Association between maternal dupilumab exposure and pregnancy outcomes in patients with moderate‐to‐severe atopic dermatitis: A nationwide retrospective cohort study-Reference-Cited by-同舟云学术

Association between maternal dupilumab exposure and pregnancy outcomes in patients with moderate‐to‐severe atopic dermatitis: A nationwide retrospective cohort study

Published:2024-01-29 Issue: Volume: Page:
ISSN:0926-9959
Container-title:Journal of the European Academy of Dermatology and Venereology
language:en
Short-container-title:Acad Dermatol Venereol

Author:

Avallone Gianluca¹^ORCID,Cavallo Francesco¹^ORCID,Tancredi Annalisa²,Maronese Carlo A.³⁴^ORCID,Bertello Martina⁵^ORCID,Fraghì Alessandro⁶,Conforti Claudio⁷⁸^ORCID,Calabrese Giulia⁹^ORCID,Di Nicola Matteo R.¹⁰,Oddenino Giorgio A.¹¹,Gargiulo Luigi¹²¹³^ORCID,Gori Niccolò¹⁴¹⁵^ORCID,Loi Camilla¹⁶¹⁷,Romita Paolo¹⁸,Piras Viviana¹⁹,Bonzano Laura²⁰^ORCID,Tolino Ersilia²¹,Paolino Giovanni¹⁰²²^ORCID,Napolitano Maddalena²³^ORCID,Patruno Cataldo²⁴,Nettis Eustachio²⁵,Ferreli Caterina²⁶^ORCID,Roccuzzo Gabriele¹,Marozio Luca²,Silvio Martina³⁴,Russo Filomena⁵,Bettolini Luca⁶^ORCID,Gallo Rosella¹¹,Mercuri Santo R.¹⁰²²,Mastorino Luca¹^ORCID,Rossi Mariateresa⁶,Zalaudek Iris⁷,Argenziano Giuseppe⁹^ORCID,Trave Ilaria¹¹^ORCID,Costanzo Antonio¹²¹³^ORCID,Chiricozzi Andrea¹⁴¹⁵^ORCID,Gurioli Carlotta¹⁶¹⁷,Foti Caterina¹⁸,Potenza Concetta²¹,Ferrucci Silvia M.³,Balato Anna⁹^ORCID,Parodi Aurora¹¹,Marzano Angelo V.³⁴^ORCID,Ortoncelli Michela¹,Ribero Simone¹^ORCID,Quaglino Pietro¹^ORCID

Affiliation:

1. Dermatology Clinic, Department of Medical Sciences University of Turin Turin Italy

2. Obstetrics and Gynecology 1U, Physiopathology of Reproduction and IVF Unit, Department of Surgical Sciences, Sant Anna Hospital University of Torino Turin Italy

3. Dermatology Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy

4. Department of Pathophysiology and Transplantation University of Milan Milan Italy

5. Dermatology Section, Department of Medical, Surgical, and Neurological Sciences, Santa Maria Alle Scotte Hospital University of Siena Siena Italy

6. Dermatology Department University of Brescia Brescia Italy

7. Dermatology Clinic, Maggiore Hospital University of Trieste Trieste Italy

8. IDI‐IRCCS, Dermatological Research Hospital Rome Italy

9. Unit of Dermatology University of Campania Luigi Vanvitelli Naples Italy

10. Unit of Dermatology IRCCS Ospedale San Raffaele Milan Italy

11. Section of Dermatology ‐ Department of Health Sciences University of Genoa, IRCCS ‐ Ospedale Policlinico San Martino Genoa Italy

12. Dermatology Unit IRCCS Humanitas Research Hospital Rozzano MI Italy

13. Department of Biomedical Sciences Humanitas University Pieve Emanuele Italy

14. UOC di Dermatologia, Dipartimento di Scienze Mediche e Chirurgiche Fondazione Policlinico Universitario A. Gemelli – IRCCS Rome Italy

15. Dermatologia, Dipartimento di Medicina e Chirurgia Traslazionale Università Cattolica del Sacro Cuore Rome Italy

16. Dermatology Unit IRCCS Azienda Ospedaliero‐Universitaria di Bologna Bologna Italy

17. Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna Bologna Italy

18. Unit of Dermatology, Department of Precision and Regenerative Medicine and Ionian Area University of Bari Aldo Moro Bari Italy

19. Unit of Dermatology, Department of Medical Sciences and Public Health Azienda Ospedaliero‐Universitaria Cagliari Cagliari Italy

20. Dermatology Unit, Arcispedale Santa Maria Nuova Azienda USL‐IRCCS Reggio Emilia Reggio Emilia Italy

21. Department of Medico‐surgical Sciences and Biotechnologies Sapienza University of Rome Polo Pontino Italy

22. Unit of Clinical Dermatology Università Vita‐Salute San Raffaele Milan Italy

23. Section of Dermatology, Department of Clinical Medicine and Surgery University of Naples Federico II Naples Italy

24. Department of Health Sciences University Magna Graecia of Catanzaro Catanzaro Italy

25. Department of Emergency and Organ Transplantation, School of Allergology and Clinical Immunology University of Bari Aldo Moro Bari Italy

26. Unit of Dermatology, Department of Medical Sciences and Public Health University of Cagliari Cagliari Italy

Abstract

AbstractBackgroundThere is limited epidemiological evidence on outcomes associated with dupilumab exposure during pregnancy; monitoring pregnancy outcomes in large populations is required.ObjectiveTo investigate the potential association between exposure to dupilumab in pregnant women with atopic dermatitis and any adverse pregnancy, neonatal, congenital and post‐partum outcomes.MethodsWe performed a multicentre retrospective cohort study across 19 Italian tertiary referral hospital. Childbearing women were eligible if aged 18–49 years and carried out the pregnancy between 1 October 2018 and 1 September 2022.ResultsWe retrospectively screened records of 5062 patients receiving dupilumab regardless of age and gender, identifying 951 female atopic dermatitis patients of childbearing age, 29 of whom had been exposed to the drug during pregnancy (3%). The median duration of dupilumab treatment prior to conception was 22.5 weeks (range: 3–118). The median time of exposure to the drug during pregnancy was 6 weeks (range: 2–24). All the documented pregnancies were unplanned, and the drug was discontinued in all cases once pregnancy status was reported. The comparison of the study cohort and the control group found no significant drug‐associated risk for adverse pregnancy, congenital, neonatal or post‐partum outcomes. The absence of a statistically significant effect of exposure on the event was confirmed by bivariate analysis and multivariate analysis adjusted for other confounding factors.ConclusionsThis cohort of pregnant patients exposed to dupilumab adds to the existing evidence concerning the safety of biologic agents in pregnancy. No safety issues were identified regarding the primary outcome assessed. In clinical practice, these data provide reassurance in case of dupilumab exposure during the first trimester. However, the continuous use of dupilumab throughout pregnancy warrants further research.

Publisher

Wiley

Subject

Infectious Diseases,Dermatology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/jdv.19794

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