Safety of Paternal DMARD or Biologic Use Save
A large cohort study of expectant fathers treated for immune-mediated inflammatory diseases (IMIDs) failed to show any detrimental effect from paternal exposure to immunosuppressive or biologic agents on offspring outcomes.
A commercial insurance claims analysis identified 7,453 expectant fathers with IMIDs (inflammatory bowel diseases, rheumatoid arthritis, psoriasis/psoriatic arthritis, ankylosing spondylitis) were assessed for a potential correlation between drug exposures (thiopurines n=461; methotrexate n=171; TNFα antagonists n=1082; or non-TNF-targeting biologic agents n=132 and adverse pregnancy outcomes. Exposed fathers were compared to fathers not exposed to any of these medications (n=5607).
The prevalence of major congenital malformations was 3.4% in unexposed fathers. Compared to unexposed fathers, there was no significant increase in congenital malformations in fathers receiving thiopurines (RR, 1.12 [95% CI, 0.66-1.76]), methotrexate (RR, 0.67 [0.21-1.55]), TNFα antagonists (RR, 1.14 [0.81-1.57]), and non-TNF-targeting biologic agents (RR, 1.75 [0.80-3.24]).
Similarly there was no increased risk of preterm birth or low birth weight in exposed fathers.