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

Taiwan J Obstet Gynecol. 2019 Sep;58(5):621-625. doi: 10.1016/j.tjog.2019.07.007.

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; NK cell activity; Pregnancy outcome; RSA; TNF-α.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Abortion, Habitual / drug therapy*
  • Abortion, Habitual / immunology
  • Adult
  • Etanercept / administration & dosage*
  • Female
  • Humans
  • Immune System Diseases / complications
  • Immune System Diseases / drug therapy*
  • Immunosuppressive Agents / administration & dosage*
  • Live Birth
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Pregnancy Complications / immunology
  • Single-Blind Method
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / blood

Substances

  • Immunosuppressive Agents
  • Tumor Necrosis Factor-alpha
  • Etanercept