Effect of combined treatment with prednisone and methotrexate versus prednisone alone over laboratory parameters in giant cell arteritis

Objective

To compare the effect of combined treatment with prednisone and methotrexate (MTX) versus prednisone alone over laboratory parameters in giant cell arteritis (GCA).

Patients and methods

We performed a double-blind, placebo-controlled, randomized clinical trial about usefulness of treatment with prednisone and MTX versus prednisone and placebo in GCA (Ann Intern Med 2001;134:106–114). As a part of follow-up of patients (n = 42), we performed laboratory analysis in 20 time points during the two-year period of follow-up. To analyze differences, we calculated the area under the curve (AUC) for erythrocyte sedimentation rate (ESR), hemoglobin, and platelets, and compared the results in both groups adjusting by time of follow-up, existence of relapses and dose of prednisone.

Results

A total of 724 laboratory measurements were done. Median value of ESR was 33 [18–56] in patients with placebo and 26 [15–44] in patients with MTX (P = 0.0002). No significant differences were observed in ESR during relapses. The mean ESR value followed a parallel course in both groups, but was lower in the group with MTX than in the group with placebo in 18 of 20 time points of follow-up. The AUC of ESR by time of follow-up was 28,461.7 ± 12,326 in the group with placebo and 19,598.4 ± 8,117 in the group with MTX (mean difference 8,863, 95% CI 1.542–16.184; P = 0.019). The course of other laboratory parameters paralleled, without statistical significance, those observed for ESR.

Conclusions

These data, along with clinical data, suggest that MTX might play a role as a disease-modifying agent in the treatment of GCA.