Prednisone plus methotrexate for polymyalgia rheumatica: a randomized, double-blind, placebo-controlled trial

Area of Science:

• Rheumatology
• Clinical Pharmacology
• Immunology

Background:

• Polymyalgia rheumatica (PMR) is primarily treated with corticosteroids.
• The efficacy of methotrexate as an adjunctive therapy for PMR remains unproven in controlled trials.

Purpose of the Study:

• To evaluate the efficacy and safety of combining prednisone with methotrexate compared to prednisone alone in PMR patients.
• To assess the steroid-sparing potential of methotrexate in PMR management.

Main Methods:

• A multicenter, randomized, double-blind, placebo-controlled trial was conducted.
• 72 patients with newly diagnosed PMR received either prednisone with methotrexate or prednisone with placebo.
• Outcomes measured included the proportion of patients off prednisone, number of disease flares, and cumulative prednisone dose over 76 weeks.

Main Results:

• Significantly more patients on prednisone plus methotrexate (28/32) achieved prednisone discontinuation by 76 weeks compared to placebo (16/30) (P = 0.003).
• The methotrexate group experienced fewer flare-ups (15/32 vs. 22/30, P = 0.04) and required a lower cumulative prednisone dose (2.1 g vs. 2.97 g, P = 0.03).
• Adverse event rates and severity were comparable between the groups.

Conclusions:

• Combination therapy with prednisone and methotrexate demonstrates significant steroid-sparing effects in polymyalgia rheumatica.
• This approach may be particularly beneficial for patients at higher risk of corticosteroid-related adverse events.
• Limitations include a short follow-up period and specific dosing regimens used.