(227) Treatment with Tumor Necrosis Factor Alpha Inhibitors During Pregnancy and Occurrence of Severe Infections Among Infants: A Descriptive Analysis Based on German Claims Data

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 558

Presenting Author(s)

Ulrike Haug
– Prof. Dr. sc. hum., Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany

Co-Author(s)

Christina Princk
– Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany
Bianca Kollhorst
– Department of Biometry and Data Management, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Germany
Kathrin Thöne
– Techniker Krankenkasse, Hamburg, Germany
Julia Borst-Ohlraun
– Techniker Krankenkasse, Hamburg, Germany
Christof Schaefer, Prof. Dr. med.
– Prof. Dr. med., PVZ Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité – Universitätsmedizin Berlin, Germany
Marlies Onken, MD
– Medical doctor, PVZ Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité – Universitätsmedizin Berlin, Germany
Katarina Dathe, MD
– Medical doctor, PVZ Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Charité – Universitätsmedizin Berlin, Germany

Background: Tumor necrosis factor inhibitors (TNFi) are often used in the treatment of autoimmune diseases such as inflammatory bowel disease or rheumatic diseases. These conditions also occur in women of childbearing age. Therefore, pregnant women may also be exposed. It is still a matter of debate whether the immunosuppressive effects of TNFi increase the risk of severe infections in infants, particularly when they were exposed during the 2nd half of pregnancy.

Objectives: Based on German claims data, we aimed to describe i) the dispensation of TNFi before and during pregnancy and ii) the occurrence of infections leading to hospitalization in the first year of life among prenatally exposed infants.

Methods: Using the German Pharmacoepidemiological Research Database (GePaRD), we included live-born children from pregnancies starting between 2006 and 2016 in women aged 12-50 years, and with at least one dispensation of TNFi in the 180 days before or during pregnancy (continuous health insurance in this period was required). We described patterns of exposure among included pregnancies. Furthermore, we assessed hospitalization of infants due to severe infections (main discharge diagnosis) in their first year of life.

Results: A total of 633 children were included. Overall, 209 (33.0%) were exposed after 20th gestational week. Among these, the proportion of infants hospitalized due to a severe infection in the first year of life was 11.0% (95% confidence interval [CI]: 7.45%-15.97%). In 243 children (38.4%), there was a dispensation of TNFi only in the 180 days before pregnancy. Of these, 9.9% (95% CI: 6.73%-14.27%) were hospitalized due to a severe infection in the first year of life.

Conclusions: Our analyses showed that among women using TNFi in the year before or during pregnancy, about one third were exposed to TNFi in the second half of pregnancy, which is considered most vulnerable to immunological effects of TNFi. In live-born children from these pregnancies, the proportion with severe infection was similar to those from mothers exposed only before pregnancy.