Novartis presented new Cosentyx (secukinumab) data in polymyalgia rheumatica (PMR) demonstrating a statistically significant, clinically meaningful difference in sustained remission rates vs placebo and significant steroid sparing. 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 use. 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 52.

No new safety signals were identified in PMR patients receiving Cosentyx. Key efficacy results at week 52: Endpoint - Cosentyx 300mg: Sustained remission 41.2%, Mean adjusted annual cumulative glucocorticoid dose 1604 mg; Cosentyx 150mg: Sustained remission 40.6%, Mean adjusted annual cumulative glucocorticoid dose 1683 mg; Placebo: Sustained remission 20.4%, Mean adjusted annual cumulative glucocorticoid dose 2093 mg. Novartis has submitted Cosentyx for polymyalgia rheumatica for health authority review in the US, EU and Japan.

Regulatory submissions in additional countries are expected to follow throughout 2026. Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (HS).

Cosentyx is also approved for use in pediatric patients, including those with PsO, juvenile idiopathic arthritis subtypes such as juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA), and in the U.S. for pediatric patients aged 12 years and older with moderate to severe HS and juvenile AS. The REPLENISH trial (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries, evaluating the efficacy and safety of Cosentyx in patients with polymyalgia rheumatica (PMR). Patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen.

The primary endpoint of the trial was to assess whether Cosentyx 300mg s.c. plus a 24-week steroid taper is superior to placebo plus a 24-week steroid taper in achieving sustained remission at week 52. Key secondary endpoints included the proportion of patients achieving complete sustained remission at week 52, the adjusted annual cumulative steroid dose, and the time to first use of escape or rescue treatment through week 52. Polymyalgia rheumatica (PMR) is a common inflammatory rheumatic disease in adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck, and hips.

Relapses are frequent, affecting up to 40% of patients in the first year, and long-term steroid use, the standard of care, carries significant risks including osteoporosis and diabetes. Beyond physical complications, PMR substantially impairs quality of life through pain, fatigue, restricted mobility, and fear of relapse.