Effects of paternal preconception exposure to conventional and biologic DMARDs on newborn outcomes
Authors' conclusion
While paternal use of methotrexate did not associate with adverse birth outcome, exposure to other immunosuppressants or biologic drugs may link to possible adverse birth outcomes despite small event numbers.
Study context
- Population
- Births to fathers diagnosed with autoimmune rheumatic diseases, Taiwan, 2004–2020; exposure = immunosuppressants or biologic drugs prescribed 38–60 weeks before delivery
- Participants
- 42,493 births
- Exposure
- Paternal preconception exposure to csDMARDs, bDMARDs or tsDMARDs vs no exposure
- Outcome
- Small for gestational age, preterm birth and congenital abnormalities in offspring
Methodological detailsInverse probability of treatment-weighted (IPTW) logistic regression, Taiwan national databases, 2004–2020
- IPTW logistic regression
- Taiwan national databases, 2004–2020
Main finding
As reported in the abstract
Birth outcomes (VSGA, preterm birth, birth defects) by paternal drug exposure
OR, birth defects (95% CI)
Azathioprine
1.47(1.31 ≈1.65)
Non-TNFis
1.69(1.48 ≈1.93)
tsDMARDs
5.19(2.33 ≈11.39)
csDMARDs alone or combined with bDMARDs or tsDMARDs
1.71(1.47–2.00)
- Ciclosporin
- increased risk of very small for gestational age (VSGA) 45% (95% CI 1.19 ≈1.76)
- Ciclosporin
- increased risk of preterm birth 51% (95% CI 1.35 ≈1.70)
Observational data: associations, not effects.
Further findings
Specific birth defects with bDMARDs
| Estimate | ||
|---|---|---|
| bDMARDs | OR, cardiovascular anomalies 1.61 (95% CI 1.37–1.89) | |
| bDMARDs | OR, oral clefts 1.62 (95% CI 1.15–2.29) | |
| bDMARDs | OR, musculoskeletal defects 2.29 (95% CI 1.82–2.89) | |
| 0.20.5125Ratio (log scale) |
- csDMARDs combined with bDMARDs or tsDMARDs: increased risks of cardiovascular anomalies, oral clefts and musculoskeletal defects
Original publication
Effects of paternal preconception exposure to conventional and biologic DMARDs on newborn outcomes. Arthritis Res Ther. Published 28 November 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →