D1.259 - Icatibant Use During Pregnancy: A South African Case Series

Hereditary angioedema (HAE) is a rare disorder caused by dysfunctional or insufficient C1 inhibtor. HAE is characterized by recurrent swelling episodes. It has been observed that pregnancy aggravates HAE activity. In low- and middle-income countries, on-demand therapy (ODT) options during pregnancy are limited. Icatibant, a bradykinin B2 receptor antagonist, is increasingly used off-label during pregnancy, however data on maternal and foetal outcomes remain scarce. We describe maternal and infant outcomes in three pregnancies in South African HAE patients during which icatibant was used off-label for ODT and compare our findings with available global data.

Pregnancy and infant outcome data were collected retrospectively through clinical records and in-person patient interviews for three women with HAE who used Icatibant during their pregnancies between 2022 and 2024. A literature review was conducted using PubMed and Google Scholar from inception until September 2024 and were directed to published data by content experts. 

From our HAE registry of 118, three women aged 19–24 were identified. The women received 1–5 doses of icatibant during pregnancy, primarily in the second and third trimesters. Icatibant was prescribed as no other ODT was available. Two pregnancy-related complications were identified: preterm labour (one case; healthy infant with low birth weight), and prolonged labour (two cases; both primigravida, healthy infants with normal birth weights). Global data on 13 additional pregnancies involving icatibant use support our findings, with sporadic reports of preterm and prolonged labour.

This case series, as well as existing literature, suggests that icatibant is an effective, well-tolerated ODT for HAE during pregnancy and that, although preterm and prolonged labour were detected, they do not seem higher than background rates.