Novartis’ Cosentyx hits primary goal in Phase 3 non-radiographic axial spondyloarthritis study
pharmafile | June 4, 2020 | News story | Research and Development | Cosentyx, Novartis, axial spondyloarthritis
New Phase 3 data has been released on the efficacy of Novartis’ interleukin (IL)-17A inhibitor Cosentyx (secukinumab), showing that the therapy led to “significant and sustained improvements in signs and symptoms” of non-radiographic axial spondyloarthritis (nr-axSpA).
The debilitating condition is recorded as affecting around 1.7 million people across the largest five EU nations and the US, though, as a frequently undiagnosed condition, its true prevalence is likely much higher. Cosentyx secured approval in Europe for this indication in April this year.
The study revealed that biologic treatment-naïve participants receiving 150mg Cosentyx saw an improvement of 41.5% at 16 weeks and 35.4% at 52 weeks on the Assessment of Spondyloarthritis International Society (ASAS) assessment scale, compared to 29.2% and 19.9% over the same periods with placebo. With these results, the study met its primary endpoint of a 40% improvement, or ASAS40, in Cosentyx patients.
The trial also met its secondary endpoints over the 52 weeks, including improvements in pain, mobility and health-related quality of life.
“With these new data and the recent first-in-class European approval of Cosentyx in non-radiographic axial spondyloarthritis, we are continuing to build on our heritage in the axial spondyloarthritis disease spectrum,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology & Dermatology at Novartis. “This fourth indication for Cosentyx further demonstrates our commitment to reimagine care for more patients.”
Matt Fellows
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