ArticleBritish journal of clinical pharmacology2022
Reported congenital malformations after exposure to non-tumour necrosis factor inhibitor biologics: A retrospective comparative study in EudraVigilance.
Article in British journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.
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Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- The quantity, reliability, transparency, reporting, and interpretation of pharmacovigilance signal detection studies in pregnancy: a meta-epidemiological study.European journal of clinical pharmacology · 2025Pooled it
- Hidradenitis Suppurativa from Preconception to Lactation: Clinical Treatment Decision-Making Review.Dermatology and therapy · 2026Review
- Pregnancy outcomes of non-tumour necrosis factor inhibitor biologic disease-modifying antirheumatic drugs among individuals with autoimmune diseases: a scoping review and proposed framework for reporting outcomes.EULAR rheumatology open · 2025Article
- A Guide to the Management of Hidradenitis Suppurativa in Pregnancy and Lactation.American journal of clinical dermatology · 2025Review
- Use of Biologics During Pregnancy Among Patients With Autoimmune Conditions.JAMA network open · 2025Article
- Communication and Therapy Planning for Patients of Reproductive Age Under Immunomodulatory Treatments for Psoriasis or Psoriatic Arthritis-Survey of the German National Psoriasis Registry PsoBest.Healthcare (Basel, Switzerland) · 2025Article
- Observational
- Ustekinumab in the Treatment of Inflammatory Bowel Diseases: Evolving Paradigms.Journal of clinical medicine · 2024Review
- Blockade of IL-6R prevents preterm birth and adverse neonatal outcomes.EBioMedicine · 2023Article
- Paradigm Shift in Diagnosis and Targeted Therapy in Recurrent Pericarditis.Current cardiology reports · 2023Review
- Reported congenital malformations after exposure to non-tumour necrosis factor inhibitor biologics: A retrospective comparative study in EudraVigilance.British journal of clinical pharmacology · 2022Article
Corrections and comments
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Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo evaluate the number and nature of reported congenital malformations (CMs) after intrauterine exposure to non-tumour necrosis factor inhibitor biologics (non-TNFi biologics) compared to certolizumab pegol (CZP).
methodsA retrospective comparative study was conducted in the EudraVigilance (EV) database. A safe biologic (CZP) was considered as the reference group. Odds ratios (ORs) for CMs were calculated for each non-TNFi biologic (including abatacept, anakinra, belimumab, ixekizumab, rituximab, secukinumab, tocilizumab, ustekinumab and vedolizumab), versus CZP (quantitative assessment). Then, CM patterns were reviewed in consultation with a clinical geneticist (qualitative assessment).
resultsORs were not statistically significant except for belimumab and vedolizumab (similar in magnitude). Except for vedolizumab, no specific CM patterns were observed for the included non-TNFi biologics. Three cases of corpus callosum agenesis (CCA) were identified for vedolizumab (versus none in CZP and other investigated non-TNFi biologics). Two of the CCA cases were associated with other neurological CMs (one cerebral ventriculomegaly with microcephaly and one polymicrogyria). This may indicate that these CCAs are related to undiagnosed genetic alterations or are associated with the underlying maternal disease, although a definite relationship with vedolizumab exposure cannot be ruled out.
conclusionNo special safety signal was identified regarding the occurrence of CMs after exposure to abatacept (n = 64), anakinra (n = 20), belimumab (n = 93), ixekizumab (n = 29), rituximab (n = 57), secukinumab (n = 128), tocilizumab (n = 124) and ustekinumab (n = 215). Regarding observed CCAs in the vedolizumab group (n = 113), no firm conclusions can be made based on available information.
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