Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W)

doi:10.1136/annrheumdis-2019-216118

中山醫學大學機構典藏 CSMUIR > 中山醫學大學研究成果 > 期刊論文 > Item 310902500/24941

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Title:	Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W)
Authors:	Dougados, M;Wei, JCC;Landewe, R;Sieper, J;Baraliakos, X;Van den Bosch, F;Maksymowych, WP;Ermann, J;Walsh, JA;Tomita, T;Deodhar, A;van der Heijde, D;Li, XQ;Zhao, FY;Bertram, CC;Gallo, G;Carlier, H;Gensler, LS
Date:	2020
Issue Date:	2022-08-09T08:10:33Z (UTC)
Publisher:	BMJ PUBLISHING GROUP
ISSN:	0003-4967
Abstract:	Objectives To investigate the efficacy and safety of ixekizumab for up to 52 weeks in two phase 3 studies of patients with active radiographic axial spondyloarthritis (r-axSpA) who were biological disease-modifying antirheumatic drug (bDMARD)-naive (COAST-V) or tumour necrosis factor inhibitor (TNFi)-experienced (COAST-W). Methods Adults with active r-axSpA were randomised 1:1:1:1 (n=341) to 80 mg ixekizumab every 2 (IXE Q2W) or 4 weeks (IXE Q4W), placebo (PBO) or 40 mg adalimumab Q2W (ADA) in COAST-V and 1:1:1 (n=316) to IXE Q2W, IXE Q4W or PBO in COAST-W. At week 16, patients receiving ixekizumab continued their assigned treatment; patients receiving PBO or ADA were rerandomised 1:1 to IXE Q2W or IXE Q4W (PBO/IXE, ADA/IXE) through week 52. Results In COAST-V, Assessment of SpondyloArthritis international Society 40 (ASAS40) responses rates (intent-to-treat population, non-responder imputation) at weeks 16 and 52 were 48% and 53% (IXE Q4W); 52% and 51% (IXE Q2W); 36% and 51% (ADA/IXE); 19% and 47% (PBO/IXE). Corresponding ASAS40 response rates in COAST-W were 25% and 34% (IXE Q4W); 31% and 31% (IXE Q2W); 14% and 39% (PBO/IXE). Both ixekizumab regimens sustained improvements in disease activity, physical function, objective markers of inflammation, QoL, health status and overall function up to 52 weeks. Safety through 52 weeks of ixekizumab was consistent with safety through 16 weeks. Conclusion The significant efficacy demonstrated with ixekizumab at week 16 was sustained for up to 52 weeks in bDMARD-naive and TNFi-experienced patients. bDMARD-naive patients initially treated with ADA demonstrated further numerical improvements after switching to ixekizumab. Safety findings were consistent with the known safety profile of ixekizumab.
URI:	http://dx.doi.org/10.1136/annrheumdis-2019-216118 https://www.webofscience.com/wos/woscc/full-record/WOS:000518219100016 https://ir.csmu.edu.tw:8080/handle/310902500/24941
Relation:	ANNALS OF THE RHEUMATIC DISEASES ,2020 ,v79 ,issue 2 ,p176-185
Appears in Collections:	[中山醫學大學研究成果] 期刊論文

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