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THU0397 Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis: 3-year results from a phase 3 extension trial (MEASURE 1)
  1. X Baraliakos1,
  2. AJ Kivitz2,
  3. A Deodhar3,
  4. J Braun1,
  5. JC Wei4,
  6. EM Delicha5,
  7. Z Talloczy6,
  8. B Porter6,
  9. on behalf of the MEASURE 1 study group
  1. 1Ruhr-University Bochum, Herne, Germany
  2. 2Altoona Center for Clinical Research, Duncansville
  3. 3Oregon Health & Science University, Portland, United States
  4. 4Chung Shan Medical University Hospital, Taichung, Taiwan, Province of China
  5. 5Novartis Pharma AG, Basel, Switzerland
  6. 6Novartis Pharmaceuticals Corporation, East Hanover, United States

Abstract

Background Rapid and sustained improvements in the signs and symptoms of ankylosing spondylitis (AS) have been reported with secukinumab, a fully human anti–IL-17A mAb, over the first 2 years (yrs) in the Phase 3 MEASURE 1 trial.1,2

Objectives To report efficacy and safety of secukinumab through 3 yrs in an extension trial (NCT01863732) to the core MEASURE 1 trial.

Methods After the 2-yr core trial, patients (pts) receiving secukinumab 150 or 75mg s.c. were invited to enter a 3-yr extension trial. Efficacy results at Week (Wk) 156 are reported for pts who were originally randomised to secukinumab. Assessments at Wk 156 included ASAS20/40, BASDAI, BASDAI50, SF-36 PCS, ASAS partial remission (ASAS PR) and ASDAS-CRP. Binary and continuous variables used multiple imputation and MMRM estimates, respectively. Analyses by anti-TNF use (naïve/intolerant to or inadequate response [IR]) was pre-specified and reported as observed. Safety analyses included all pts who received ≥1 dose of secukinumab.

Results A total of 290/371 pts (78%) completed the 2-yr core trial. Of these, 274 pts entered the extension trial, with 260 completing 156 wks (83/87 pts [95%] in IV→150mg; 95/100 pts [95%] in IV→75mg; 82/87 [94%] pts in placebo→secukinumab). At Wk 156, clinical improvements were sustained across all endpoints (Table, Figure). Similar trends were observed regardless of prior anti-TNF use (Table). Across the treatment period (secukinumab exposure [mean±SD]: 964.3±372.1 days), exposure-adjusted incidence rate with secukinumab for serious infections, Crohn's disease and malignant/unspecified tumours was 1.1, 0.5 and 0.5 per 100 pt-yrs, respectively.

Table 1.

Summary of 156-wk efficacy results

Conclusions Secukinumab provided sustained efficacy in signs/symptoms and physical function in pts with active AS over 3 yrs. Secukinumab was well tolerated with a favorable safety profile consistent with that reported previously.1,2

References

  1. Baeten D, et al. N Engl J Med 2015;373:2534–48.

  2. Braun J, et al. Ann Rheum Dis 2016;doi: 10.1136/annrheumdis-2016-209730.

References

Disclosure of Interest X. Baraliakos Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Werfen, Consultant for: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Werfen, A. Kivitz Consultant for: AbbVie, Pfizer, Genentech, UCB, Celgene, Speakers bureau: Celgene, Pfizer, Genentech, A. Deodhar Grant/research support from: Eli Lilly, Janssen, Novartis, Pfizer, UCB, Consultant for: Eli Lilly, Janssen, Novartis, Pfizer, UCB, J. Braun Grant/research support from: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, UCB, Consultant for: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, UCB, Speakers bureau: Abbvie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, UCB, J. Wei Grant/research support from: BMS, Janssen, Pfizer, Sanofi-Aventis, Novartis, Consultant for: Pfizer, Celgene, Chugai, UCB Pharma, TSH Taiwan, Speakers bureau: AbbVie, BMS, Chugai, Janssen, Pfizer, E. Delicha Employee of: Novartis, Z. Talloczy Shareholder of: Novartis, Employee of: Novartis, B. Porter Shareholder of: Novartis, Employee of: Novartis

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