Six RCTs were included in the review (808 participants). Five trials were unclear about concealment of allocation. All the trials were open-label trials. Only three trials used intention-to-treat anaylsis. Overall, five out of six trials were low quality (scored between 0 and 2). Median follow-up ranged from six months to 37 months (where reported).
Primary outcomes: There was a lower incidence of biopsy-proven acute rejection with alemtuzumab compared with control groups (RR 0.63, 95%CI 0.45 to 0.87; no heterogeneity p=0.49; six RCTs). The result was similar when alemtuzumab was compared with anti-thymocyte globulin only (RR 0.32, 95% CI 0.11 to 0.91; no heterogeneity p=0.23; three RCTs). However, no significant difference was found when only patients with high-risk were included.
Secondary outcomes: No statistical significance differences were found between alemtuzumab and control groups for delayed graft function (three RCTs), infection (five RCTs), mortality (six RCTs) and graft loss (six RCTs).
Other safety outcomes: No significant difference was found between two groups for the incidence of malignancy (three RCTs), new-onset diabetes mellitus (three RCTs), and cytomegalovirus infection (three RCTs).