EXPERIENCE WITH RECOMBINANT HUMAN C1 ESTERASE INHIBITOR FOR HEREDITARY ANGIOEDEMA ATTACKS DURING PREGNANCY

Abstract

Introduction Recombinant human C1 esterase inhibitor (rhC1-INH) is indicated in the United States for treating hereditary angioedema (HAE) attacks in adolescents/adults. Data are limited on rhC1-INH treatment in women with HAE who are pregnant. Methods Pregnant women with HAE from the United States and Europe who received rhC1-INH were followed to full term and were assessed for adverse events (AEs) that occurred during pregnancy as well as for neonatal outcomes. Results Ten pregnant women (age, 20-33 years) with HAE treated with rhC1-INH were identified. One woman received a 4200-IU dose pre-delivery as short-term prophylaxis and 9 were treated with rhC1-INH (2100 IU-4200 IU) for 1 (n=1), 2 (n=2), 4 (n=1), 6 (n=1), 8 (n=1), 9 (n=2), or 40 (n=1) HAE attacks. Ten laryngeal attacks occurred in 2 patients; all 10 attacks responded to rhC1-INH within 2 to 4 hours postdose. In addition, 4 facial attacks occurred in 1 patient and 1 in another patient that were successfully treated with 1 rhC1-INH dose and no rescue medications. There were no AEs considered related to rhC1-INH during the pregnancy period. Of 6 women with birth delivery method details available, 4 had a vaginal delivery and 2 a cesarean, all without complications. All 10 women gave birth at full term to healthy babies. No fetal distress or congenital abnormalities were reported. Conclusions rhC1-INH treatment for HAE attacks in pregnant women was generally safe and well tolerated. All 10 women delivered healthy babies at full term without complications.