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)
Authors: X Baraliakos, AJ Kivitz, A Deodhar, J Braun, JC Wei, EM Delicha, Z Talloczy, B Porter
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> 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.<sup>1,2</sup> <h3>Objectives</h3> To report efficacy and safety of secukinumab through 3 yrs in an extension trial (NCT01863732) to the core MEASURE 1 trial. <h3>Methods</h3> 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. <h3>Results</h3> 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, Crohn9s disease and malignant/unspecified tumours was 1.1, 0.5 and 0.5 per 100 pt-yrs, respectively. <h3>Conclusions</h3> 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.<sup>1,2</sup> <h3>References</h3> Baeten D, et al. N Engl J Med 2015;373:2534–48. Braun J, et al. Ann Rheum Dis 2016;doi: 10.1136/annrheumdis-2016-209730. <h3>Disclosure of Interest</h3> 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