FRI0414 SECUKINUMAB PROVIDES RAPID AND SIGNIFICANT IMPROVEMENT IN THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS: PRIMARY (16-WEEK) RESULTS FROM A PHASE 3 CHINA-CENTRIC STUDY, MEASURE 5
Authors: Feng Huang, Fei Sun, Weiguo Wan, Lijun Wu, Lingli Dong, Xiao Zhang, Tae-Hwan Kim, Raj Sengupta, Ladislav Šenolt, Yi Wang, Haomin Qiu, Brian Porter, Sibylle Haemmerle
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Secukinumab (SEC), a fully human monoclonal antibody to IL-17A, has demonstrated significant and sustained efficacy in patients (pts) with ankylosing spondylitis (AS) across several phase 3 studies.<sup>1-3</sup> MEASURE 5 (NCT02896127) is a placebo (PBO)-controlled phase 3 China centric 1-year study in pts with active AS. <h3>Objectives</h3> To present the primary efficacy and safety results of the MEASURE 5 study. <h3>Methods</h3> Pts were randomised (2:1) to receive subcutaneous (s.c.) SEC 150 mg or PBO at baseline (BL), Weeks (Wks) 1, 2, 3, and 4, and then every 4 wks (q4w) thereafter through Wk 52. All PBO pts were switched to s.c. SEC 150 mg q4w starting at Wk 16. Primary endpoint was ASAS20 at Wk 16. Key secondary endpoints were ASAS40, hsCRP, ASAS5/6, BASDAI, SF-36 PCS, ASQoL and ASAS partial remission (PR). Randomisation was stratified by geographic location (China vs. non-China). Statistical analyses used non-responder imputation (NRI) for binary and mixed-effect model repeated measures (MMRM) for continuous variables. A pre-defined hierarchical testing strategy was used for overall population to adjust multiplicity. Safety analysis included all pts who received ≥1 dose of SEC. <h3>Results</h3> A total of 458 pts were randomised; 327 (71.4%) from China and 131 (28.6%) from Czech Republic, South Korea and UK. Overall, 97.7% (298/305) and 97.4% (149/153) pts in the SEC and PBO groups, respectively, completed 16 wks. BL characteristics were comparable between groups. Approximately 24% of pts were anti-TNF-inadequate responders/intolerant. The primary endpoint was met; SEC (58.4%) significantly improved ASAS20 response at Wk 16 vs. PBO (36.6%; <i>P</i> &lt; 0.0001); corresponding rates were 56.0% vs. 38.5% (<i>P</i> &lt; 0.01) in the Chinese population. Improvements were demonstrated in all secondary endpoints at Wk 16 for SEC vs. PBO (overall and Chinese populations; Table). Serious AE rates were reported in 3.3% and 2.0% of SEC and PBO pts, respectively. Uveitis was reported in 1.0% (SEC) and 0.7% (PBO) of pts. No MACE, IBD or deaths were reported. <h3>Conclusion</h3> SEC demonstrated rapid and significant improvement in the signs and symptoms of AS in both the overall and Chinese populations. Secukinumab was well tolerated with no new safety signals identified. <h3>References</h3> [1] Baeten D, et al. N Engl J Med. 2015;373:2534-48. [2] Pavelka K, et al. Arthritis Res Ther. 2017;19:285. [3] Kivitz AJ, et al. Rheumatol Ther. 2018;5:447-62. <h3>Disclosure of Interests</h3> Feng Huang: None declared, Fei Sun: None declared, Weiguo Wan: None declared, Lijun Wu: None declared, Lingli Dong: None declared, Xiao Zhang: None declared, Tae-hwan Kim: None declared, Raj Sengupta Grant/research support from: AbbVie, Celgene Corporation, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Merck Sharp &amp; Dohme, Novartis, Pfizer, and UCB, Ladislav Šenolt Grant/research support from: AbbVie, Consultant for: AbbVie, Bristol-Myers Squibb, Celgene Corporation, Merck Sharp and Dohme, Novartis, Pfizer, Roche, UCB, Amgen, Takeda, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, Roche, UCB, Yi Wang Shareholder of: Novartis, Employee of: Novartis, Haomin Qiu Shareholder of: Novartis, Employee of: Novartis, Brian Porter Shareholder of: Novartis, Employee of: Novartis, Sibylle Haemmerle Shareholder of: Novartis, Employee of: Novartis