Novartis announced 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[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.
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.
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.
