Novartis’ Cosentyx achieved positive Phase 3 results in polymyalgia rheumatica, significantly improving sustained remission and reducing steroid use in the REPLENISH trial, with regulatory filings underway in the US, EU, and Japan.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
Novartis has reported positive Phase 3 results for Cosentyx (secukinumab) in polymyalgia rheumatica (PMR), marking a significant advance in a disease that has long relied on glucocorticoids for disease control.
Results from the pivotal REPLENISH trial (NCT05767034), presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress and published in the New England Journal of Medicine, met the primary endpoint and all key secondary endpoints.
Both the 300 mg and 150 mg Cosentyx treatment arms achieved statistically significant and clinically meaningful improvements in sustained remission through Week 52 compared with placebo. The treatment effect remained durable throughout the one‑year study period.
Clinical Impact
PMR is a common inflammatory rheumatic disease affecting adults aged 50 years and older. The condition causes pain and stiffness in the shoulders, neck, and hips, while frequent relapses often require prolonged glucocorticoid therapy.
Long‑term steroid use is associated with significant complications, including osteoporosis, diabetes, and other treatment‑related adverse effects.
At Week 52, sustained remission was achieved in 41.2% of patients receiving Cosentyx 300 mg and 40.6% of those receiving Cosentyx 150 mg, compared with 20.4% in the placebo group. Both treatment arms demonstrated statistically significant improvements versus placebo (P<0.001).
Cosentyx also reduced cumulative glucocorticoid exposure: patients on the 300 mg dose recorded an adjusted annual cumulative steroid dose of 1,604 mg, while those on the 150 mg dose received 1,683 mg. In contrast, patients in the placebo arm required 2,093 mg, underscoring the steroid‑sparing benefit of IL‑17A inhibition.
Safety Profile
No new safety signals emerged during the REPLENISH study. The overall safety profile remained consistent with the established experience of Cosentyx across its approved rheumatology and dermatology indications.
Clinical Perspectives on IL-17A Inhibition in PMR
Professor Christian Dejaco, Director of Rheumatology at South Tyrol Health Trust in Italy, said the findings address a major unmet need in PMR by demonstrating durable disease control with fewer relapses while reducing steroid exposure. Professor John Stone of Harvard Medical School and Massachusetts General Hospital, the global principal investigator of REPLENISH, noted that the results support IL‑17A inhibition as a promising therapeutic strategy in PMR and reinforce the role of targeted immune modulation in disease management. Angelika Jahreis, Global Head of Immunology Development at Novartis, added that the data highlight Cosentyx’s potential to improve disease control while reducing dependence on steroids, supporting the company’s efforts to expand access for PMR patients worldwide.
Global Regulatory Reviews Underway for PMR Indication
Novartis has submitted regulatory applications for Cosentyx in PMR in the United States, European Union, and Japan, with additional filings expected throughout 2026. If approved, Cosentyx would be the first IL‑17A inhibitor for PMR, offering a much‑needed steroid‑sparing option in a disease with limited advanced therapies.
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.