European Commission approves Cosentyx for the treatment of in polymyalgia rheumatica in adults – Novartis
Novartis announced that the European Commission (EC) has approved Cosentyx (secukinumab) for the treatment of adults with polymyalgia rheumatica (PMR) who have had an inadequate response to glucocorticoids or who experience relapse during glucocorticoid taper.
With this approval, Cosentyx becomes the first and only interleukin-17A (IL-17A) inhibitor approved in Europe for adults with PMR.
PMR is a common inflammatory rheumatic disease in adults aged over 50, characterized by acute pain and stiffness in the shoulders, neck, and hips. It is particularly prevalent among people of Northern European descent. Despite the considerable burden of symptoms on patients, advanced treatment options have remained limited. The current standard of care involves prolonged steroid use, which is associated with high relapse rates and significant adverse outcomes.
“The approval of secukinumab marks an important advancement for people living with PMR and has the potential to transform how we manage this disease beyond prolonged steroid use alone,” said Prof. Christian Dejaco, Director, Department of Rheumatology, South Tyrol Health Trust, Bruneck, Italy. “Its ability to help patients achieve sustained disease control while tapering steroids, together with its established safety profile, may help address a longstanding challenge in PMR care.”
Supported by data from the Phase III REPLENISH trial, the Cosentyx recommended dose for adults with PMR is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing, in combination with a tapering course of glucocorticoids, after which Cosentyx can be continued as monotherapy. Based on clinical response, the maintenance dose can be increased to 300 mg.
“People living with PMR need treatment options that can help deliver lasting disease control, prevent relapses and support better long-term outcomes,” said Patrick Horber, President, International, Novartis. “The approval of Cosentyx in PMR marks an important step forward for patients who continue to face significant challenges with long-term disease management. This milestone adds to the meaningful progress Cosentyx has already brought to many people living with immune-mediated diseases.”
About REPLENISH trial
The REPLENISH trial (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries, evaluating the efficacy and safety of Cosentyx in patients with polymyalgia rheumatica (PMR). Patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen. The primary endpoint of the trial was to assess whether Cosentyx 300mg s.c. plus a 24-week steroid taper is superior to placebo plus a 24-week steroid taper in achieving sustained remission at week 52. Key secondary endpoints included the proportion of patients achieving complete sustained remission at week 52, the adjusted annual cumulative steroid dose, and the time to first use of escape or rescue treatment through week 52.
