Objectives To evaluate the efficacy and safety of leflunomide in treating lupus nephritis (LN).
Methods According to the requirements of meta-analysis, a literature search about efficacy and safety of leflunomide therapy in LN was performed among Cochrane clinical controlled trials database, PubMed, BMJ-Clinical Evidence, CNKI, VIP and Wanfang data from the establishment of the database till December 2010.All included RCTs were graded in term of randomization, allocation concealment and blinding and non-RCTs were graded in term of grouping method, blinding, withdrawal and loss of follow-up, baseline comparability, diagnostic criteria and bias control. RevMan 5.0 software was used for meta-analysis.
Results A total of 828 literatures were included. Five RCTs and 2 non-RCTs were enrolled for meta-analysis. Four RCTs described the method of random allocation, 1 literature used double blind method. Five RCTs were all lack of information about allocation concealment, selectively reporting and other bias, but reported withdrawal and loss of subjects. Two non-RCTs were lack of grouping method and blinding, but reported withdrawal and loss of subjects, also used established diagnostic criteria. Leflunomide group was treated with leflunomide and glucocorticoid, while control group was given cyclophosphamide and glucocorticoid or placebo. 1. There was no significant difference in complete remission rate (OR=1.51, 95%CI: 0.90-2.54), partial remission rate (OR=1.06, 95%CI: 0.70-1.61) or overall remission (OR=1.63, 95%CI: 0.98-2.71) between leflunomide group and cyclophosphamide group. 2. The 24 h urine protein, SCr and SLEDAI scores of leflunomide group were significantly lower than that of cyclophosphamide group. There was no significant difference in C3,positive rate of anti-ds DNA between leflunomide group and cyclophosphamide group. 3. There was no significant difference in infection, herpes zoster,hypertension, palpitations, leukopenia, alopecial, elevation in ALT, memoxenia, rashes, or the incidence of gastrointestinal reactions between the two groups.
Conclusions Based on the current evidence, the efficacy and safety of leflunomide for treatment of LN are close to cyclophosphamide. Further evidence from RCT studies is needed to elucidate the efficacy and safety of leflunomide for LN.
Disclosure of Interest None declared