NEJM publishes results of Cosentyx Phase III studies in ankylosing spondylitis
Novartis announced today that the results of the MEASURE 1 and MEASURE 2 Phase III studies for Cosentyx® (secukinumab) in ankylosing spondylitis (AS) were published in TheNew England Journal of Medicine (NEJM). These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in reducing the signs and symptoms of active AS – a long-term, painful and debilitating inflammation of the spine.
In both studies, the primary endpoint was the proportion of patients meeting the Assessment of Spondyloarthritis International Society 20 (ASAS20) response criteria at Week 16 with Cosentyx 150 mg. In MEASURE 1 and MEASURE 2, ASAS20 response rates with Cosentyx 150 mg vs placebo at Week 16 were 61% (vs 29%, p<0.001) and 61% (vs 28%, p<0.001), respectively. Patients enrolled in these studies were either inadequate responders or intolerant to anti-tumor-necrosis-factor medicines (anti-TNFs), or had not been previously treated with anti-TNF therapies.
In exploratory analyses, clinical improvements with Cosentyx were seen at Week 1 and ASAS20 responses seen at the Week 16 primary endpoint were sustained to the Week 52 exploratory endpoint. Efficacy assessments, except those at Week 16, were also exploratory endpoints.
Cosentyx is the first IL-17A antagonist and the first biologic other than the current biologic standard of care – anti-TNFs – to demonstrate efficacy in Phase III AS studies.