Dupilumab Viable for Atopic Dermatitis During Pregnancy, Breastfeeding

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Dupilumab may be considered a viable atopic dermatitis treatment option for pregnant and breastfeeding women, new findings suggest, given both the limited therapy options in this patient population and the drug’s favorable safety profile for such patients.¹

These findings resulted from new research authored in part by Stamatios Gregoriou, from the department of dermatology and venereology at the Andreas Sygros Hospital for Skin Diseases in Athens, Greece. Gregoriou and colleagues noted that data is limited on biologic therapy use during pregnancy and breastfeeding, leading to guidelines that commonly urge the use of cyclosporin in pregnancy for the skin condition if it is not controlled through topicals.²

“Consequently, treatment options for women who cannot receive cyclosporine are needed,” Gregoriou and colleagues wrote. “This systematic review summarizes the literature on dupilumab's use during pregnancy and breastfeeding and associated maternal and neonatal outcomes.”¹

Review of Data on Pregnant Patients with Atopic Dermatitis

The investigative team carried out a series of systematic literature searches using the Scopus, MEDLINE/PubMed, and CENTRAL databases, with data drawn from these databases inception to February 2024. The team sought to collect observational studies, randomized trials, case series, and case reports covering the use of dupilumab during pregnancy.

They also conducted an updated search in July 2024 during which 3 studies deemed to be eligible were added to their data. The team had a pair of independent authors screen the studies, as well as to carry out data extraction and assessments of bias risk.

Among the team’s total of 85 articles that they had first identified, they screened 64 articles after deduplication. A review and statistical analysis was carried out for 14 studies after they met the investigators’ criteria for eligibility. They extracted data from 63 women in their analysis, drawn from the 14 articles.

There were a total of 61 pregnant and 2 breastfeeding-only subjects in this assessment. The investigative team noted that 29 cases presented with available data on dupilumab implementation during pregnancy. They added that among those they included from the trials, there had been a mean maternal age of 33.2 years.

The team, for the 28 cases that discontinued use of dupilumab upon pregnancy discovery had a mean age of 32.4 years. The investigators added that the median time of exposure to the medication during pregnancy was shown to be 6 weeks.

Overall, the literature review and its analysis led to the conclusion that disease control was generally well-maintained, although it was noted that some individuals reported flares in their atopic dermatitis after cessation of dupilumab or following childbirth.

In their assessment of pregnancy and birth outcomes, the research team highlighted 1 study which concluded that there had been 7 premature infants but had not specified their birth weights. Additional analyses showed that 3 newborns had been shown to have lower birth weight but also proper development and weight gain postnatally.

There were 2 publications with miscarriages documented by investigators, with 1 involved patient having received the teratogenic medication valproate due to uncontrolled epilepsy. Another study demonstrated that 5 of 28 individuals had miscarriage events, although the authors of this research had not raised specific concerns regarding dupilumab and its safety.

The research team noted that 17 subjects continued breastfeeding while using dupilumab, without any reports of abnormal newborn development or any complications. The team also highlighted that adverse events linked to use of dupilumab had mostly involved joint pain and ocular symptoms and had been shown to be relatively rare.

In terms of limitations to this review, the investigators highlighted the heterogeneity of reported outcomes, study designs, and they noted the small sample size. Despite the fact that most studies had been classified as high quality, all of the studies included in the review were case reports or series that also had known limitations.

Consequently, they pointed to a lack of definitive conclusions to be drawn from the available evidence.

“In conclusion, in light of the limited treatment choices for [atopic dermatitis] during pregnancy, dupilumab could be considered a viable option with a favourable safety profile for pregnant and breastfeeding women, especially after careful patient evaluation,” they wrote. “However, our findings suggest that further research is necessary to investigate its safety and efficacy in this population.”¹

References

1. ^{Gregoriou, S., Routsi, E., Koumprentziotis, I.-A., Papapanou, M. and Stratigos, A. (2025), Dupilumab use for atopic dermatitis during pregnancy: A systematic review. J Eur Acad Dermatol Venereol. https://doi.org/10.1111/jdv.20570.}
2. ^{Deleuran M, Dézfoulian B, Elberling J, Knutar I, Lapeere H, Lossius AH, et al. Systemic anti-inflammatory treatment of atopic dermatitis during conception, pregnancy and breastfeeding: interdisciplinary expert consensus in northern Europe. J Eur Acad Dermatol Venereol. 2024; 38: 31–41.}