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