarani Carlo author non-byline.; Tomita Tetsuya author non-byline.; Taniguchi Yoshinori author non-byline.; Tamaki Hiromichi author non-byline.; Tsuda Tokutaro author non-byline.; Tada Kurisu author non-byline.; Dobashi Hiroaki author non-byline.; Okano Tadashi author non-byline.; Inui Kentaro author non-byline.; Ueki Yukitaka author non-byline.; Matsumoto Yoshifuji author non-byline.; Koyama Yoshinobu author non-byline.; Atsumi Tatsuya author non-byline.; Goto Hitoshi author non-byline.; Takakubo Yuya author non-byline.; Lee Yeon-Ah author non-byline.; Ju Ji Hyeon author non-byline.; Kang Seong Wook author non-byline.; Kim Tae-Hwan author non-byline.; Lee Chang Keun author non-byline.; Lee Eun Bong author non-byline.; Lee Sang Heon author non-byline.; Park Min-Chan author non-byline.; Shin Kichul author non-byline.; Lee Sang-Hoon author non-byline.; Barrera Rodriguez Aaron Alejandro author non-byline.; Cons-Molina Fidencio author non-byline.; Barragan Sergio Duran author non-byline.; Skinner Cassandra Michelle author non-byline.; Tena Cesar Francisco Pacheco author non-byline.; Remus Cesar Ricardo Ramos author non-byline.; Rizo Rodriguez Juan Cruz author non-byline.; van de Sande Marleen G. author non-byline.; Griep Eduard author non-byline.; Szymanska Malgorzata author non-byline.; Blicharski Tomasz author non-byline.; Brzezicki Jan author non-byline.; Dudek Anna author non-byline.; Hrycaj Pawel author non-byline.; Plebanski Rafal author non-byline.; Racewicz Artur author non-byline.; Wojciechowski Rafal author non-byline.; Krogulec Marek author non-byline.; Opris-Belinski Daniela author non-byline.; Ramazan Ana Maria author non-byline.; Matsievskaya Galina author non-byline.; Schmidt Evgeniya author non-byline.; Dubinina Tatiana author non-byline.; Stanislav Marina author non-byline.; Yakushin Sergey author non-byline.; Ershova Olga author non-byline.; Rebrov Andrey author non-byline.; Fernandez Carlos Gonzalez author non-byline.; Masmitja Jordi Gratacos author non-byline.; Burson Juan Sanchez author non-byline.; Chen Hung-An author non-byline.; Chen Ying-Chou author non-byline.; Hsieh Song-Chou author non-byline.; Lan Joung-Liang author non-byline.; Wei Cheng-Chung author non-byline.; Barkham Nicholas author non-byline.; Gaffney Karl author non-byline.; Khan Sophia author non-byline.; Packham Jonathan author non-byline.; Watson Pippa author non-byline.; Churchill Melvin author non-byline.; Deodhar Atulya author non-byline.; Flint Kathleen author non-byline.; Gaylis Norman author non-byline.; Greenwald Maria author non-byline.; Howell Mary author non-byline.; Ince Akgun author non-byline.; Drucker Yoel author non-byline.; Kaine Jeffery L. author non-byline.; Kivitz Alan author non-byline.; Klein Steven author non-byline.; Legerton Clarence author non-byline.; Mehta Daksha author non-byline.; Mueller Eric author non-byline.; Peters Eric author non-byline.; Querubin Roel N. author non-byline.; Reveille John author non-byline.; Sayers Michael author non-byline.; Scoville Craig author non-byline.; Shanahan Joseph author non-byline.; Roseff Richard author non-byline.; Harris Mark author non-byline.; Diegel Roger author non-byline.; Thai Christine author non-byline.; Cortes-Maisonet Gregorio author non-byline.; Soto-Raices Oscar author non-byline.; Pantojas Carlos author non-byline.;
• Is Part Of: Annals of the rheumatic diseases. Volume 80:Issue 8(2021)
• Page Start: 1022
• Page End: 1030
• Publication Date: 2021-05-06
• Subjects: spondylitis -- ankylosing -- biological therapy -- antirheumatic agents -- immune system diseases; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2020-219717
• Languages: English
• ISSNs: 0003-4967

Abstract

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.