Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica

Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica Published June 3, 2026 N Engl J Med 2026;395:637-647 DOI: 10.1056/NEJMoa2602567 Abstract Background Polymyalgia rheumatica is a common inflammatory disease characterized by pain and stiffness in the shoulders and hips. Glucocorticoids are the first-line treatment, but relapses and glucocorticoid-related toxic effects are common, which underscores the need for effective alternatives. Secukinumab is a fully human monoclonal antibody that selectively inhibits interleukin-17A. Methods We enrolled patients with recently relapsed polymyalgia rheumatica and randomly assigned them, in a 1:1:1 ratio, to receive secukinumab at a dose of 300 mg (SEC-300 group), secukinumab at a dose of 150 mg (SEC-150 group), or placebo for 52 weeks. Patients in all the groups also received prednisone on a tapering schedule for 24 weeks. The primary outcome was sustained remission at week 52, defined as remission (the absence of signs or symptoms attributable to polymyalgia rheumatica and no new diagnosis of giant-cell arteritis that warranted escape or rescue treatment) that was sustained from week 12 until week 52. The annual cumulative glucocorticoid dose was a secondary outcome. Safety was also assessed. Results A total of 381 patients underwent randomization, and 127 were assigned to each group. At 52 weeks, sustained remission was observed in 41.2% (95% confidence interval [CI], 32.8 to 49.7) of the patients in the SEC-300 group, in 40.6% (95% CI, 32.2 to 49.0) of those in the SEC-150 group, and in 20.4% (95% CI, 13.6 to 27.2) of those in the placebo group (P<0.001 for the comparison of each secukinumab dose with placebo). The mean adjusted annual cumulative glucocorticoid dose was 1603.7 mg in the SEC-300 group, 1683.2 mg in the SEC-150 group, and 2093.0 mg in the placebo group. Serious adverse events occurred in 13.5% of the patients in the SEC-300 group, in 15.9% in the SEC-150 group, and in 14.2% in the placebo group. Nasopharyngitis, hypersensitivity reactions, urinary tract infections, fungal infections, and back pain were more common in the secukinumab groups than in the placebo group. Conclusions Among patients with relapsed polymyalgia rheumatica, treatment with secukinumab plus a 24-week glucocorticoid taper resulted in a higher percentage of patients with remission and in lower cumulative glucocorticoid doses than a glucocorticoid taper alone. (Funded by Novartis; REPLENISH ClinicalTrials.gov number, NCT05767034.) Are you a member of an institution such as a university or hospital?Learn more about Institutional Access Notes This article was published on June 3, 2026, at NEJM.org. A data sharing statement provided by the authors is available with the full text of this article at NEJM.org. Supported by Novartis. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org. We thank all the investigators, the site staff, and the patients who participated in the trial; and Ishita Guha Thakurta, Ph.D., and Nihal Ganesh Maremanda, Ph.D. (Novartis Healthcare, Hyderabad, India), for medical writing support and assistance. Supplementary Material Information & Authors Information Published In Copyright Copyright © 2026 Massachusetts Medical Society. All rights reserved. For personal use only. Any commercial reuse of NEJM Group content requires permission. History Published online: June 3, 2026 Published in issue: August 13, 2026 Topics Authors Metrics & Citations Metrics Altmetrics Citations Export citation Select the format you want to export the citation of this publication. Cited by - Secukinumab shows diverging efficacy in PMR and GCA, Nature Reviews Rheumatology, (2026).https://doi.org/10.1038/s41584-026-01413-2 - Sécukinumab dans l’artérite à cellules géantes : décryptage des résultats de l’essai GCAptAIN, La Revue de Médecine Interne, (2026).https://doi.org/10.1016/j.revmed.2026.06.012 - Emerging Era for Polymyalgia Rheumatica and GCA — Interleukin-17A Targeting, New England Journal of Medicine, 395, 7, (705-707), (2026)./doi/full/10.1056/NEJMe2605851 Loading...