Secukinumab doubles sustained remission and spares glucocorticoids in polymyalgia rheumatica

In the phase 3 REPLENISH (NCT05767034) trial, both doses of the interleukin (IL)-17A inhibitor secukinumab approximately doubled sustained remission rates compared with placebo in patients with recently relapsed polymyalgia rheumatica (PMR) while significantly reducing cumulative glucocorticoid exposure. REPLENISH is the largest randomised controlled trial conducted in PMR to date and met its primary and all secondary endpoints.

“Polymyalgia rheumatica is one of the most common immune-mediated diseases in the elderly. There is a medical need for new treatment options for these patients,” said Prof. Christian Dejaco (Medical University of Graz, Austria) [1]. At present, glucocorticoids remain the mainstay of treatment despite frequent relapses and well-recognised adverse effects. Circulating T helper 17 (Th17) cells and serum IL-17A levels are elevated in patients with PMR compared with healthy controls, and phase 2 data provided the rationale for testing the anti–IL-17A antibody secukinumab.

The randomised, double-blind, placebo-controlled trial enrolled 381 patients aged 50 years or older with recently relapsed PMR, who were randomised in a 1:1:1 ratio to secukinumab 300 mg, secukinumab 150 mg, or placebo, each combined with a 24-week open-label prednisone taper. The primary endpoint was sustained remission at week 52. Approximately 80% of patients receiving secukinumab completed the study treatment, compared with 68% of patients receiving placebo.

Both secukinumab doses were superior to placebo. Sustained remission was achieved by 41.2% of patients receiving 300 mg and 40.6% receiving 150 mg, compared with 20.4% receiving placebo (both comparisons P<0.001). Complete sustained remission, which additionally required normalisation of acute phase reactions, showed a similar pattern (28.2% and 24.5% vs 4.7%, respectively; both comparisons P<0.001).

Moreover, secukinumab demonstrated a clear glucocorticoid-sparing effect. The adjusted mean annual cumulative glucocorticoid dose was reduced to 1603.7 mg and 1683.2 mg with secukinumab 300 mg and 150 mg, respectively, compared with 2093.0 mg with placebo (P<0.001 for the 300 mg dose and P<0.01 for the 150 mg dose). Glucocorticoid toxicity index scores were correspondingly lower. Secukinumab also approximately halved the risk of requiring escape or rescue therapy, extending median time to first rescue treatment to 337 and 282 days, respectively, compared with 157 days with placebo.

Adverse and serious adverse events were broadly comparable across treatment arms, with no new safety signals.

“These data suggest that IL-17A inhibition with secukinumab is a promising novel treatment option with a glucocorticoid-sparing effect in patients with recently-relapsed PMR,” Prof. Dejaco concluded.

Dejaco C, et al. Secukinumab in polymyalgia rheumatica: Results of the phase 3 REPLENISH trial. OP0116, European Congress of Rheumatology EULAR 2026, 3–6 June 2026,