Safety of Recombinant Human C1 Esterase Inhibitor for Hereditary Angioedema Attacks in Pregnant Women
Saturday, March 3, 2018
South Hall A2 (Convention Center)
Dumitru Moldovan, MD, PhD, Jonathan A. Bernstein, MD FAAAAI, Roman Hakl, MD, Luca Bellizzi, Anurag Relan
RATIONALE: A genetic deficiency of plasma protein C1 esterase inhibitor (C1-INH) results in hereditary angioedema (HAE). Recombinant human C1-INH (rhC1-INH) is used to treat attacks in adolescents and adults with HAE. Data are limited on treatment of pregnant women with HAE. Changes in hormone levels during pregnancy may exacerbate HAE attacks or attenuate treatment efficacy.

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 and neonatal outcomes.

RESULTS: Eight pregnant women (age, 21-33 years) with HAE treated with rhC1-INH were identified. Seven women were treated with rhC1-INH (2100 IU−4200 IU) for 1 (n=1), 2 (n=2), 6 (n=1), 8 (n=1), 9 (n=1), or 40 (n=1) HAE attacks; 10 laryngeal attacks occurred in 2 patients. One woman received 2 administrations of rhC1-INH 50 IU/kg as prophylaxis during a clinical trial. rhC1-INH was effective in all attacks with no additional rescue medications needed. There were no AEs considered related to rhC1-INH treatment during the pregnancy period. Of 4 women with birth delivery data, 3 had a vaginal delivery and 1 a cesarean without complications. All 8 women gave birth at full term to healthy babies. No fetal distress or congenital abnormalities were reported.

CONCLUSIONS: Treatment with rhC1-INH for HAE attacks in pregnant women was generally safe and well tolerated. Delivery at full term with the births of healthy babies occurred without complications.