ArticleBritish journal of clinical pharmacology2020
The pre- and post-authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation.
Article in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review.Drugs · 2020Pooled it
- Inconsistent medication recommendations for immune-mediated inflammatory diseases across pregnancy, lactation, and paternal preconception: a guideline-based review.Frontiers in pharmacology · 2026Review
- Article
- Hidradenitis Suppurativa Treatment During Pregnancy and Lactation: Navigating Challenges.International journal of dermatology · 2025Review
- EMA perspective on the value of model-informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding.CPT: pharmacometrics & systems pharmacology · 2024Article
- Reported congenital malformations after exposure to non-tumour necrosis factor inhibitor biologics: A retrospective comparative study in EudraVigilance.British journal of clinical pharmacology · 2022Article
- The impact of gender and sex in psoriasis: What to be aware of when treating women with psoriasis.International journal of women's dermatology · 2022Review
- Opportunities and Challenges for PBPK Model of mAbs in Paediatrics and Pregnancy.The AAPS journal · 2022Review
- [Current aspects of antirheumatic therapy in pregnancy planning, during pregnancy and breastfeeding].Zeitschrift fur Rheumatologie · 2021Review
- Modern treatment approach results in low disease activity in 90% of pregnant rheumatoid arthritis patients: the PreCARA study.Annals of the rheumatic diseases · 2021Article
- The Influence of Treatment of Inflammatory Arthritis During Pregnancy on the Long-Term Children's Outcome.Frontiers in pharmacology · 2021Review
- Practical recommendations for systemic treatment in psoriasis according to age, pregnancy, metabolic syndrome, mental health, psoriasis subtype and treatment history (BETA-PSO: Belgian Evidence-based Treatment Advice in Psoriasis; part 1).Journal of the European Academy of Dermatology and Venereology : JEADV · 2020Article
- The pre- and post-authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation.British journal of clinical pharmacology · 2020Article
Corrections and comments
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Authors and funding
8 authors at 3 institutions in 1 country.
Funding
Abstract
aimsThe 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.
methodsInitial 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.
resultsFor 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.
conclusionsIn 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.