Secukinumab Demonstrates Sustained Efficacy And Safety In A Taiwanese Subpopulation With Active Ankylosing Spondylitis: Four-Year Results From A Phase 3 Study, Measure 1

FRONTIERS IN IMMUNOLOGY(2020)

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摘要
ObjectivesTo present the long-term (4-year) efficacy and safety of secukinumab in Taiwanese patients with active AS in the MEASURE 1 extension study.MethodsThis 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.ResultsOf 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.ConclusionSecukinumab 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 identifierNCT01863732.
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关键词
biologics, interleukin-17A inhibitor, Taiwan, secukinumab, ankylosing spondylitis
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