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

Abstract

Abstract Background 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.1-3 MEASURE 5 (NCT02896127) is a placebo (PBO)-controlled phase 3 China centric 1-year study in pts with active AS.

Objectives To present the primary efficacy and safety results of the MEASURE 5 study.

Methods 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.

Results 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%; P < 0.0001); corresponding rates were 56.0% vs. 38.5% (P < 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.

Conclusion 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.