Novartis has announced the Phase III REPLENISH trial met its primary endpoint, with Cosentyx (secukinumab) demonstrating statistically significant and clinically meaningful sustained remission versus placebo in polymyalgia rheumatica (PMR) patients through 52 weeks, alongside all secondary endpoints including complete remission rates and cumulative glucocorticoid dose reduction. The global, randomised, double-blind study enrolled patients across 300 mg and 150 mg dosing arms combined with a 24-week steroid tapering regimen, evaluating IL-17A inhibition in elderly participants, where chronic corticosteroid use carries significant osteoporosis and diabetes risks. Detailed data will be presented at an upcoming medical congress, with a new indication application planned for H1 2026.

PMR represents the second most common inflammatory rheumatic disease in adults over 50 years, and is characterised by shoulder, neck and hip pain with 40% relapse rate within the first year. Current standard-of-care relies on long-term glucocorticoid therapy which is associated with substantial morbidity, particularly in elderly patients. Cosentyx's mechanism targeting the IL-17 pathway demonstrates potential for steroid-sparing effect, addressing an unmet need for disease-modifying therapies in a condition affecting approximately 200,000 patients annually in the European Union and US alone. The positive results expand Cosentyx's immunology reach beyond psoriasis, ankylosing spondylitis and psoriatic arthritis into a new autoimmune indication with significant commercial opportunity.

According to PharmCube's NextBiopharm® database, Cosentyx is still under clinical development in 26 indications. Click here to request a free trial for NextBiopharm®.