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

Front Immunol. 2020 Nov 26:11:561748. doi: 10.3389/fimmu.2020.561748. eCollection 2020.

Abstract

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.

Clinicaltrialsgov identifier: NCT01863732.

Keywords: Taiwan; ankylosing spondylitis; biologics; interleukin-17A inhibitor; secukinumab.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravenous
  • Adult
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antibodies, Monoclonal, Humanized / adverse effects*
  • Antirheumatic Agents / administration & dosage
  • Antirheumatic Agents / adverse effects*
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Spondylitis, Ankylosing / drug therapy*
  • Spondylitis, Ankylosing / epidemiology*
  • Taiwan / epidemiology
  • Treatment Outcome
  • Young Adult

Substances

  • Antibodies, Monoclonal, Humanized
  • Antirheumatic Agents
  • secukinumab

Associated data

  • ClinicalTrials.gov/NCT01863732