A phase 3 trial found that secukinumab (Cosentyx) doubled remission rates compared to placebo in patients with relapsed polymyalgia rheumatica. Both the 150 mg and 300 mg doses hit the primary endpoint at 52 weeks, and patients on the drug needed significantly less prednisone. Novartis is now seeking regulatory approval in the U.S., Europe, and Japan.
Secukinumab, an IL-17A inhibitor already approved for psoriasis and psoriatic arthritis, has now shown strong results in polymyalgia rheumatica (PMR) — a common inflammatory condition causing pain and stiffness in the shoulders and hips. In the phase 3 REPLENISH trial published in the New England Journal of Medicine, the drug roughly doubled sustained remission rates at 52 weeks compared to placebo, offering a meaningful alternative to long-term glucocorticoid use.
The trial enrolled 381 patients with recently relapsed PMR, randomized equally to secukinumab 300 mg, 150 mg, or placebo — all alongside a 24-week prednisone taper. Both active doses significantly outperformed placebo on the primary endpoint, and patients on secukinumab also required less cumulative steroid exposure over the year. Overall adverse event rates were similar across groups, though the drug was associated with higher rates of nasopharyngitis, UTIs, and fungal infections.
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Why it matters: PMR is one of the most common inflammatory diseases in older adults, and glucocorticoids — while effective — carry significant long-term risks. Secukinumab's ability to achieve remission and reduce steroid burden could represent a meaningful shift in how this condition is managed. Novartis is now pursuing regulatory approval in the U.S., Europe, and Japan.
