A randomized controlled trial of etanercept in the treatment of refractory recurrent spontaneous abortion with innate immune disorders.

Abstract

OBJECTIVE\nTo evaluate the effectiveness of etanercept in the treatment of refractory recurrent spontaneous abortion with innate immune disorders.\n\n\nMATERIALS AND METHODS\nA randomized controlled trial in patients with refractory innate immune RSA was conducted in our hospital. 188 patients were selected, all with at least 4 consecutive miscarriages and caused by innate immunity disorders. Patients were randomly allocated into 2 groups. One group (n\xa0=\xa095) used etanercept 25\xa0mg per week starting from the first day after menstruation, while the other (n\xa0=\xa093) with placebo. Delivery of a healthy baby without malformations was regarded as the primary outcome.\n\n\nRESULTS\nIn etanercept group, 85 (89.47%) patients delivered a healthy baby, while in placebo group, this number was only 67 (72.04%) [P\xa0=\xa00.01, OR\xa0=\xa03.30; 95% CI(1.49～7.32)]. Significantly lower levels of TNF-α and NK cell activity were observed in gestation weeks 4-10 in etanercept group versus placebo group (P\xa0<\xa00.05).\n\n\nCONCLUSION\nThe results provide a proof of principle that etanercept can be an attractive therapeutic strategy for refractory innate immune RSA.