ArticleThe American journal of gastroenterology2016
Birth Outcomes in Children Fathered by Men Treated with Anti-TNF-α Agents Before Conception.
Article in The American journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
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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
19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.
- British Society for Rheumatology guideline on prescribing drugs in pregnancy and breastfeeding: immunomodulatory anti-rheumatic drugs and corticosteroids.Rheumatology (Oxford, England) · 2023Guideline
- The effect of paternal exposure to immunosuppressive drugs on sexual function, reproductive hormones, fertility, pregnancy and offspring outcomes: a systematic review.Human reproduction update · 2020Pooled it
- The influence of paternal preconception health on birth defects and head circumference: A scoping review.PLOS global public health · 2026Article
- The influence of paternal preconception health on infant birth weight: A scoping review.PloS one · 2026Article
- Effects of paternal preconception exposure to conventional and biologic DMARDs on newborn outcomes.Arthritis research & therapy · 2025Article
- Scoping review of biosimilar disease-modifying antirheumatic drugs in pregnancy: evidence gaps and proposed outcome reporting framework.Rheumatology international · 2025Article
- Safety concerns of paternal drug exposure on fertility, pregnancy and offspring: An analysis based on the FDA adverse event reporting system.Andrology · 2025Article
- Pregnancy Outcomes of Targeted Synthetic Disease-Modifying Antirheumatic Drugs Among Patients With Autoimmune Diseases: A Scoping Review.Arthritis care & research · 2025Article
- The safety of paternal and maternal use of 5-aminosalicylic acid during conception and pregnancy: a nationwide cohort study.Alimentary pharmacology & therapeutics · 2022Article
- Paternal use of medications for inflammatory bowel disease and the risk of hospital-diagnosed infections in the offspring: a nationwide cohort study.Alimentary pharmacology & therapeutics · 2022Article
- Anything New about Paternal Contribution to Reproductive Outcomes? A Review of the Evidence.The world journal of men's health · 2021Review
- Rheumatology-led pregnancy clinic: men perspective.Clinical rheumatology · 2021Review
- Paternal Exposure to Immunosuppressive and/or Biologic Agents and Birth Outcomes in Patients With Immune-Mediated Inflammatory Diseases.Gastroenterology · 2021Article
- Biologics During Pregnancy and Breastfeeding Among Women With Rheumatic Diseases: Safety Clinical Evidence on the Road.Frontiers in pharmacology · 2021Review
- Pregnancy outcomes in partners of male ankylosing spondylitis patients treated with anti-tumour necrosis factor-α biologics: real-life results from a single-centre cross-sectional study.Rheumatology international · 2020Observational
- The use of biologics for autoimmune rheumatic diseases in fertility and pregnancy.Obstetric medicine · 2020Review
- Exposure to Infliximab During Pregnancy: Post-Marketing Experience.Drug safety · 2020Article
- Family Planning and Rheumatoid Arthritis.Current rheumatology reports · 2019Review
- Paternal Disease Activity Is Associated With Difficulty in Conception Among Men With Inflammatory Bowel Diseases.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe safety of paternal use of anti-tumor necrosis factor-α (TNF-α) agents immediately prior to conception is practically unknown. On the basis of nationwide data from Danish health registries, we examined the association between paternal use of anti-TNF-α agents within 3 months before conception and adverse birth outcomes.
methodsThis nationwide cohort study is based on data from all women who had a live born singleton child in Denmark from 1 January 2007 through 2013. Children fathered by men treated with anti-TNF-α agents within three months before conception constituted the exposed cohort (N=372), and children fathered by men not treated before conception constituted the unexposed cohort (N=399,498). The outcomes were congenital abnormalities (CAs), preterm birth, and small for gestational age (SGA). We adjusted for multiple covariates, and considered paternal underlying disease and concomitant medication.
resultsThe adjusted risks of CAs and preterm birth were close to unity, and the adjusted odds ratio (OR) for SGA was 1.70 (95% confidence interval (CI): 0.94-3.09). Restricting our analysis to fathers with inflammatory bowel disease, we found no increased risk of CAs or SGA, and the adjusted OR for pretem birth was 1.42 (95% CI: 0.52-3.86). Restricting our analysis to fathers with rheumatologic/dermatological diseases, we found no increased risk of CAs or preterm birth, and the adjusted OR for SGA was 1.70 (95% CI: 0.74-3.89).
conclusionsOur results are overall reassuring regarding the safety of paternal preconceptional use of anti-TNF-α agents. The result regarding SGA should, however, be interpreted with caution as we found an increased risk, although not significantly increased.
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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.