Secukinumab Wins First IL-17A PMR Label in Europe — Regulatory Win, HTA Battle Ahead

CHMP Recommends Cosentyx for Polymyalgia Rheumatica

Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Cosentyx (secukinumab). This recommendation is for the treatment of polymyalgia rheumatica (PMR) in adults who have had an inadequate response to steroids or experienced relapse during steroid taper. If approved, Cosentyx would be the first interleukin-17A (IL-17A) inhibitor licensed in Europe for PMR. The positive opinion is supported by results from the pivotal Phase III REPLENISH trial, which met all primary and secondary endpoints, demonstrating sustained remission and steroid-sparing effects, with a safety profile consistent with its established use.

• The positive CHMP opinion marks a significant regulatory milestone, positioning Cosentyx as the potential first interleukin-17A (IL-17A) inhibitor approved in Europe for polymyalgia rheumatica (PMR). This addresses a critical unmet need for advanced treatment options, as current standard of care often involves long-term steroid use, which is associated with significant risks and poor outcomes for patients.
• The recommendation is strongly supported by the pivotal Phase III REPLENISH trial (NCT05767034) results. The study successfully met all primary and secondary endpoints across both Cosentyx 300mg and 150mg treatment arms, including achieving complete sustained remission and extending the time until patients required additional treatment through week 52, demonstrating robust efficacy.
• Cosentyx demonstrated a safety profile consistent with its well-established use in other autoimmune diseases, with no new safety signals identified in PMR patients. The trial data, published in the New England Journal of Medicine and presented at the 2026 EULAR Congress, highlight Cosentyx's ability to provide sustained remission, reduce flares, and offer steroid-sparing effects, potentially transforming care for PMR patients in Europe.

Navigating Challenges in Polymyalgia Rheumatica Treatment

Glucocorticoids remain the cornerstone of PMR management, yet their long-term use in an elderly population carries a substantial burden of adverse effects and a high rate of disease relapse, creating a persistent therapeutic dilemma for clinicians and drug developers alike.

• High relapse rates undermine durable remission. In a retrospective Korean cohort of 51 PMR patients, only 8 (15.7%) achieved remission, while 28 of 41 patients followed up (68.3%) experienced at least one flare. The mean number of flares was 1.5 ± 1.6, and the frequency of flare was significantly lower in patients who did achieve remission (p = 0.02), underscoring how difficult sustained disease control is in practice.

• Glucocorticoid-related adverse effects are frequent and clinically significant. The predominantly post-menopausal female population most commonly affected by PMR is also the population most vulnerable to glucocorticoid-induced osteoporosis and fragility fractures. Across GCA/PMR cohorts, newly recorded adverse effects have included chronic kidney disease progression (29%), bone fractures (23.2%), cataracts (18.1%), dementia, and arterial hypertension (each at 12.3%). Long-term glucocorticoid exposure demands particular vigilance for complications that may be minimally symptomatic in the short term but carry major long-term impact.

• Biological alternatives show promise but remain incompletely defined. Anti-interleukin-6 agents (tocilizumab, sarilumab) have demonstrated consistent efficacy and a steroid-sparing effect in PMR, with an acceptable safety profile. However, evidence is insufficient to support tocilizumab as monotherapy; its use in combination with glucocorticoids is the better-supported option. Current data do not identify any particular efficacy for anti-TNF agents in PMR.

• Emerging small-molecule therapies are still establishing their role. JAK inhibitors — specifically tofacitinib and baricitinib for PMR — demonstrate potential to induce remission and reduce glucocorticoid burden in a subset of patients. Methotrexate, the primary conventional synthetic DMARD, shows only modest overall efficacy and is positioned for patients with definitive contraindications or restricted access to JAK inhibitors. The exact place of these agents within treatment algorithms remains to be fully defined.

• Predicting relapse risk lacks validated clinical tools. Inferential statistical methods have failed to identify reliable biomarkers and risk factors for relapse during glucocorticoid tapering. Machine learning approaches — particularly Random Forest algorithms incorporating diabetes mellitus status, concomitant PMR, and erythrocyte sedimentation rate at glucocorticoid baseline — have shown accuracy of 71.4% and an AUROC of 0.76 in predicting GCA flare, but validated predictive models for PMR-specific relapse remain an unmet need.

Unpacking the REPLENISH Trial Data for Cosentyx

Several randomized controlled trials have evaluated steroid-sparing and biologic strategies in PMR, spanning TNF inhibition, IL-6 receptor blockade, IL-17A inhibition, and conventional DMARDs. The table below summarizes key design parameters and endpoints across these trials.

Secukinumab's Potential to Redefine PMR Management

The European Medicines Agency's positive opinion for Cosentyx (secukinumab) in polymyalgia rheumatica (PMR) signals a pivotal moment for patients grappling with this chronic inflammatory condition. PMR predominantly affects individuals over 50, causing debilitating pain and stiffness, and its management has long been dominated by glucocorticoids. While effective, the prolonged use of these steroids is fraught with challenges, including a high frequency of relapses upon tapering and a spectrum of adverse effects that significantly impact quality of life, especially in an older patient population.

This recommendation for secukinumab, an IL-17A inhibitor, represents a crucial step forward. It offers a novel therapeutic pathway for patients who have not responded adequately to steroids or have experienced relapses, providing a much-needed steroid-sparing option. The clinical data supporting this opinion demonstrated sustained remission and a reduction in the cumulative glucocorticoid dose, which are key outcomes for improving long-term patient health.

However, the evolving PMR landscape presents both opportunities and considerations:

• Expanding Therapeutic Choices: Secukinumab would join IL-6 inhibitors like tocilizumab and sarilumab as biologic options, offering clinicians and patients more choices beyond conventional immunosuppressants like methotrexate.

• Managing Side Effects: While offering steroid-sparing benefits, the safety profile of secukinumab, including increased rates of certain infections and hypersensitivity reactions, will require careful consideration during patient selection and monitoring.

• Integration into Care Pathways: The continued need for a glucocorticoid taper alongside secukinumab suggests that a comprehensive, personalized approach to PMR management, potentially involving early referral to specialist settings and careful patient stratification, will remain essential to optimize outcomes and minimize treatment-related burdens.