Novartis's Cosentyx Shows Strong Results in Phase III PMR Trial

Novartis announced that Cosentyx met its primary endpoint and all secondary endpoints in the Phase III REPLENISH study, a significant milestone in the treatment of polymyalgia rheumatica.

At Week 52, Cosentyx demonstrated statistically significant and clinically sustained remission compared to placebo. Full results will be unveiled at an upcoming medical congress; intended submissions to health authorities are planned for the first half of 2026.

The REPLENISH trial (NCT05767034) is a large Phase III study being conducted in patients globally from 27 countries. Patients in this trial were randomized to receive Cosentyx 300mg, Cosentyx 150mg, or placebo, with each treatment group receiving a steroid taper over 24 weeks. The primary endpoint was whether or not Cosentyx 300mg plus taper demonstrated superior sustained remission at week 52 compared to placebo. Key secondary endpoints included cumulative steroid use, complete sustained remission, and time to escape or additional treatment.

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“Polymyalgia rheumatica is an inflammatory rheumatic disease characterized by bilateral pain of the neck, shoulders, or hips, morning stiffness, and fatigue. It tends to flare and significantly impact patients’ quality of life,” said Angelika Jahreis, Global Head, Immunology Development, Novartis.

Cosentyx is a fully human bioloic which inhibits interleukin-17A, a major driver of inflammation with immune-mediated diseases. Cosentyx is already indicated for several diseases, including psoriatic arthritis, psoriasis, ankylosing spondylitis and hidradenitis suppurativa. Since its launch in 2015, Cosentyx has been prescribed to more than 1.8 million patients worldwide.

Polymyalgia rheumatica is the second most common inflammatory rheumatic disease in adults over the age of 50, and is often accompanied by severe stiffness and pain. Currently, the mainstay of treatment is steroid therapy, but this class has its risks, including osteoporosis and diabetes.