Novartis has announced positive results from its Phase III REPLENISH trial, demonstrating that Cosentyx (secukinumab) met the primary endpoint and all secondary endpoints for the treatment of polymyalgia rheumatica (PMR), a rare inflammatory rheumatic disease. The interleukin-17A inhibitor showed statistically significant and clinically meaningful sustained remission compared to placebo at Week 52.
Trial Results and Clinical Significance
The Phase III REPLENISH trial evaluated Cosentyx in adults with polymyalgia rheumatica, a condition characterized by bilateral pain in the neck, shoulders, or hips, along with morning stiffness and fatigue. At the primary endpoint of Week 52, patients receiving Cosentyx demonstrated sustained remission that was both statistically significant and clinically meaningful when compared to placebo.
Beyond the primary endpoint, the trial achieved success across all secondary measures. Notably, the study showed a reduction in annual cumulative steroid dose versus placebo through Week 52, which could represent a significant clinical advantage for patients who typically require long-term corticosteroid treatment for PMR management.
Safety Profile and Drug Background
The safety profile of Cosentyx remained consistent with its established safety data throughout the trial. Cosentyx is currently used to treat multiple immune-mediated inflammatory diseases, and this latest trial expands its potential therapeutic applications to include polymyalgia rheumatica.
Regulatory Timeline
Novartis plans to present the complete trial data at an upcoming medical congress and intends to submit the results to health authorities in the first half of 2026. This timeline suggests that regulatory approval for this new indication could potentially be achieved within the next two years, pending successful review by regulatory agencies.
