The FINANCIAL — Novartis announced on December 23 that the 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 (NEJM).
These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in the signs and symptoms of active AS – a long-term, painful and debilitating inflammation of the spine. 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%, p<0.001) for MEASURE 1 and 61.1% (vs 28.4%, p<0.001) 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, according to Novartis.
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.
“Ankylosing spondylitis is a debilitating disease and many patients do not achieve a sufficient and sustained response from current therapies,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “These two studies demonstrate the potential of Cosentyx to address this significant unmet need and we look forward to continuing to generate longer term data on the effect of IL-17A inhibition on ankylosing spondylitis.”
Cosentyx is the first IL-17A inhibitor to demonstrate efficacy in Phase III AS studies and was recently approved in Europe to treat active AS in adults who have responded inadequately to conventional therapy, such as non-steroidal anti-inflammatory drugs (NSAIDs). New treatment options are needed for patients who do not achieve an adequate response to NSAIDs or anti-TNFs, with up to 40% of patients not responding sufficiently to the latter.
Cosentyx was well tolerated in both studies, with an overall safety profile consistent to that reported in clinical trials across multiple indications involving more than 9,600 patients, as well as over 12,500 patients who have already been treated in the post-marketing setting,. The most common adverse events (AEs) seen at Week 16 were upper respiratory tract infection, headache and dyslipidemia (abnormal cholesterol / triglyceride levels).