A series of patients with polymyalgia rheumatica (PMR) who received the steroid-sparing combination therapy, prednisone and methotrexate (MTX), underwent a long-term follow-up study at five years to investigate possible reductions of steroid-related side effects. Additional end-points were the number of patients still in need of steroid treatment, the cumulative steroid dose, and the number of flare-ups of PMR.
Fifty-seven PMR patients who were enrolled in a double-blind placebo-controlled randomised trial on the efficacy of MTX added to standard steroid treatment were reviewed after 5 years. Information was collected on the patients' previous health conditions or causes of death through a standardized questionnaire by direct visit, chart review, or interviews with relatives.
After 6 years from initiation of therapy, MTX-treated patients had lower ESR (17.1+/-9.7 mm/h vs. 26.8+/-22.9 mm/h, p=0.08) and CRP (2.7+/-2.3 mg/L vs. 10.2+/-16.4 mg/L, p=0.04). 31% MTX-treated patients were still on steroids in comparison with 39.3% controls. The mean cumulative dosage of prednisone in MTX-treated patients was 2.6+/-3.8 g in comparison with 3.2+/-4.1 g for controls (p=0.6). PMR flare-ups were seen in 30.8% of MTX-treated patients and in 44.4% of controls (p=0.39). During the follow-up, 58 and 55 side effects were observed in MTX-treated patients and in controls, respectively.
MTX-treated patients showed slightly less residual inflammation than controls, with the same incidence of steroid-related side effects. PMR is not a benign condition, as often reported, since one third of patients need steroid treatment for more than 6 years.