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Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1

OBJECTIVES: To present the long-term (4-year) efficacy and safety of secukinumab in Taiwanese patients with active AS in the MEASURE 1 extension study. METHODS: This post hoc analysis reports data from Taiwanese patients originally randomized to subcutaneous secukinumab 150 or 75mg or placebo every...

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Autores principales: Tseng, Jui-Cheng, Wei, James Cheng-Chung, Deodhar, Atul, Martin, Ruvie, Porter, Brian, McCreddin, Suzanne, Talloczy, Zsolt
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7725874/
https://www.ncbi.nlm.nih.gov/pubmed/33324394
http://dx.doi.org/10.3389/fimmu.2020.561748
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author Tseng, Jui-Cheng
Wei, James Cheng-Chung
Deodhar, Atul
Martin, Ruvie
Porter, Brian
McCreddin, Suzanne
Talloczy, Zsolt
author_facet Tseng, Jui-Cheng
Wei, James Cheng-Chung
Deodhar, Atul
Martin, Ruvie
Porter, Brian
McCreddin, Suzanne
Talloczy, Zsolt
author_sort Tseng, Jui-Cheng
collection PubMed
description OBJECTIVES: To present the long-term (4-year) efficacy and safety of secukinumab in Taiwanese patients with active AS in the MEASURE 1 extension study. METHODS: This post hoc analysis reports data from Taiwanese patients originally randomized to subcutaneous secukinumab 150 or 75mg or placebo every 4 weeks (following intravenous loading dose) who were invited to enter the 3-year extension study. Assessments at Week 208 included ASAS20/40 responses and other clinically relevant endpoints. Efficacy data are presented as observed. Safety analyses included all patients who received ≥1 dose of secukinumab. RESULTS: Of the 57 Taiwanese patients in the core trial, 48 entered the extension study and 87.5% patients (42/48) completed 4 years of treatment. Thirteen Taiwanese patients (including placebo-switchers) were escalated from 75 to 150mg (approved dose) at some point starting from Week 172. ASAS20/40 responses were sustained through 4 years in the Taiwanese patients who were originally randomized to secukinumab 150mg. Clinical responses were improved in those patients who received dose-escalation from 75 to 150mg during the study. No unexpected safety signals were reported. CONCLUSION: Secukinumab 150mg demonstrated sustained efficacy over 4 years in Taiwanese patients with active ankylosing spondylitis. The safety profile of secukinumab was consistent with previous reports. CLINICALTRIALS.GOV IDENTIFIER: NCT01863732.
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spelling pubmed-77258742020-12-14 Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1 Tseng, Jui-Cheng Wei, James Cheng-Chung Deodhar, Atul Martin, Ruvie Porter, Brian McCreddin, Suzanne Talloczy, Zsolt Front Immunol Immunology OBJECTIVES: To present the long-term (4-year) efficacy and safety of secukinumab in Taiwanese patients with active AS in the MEASURE 1 extension study. METHODS: This post hoc analysis reports data from Taiwanese patients originally randomized to subcutaneous secukinumab 150 or 75mg or placebo every 4 weeks (following intravenous loading dose) who were invited to enter the 3-year extension study. Assessments at Week 208 included ASAS20/40 responses and other clinically relevant endpoints. Efficacy data are presented as observed. Safety analyses included all patients who received ≥1 dose of secukinumab. RESULTS: Of the 57 Taiwanese patients in the core trial, 48 entered the extension study and 87.5% patients (42/48) completed 4 years of treatment. Thirteen Taiwanese patients (including placebo-switchers) were escalated from 75 to 150mg (approved dose) at some point starting from Week 172. ASAS20/40 responses were sustained through 4 years in the Taiwanese patients who were originally randomized to secukinumab 150mg. Clinical responses were improved in those patients who received dose-escalation from 75 to 150mg during the study. No unexpected safety signals were reported. CONCLUSION: Secukinumab 150mg demonstrated sustained efficacy over 4 years in Taiwanese patients with active ankylosing spondylitis. The safety profile of secukinumab was consistent with previous reports. CLINICALTRIALS.GOV IDENTIFIER: NCT01863732. Frontiers Media S.A. 2020-11-26 /pmc/articles/PMC7725874/ /pubmed/33324394 http://dx.doi.org/10.3389/fimmu.2020.561748 Text en Copyright © 2020 Tseng, Wei, Deodhar, Martin, Porter, McCreddin and Talloczy http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Immunology
Tseng, Jui-Cheng
Wei, James Cheng-Chung
Deodhar, Atul
Martin, Ruvie
Porter, Brian
McCreddin, Suzanne
Talloczy, Zsolt
Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1
title Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1
title_full Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1
title_fullStr Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1
title_full_unstemmed Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1
title_short Secukinumab Demonstrates Sustained Efficacy and Safety in a Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From a Phase 3 Study, MEASURE 1
title_sort secukinumab demonstrates sustained efficacy and safety in a taiwanese subpopulation with active ankylosing spondylitis: four-year results from a phase 3 study, measure 1
topic Immunology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7725874/
https://www.ncbi.nlm.nih.gov/pubmed/33324394
http://dx.doi.org/10.3389/fimmu.2020.561748
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