Safety of Dupilumab Therapy for Atopic Dermatitis during Pregnancy: A Systematic Review and Meta-analysis

Atopic dermatitis (AD) is the most common skin condition among pregnant women. However, there is limited information on the safety of biologicals during pregnancy. A systematic review and meta-analysis was conducted following the PRISMA guidelines to evaluate the effects of exposure to biologicals d...

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Main Authors: Verónica Sánchez-García, Eva de-Miguel-Balsa, José-Manuel Ramos-Rincón, Isabel Belinchón-Romero
Format: Article
Language:English
Published: Medical Journals Sweden 2025-02-01
Series:Acta Dermato-Venereologica
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Online Access:https://medicaljournalssweden.se/actadv/article/view/41307
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author Verónica Sánchez-García
Eva de-Miguel-Balsa
José-Manuel Ramos-Rincón
Isabel Belinchón-Romero
author_facet Verónica Sánchez-García
Eva de-Miguel-Balsa
José-Manuel Ramos-Rincón
Isabel Belinchón-Romero
author_sort Verónica Sánchez-García
collection DOAJ
description Atopic dermatitis (AD) is the most common skin condition among pregnant women. However, there is limited information on the safety of biologicals during pregnancy. A systematic review and meta-analysis was conducted following the PRISMA guidelines to evaluate the effects of exposure to biologicals during pregnancy and/or preconception in women with AD, and to estimate the pooled prevalence of spontaneous abortions and congenital malformations in their newborns. MEDLINE, Embase, Scopus, and Web of Science to 31 May 2024 were searched to identify randomized controlled trials and non-randomized studies. To test the robustness of our findings, sensitivity analyses were performed. Fifteen observational studies involving 115 pregnant women with a mean age of 33.46 years (standard deviation [SD] 3.02 were included). All studies evaluated dupilumab. The mean duration of exposure to dupilumab during pregnancy was 27.52 weeks (SD 11.16). The weighted prevalence of spontaneous abortions was 18.9% (95% confidence interval 5.3 to 38.2). There were no reports of congenital malformations. The sensitivity analyses showed no significant differences in weighted prevalences. In conclusion, the current scientific evidence suggests that dupilumab is probably safe during pregnancy and preconception in women with AD, with no significant increase in the risk of miscarriage or congenital malformations compared to the general population. However, the results of this review are inconclusive due to the limited number of large, well-designed clinical studies.
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spelling doaj-art-6e43f77190b74177b34a770b3a8a871d2025-02-12T08:54:44ZengMedical Journals SwedenActa Dermato-Venereologica0001-55551651-20572025-02-0110510.2340/actadv.v105.41307Safety of Dupilumab Therapy for Atopic Dermatitis during Pregnancy: A Systematic Review and Meta-analysisVerónica Sánchez-García0https://orcid.org/0000-0001-6680-9716Eva de-Miguel-Balsa1https://orcid.org/0000-0002-2117-7257José-Manuel Ramos-Rincón2https://orcid.org/0000-0002-6501-9867Isabel Belinchón-Romero3https://orcid.org/0000-0002-6007-7320Dermatology Department, Dr Balmis General University Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, SpainDepartment of Clinical Medicine, Miguel Hernández University, Alicante, SpainDepartment of Clinical Medicine, Miguel Hernández University, Alicante, SpainDermatology Department, Dr Balmis General University Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain; Department of Clinical Medicine, Miguel Hernández University, Alicante, SpainAtopic dermatitis (AD) is the most common skin condition among pregnant women. However, there is limited information on the safety of biologicals during pregnancy. A systematic review and meta-analysis was conducted following the PRISMA guidelines to evaluate the effects of exposure to biologicals during pregnancy and/or preconception in women with AD, and to estimate the pooled prevalence of spontaneous abortions and congenital malformations in their newborns. MEDLINE, Embase, Scopus, and Web of Science to 31 May 2024 were searched to identify randomized controlled trials and non-randomized studies. To test the robustness of our findings, sensitivity analyses were performed. Fifteen observational studies involving 115 pregnant women with a mean age of 33.46 years (standard deviation [SD] 3.02 were included). All studies evaluated dupilumab. The mean duration of exposure to dupilumab during pregnancy was 27.52 weeks (SD 11.16). The weighted prevalence of spontaneous abortions was 18.9% (95% confidence interval 5.3 to 38.2). There were no reports of congenital malformations. The sensitivity analyses showed no significant differences in weighted prevalences. In conclusion, the current scientific evidence suggests that dupilumab is probably safe during pregnancy and preconception in women with AD, with no significant increase in the risk of miscarriage or congenital malformations compared to the general population. However, the results of this review are inconclusive due to the limited number of large, well-designed clinical studies. https://medicaljournalssweden.se/actadv/article/view/41307atopic dermatitisbiological therapypregnancyspontaneous abortioncongenital abnormalities
spellingShingle Verónica Sánchez-García
Eva de-Miguel-Balsa
José-Manuel Ramos-Rincón
Isabel Belinchón-Romero
Safety of Dupilumab Therapy for Atopic Dermatitis during Pregnancy: A Systematic Review and Meta-analysis
Acta Dermato-Venereologica
atopic dermatitis
biological therapy
pregnancy
spontaneous abortion
congenital abnormalities
title Safety of Dupilumab Therapy for Atopic Dermatitis during Pregnancy: A Systematic Review and Meta-analysis
title_full Safety of Dupilumab Therapy for Atopic Dermatitis during Pregnancy: A Systematic Review and Meta-analysis
title_fullStr Safety of Dupilumab Therapy for Atopic Dermatitis during Pregnancy: A Systematic Review and Meta-analysis
title_full_unstemmed Safety of Dupilumab Therapy for Atopic Dermatitis during Pregnancy: A Systematic Review and Meta-analysis
title_short Safety of Dupilumab Therapy for Atopic Dermatitis during Pregnancy: A Systematic Review and Meta-analysis
title_sort safety of dupilumab therapy for atopic dermatitis during pregnancy a systematic review and meta analysis
topic atopic dermatitis
biological therapy
pregnancy
spontaneous abortion
congenital abnormalities
url https://medicaljournalssweden.se/actadv/article/view/41307
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AT evademiguelbalsa safetyofdupilumabtherapyforatopicdermatitisduringpregnancyasystematicreviewandmetaanalysis
AT josemanuelramosrincon safetyofdupilumabtherapyforatopicdermatitisduringpregnancyasystematicreviewandmetaanalysis
AT isabelbelinchonromero safetyofdupilumabtherapyforatopicdermatitisduringpregnancyasystematicreviewandmetaanalysis