Novartis Cosentyx Phase III PMR data published in NEJM
Novartis has published Phase III data for Cosentyx (secukinumab) in polymyalgia rheumatica (PMR), reporting that the IL-17A inhibitor achieved sustained remission in approximately twice the proportion of patients compared with placebo at one year. The REPLENISH trial results appeared simultaneously in the New England Journal of Medicine and were presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress in June.
In the trial, 41.2% of patients receiving Cosentyx 300mg and 40.6% on the 150mg dose achieved sustained remission at week 52, versus 20.4% in the placebo arm — both active-dose comparisons were statistically significant at p<0.001. The study also demonstrated meaningful steroid sparing: mean adjusted annual cumulative glucocorticoid doses of 1,604 mg and 1,683 mg in the 300mg and 150mg arms respectively, against 2,093 mg in the placebo group. All primary and secondary endpoints were met across both dose levels, and no new safety signals were identified, with the observed profile consistent with Cosentyx's established record across its approved indications.
Trial design and disease context
The REPLENISH trial (NCT05767034) was a global Phase III, double-blind, randomised, placebo-controlled study conducted across 27 countries. Patients in all three arms followed a 24-week steroid taper regimen. The primary endpoint assessed whether Cosentyx 300mg plus the taper regimen was superior to placebo plus taper in achieving sustained remission at week 52; key secondary endpoints included complete sustained remission rates, cumulative steroid exposure, and time to first rescue treatment.
PMR is among the most common inflammatory rheumatic diseases in adults over 50, causing acute pain and stiffness in the shoulders, neck, and hips. Relapses affect up to 40% of patients within the first year, and prolonged corticosteroid use — the current standard of care — carries well-documented risks including osteoporosis, diabetes, and cardiovascular complications. Prof John Stone of Harvard Medical School and Massachusetts General Hospital, global principal investigator for REPLENISH, said the results "support IL-17A inhibition as a promising therapeutic approach" in the disease.
Regulatory path and competitive landscape
Novartis has already submitted Cosentyx for the PMR indication with health authorities in the US, EU, and Japan, with further country filings expected across 2026. Approval in these major markets would represent a significant label expansion for a product that already carries approvals in psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa.
The competitive landscape in PMR is narrow by the standards of most immune-mediated inflammatory diseases. Sanofi's sarilumab (Kevzara), an IL-6 receptor inhibitor, holds approval in PMR in both the US and EU, making it the principal existing advanced therapy against which Cosentyx's steroid-sparing and remission data will be compared by prescribers and payers. The mechanistic distinction — IL-17A inhibition versus IL-6 receptor blockade — may appeal to rheumatologists managing patients who have not responded adequately to IL-6-pathway agents, though head-to-head data are not available.
Payer scrutiny will be a key consideration given that corticosteroids remain cheap and widely accessible. Novartis will need to demonstrate durable health-economic benefit from reduced steroid-related adverse events and relapse-driven healthcare utilisation to support reimbursement negotiations, particularly in markets with stringent comparative-effectiveness requirements such as England and Germany. Analysts will be watching closely for the EMA's Committee for Medicinal Products for Human Use opinion and the FDA's PDUFA date, neither of which has been disclosed publicly at this stage.