Treatment of refractory polymyalgia rheumatica with etanercept: An open pilot study

Objective. To investigate whether etanercept has a steroid-sparing effect in the treatment of patients with relapsing polymyalgia rheumatica (PMR). Methods. The study group comprised patients with relapsing PMR who were not able to reduce their prednisone dosage below 7.5-10 mg/day and who had experienced corticosteroid-related side effects. Patients received injections of etanercept 25 mg twice weekly for 24 weeks, and were followed up for 3 additional months after treatment withdrawal. Patients regularly underwent clinical assessment, measurement of erythrocyte sedimentation rate and C-reactive protein level, and ultrasound (US) examination of the shoulders during the 9 months of the followup period. Results. All 6 enrolled patients responded to etanercept with sustained remission (improvement of at least 70% according to European League Against Rheumatism response criteria for PMR in 4 patients and at least 50% in 2 patients) and were able to significantly reduce their median prednisone daily dosage without experiencing a disease relapse (8.75 mg versus 2.5 mg; P = 0.026) at the end of the 9-month study period. US shoulder examination performed at the end of followup demonstrated a parallel reduction of glenohumeral and periarticular inflammation. A significant reduction in the cumulative prednisone dose 9 months before versus the 9-month study period was observed (mean +/- SD 1,767 +/- 524 mg versus 730 +/- 182 mg; P = 0.028). Three patients developed nonsevere side effects: bacterial cystitis in 2 and influenza in 1. Conclusion. These results, which should be confirmed in a controlled study, suggest that etanercept may be a safe and useful corticosteroid-sparing agent in relapsing PMR.