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)

Maxime Dougados, James Cheng Chung Wei, Robert Landewé, Joachim Sieper, Xenofon Baraliakos, Filip Van Den Bosch, Walter P. Maksymowych, Joerg Ermann, Jessica A. Walsh, Tetsuya Tomita, Atul Deodhar, Désirée Van Der Heijde, Xiaoqi Li, Fangyi Zhao, Clinton C. Bertram, Gaia Gallo, Hilde Carlier, Lianne S. Gensler

Research output: Contribution to journalArticle

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. Trial registration number: NCT02696785/NCT02696798.

Original languageEnglish (US)
JournalAnnals of the rheumatic diseases
DOIs
StateAccepted/In press - Jan 1 2019

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LY2439821
Randomized Controlled Trials
Safety
Placebos
Antirheumatic Agents
Tumor Necrosis Factor-alpha
Health Status

Keywords

  • Ankylosing spondylitis
  • DMARDs (biologic)
  • spondyloarthritis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

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). / Dougados, Maxime; Wei, James Cheng Chung; Landewé, Robert; Sieper, Joachim; Baraliakos, Xenofon; Van Den Bosch, Filip; Maksymowych, Walter P.; Ermann, Joerg; Walsh, Jessica A.; Tomita, Tetsuya; Deodhar, Atul; Van Der Heijde, Désirée; Li, Xiaoqi; Zhao, Fangyi; Bertram, Clinton C.; Gallo, Gaia; Carlier, Hilde; Gensler, Lianne S.

In: Annals of the rheumatic diseases, 01.01.2019.

Research output: Contribution to journalArticle

Dougados, M, Wei, JCC, Landewé, R, Sieper, J, Baraliakos, X, Van Den Bosch, F, Maksymowych, WP, Ermann, J, Walsh, JA, Tomita, T, Deodhar, A, Van Der Heijde, D, Li, X, Zhao, F, Bertram, CC, Gallo, G, Carlier, H & Gensler, LS 2019, '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)', Annals of the rheumatic diseases. https://doi.org/10.1136/annrheumdis-2019-216118
Dougados, Maxime ; Wei, James Cheng Chung ; Landewé, Robert ; Sieper, Joachim ; Baraliakos, Xenofon ; Van Den Bosch, Filip ; Maksymowych, Walter P. ; Ermann, Joerg ; Walsh, Jessica A. ; Tomita, Tetsuya ; Deodhar, Atul ; Van Der Heijde, Désirée ; Li, Xiaoqi ; Zhao, Fangyi ; Bertram, Clinton C. ; Gallo, Gaia ; Carlier, Hilde ; Gensler, Lianne S. / 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). In: Annals of the rheumatic diseases. 2019.
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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. Trial registration number: NCT02696785/NCT02696798.",
keywords = "Ankylosing spondylitis, DMARDs (biologic), spondyloarthritis",
author = "Maxime Dougados and Wei, {James Cheng Chung} and Robert Landew{\'e} and Joachim Sieper and Xenofon Baraliakos and {Van Den Bosch}, Filip and Maksymowych, {Walter P.} and Joerg Ermann and Walsh, {Jessica A.} and Tetsuya Tomita and Atul Deodhar and {Van Der Heijde}, D{\'e}sir{\'e}e and Xiaoqi Li and Fangyi Zhao and Bertram, {Clinton C.} and Gaia Gallo and Hilde Carlier and Gensler, {Lianne S.}",
year = "2019",
month = "1",
day = "1",
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T1 - 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)

AU - Dougados, Maxime

AU - Wei, James Cheng Chung

AU - Landewé, Robert

AU - Sieper, Joachim

AU - Baraliakos, Xenofon

AU - Van Den Bosch, Filip

AU - Maksymowych, Walter P.

AU - Ermann, Joerg

AU - Walsh, Jessica A.

AU - Tomita, Tetsuya

AU - Deodhar, Atul

AU - Van Der Heijde, Désirée

AU - Li, Xiaoqi

AU - Zhao, Fangyi

AU - Bertram, Clinton C.

AU - Gallo, Gaia

AU - Carlier, Hilde

AU - Gensler, Lianne S.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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. Trial registration number: NCT02696785/NCT02696798.

AB - 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. Trial registration number: NCT02696785/NCT02696798.

KW - Ankylosing spondylitis

KW - DMARDs (biologic)

KW - spondyloarthritis

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U2 - 10.1136/annrheumdis-2019-216118

DO - 10.1136/annrheumdis-2019-216118

M3 - Article

C2 - 31685553

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JO - Annals of the Rheumatic Diseases

JF - Annals of the Rheumatic Diseases

SN - 0003-4967

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