Secukinumab in Relapsed Polymyalgia Rheumatica

Key Takeaways

• Sustained remission at week 52 was reported more often with both secukinumab doses than with placebo.
• Annual cumulative glucocorticoid dose was lower in the secukinumab groups than in the placebo group.
• Serious adverse event rates were similar across groups, while several common adverse events were reported more often with secukinumab.

In relapsed polymyalgia rheumatica, sustained remission at week 52 occurred in 41.2% and 40.6% of patients receiving secukinumab 300 mg or 150 mg, respectively, plus a prednisone taper, compared with 20.4% with placebo plus the same taper in a phase 3 randomized trial.

The REPLENISH trial enrolled 381 patients with recently relapsed polymyalgia rheumatica and randomly assigned them in a 1:1:1 ratio. Each group contained 127 patients who received secukinumab 300 mg, secukinumab 150 mg, or placebo during the 52-week study period. All participants also received prednisone according to the same 24-week tapering schedule, preserving a common glucocorticoid background across the groups. Secukinumab is a fully human monoclonal antibody that selectively inhibits interleukin-17A.

The primary outcome was sustained remission at week 52, defined as remission — the absence of signs or symptoms attributable to polymyalgia rheumatica and no new diagnosis of giant-cell arteritis that warranted escape or rescue treatment — sustained from week 12 through week 52.

At week 52, sustained remission occurred in 41.2% of the secukinumab 300 mg group, 40.6% of the secukinumab 150 mg group, and 20.4% of the placebo group. Investigators reported P<0.001 for the comparison of each secukinumab dose with placebo. Annual cumulative glucocorticoid dose was a secondary outcome. Mean adjusted annual cumulative glucocorticoid doses were 1603.7 mg, 1683.2 mg, and 2093.0 mg in the secukinumab 300 mg, secukinumab 150 mg, and placebo groups, respectively.

Safety was assessed across the 52-week treatment period in all three groups. Serious adverse events occurred in 13.5% of the secukinumab 300 mg group, 15.9% of the secukinumab 150 mg group, and 14.2% of the placebo group. Nasopharyngitis, hypersensitivity reactions, urinary tract infections, fungal infections, and back pain were more common in the secukinumab groups than in placebo.