en.Wedoany.com Reported - Novartis has announced new data from the Phase III REPLENISH trial evaluating Cosentyx (secukinumab) in patients with polymyalgia rheumatica (PMR). The results showed that the drug achieved statistically significant and clinically meaningful differences in sustained remission rates compared to placebo, along with a significant reduction in steroid use. The study was published in the New England Journal of Medicine and presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) congress.

PMR is an inflammatory rheumatic disease primarily characterized by disabling pain and stiffness in the shoulders and pelvic girdle. Current treatment options have long relied on steroids, but recurrence rates are high, affecting up to 40% of patients within the first year, and long-term steroid use may pose risks such as osteoporosis and diabetes. Professor Christian Dejaco, Head of the Department of Rheumatology at the South Tyrolean Health Trust in Bruneck, Italy, stated that there is an unmet need for a treatment that can consistently control symptoms over time, reduce relapses, and decrease dependence on steroids. He expressed encouragement from the REPLENISH trial results, which showed that Cosentyx, with a known safety profile, can reduce disease flares over the long term while lowering patients' steroid exposure.

The REPLENISH trial (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted in 27 countries. Patients were randomized to receive Cosentyx 300mg, Cosentyx 150mg, or placebo, all combined with a 24-week steroid tapering regimen. All primary and secondary endpoints of the trial were met in both Cosentyx treatment groups, including complete sustained remission and time to need for additional treatment through Week 52. No new safety signals were identified in PMR patients treated with Cosentyx. Specific data showed that at Week 52, the sustained remission rate was 41.2% in the Cosentyx 300mg group and 40.6% in the Cosentyx 150mg group, both superior to the 20.4% in the placebo group (P values adjusted for multiplicity were all <0.05).

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