Novartis announced that its biologic therapy Cosentyx (secukinumab) achieved the primary endpoint and all secondary endpoints in the Phase III REPLENISH trial, demonstrating statistically significant and clinically meaningful sustained remission at Week 52 in adults with polymyalgia rheumatica (PMR).
The company plans to present detailed findings at an upcoming medical congress and submit the data to health authorities in the first half of 2026.
Breakthrough in PMR Management
Polymyalgia rheumatica (PMR) is an inflammatory rheumatic disease marked by pain and stiffness in the shoulders, neck, and hips, along with fatigue and morning stiffness. It predominantly affects individuals aged 50 years and older and is currently treated with long-term corticosteroid therapy, which carries significant side effects including osteoporosis and diabetes.
Angelika Jahreis, Global Head of Immunology Development at Novartis, said:
“These results highlight the potential of Cosentyx to help patients achieve and sustain disease remission and reduce corticosteroids, which can lead to significant side effects in this typically elderly patient population. Today’s results represent another breakthrough in transforming care in rheumatology.”
About the REPLENISH Trial
The REPLENISH trial (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries.
Participants were assigned to one of three treatment arms:
- Cosentyx 300 mg,
- Cosentyx 150 mg, or
- Placebo,
each combined with a 24-week steroid taper regimen.
The primary endpoint was to determine whether secukinumab 300 mg subcutaneous injection plus a 24-week steroid taper was superior to placebo in achieving sustained remission at Week 52.
Key secondary endpoints included:
- Complete sustained remission at Week 52
- Adjusted annual cumulative steroid dose
- Time to first use of escape or rescue treatment through Week 52
Novartis confirmed that all primary and secondary endpoints were met, with Cosentyx showing durable remission and meaningful steroid-sparing effects.
About Cosentyx (secukinumab)
Cosentyx is a fully human monoclonal antibody that selectively inhibits interleukin-17A (IL-17A), a key cytokine involved in multiple immune-mediated inflammatory diseases.
It is approved for adults with:
- Psoriatic arthritis (PsA)
- Moderate to severe plaque psoriasis (PsO)
- Ankylosing spondylitis (AS)
- Non-radiographic axial spondyloarthritis (nr-axSpA)
- Hidradenitis suppurativa (HS)
It is also approved for pediatric patients with PsO, enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA).
Since its global launch in 2015, Cosentyx has been prescribed to over 1.8 million patients and is approved in more than 100 countries. The therapy is supported by a decade of real-world evidence, demonstrating long-term safety and sustained efficacy.
Understanding Polymyalgia Rheumatica
PMR is the second most common inflammatory rheumatic disease in adults over 50. Symptoms include acute shoulder and hip pain, stiffness, and fatigue, often leading to restricted mobility and decreased quality of life.
Relapses are frequent, affecting up to 40% of patients within the first year, and reliance on long-term corticosteroids remains a major clinical challenge.
The REPLENISH results position Cosentyx as a potential first biologic alternative capable of reducing corticosteroid dependence while achieving sustained disease control.
