# Treatment with tumor necrosis factor inhibitors during pregnancy and occurrence of severe infections among exposed infants in Germany

## TL;DR

This study examines the use of tumor necrosis factor inhibitors during pregnancy and finds similar rates of severe infections in infants exposed in the womb compared to those not exposed.

## Contribution

The study provides real-world evidence on the risk of severe infections in infants exposed to TNFi during pregnancy.

## Key findings

- About 23.8% of infants were exposed to TNFi after the 20th gestational week.
- Hospitalization rates for infections were similar between infants exposed in late pregnancy and those exposed only before pregnancy.

## Abstract

Tumor necrosis factor inhibitors (TNFi) are often used in the treatment of autoimmune diseases. Their use during pregnancy, particularly in the 2nd half, has been a matter of debate due to a potential risk of severe infections in infants. We aimed to describe (i) the dispensation of TNFi before and during pregnancy and (ii) the occurrence of hospitalizations with infections among prenatally exposed infants.

Using the GePaRD database (claims data covering 20% of the German population), we included pregnancies ending in a live birth between 2006 and 2018 in women aged 12–50 years with ≥ 1 dispensation of TNFi in the year before or during pregnancy. We assessed maternal exposure to TNFi and hospitalization with infections among infants in the first year of life.

Among 1,113 children included, 265 (23.8%) were exposed to TNFi after the 20th gestational week. Among these, the proportion of infants hospitalized due to an infection in the first year of life was 11.7% (95% confidence interval [CI]: 8.4%-16.1%). In 529 children (47.5%), TNFi were dispensed only in the 365 days before pregnancy. Of these, 11.3% (95% CI: 8.9%-14.3%) were hospitalized due to an infection.

Our analyses showed that among children whose mothers used TNFi in the year before or during pregnancy, about one fourth was exposed to TNFi in the second half of pregnancy. Among these children, the proportion hospitalized with a severe infection in the first year of life was similar to that from mothers exposed only before pregnancy.

The online version contains supplementary material available at 10.1186/s12884-025-08590-0.