October 03, 2022
2 min read
Paternal and maternal use of 5-aminosalicylic acid for treatment of Crohn’s disease or ulcerative colitis before conception and during pregnancy is safe, based on offspring outcomes in a nationwide Danish cohort study.
“This study gives the first controlled results of different adverse birth outcomes after preconceptual paternal use of , and it has the largest number of prescribed 5-ASA during pregnancy to date,” Bente Mertz Nørgård, MD, PhD, DMSc, chief physician and professor at the University of Southern Denmark and Odense University Hospital, and colleagues wrote in Alimentary Pharmacology & Therapeutics.
Using data from Danish health registries, investigators identified 2,168 single children born to fathers who used 5-ASA for UC or CD within 3 months of conception and 7,732 children fathered by men who had UC or CD but did not use 5-ASA before conception. All children in the paternal exposure population were born between Jan. 1, 1997, and Dec. 31, 2018.
Researchers also identified 3,618 children born to mothers with UC or CD, who were exposed in utero to 5-ASA in the 30 days prior to conception or during pregnancy, and 7,128 children of women with UC or CD, who were not exposed to treatment. All children in the maternal exposure population were born between Jan. 1, 1995, and Dec. 31, 2015. Researchers noted that mothers and fathers in all cohorts of the study could be treated with drugs other than 5-ASA.
Study outcomes included preterm birth (defined as birth before 37 weeks of pregnancy), small for gestational age (SGA) according to the Marsal algorithm, low Apgar score (7) and major congenital abnormalities, in accordance with EUROCAT guidelines.
Most mothers and fathers in the study population used mesalazine. In the exposed and unexposed cohorts, most fathers were aged 31 to 40 years at the time of their child’s birth and had no comorbidities. In both cohorts of mothers, the women had no comorbidities, did not smoke and had normal BMI.
Among children born to fathers with UC who used 5-ASA, investigators reported no increased risk for preterm birth, low Apgar score or SGA. While the HR for major congenital abnormalities among the exposed group was 1.3 (95% CI, 0.92-1.85), this finding was not statistically significant.
Among children of men with CD, those exposed to 5-ASA had an OR of 1.52 (95% CI, 0.65-3.55) for SGA. However, researchers reported no significantly increased odds for any other examined outcome in the exposed group.
Regarding maternal exposure to 5-ASA, investigators reported an OR of 1.46 (95% CI, 0.93-2.3) for SGA in children of women with UC. Similarly, maternal use of 5-ASA for CD resulted in an increased but not statistically significant HR for major congenital abnormalities (HR = 1.44; 95% CI, 0.84-2.47).
According to researchers, limitations of the study included lack of information about drug compliance and inability to examine a possible dose-effect response.
“Based on our overall results, paternal use of 5-ASA prior to conception was not associated with a significantly increased risk of adverse outcomes in the offspring,” Nørgård and colleagues wrote. “Additionally, maternal use of 5-ASA during pregnancy was safe and there were no statistically significantly increased risks of adverse outcomes in the offspring.
“To study an impact of rarely used 5-ASA compounds, such as olsalazine and balsalazine, other datasets are needed.”