Success for AIN 457 in two Phase III trials for Ankylosing Spondylitis- Novartis

Novartis announced that AIN 457 (secukinumab) met primary and key secondary endpoints in two pivotal Phase III studies (MEASURE 1 and MEASURE 2) in patients with Ankylosing Spondylitis (AS). Key endpoints included improvements in signs and symptoms of the disease versus placebo and associated improvements in physical function and quality of life.

MEASURE 1 and MEASURE 2 are randomized, placebo-controlled, multicenter studies designed to demonstrate efficacy of secukinumab in AS compared to placebo and to assess safety, tolerability and long-term effectiveness. The Assessment of Spondyloarthritis International Society criterion (ASAS 20) was the primary endpoint. Secukinumab showed an acceptable safety profile in both studies which was consistent with that observed in the large psoriasis clinical trial program, involving approximately 4,000 patients. Detailed results of the studies will be presented at an upcoming medical congress.