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

Abstract

Objective: To evaluate the effectiveness of etanercept in the treatment of refractory recurrent spontaneous abortion with innate immune disorders. Materials and methods: A 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 = 95) used etanercept 25 mg per week starting from the first day after menstruation, while the other (n = 93) with placebo. Delivery of a healthy baby without malformations was regarded as the primary outcome. Results: In etanercept group, 85 (89.47%) patients delivered a healthy baby, while in placebo group, this number was only 67 (72.04%) [P = 0.01, OR = 3.30; 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 < 0.05). Conclusion: The results provide a proof of principle that etanercept can be an attractive therapeutic strategy for refractory innate immune RSA. Keywords: Etanercept, RSA, TNF-α, NK cell activity, Pregnancy outcome