Anti-CD22 epratuzumab for systemic lupus erythematosus: A systematic review and meta-analysis of randomized controlled trials.

Systemic lupus erythematosus (SLE) is a remarkable and challenging autoimmune disorder that is characterized by a broad range of clinical manifestations, such as flares and remissions. Recently, the humanized anti-CD22 antibody epratuzumab for SLE has been extensively studied. The aim of the present study was to perform a meta-analysis on the findings of associated randomized controlled trials in order to evaluate the effects of epratuzumab on SLE. Data from publications in PubMed, EMBASE and the Cochrane Library were collected up to March 2017. To calculate the risk ratio or standardized mean differences (SMDs) with 95% confidence intervals (CIs), a random effect model was applied when heterogeneity was significant and a fixed effect model was used when heterogeneity was negligible. All statistical tests were performed using Review Manager 5.3 software. A total of 1,921 participants in 4 studies (5 trials) that met the selection criteria were analyzed in this meta-analysis. Analyses of the BILAG-based Combined Lupus Assessment (BICLA) response and SLE Disease Activity Index 2000 (SLEDA-2K) score revealed that epratuzumab (720-3,600 mg) significantly improved the BICLA response (RR=1.09; 95% CI, 1.04 to 1.14) and decreased the SLEDA-2K score (SMD=-0.31; 95% CI, -0.67 to 0.06; P=0.10). While the British Isles Lupus Assessment Group index score was not significantly altered between the epratuzumab and control groups. For safety analyses, no statistically significant differences were identified between the two groups, which were proved by the pooled results (all P-values >0.05). These findings suggested that epratuzumab may be relatively safe and may have better therapeutic effectiveness than placebo control conditions in patients with SLE.