Dupilumab Can Safely Treat Atopic Dermatitis During Pregnancy
Researchers explored the current evidence regarding women’s reactions to biological therapies for treating atopic dermatitis during pregnancy.
Dupilumab (Dupixent) was deemed safe for the treatment of atopic dermatitis (AD) in women during pregnancy or breastfeeding, according to data from a meta-analysis published in Acta Dermato-Venereologica.1 However, due to a lack of robust clinical studies included in the analysis, researchers suggested more research is necessary to understand the efficacy and safety of biologics in treating pregnant women with AD.
“AD is the most common skin condition among pregnant women,” wrote authors of the study. “It accounts for around 50% of all dermatoses of pregnancy and usually develops in the second or third trimester.”
During pregnancy, T helper 2 (Th2) responses within the body help women keep their fetus protected, avoiding any risks of spontaneous abortion. But with AD’s prominence among pregnant women, the skin disease presents a potentially harmful occurrence. With AD being a Th2-driven disease—meaning Th2 cells contribute to the development of AD2—women who have the disease are significantly prone to flare-ups.1
Until biologics are further understood among this population, topical corticosteroids have been the first-line treatment option for managing AD in women who are pregnant. | image credit: fotoduets / stock.adobe.com
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“To treat moderate-to-severe AD during pregnancy, the European Task Force on Atopic Dermatitis recommends systematic corticosteroids, cyclosporine, and azathioprine,” continued authors of the study. “Currently, 2 biological drugs are approved for moderate-to-severe AD: dupilumab (approved in 2017), a monoclonal antibody that blocks the IL-4 and IL-13 signaling pathways; and tralokinumab (approved in 2021), an anti-IL-13 antibody.”
However, according to both European and US guidelines, data on the safety and efficacy of biologics for treating pregnant women’s AD is lacking. Until biologics are further understood among this population, topical corticosteroids have been the first-line treatment option for managing AD in women who are pregnant.3
But biologic therapies, such as dupilumab and tralokinumab, have shown promise in these populations despite a lack of evidence, forcing researchers of the current study to seek further information on the impact these medications have on pregnant women—namely the medications’ safety and efficacy.
“In view of the high prevalence of AD in women of childbearing age, it is crucial to determine the safety of biological therapy during pregnancy and breastfeeding to optimize maternal and neonatal outcomes,” they wrote.1 “We carried out a systematic review and meta-analysis to evaluate the current evidence on the impact of exposure to biologicals in women with AD during pregnancy and preconception.”
Researchers conducted a meta-analysis and systematic review to understand the effects of biologics on women with AD undergoing pregnancy and/or preconception. They also explored whether or not biologic use could lead to increased risk of spontaneous abortions and congenital malformations in pregnant women’s newborn children.
They searched randomized and non-randomized controlled trials up to May 31, 2024, regarding pregnant women and their outcomes after taking biologics to treat AD. Women were only included in the analysis if, in their respective trials, they had an AD diagnosis during pregnancy or while planning to conceive. Women also had to be taking biological therapy at least 3 months before pregnancy (preconception period) or during any trimester of pregnancy.
“Regarding pregnancy outcomes, our meta-analysis shows that the weighted prevalence of spontaneous abortions and congenital malformations in newborns exposed to dupilumab during pregnancy did not differ from rates estimated in the general population, which are 11–22% for spontaneous abortion, and 2–5.5% for congenital malformations,” they continued.1 “In our review, among the 73 pregnancies with known results, the weighted prevalence of spontaneous abortions was 18.9%. There were no reports of congenital malformations in the live newborns.”
Researchers yielded results that support the use of dupilumab among pregnant women with AD. However, upon their exploration of biologics and their use in pregnant women with AD, they identified a significant need for more research. While evidence was found regarding the safety of these drugs in pregnant women, there is a long ways to go before biologics are the first-line option in this population.
But as physicians continue to prescribe these drugs off-label,1 researchers suggest that more work needs to be done to better understand the potential of drugs like dupilumab for treating AD in at-risk populations.
“In conclusion, our findings are relatively reassuring: data published in a small number of pregnancies suggest that dupilumab is probably safe during pregnancy and breastfeeding. Most studies found no significant increase in the risk of adverse maternal outcomes, pregnancy outcomes, or fetal outcomes,” concluded authors of the study.1 “The findings of this review are inconclusive owing to the limited number of large, well-designed clinical studies. There is a need for appropriate pharmacological trials in women of reproductive age.”
READ MORE: Dermatology Resource Center
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