Article
Secukinumab Significantly Improves Signs and Symptoms of Active Ankylosing Spondylitis: 52 Week Data from MEASURE 2, a Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial with Subcutaneous Loading and Maintenance Dosing
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Published: | September 1, 2015 |
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Introduction: In MEASURE 2 (NCT01649375), subcutaneous (s.c) administration of secukinumab improved the signs and symptoms of ankylosing spondylitis (AS) through 16 weeks (wks) of therapy [1].
The objective is to investigate the long-term (52 wks) efficacy and safety of s.c secukinumab in in the MEASURE 2 study.
Methods: 219 adults with active AS, despite therapy with nonsteroidal anti-inflammatory drugs, were randomized to receive s.c secukinumab 150mg, 75mg, or placebo (PBO) at baseline, Wk 1, 2, and 3, and every 4 wks starting from Wk 4. At Wk 16, subjects in the PBO group were re-randomized to secukinumab 150mg or 75mg every 4 wks. The primary endpoint was the proportion of subjects achieving an Assessment of Spondyloarthritis International Society (ASAS) 20 response at Wk 16. Secondary endpoints included ASAS40, high sensitivity C-reactive protein (hsCRP), ASAS 5/6, Bath Ankylosing Spondylitis Disease Activity (BASDAI), Short Form-36 Health Survey Physical Component Summary (SF-36 PCS), Ankylosing Spondylitis Quality of Life (ASQoL), and ASAS partial remission.
Results: 181 pts (82.6%) completed 52 wks of treatment. ASAS20 response rate at Wk 16 was 61.1% with secukinumab 150mg vs 28.4% with PBO (P=0.0001). Secukinumab 150mg also significantly improved hsCRP, ASAS40, ASAS 5/6, BASDAI, SF-36 PCS and ASQoL at Wk 16, compared with PBO. Clinical responses with secukinumab. 75mg did not reach statistical significance for any of the pre-specified endpoints. Improvements with secukinumab 150mg were sustained through Wk 52; ASAS20/40 response rates with secukinumab 150mg were 73.8%/57.4% at Wk 52 (observed data). ASAS20/40 response rates in subjects originally randomized to PBO who received secukinumab 150mg (n=34) were 75.0%/56.3% at Wk 52. Exposure-adjusted adverse event (AE) rates were 214.1, 211.7 and 443.2 per 100 patient-years with secukinumab 150mg, 75mg and PBO, respectively. The respective rates of serious AEs were 6.6, 7.7 and 14.0. The most common serious AE (SAE) was serious infections; no subject discontinued therapy due to a SAE.
Conclusion: Secukinumab 150mg s.c provided sustained improvements to 52 weeks in the signs and symptoms of AS, reducing inflammation, and improving physical function and health-related quality of life. Secukinumab was well tolerated; safety findings were consistent with previous reports.