title: No excess risks in offspring with paternal preconception exposure to disease-modifying antirheumatic drugs.
abstract: OBJECTIVE
  To examine pregnancy outcomes in the partners of male patients with inflammatory joint disease who were or were not exposed to disease-modifying antirheumatic drugs (DMARDs) before conception compared with the outcomes in reference subjects from the general population.
  
  
  METHODS
  Linkage of data from a longitudinal observational study of patients with inflammatory joint disease (the Norwegian Disease-Modifying Antirheumatic Drug [NOR-DMARD] registry study) and the Medical Birth Registry of Norway (MBRN) enabled a comparison of pregnancy outcomes in the partners of men with inflammatory joint disease. Outcomes of pregnancies in which the father was exposed to DMARDs within 12 weeks of conception and those in which the father was never exposed to DMARDs were analyzed separately and compared with the outcomes in reference subjects. Potential associations between DMARD exposure and adverse pregnancy outcomes were assessed by logistic regression analysis.
  
  
  RESULTS
  A total of 1,796 men with inflammatory joint disease were associated with 2,777 births in the MBRN. In 110 of these births, the father had been exposed to DMARDs within 12 weeks before conception, and in 230 births the father had never been exposed to DMARDs before conception. The DMARDs (monotherapy or combination treatment) to which the fathers were exposed most frequently within 12 weeks of conception were methotrexate (n = 49), sulfasalazine (n = 17), and tumor necrosis factor inhibitors (n = 57). Neither adverse pregnancy outcomes nor occurrence of congenital malformations differed between patients and reference subjects in either group.
  
  
  CONCLUSIONS
  Preconception paternal exposure to DMARDs was not associated with an increase in adverse pregnancy outcomes. Importantly, no increased risk of congenital malformations was observed.
authors.affiliation: Trondheim University Hospital and Norwegian University of Science and Technology, Trondheim, Norway.
authors.forename: Marianne
authors.initials: M
authors.lastname: Wallenius
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lie
authors.forename: Anne K
authors.initials: AK
authors.lastname: Daltveit
authors.forename: Kjell Å
authors.initials: KÅ
authors.lastname: Salvesen
authors.forename: Johan F
authors.initials: JF
authors.lastname: Skomsvoll
authors.forename: Synøve
authors.initials: S
authors.lastname: Kalstad
authors.forename: Åse S
authors.initials: ÅS
authors.lastname: Lexberg
authors.forename: Knut
authors.initials: K
authors.lastname: Mikkelsen
authors.forename: Tore K
authors.initials: TK
authors.lastname: Kvien
authors.forename: Monika
authors.initials: M
authors.lastname: Østensen
mesh_terms: D000293:Adolescent; D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009664:Norway; D018812:Paternal Exposure / Q000009:adverse effects*; D047489:Preconception Injuries / Q000139:chemically induced* / Q000453:epidemiology; D011247:Pregnancy; D011256:Pregnancy Outcome; D012042:Registries; D012044:Regression Analysis; D012189:Retrospective Studies; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012307:Risk Factors; D013997:Time Factors; D055815:Young Adult
chemical_list: D018501:Antirheumatic Agents