Novartis wins European Commission approval for Cosentyx in polymyalgia rheumatica after Phase III REPLENISH results showed higher remission rates and lower glucocorticoid exposure.
Written By: Anshu Gupta, PharmD
Reviewed by: Pharmacally Editorial Team
Novartis has received European Commission approval for Cosentyx (secukinumab) to treat adults with polymyalgia rheumatica (PMR) who have an inadequate response to glucocorticoids or experience relapse during glucocorticoid tapering. The decision makes Cosentyx the first and only interleukin-17A (IL-17A) inhibitor approved in Europe for this indication.
Addressing Treatment Challenges in PMR
PMR is an inflammatory rheumatic disease that primarily affects adults aged 50 years and older. It commonly causes pain and stiffness in the shoulders, neck and hips, restricting mobility and interfering with daily activities. Glucocorticoids remain the standard treatment, but relapses and complications associated with prolonged exposure, including osteoporosis and diabetes, present persistent management challenges.
Novartis reports that up to 40% of patients experience relapse during the first year. The new indication addresses adults whose disease remains inadequately controlled or returns as glucocorticoid doses are reduced, offering an additional treatment option for this population.
Phase III REPLENISH Trial Supported the Approval
The European Commission’s decision was supported by REPLENISH (NCT05767034), a global, multicentre, randomised, double-blind, placebo-controlled Phase III trial conducted across 27 countries. The study evaluated secukinumab 300 mg, secukinumab 150 mg and placebo, with all groups following a 24-week glucocorticoid tapering regimen.
The primary endpoint assessed whether secukinumab 300 mg plus glucocorticoid tapering was superior to placebo plus the same tapering regimen in achieving sustained remission at Week 52. Key secondary endpoints included complete sustained remission, adjusted annual cumulative glucocorticoid dose and time to first use of escape or rescue treatment.
At Week 52, sustained remission was achieved by 41.2% of patients receiving secukinumab 300 mg and 40.6% receiving 150 mg, compared with 20.4% receiving placebo. Both doses showed statistically significant differences versus placebo. The adjusted annual cumulative glucocorticoid dose was also lower with secukinumab: 1,604 mg with the 300 mg dose and 1,683 mg with the 150 mg dose, compared with 2,093 mg with placebo.
Novartis reported that the safety results were consistent with the established Cosentyx safety profile.
Dosing and Administration
The recommended starting regimen for adults with PMR is secukinumab 150 mg administered subcutaneously at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Treatment is given alongside a tapering course of glucocorticoids. After glucocorticoids have been discontinued, Cosentyx can be continued as monotherapy. Depending on clinical response, the maintenance dose may be increased to 300 mg.
This approach combines targeted treatment with planned glucocorticoid reduction. However, the regimen does not mean that every patient will be able to discontinue glucocorticoids or remain relapse-free.
Mechanism of Action and Regulatory Outlook
Secukinumab is a fully human biologic that selectively inhibits IL-17A, a cytokine involved in immune-mediated inflammation. Cosentyx is already approved for several other inflammatory conditions, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa.
The PMR indication expands secukinumab’s use into another inflammatory rheumatic disease with persistent treatment challenges. Novartis has reported that regulatory reviews for this indication are also ongoing in the United States and Japan.
Clinical Interpretation
The REPLENISH results support secukinumab as a treatment option for adults with PMR who respond inadequately to glucocorticoids or relapse during tapering. Sustained remission at Week 52 occurred in approximately twice as many patients receiving secukinumab as those receiving placebo. The lower adjusted cumulative glucocorticoid doses also suggest that treatment may reduce steroid exposure, an important consideration in a disease often requiring prolonged therapy.
Nevertheless, sustained remission was achieved by approximately 41% of patients in the secukinumab groups, meaning most participants did not meet this endpoint. Although the trial also demonstrated lower cumulative glucocorticoid exposure, these findings do not establish that all patients can stop steroids or that long-term steroid-related complications will be prevented. The company’s safety statement should likewise be interpreted alongside the detailed trial safety data and the limitations of the available follow-up.
Overall, the approval provides a new targeted option for a defined group of adults with difficult-to-control PMR. Its clinical value will depend on how sustained disease control, glucocorticoid reduction, tolerability and longer-term outcomes translate into routine practice.
Reference
Novartis receives European Commission approval for Cosentyx® in polymyalgia rheumatica (PMR), Novartis, 21 October 2026
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination with Glucocorticoid Taper Regimen, in Patients with Polymyalgia Rheumatica (PMR) (REPLENISH), ClinicalTrials.gov ID NCT05767034
About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.