Efficacy of methotrexate in patients with polymyalgia rheumatica

Abstract

Introduction: The use of steroids especially for a long time is universally used for the treatment of polymyalgia rheumatica (PMR). Because the adverse effects of long-term steroid therapy are common and deleterious, steroids-sparing combination therapy has been found a vital role for treating PMR. The current study came to address comparing the efficacy and safety of prednisolone plus methotrexate as a steroids-sparing combination therapy and prednisolone alone in patients with PMR.Materials and Methods: Fifty eight untreated patients with newly diagnosed PMR were consecutively entered and randomly assigned to receive prednisolone plus methotrexate or prednisolone alone. A single dose of methotrexate (10 mg per week, orally) was administered for the case group. The both groups were administered oral prednisolone (15 mg/day for 4 weeks) and supplement of calcium-vitamin D (1000 mg/day). Subjects continued their active treatment with gradual tapering of the steroid dosage. The remission rate at a total of 44 weeks follow-up, and other measures of disease activity, i.e. erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) were the main outcome measures. Results: Fifty eight patients entered (29 cases and 29 controls) and 47 patients completed the trial (24 cases and 23 controls). On follow-up over the full 44 weeks, mean ESR level was significantly more decreased in the case compared to control group within the full 44 weeks (52.44 versus 39.38 mm/1st h, P=0.002). There was no difference in the decrease of mean CRP (75.86 versus 51.75 mm/1st h, P=0.312) and also last to first measures (79.39 versus 57.75 mm/1st h, P=0.356) between the case and control groups. Subsequent analyses at week 44 of follow-up showed a significant higher remission rate in the case compared to the control groups (43.5% versus 8.3%, P=0.006). However, the relapse rate was similar in both groups (34.8% versus 33.3%, P=0.917). Significant differences in cumulative steroid dosage per patient was also revealed in the two treatment groups at week 44 that the mean prednisolone equivalent in the case and control groups was 3225.00 ± 162.66 mg and 3715.85 ± 136.14 mg (P=0.026).Conclusion: Higher remission as well as reduced disease activity seems to be more achieved with steroids-sparing combination therapy (prednisolone plus methotrexate) compared with prednisolone alone in patients with PMR