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

• Published in: Taiwanese journal of obstetrics & gynecology Vol. 58; no. 5; pp. 621 - 625
• Main Authors: Fu, Jinhua, Li, Lin, Qi, Lijuan, Zhao, Long
• Format: Journal Article
• Language: English
• Published: China (Republic : 1949- ) Elsevier B.V 01.09.2019; Elsevier
• Subjects: Abortion, Habitual - drug therapy; Abortion, Habitual - immunology; Adult; Etanercept; Etanercept - administration & dosage; Female; Humans; Immune System Diseases - complications; Immune System Diseases - drug therapy; Immunosuppressive Agents - administration & dosage; Live Birth; NK cell activity; Pregnancy; Pregnancy Complications - drug therapy; Pregnancy Complications - immunology; Pregnancy outcome; RSA; Single-Blind Method; TNF-α; Treatment Outcome; Tumor Necrosis Factor-alpha - blood; RSA; Etanercept; TNF-α; Pregnancy outcome; NK cell activity
• ISSN: 1028-4559; 1875-6263
• DOI: 10.1016/j.tjog.2019.07.007

To evaluate the effectiveness of etanercept in the treatment of refractory recurrent spontaneous abortion with innate immune disorders. 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. 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). The results provide a proof of principle that etanercept can be an attractive therapeutic strategy for refractory innate immune RSA.