Short-course prednisone and methotrexate in a cohort of patients with polymyalgia rheumatica: a potential therapeutic approach.

OBJECTIVES: The optimal treatment of polymyalgia rheumatica (PMR) is far from being fully elucidated. Only a few trials explored the role of conventional DMARDs: none of them adequately ruled out subclinical giant cell arteritis (GCA). The aim of this study was to assess whether the precocious administration of methotrexate (MTX) and a short course of glucocorticoids (GCs) could be safe and effective in recently diagnosed PMR. METHODS: Patients with a recent diagnosis of PMR were prospectively enrolled, upon exclusion of GCA, and treated with MTX and gradually tapered prednisone (PDN). As a control group, a historical cohort treated with GC-monotherapy was included. The primary endpoint was PDN-free remission at 24 weeks. Secondary endpoints were sustained remission at 52 weeks, number of relapses, PDN dosage, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) at 26 and 52 weeks, compared to historical cohort. RESULTS: The prospective and historical cohorts included 41 and 63 patients, respectively. In the MTX-group, at 26 weeks, 66% of patients were in steroid-free remission and a significant reduction of CRP and ESR was observed, while mean daily PDN dosage dropped to 3.42 mg. Twenty-four subjects reached 52-week phase of the study and 83% maintained GC-free remission. A higher number of relapses were reported in the retrospective cohort (12, 27% vs. 34, 43%), in which up to 49 patients were still taking PDN. CONCLUSION: In conclusion, upon a subclinical GCA is excluded, MTX at adequate dosages, is a suitable option for the treatment of PMR, allowing a precocious discontinuation of oral GCs.