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The pre- and post-authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation.

Abstract：

AIMS:The effects of biologics on reproduction/lactation are mostly unknown although many patients that receive biologics are women of reproductive age. The first objective of this study was to investigate the publicly available data on pregnancy/lactation before and after marketing authorization in Europe of biologics for the indications of rheumatologic inflammatory autoimmune diseases and inflammatory bowel disease. Secondary objectives included the assessment of the clinical relevance of the provided data and comparison of initial and post-authorization data. METHODS:Initial and post-authorization data were extracted from the European Public Assessment Reports and the latest versions of Summary of Product Characteristics using publicly available documents on the European Medicines Agency's website. Four sections were categorized regarding pregnancy outcomes: pre-clinical/animal studies, human female fertility, pregnancy-related outcomes and congenital malformations in the human fetus. Three sections were categorized regarding lactation outcomes: pre-clinical/animal studies, excretion in human breast milk and absorption in children through breastfeeding. The clinical applicability of each category was scored by specified criteria, based on scientific literature, and further as defined by the authors. RESULTS:For the 16 included biologics, post-authorization data were delivered only for adalimumab, certolizumab pegol, etanercept and infliximab. For the 12 remaining biologics limited data on pregnancy and lactation during the post-marketing period of 2-21 years were available. CONCLUSIONS:In this article several suggestions are provided for improving a multidisciplinary approach to these issues. The initiation of suitable registries by marketing authorization holders and data transparency for clinicians and academics are highly endorsed.

journal_name

Br J Clin Pharmacol

journal_title

British journal of clinical pharmacology

authors

Ghalandari N,Dolhain RJEM,Hazes JMW,Siezen CLE,van der Laan JW,Crijns HJMJ,van Puijenbroek EP,van der Woude CJ

doi

10.1111/bcp.14145

subject

Has Abstract

pub_date

2020-03-01 00:00:00

pages

580-590

issue

eissn

0306-5251

issn

1365-2125

journal_volume

pub_type

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The pre- and post-authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation.