Novartis has announced that its treatment for polymyalgia rheumatica (PMR), Cosentyx (secukinumab), achieved all primary and secondary endpoints in the phase 3 REPLENISH trial.
REPLENISH is a global, multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 study evaluating the safety and efficacy of Cosentyx in patients with PMR. Participants across 27 countries were assigned to one of three treatment arms – Cosentyx 150 mg, Cosentyx 300 mg, or placebo – in combination with a 24-week steroid tapering regimen.
At Week 52, Novartis reported that Cosentyx – an interleukin-17A (IL-17A) inhibitor already approved for several inflammatory conditions, including psoriatic arthritis – met its primary endpoint, demonstrating statistically significant and clinically meaningful sustained remission compared with placebo.
All secondary endpoints were also met, including the proportion of patients achieving complete sustained remission at Week 52, the adjusted annual cumulative corticosteroid dose, and the time to first use of escape or rescue therapy.
“PMR is an inflammatory rheumatic disease characterised 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.
“These results highlight the potential of Cosentyx to help patients achieve and sustain disease remission and reduce corticosteroids, which can lead to significant side effects in this typically elderly patient population. Today’s results represent another breakthrough in transforming care in rheumatology.”
Novartis plans to present the full data at an upcoming medical congress and submit findings to health authorities in early 2026.