ArticleGastroenterology2021
Paternal Exposure to Immunosuppressive and/or Biologic Agents and Birth Outcomes in Patients With Immune-Mediated Inflammatory Diseases.
Article in Gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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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.
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Who cites it
15 citing papers in PubMed, 31 citations in OpenAlex.
- Current Evidence on IL-17 and IL-(12)/23 Inhibitor Safety during Pregnancy in Psoriasis: A Call for Harmonized Data Collection.Acta dermato-venereologica · 2026Article
- Psoriasis and Psoriatic Arthritis in Pregnancy: Current Evidence and Clinical Considerations.Cureus · 2026Review
- The influence of paternal preconception health on infant birth weight: A scoping review.PloS one · 2026Article
- The influence of paternal preconception health on birth defects and head circumference: A scoping review.PLOS global public health · 2026Article
- Effects of paternal preconception exposure to conventional and biologic DMARDs on newborn outcomes.Arthritis research & therapy · 2025Article
- Safety concerns of paternal drug exposure on fertility, pregnancy and offspring: An analysis based on the FDA adverse event reporting system.Andrology · 2025Article
- Linking household members and defining relational networks using routine health data.Current opinion in pediatrics · 2025Review
- Contraception Requirements in Early Clinical Trials: Considerations Towards an Evidence-Based Approach.Pharmaceutical medicine · 2025Review
- The Dutch Pregnancy Drug Register: Suitable to Study Paternal Drug Exposures?International journal of environmental research and public health · 2023Article
- Pregnancy in Patients with Inflammatory Bowel Diseases-A Literature Review.Life (Basel, Switzerland) · 2023Review
- The safety of paternal and maternal use of 5-aminosalicylic acid during conception and pregnancy: a nationwide cohort study.Alimentary pharmacology & therapeutics · 2022Article
- Burden of pemphigus vulgaris with a particular focus on women: A review.International journal of women's dermatology · 2022Review
- 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
- The Possible Effects of Inflammatory Bowel Disease Medications on Sperm Quality.Gastroenterology & hepatology · 2022Article
- Network Pharmacology and Molecular Docking Study of the Chinese Miao Medicine Sidaxue in the Treatment of Rheumatoid Arthritis.Drug design, development and therapy · 2022Article
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Authors and funding
11 authors at 3 institutions in 1 country.
Funding
Abstract
BACKGROUND &
aimsWe conducted a retrospective cohort study to inform the safety of exposure to immunosuppressive and/or biologic agents around conception in expectant fathers with immune-mediated inflammatory diseases (IMIDs) on birth outcomes.
methodsUsing a deidentified administrative claims database (OptumLabs Data Warehouse), we identified 7453 expectant fathers with IMIDs (inflammatory bowel diseases, rheumatoid arthritis, psoriasis/psoriatic arthritis, and ankylosing spondylitis) linked to newborns with periconception medication exposure between 38 and 60 weeks before the newborn birth date (34-58 weeks prior for preterm newborns) and neonatal follow-up for 3 months after the birth date. Through logistic regression adjusting for paternal age and race (and, in a subset, for maternal age, race, presence of IMIDs, and nonsingleton births), we compared the risk of major congenital malformations (primary outcome) and preterm birth and low birth weight in fathers exposed to thiopurines (n = 461), methotrexate (n = 171), tumor necrosis factor (TNF) α antagonists (n = 1082), or non-TNF-targeting biologic agents (n = 132) vs fathers not exposed to any of these medications (n = 5607).
resultsAs compared to unexposed fathers (3.4% prevalence of major congenital malformations), exposure to thiopurines (relative risk [RR], 1.12; 95% confidence interval [CI], 0.66-1.76), methotrexate (RR, 0.67; 95% CI, 0.21-1.55), TNF-α antagonists (RR, 1.14; 95% CI, 0.81-1.57), and non-TNF-targeting biologic agents (RR, 1.75; 95% CI, 0.80-3.24) was not associated with increased risk of major congenital malformations. No association was observed between paternal medication exposure and risk of preterm birth or low birth weight. Results were stable on subanalyses of linked father-mother-newborn triads.
conclusionsIn a large cohort study of 7453 expectant fathers with IMIDs, exposure to immunosuppressive or biologic agents around conception was not associated with increased risk of adverse birth outcomes.
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