Woman on HAE treatment early in pregnancy delivers healthy baby

A woman with hereditary angioedema (HAE) gave birth to a healthy baby after being briefly exposed to Orladeyo  (berotralstat) early in her pregnancy, according to a case report from Italy.

The woman became pregnant about three months after starting Orladeyo, and the fetus was exposed to the treatment for approximately one month.

“We report the first case of limited exposure to [Orladeyo] during pregnancy with no harmful effect on the newborn,” the researchers wrote. “Our data add information on the use of the drug in this specific setting.”

The case study, “Berotralstat During Pregnancy in a Patient With Hereditary Angioedema,” was published in the Journal of Allergology and Clinical Immunology.

HAE is caused by genetic mutations that result in a lack or dysfunction of a protein called C1 esterase inhibitor (C1-INH), leading to overproduction of bradykinin, a signaling molecule that causes blood vessels to widen and become more permeable (leaky). Swelling attacks occur when too much fluid leaks from blood vessels and accumulates in nearby tissues.

For pregnant women with HAE, plasma-derived C1-inhibitor therapies, such as Cinryze and Haegarda, are the preferred treatments to prevent swelling attacks in the long term. Other preventive treatments, such as Orladeyo, have limited safety data in pregnancy.

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The researchers described the case of a 36-year-old woman who became pregnant after switching to Orladeyo from danazol, which she had taken for 10 years to prevent swelling attacks. Danazol had led to several adverse events, including weight gain, lack of menstrual periods, signs of masculinization, and sudden mood changes.

The woman tapered Danazol doses over the course of four weeks after starting Orladeyo. Her menstrual cycle returned to normal, and she became pregnant about three months after starting the new drug. Based on the estimated conception date, the fetus was exposed to the treatment for approximately one month.

Orladeyo was discontinued, and the woman was treated with plasma-derived C1-inhibitor therapy during pregnancy because of recurrent angioedema attacks. She switched back to Orladeyo about two months after giving birth.

“The drug had no impact on the child or the mother’s health,” the researchers wrote.

While studies in pregnant rats found that Orladeyo crossed the placenta without harming the developing fetus when administered at the clinical dose of 150 mg, the researchers noted that human data remain very limited. “Future evidence is needed to confirm the safety of [Orladeyo] in pregnant and breastfeeding women,” they wrote.