A randomized, placebo-controlled trial 1 analyzed the safety and efficacy of combined therapy with corticosteroids and methotrexate in giant-cell arteritis. 42 patients with new-onset giant-cell arteritis were randomised to corticosteroid therapy plus methotrexate or placebo given weekly from the start of corticosteroid therapy for 24 months.
Compared with combined prednisone and placebo therapy, treatment with prednisone and methotrexate reduced the proportion of patients who experienced at least one relapse (45% vs. 84.2%; P = 0.02) and the proportion of patients who experienced multiple relapses (P = 0.004). The mean cumulative dose of prednisone was 4187 ± 1529 mg in the methotrexate group and 5489.5 ± 1396 mg in the placebo group (mean difference 1302 mg, 95% CI 350 to 2253 mg; P = 0.009). Overall, the rate and severity of adverse events were similar between groups. Treatment was discontinued in 3 patients in the methotrexate group who experienced definite drug-related adverse events. In sensitivity analysis that included patients lost to follow-up, differences between groups in number of relapses and cumulative dose of prednisone were significant.
Comment: The quality of evidence is downgraded by sparse data and potential reporting bias (no thorough search for literature was performed).
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