Abstract
The present systematic review evaluated the efficacy and safety of tacrolimus (TAC) and other immunosuppressants in the treatment of systemic lupus erythematosus (SLE), providing evidence-based recommendations for clinical practice. PubMed, Web of Science, Embase and Cochrane Library databases were searched for clinical studies comparing TAC with other immunosuppressive drugs. A total of 12 studies, including 10 randomized controlled trials and two cohort studies involving 1,217 patients, were identified. The results indicated that TAC was significantly superior to cyclophosphamide (CYC) in complete remission (CR) rates [odds ratio (OR)=1.83, 95% confidence interval (CI): 1.33-2.51], whereas no significant differences were found when compared with mycophenolate mofetil [(MMF); OR=0.93; 95% CI: 0.58-1.47] or azathioprine [(AZA); OR=0.95; 95% CI: 0.49-1.84]. Thus, significant differences were found in the partial remission rates between TAC and CYC, MMF, or AZA. TAC demonstrated improvements in the short-term SLE disease activity index scores and albumin levels, with long-term efficacy comparable to that of MMF and CYC. Furthermore, the infection rate with TAC was lower than that with MMF (OR=0.48; 95% CI: 0.31-0.75), but similar to those with CYC and AZA. TAC also showed a lower incidence of leukopenia than AZA (OR=0.13; 95% CI: 0.04-0.43). In conclusion, TAC is superior to CYC in achieving CR in patients with SLE, with comparable efficacy to MMF and AZA. TAC improves short-term disease activity and albumin levels, and its long-term efficacy is similar to those of MMF and CYC.