Efficacy and safety of tacrolimus in systemic lupus erythematosus patients with refractory thrombocytopenia: a retrospective study.

Objective We evaluated the efficacy and safety of tacrolimus in systemic lupus erythematosus patients with refractory thrombocytopenia. Methods We retrospectively reviewed the data for 20 systemic lupus erythematosus patients with refractory thrombocytopenia and treated with tacrolimus during the period January 2013 to January 2015. In addition to glucocorticoids, all patients were treated with tacrolimus, 1 mg taken twice daily. The clinical effect of tacrolimus treatment in patients was evaluated by analysis of platelet counts at baseline and after one, three and six months of tacrolimus treatment. Levels of anti-double-stranded DNA antibodies and complement C3, C4 were determined individually. Results After one month of tacrolimus treatment, three patients (15%) did not respond, three patients (15%) achieved a complete response and the other 14 patients (75%) achieved a partial response. After three months of tacrolimus treatment, the platelet counts of all patients were significantly improved. A partial response was seen in 14 patients (75%) and the complete response rate increased to 25% (five patients). After six months, all patients attained partial response or complete response without relapse, and the rate of complete response increased to 75%. Compared to pretreatment, anti-double-stranded DNA antibody levels and the disease activity index score were markedly decreased after tacrolimus treatment. The levels of serum C3 and C4 were increased significantly ( P < 0.05). Conclusions Our survey revealed that a six-month course of tacrolimus is a safe and effective treatment for systemic lupus erythematosus patients with refractory thrombocytopenia.