Safety of a C1 Esterase Inhibitor Concentrate in Pregnant Women with Hereditary Angioedema: Findings from the International Berinert Patient Registry
Monday, March 7, 2016
South Exhibit Hall H (Convention Center)
James A. Fox, MD FAAAAI, Inmaculada Martinez-Saguer, Arthur B. Vegh, MD FAAAAI, Walter A Wuillemin, PhD, MD, Jonathan M. Edelman, MD, Debora Williams-Herman, MD, Mikhail Rojavin, PhD, Tanja Rosenberg, MD

Increased estrogen levels during pregnancy can exacerbate hereditary angioedema (HAE), yet disease and treatment ramifications have not been well studied in pregnant women. Using data from the international Berinert patient registry, we analyzed outcomes of pregnancies exposed to plasma-derived, pasteurized, nanofiltered C1-Inhibitor concentrate (pnfC1-INH; Berinert/CSL Behring) during routine HAE management.

Methods: This observational registry, conducted between 2010 and 2014 at 34 US and 7 European sites, gathered data on 318 subjects and 15,000 pnfC1-INH infusions. Whenever possible, subjects who used pnfC1-INH during pregnancy were followed to term to assess neonatal outcomes and maternal adverse events (AEs).


The registry database included eleven pregnancies in ten subjects who were using pnfC1-INH for HAE attack treatment and/or prophylaxis. Eight pregnancies concluded in the birth of a healthy baby. Of the remaining three pregnancies: one (16-year-old subject) was voluntarily terminated at 9 weeks gestation; a second (30-year-old subject, previous miscarriage) ended as a first-trimester spontaneous abortion one week after the subject’s last pnf-C1INH infusion and was considered unrelated to pnf-C1INH treatment; the third occurred in a 30-year-old subject who exited the registry approximately two months before her due date with no further follow-up, although no AEs or complications were recorded up to that point. Five of these subjects had no AEs during registry participation; the remaining 6 had no AEs that were considered related to pnfC1-INH.


Berinert administration during pregnancy was generally safe and not associated with any treatment-related AEs. In all registry pregnancies followed to term, the birth of a healthy baby was reported.