NEJM publishes results of Cosentyx Phase III studies in ankylosing spondylitis

Novartis Pharmaceuticals CorporationDec 24 2015

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 The New 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.

"I've seen in my patients how painful and debilitating ankylosing spondylitis can be," said Dr. Atul Deodhar, professor of medicine and medical director of Rheumatology Clinics at Oregon Health & Science University, and an investigator in the secukinumab clinical trial program. "These data demonstrate the potential of secukinumab as a new treatment option for ankylosing spondylitis and adds to our growing understanding of the key role IL-17 plays in the pathophysiology of the disease."

Cosentyx was well tolerated in both studies, with a safety profile consistent to that observed in a large psoriasis clinical trial program. The most common adverse events (AEs) seen through Week 16 in both studies were nasopharyngitis (upper respiratory tract infection), dyslipidemia (abnormal cholesterol/triglyceride levels), and headache. In MEASURE 1, 68% of Cosentyx patients experienced an AE through Week 16 compared to 56% of placebo patients. Serious adverse event (SAE) rates were 2% for Cosentyx patients and 4% for placebo. In MEASURE 2, 61% of secukinumab patients experienced an AE through Week 16 compared to 64% of placebo patients. SAE rates were 6% for Cosentyx patients and 4% for placebo.