Phase III results for Cosentyx (secukinumab) in ankylosing spondylitis published in New England Journal of Medicine- Novartis

Novartis announced results of the MEASURE 1 and MEASURE 2 Phase III studies for Cosentyx (secukinumab) in ankylosing spondylitis (AS) were published in the New England Journal of Medicine. These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in the signs and symptoms of active AS. Collectively the studies form the largest clinical trial program ever conducted in AS, involving 590 patients.

In both studies, the primary endpoint was the proportion of patients with at least 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria at week 16 with Cosentyx 150 mg. ASAS 20 response rates with Cosentyx 150 mg vs placebo at Week 16 were 60.8% (vs 28.7%) for MEASURE 1 and 61.1% (vs 28.4%) for MEASURE 2. The studies enrolled anti-tumor necrosis factor (anti-TNF) naïve patients and patients who had previously failed anti-TNF therapy, with clinical benefits demonstrated across the trial populations. Clinical improvements were seen as early as Week 1 and were sustained throughout the studies, with up to 77% of patients achieving an ASAS 20 response at the end of Week 52. Efficacy assessments, except those at Week 16, were exploratory endpoints.