Novartis’ Cosentyx shows benefits in Phase III AS trials
pharmafile | January 4, 2016 | News story | Research and Development, Sales and Marketing |Â Â Cosentyx, Novartis, Secukinumab, ankylosing spondylitisÂ
Novartis says results from two Phase III studies for Cosentyx in ankylosing spondylitis (AS) showing significant clinical improvements versus placebo.
Results from MEASURE 1 and MEASURE 2 – which collectively form the largest clinical trial program ever conducted in AS, involving 590 patients – were published in the New England Journal of Medicine (NEJM). The studies looked at improvements in 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 with at least 20% improvement in Assessment of Spondyloarthritis International Society (ASAS 20) response criteria after 16 weeks treatment with Cosentyx (secukinumab) 150 mg. ASAS 20 response rates with Cosentyx 150 mg vs placebo at week 16 were 60.8% v 28.7% in MEASURE 1, and 61.1% v 28.4% for MEASURE 2.
Clinical improvements were seen as early as week one and were sustained throughout the studies, with up to 77% of patients achieving an ASAS 20 response at the end of Week 52.
“Ankylosing spondylitis is a debilitating disease and many patients do not achieve a sufficient and sustained response from current therapies,” says Vasant Narasimhan, global head of development at 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 was well tolerated in both studies, with the most common adverse events seen at week 16 being upper respiratory tract infection, headache and dyslipidemia (abnormal cholesterol / triglyceride levels).
Cosentyx is the first IL-17A inhibitor to demonstrate efficacy in Phase III AS studies. It 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).
There is a significant unmet clinical need for new AS treatments for patients who do not achieve an adequate response to NSAIDs or anti-TNFs. Up to 40% of patients do not respond sufficiently to the latter. AS occurs in approximately 2 million people in the United States and Europe and typically affects young men and women aged 25 or older.
Joel Levy
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