Novartis Announces Successful Phase III Trial of IL-17A Monoclonal Antibody Cosentyx® in Polymyalgia Rheumatica

On October 22, 2025, Novartis announced,Its heavy-hitting IL-17A monoclonal antibody drug Cosentyx®(Secukinumab, secukinumab)In the Phase III clinical study of adult polymyalgia rheumatica (Polymyalgia Rheumatica, PMR)Achieve Major Breakthrough：Drug SuccessAchieved the primary endpoint and all secondary endpoints, demonstrating statistically and clinically significant sustained relief compared to placebo at week 52.

Secukinumab is aTargeting Interleukin-17A (IL-17A)TheFully Human Monoclonal IgG1 AntibodyBy directly inhibiting the IL-17A signaling pathway, it blocks its key pro-inflammatory role in various immune-mediated inflammatory diseases. This drug, independently developed by Novartis, is one of the world's first IL-17A inhibitors and has been approved in more than 100 countries worldwide for the treatment ofPsoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis, and Hidradenitis SuppurativaAutoimmune diseases.

In this global Phase III randomized, double-blind, placebo-controlled study, Cosentyx combined with a 24-week steroid tapering regimen achieved significant and sustained disease remission at Week 52. The study also showed that the cumulative dose of glucocorticoids in patients using Cosentyx was significantly lower than in the placebo group, and the drug was well tolerated.Its safety profile is consistent with previously known drug characteristics.Novartis plans to submit a marketing application for this indication to regulatory authorities in the first half of 2026.

Angelika Jahreis, MD, Global Head of Immunology Development at Novartis, stated: "These results highlight the potential of Cosentyx® in helping PMR patients achieve and maintain remission while reducing the use of glucocorticoids. This advancement marks another significant breakthrough in the treatment landscape of rheumatology and immunology."

The release of this research achievement not only brings new hope to the field of PMR, which has long lacked innovative therapies, but also once again demonstrates Novartis' depth and innovation strength in the area of immune-inflammatory diseases. In the future, as data continues to be disclosed and regulatory submissions progress, Cosentyx is expected to become the first targeted biologic treatment option for PMR, driving the treatment model for this disease from a "steroid-dependent" era into a new age of "precise immune regulation."

PMR is an inflammatory rheumatic disease commonly seen in people aged 50 and above, mainly characterized by bilateral pain in the neck, shoulders, and hips, morning stiffness, and fatigue. The current standard treatment still relies on long-term glucocorticoids, but with a high recurrence rate and significant risks from prolonged use, including complications such as osteoporosis and diabetes, leaving very limited treatment options.

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