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

被引：6

作者：

Avallone, Gianluca ^{[1
,2
]}

Cavallo, Francesco ^{[2
]}

Tancredi, Annalisa ^{[3
]}

Maronese, Carlo A. ^{[4
,5
]}

Bertello, Martina ^{[6
]}

Fraghi, Alessandro ^{[7
]}

Conforti, Claudio ^{[8
,9
]}

Calabrese, Giulia ^{[10
]}

Di Nicola, Matteo R. ^{[11
]}

Oddenino, Giorgio A. ^{[12
]}

Gargiulo, Luigi ^{[13
,14
]}

Gori, Niccolo ^{[15
,16
]}

Loi, Camilla ^{[17
,18
]}

Romita, Paolo ^{[19
]}

Piras, Viviana ^{[20
]}

Bonzano, Laura ^{[21
]}

Tolino, Ersilia ^{[22
]}

Paolino, Giovanni ^{[11
,23
]}

Napolitano, Maddalena ^{[24
]}

Patruno, Cataldo ^{[25
]}

Nettis, Eustachio ^{[26
]}

Ferreli, Caterina ^{[27
]}

Roccuzzo, Gabriele ^{[2
]}

Marozio, Luca ^{[3
]}

Silvio, Martina ^{[4
,5
]}

Russo, Filomena ^{[6
]}

Bettolini, Luca ^{[7
]}

Gallo, Rosella ^{[12
]}

Mercuri, Santo R. ^{[11
,23
]}

Mastorino, Luca ^{[2
]}

Rossi, Mariateresa ^{[7
]}

Zalaudek, Iris ^{[8
]}

Argenziano, Giuseppe ^{[10
]}

Trave, Ilaria ^{[12
]}

Costanzo, Antonio ^{[13
,14
]}

Chiricozzi, Andrea ^{[15
,16
]}

Gurioli, Carlotta ^{[17
,18
]}

Foti, Caterina ^{[19
]}

Potenza, Concetta ^{[22
]}

Ferrucci, Silvia M. ^{[4
]}

Balato, Anna ^{[10
]}

Parodi, Aurora ^{[12
]}

Marzano, Angelo V. ^{[4
,5
]}

Ortoncelli, Michela ^{[2
]}

Ribero, Simone ^{[2
]}

Quaglino, Pietro ^{[2
]}

机构：

[1] Univ Turin, Dept Med Sci, Sect Dermatol, Via Cherasco 23, I-10121 Turin, Italy

[2] Univ Turin, Dept Med Sci, Dermatol Clin, Turin, Italy

[3] Univ Torino, St Anna Hosp, Physiopathol Reprod & IVF Unit, Obstet & Gynecol 1U,Dept Surg Sci, Turin, Italy

[4] Fdn IRCCS Ca Granda Osped Maggiore Policlin, Dermatol Unit, Milan, Italy

[5] Univ Milan, Dept Pathophysiol & Transplantat, Milan, Italy

[6] Univ Siena, Santa Maria Alle Scotte Hosp, Dermatol Sect, Dept Med Surg & Neurol Sci, Siena, Italy

[7] Univ Brescia, Dermatol Dept, Brescia, Italy

[8] Univ Trieste, Maggiore Hosp, Dermatol Clin, Trieste, Italy

[9] Dermatol Res Hosp, IDI IRCCS, Rome, Italy

[10] Univ Campania Luigi Vanvitelli, Unit Dermatol, Naples, Italy

[11] IRCCS Osped San Raffaele, Unit Dermatol, Milan, Italy

[12] Univ Genoa, IRCCS Osped Policlin San Martino, Dept Hlth Sci, Sect Dermatol, Genoa, Italy

[13] IRCCS Humanitas Res Hosp, Dermatol Unit, Rozzano, MI, Italy

[14] Humanitas Univ, Dept Biomed Sci, Pieve Emanuele, Italy

[15] Fdn Policlin Univ A Gemelli IRCCS, Dipartimento Sci Med & Chirurg, UOC Dermatol, Rome, Italy

[16] Univ Cattolica Sacro Cuore, Dipartimento Med & Chirurg Traslaz, Dermatol, Rome, Italy

[17] IRCCS Azienda Osped Univ Bologna, Dermatol Unit, Bologna, Italy

[18] Univ Bologna, Dept Med & Surg Sci, Alma Mater Studiorum, Bologna, Italy

[19] Univ Bari Aldo Moro, Dept Precis & Regenerat Med & Ionian Area, Unit Dermatol, Bari, Italy

[20] Azienda Osped Univ Cagliari, Dept Med Sci & Publ Hlth, Unit Dermatol, Cagliari, Italy

[21] Azienda USL IRCCS Reggio Emilia, Dermatol Unit, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy

[22] Sapienza Univ Rome, Dept Med Surg Sci & Biotechnol, Polo Pontino, Rome, Italy

[23] Univ Vita Salute San Raffaele, Dermatol Clin, Milan, Italy

[24] Univ Naples Federico II, Dept Clin Med & Surg, Sect Dermatol, Naples, Italy

[25] Magna Graecia Univ Catanzaro, Dept Hlth Sci, Catanzaro, Italy

[26] Univ Bari Aldo Moro, Sch Allergol & Clin Immunol, Dept Emergency & Organ Transplantat, Bari, Italy

[27] Univ Cagliari, Dept Med Sci & Publ Hlth, Unit Dermatol, Cagliari, Italy

来源：

JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY | 2024年 / 38卷 / 09期

关键词：

PLACEBO;

D O I：

10.1111/jdv.19794

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

BackgroundThere 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.

引用

页码：1799 / 1808

页数：10

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