European Task Force on Atopic Dermatitis (ETFAD) Position Paper: treatment of parental atopic dermatitis during preconception, pregnancy and lactation period

Abstract

Corrigendum to: European Task Force on Atopic Dermatitis (ETFAD) Position Paper: treatment of parental atopic dermatitis during preconception, pregnancy and lactation period Vestergaard C, Wollenberg A, Barbarot S, Christen-Zaech S, Deleuran M, Spuls P, Flohr C, Trzeciak M, von Kobyletzki L, Seneschal J, Paul C, Bieber T, Werfel T, Fölster-Holst R, Darsow U, Gieler U, Svensson Å, Cork M, Stalder JF, De Raeve L, Kunz B, Simon D, Chernyshov P, Hijnen D, Gelmetti C, Ring J, Taieb A, de Bruin-Weller M, Thyssen JP. J Eur Acad Dermatol Venereol. 2019 Sep;33(9):1644–1659. https://doi.org/10.1111/jdv.15709. Epub 2019 Jun 23. Crisaborole ointment is not recommended for treatment of AD in pregnant women In our recent European Task Force on Atopic Dermatitis (ETFAD) position paper, treatment of parental atopic dermatitis (AD) during preconception, pregnancy and lactation period was recommended according to expert opinion. We utilized a ‘safety first’ approach, but for some medications, there is very little safety data available. In these instances, one must make use of sparse evidence from case reports and case series to deduct safety, but also rely on the number of years a medication has been on the market without being associated with teratogenicity. Evidence from animal studies, as well as clinical data from other indications than AD may further be helpful. We incorrectly stated that ‘according to the label, crisaborole is contraindicated in pregnant females’. Crisaborole (EUCRISA) ointment is not licensed in the EU for any indication. In consequence, there is no summary of product characteristics (SMPC) of the European Medicines Agency (EMA) available for this drug. The US label states: ‘There is no available data with EUCRISA in pregnant women to inform the drug-associated risk for major birth defects and miscarriage, and In animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnantrats and rabbits during organogenesis at doses up to 5 and 3 times, respectively, the maximum recommended human dose (MRHD).’ Furthermore it states: ‘There is no information available on the presence of EUCRISA in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production after topical application of EUCRISA to women who are breastfeeding. EUCRISA is systemically absorbed. The lack of clinical data during lactation precludes a clear determination of the risk of EUCRISA to a breastfed infant. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EUCRISA and any potential adverse effects on the breastfed infant from EUCRISA or from the underlying maternal condition.’ In summary, we acknowledge and apologize for the misquotation regarding the US label. A corrected line would read: Crisaborole is not licensed for any indication in the EU. According to the US label, there is no available data with EUCRISA in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. As there is still no data available on humans, the ETFAD recommends that, due to lack of experience with this drug during pregnancy, crisaborole ointment should not be used preconceptionally, in pregnancy or during lactation. On behalf of the author group Christian Vestergaard, Andreas Wollenberg, Jacob P. Thyssen