Business
Novartis Cosentyx® PMR data in New England Journal of Medicine showed sustained remission vs placebo in twice as many patients
Clinically meaningful, statistically significant efficacy achieved in primary and all secondary endpoints, including reduced steroid use; safety consistent with established Cosentyx profile1,2Polymyalgia rheumatica (PMR) is an inflammatory rheumatic disease primarily affecting people over 50; extended steroid use associated with poor outcomes with limited advanced treatments3-7Data have been submitted for health authority review in US, EU and Japan; additional country filings to follow throughou
About this update from Novartis Ag
Basel, June 3, 2026 – Novartis presented today new Cosentyx® (secukinumab) data in polymyalgia rheumatica (PMR) demonstrating a statistically significant, clinically meaningful difference in sustained remission rates vs placebo and significant steroid sparing8. Published in the New England Journal of Medicine and simultaneously presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress, Phase III REPLENISH data showed that the effect of Cosentyx treatment was sustained through week 52 in this investigational use8. “PMR is an inflammatory rheumatic disease, characterized by disabling pain and stiffness in shoulders and pelvic girdle. There is an unmet need for a treatment that keeps symptoms under control over time with fewer relapses —while also reducing reliance on steroids,” said Prof Christian Dejaco, Director, Dept of Rheumatology, South Tyrol Health Trust, Bruneck, Italy. “I am encouraged by the REPLENISH trial results which showed that Cosentyx, with its known safety profile, can reduce flares in the longer term while lowering patients’ steroid exposure.” All primary and secondary endpoints of the REPLENISH trial were met across both Cosentyx 300mg and 150mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 528. No new safety signals were identified in PMR patients receiving Cosentyx8. "The publication of the REPLENISH data in the New England Journal of Medicine reflects the importance of these findings for patients with polymyalgia rheumatica (PMR), a disease with very limited advanced treatment options,” said Prof John Stone, MD, MPH, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, global principal investigator for the REPLENISH trial and lead author of the New England Journal of Medicine article. “The Phase III results showed a higher proportion of PMR patients achieved sustained remission with Cosentyx and further support IL-17A inhibition as a promising therapeutic approach in this disease.” “Today’s results demonstrate that Cosentyx fills an unmet need by providing relief and renewed hope for people living with polymyalgia rheumatica (PMR) through improvement in disease control while reducing steroid use,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “We look forward to workin...