Efficacy and safety of biological agents in patients with giant cell arteritis: A meta-analysis of randomized trials.

Abstract

This study assessed the efficacy and safety of biological agents in patients with giant cell arteritis (GCA). A meta-analysis of 6 randomized clinical trials (RCTs) (260 patients and 193 controls) to examine the efficacy and safety of tocilizumab, tumor necrosis factor (TNF) inhibitors, and abatacept relative to that of placebo in GCA patients was performed. The remission rate was significantly higher for tocilizumab-treated patients than that for placebo-treated controls (odds ratio (OR) 7.009, 95% confidence interval (CI) 3.854 - 12.75, p < 0.001). In addition, the relapse rate was significantly lower for the tocilizumab group than that for the placebo group (OR 0.222, 95% CI 0.129 - 0.381, p < 0.001). Further, no significant difference in remission and relapse was observed between groups treated with TNF inhibitors, abatacept, and placebo. The number of serious adverse events (SAEs) was significantly lower in tocilizumab-treated patients than that in placebo-treated controls (OR 0.539, 95% CI 0.296 - 0.982, p = 0.044). However, there was no significant difference in SAEs among patients treated with TNF inhibitors, abatacept, and placebo. The infection rate was significantly higher in TNF inhibitor-treated patients than in those treated with placebo (OR 2.407, 95% CI 1.168 - 4.960, p = 0.017), while there was no significant difference in infection rate between individuals treated with tocilizumab, abatacept, and placebo. Tocilizumab was found to be more effective than placebo in GCA patients, but TNF inhibitors and abatacept were not. Further, TNF inhibitors were associated with a higher risk of infection.