Observational studyBritish journal of clinical pharmacology2015
Pregnancy outcome after TNF-α inhibitor therapy during the first trimester: a prospective multicentre cohort study.
Observational study in British journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 54 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
54 citing papers in PubMed, 6 syntheses or guidelines pooled it, 157 citations in OpenAlex.
- Anti-tumor necrosis factor-α therapy may not be safe during pregnancy in women with inflammatory bowel disease: an updated meta-analysis and systematic review.BMC pregnancy and childbirth · 2024Pooled it
- Rational approach to the prescription of anti-rheumatic drugs in rheumatoid arthritis: a product leaflet-based strategy in Italy.Frontiers in immunology · 2024Pooled it
- British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.Rheumatology (Oxford, England) · 2023Guideline
- Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: A systematic review and meta-analysis.BJOG : an international journal of obstetrics and gynaecology · 2022Pooled it
- Adverse Pregnancy Outcomes Following Exposure to Biologics in Women With Crohn's Disease: A Systematic Review and Meta-Analysis.Frontiers in medicine · 2021Pooled it
- Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review.Drugs · 2020Pooled it
- Antibody Transfer From Mother to Fetus/Infant: An Opportunity for Model-Informed Precision Medicine.Journal of clinical pharmacology · 2026Article
- A clinical care pathway for managing pregnancy in patients with inflammatory arthritis.Clinical rheumatology · 2026Review
- A real-world pharmacovigilance study of Certolizumab pegol based on FAERS database.Scientific reports · 2025Article
- Genetically proxied tumour necrosis factor inhibition and pregnancy-related maternal and foetal outcomes in the general population: a Mendelian randomization study.Rheumatology advances in practice · 2025Article
- Tumor Necrosis Alpha (TNF-α) Antagonists Used in Chronic Inflammatory Rheumatic Diseases: Risks and their Minimization Measures.Current drug safety · 2024Review
- Placental transfer of tofacitinib in theCurrent research in toxicology · 2024Article
- BAFF and APRIL counterregulate susceptibility to inflammation-induced preterm birth.Cell reports · 2023Article
- Drug switching in axial spondyloarthritis patients in Germany - a social listening analysis.Therapeutic advances in musculoskeletal disease · 2023Article
- Pregnant women with immune mediated inflammatory diseases who discontinue biologics have higher rates of disease flare.Archives of gynecology and obstetrics · 2022Article
- Vaginal delivery after improvement in COVID-19 by monoclonal antibody treatment: A case report and literature review.Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy · 2022Review
- TNF-Expert reviews in molecular medicine · 2022Review
- Recent Advances in Treatment of Recurrent Spontaneous Abortion.Obstetrical & gynecological survey · 2022Review
- Outcomes of Continuation vs Discontinuation of Adalimumab Therapy During Third Trimester of Pregnancy in Inflammatory Bowel Disease.Gastro hep advances · 2022Article
- [Insights into pregnancy and breastfeeding in inflammatory rheumatic diseases through observational data].Zeitschrift fur Rheumatologie · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 10 institutions in 8 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTNF-α inhibitors are considered relatively safe in pregnancy but experience is still limited. The aim of this study was to evaluate the risk of major birth defects, spontaneous abortion, preterm birth and reduced birth weight after first trimester exposure to TNF-α inhibitors.
methodsPregnancy outcomes of women on adalimumab, infliximab, etanercept, certolizumab pegol or golimumab were evaluated in a prospective observational cohort study and compared with outcomes of a non-exposed random sample. The samples were drawn from pregnancies identified by institutes collaborating in the European Network of Teratology Information Services.
resultsIn total, 495 exposed and 1532 comparison pregnancies were contributed from nine countries. The risk of major birth defects was increased in the exposed (5.0%) compared with the non-exposed group (1.5%; adjusted odds ratio (ORadj ) 2.2, 95% CI 1.0, 4.8). The risk of preterm birth was increased (17.6%; ORadj 1.69, 95% CI 1.1, 2.5), but not the risk of spontaneous abortion (16.2%; adjusted hazard ratio [HRadj ] 1.06, 95% CI 0.7, 1.7). Birth weights adjusted for gestational age and sex were significantly lower in the exposed group compared to the non-exposed cohort (P = 0.02). As a diseased comparison group was not possible to ascertain, the influence of disease and treatment on birth weight and preterm birth could not be differentiated.
conclusionsTNF-α inhibitors may carry a risk of adverse pregnancy outcome of moderate clinical relevance. Considering the impact of insufficiently controlled autoimmune disease on the mother and the unborn child, TNF-α inhibitors may nevertheless be a treatment option in women with severe disease refractory to established immunomodulatory drugs.
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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.