Published: 05-09-2019 08:00 | Updated: 09-10-2019 10:31

Study rejects link between common IBD drug and serious infections in children

In a new register-based study, Swedish and Danish researchers show that common drugs for Inflammatory Bowel Disease (IBD), so called TNF-α inhibitors, are not linked to increased risk of serious infections in children. Previous studies have shown an increased risk in corresponding adult patients. The results are published in The Lancet Gastroenterology & Hepatology.

Porträtt av Viktor Wintzell.
Viktor Wintzell. Photo: private

“Together with previous data, our real-world study provides important clinical information suggesting that there is a difference between children and adults when it comes to risk of infection from TNF-α inhibitors”, comments first study-author Viktor Wintzell, statistician and doctoral student at the Department of Medicine Solna, Karolinska Institutet. “This can be due to many factors, such as differences in treatment patterns and background risk of serious infection between adults and children”.

There are millions of sufferers of IBD globally and it is one of the most common chronic diseases in children. The most common types of IBD are ulcerative colitis and Crohn’s disease. Tumor necrosis factor alpha (TNF-α) inhibitors are effective and common treatments in IBD. While TNF-α inhibitors are in general safe, studies have shown that they increase the risk of serious infection with 43-71 per cent in adult patients. However, little is known about this potential adverse event in children with IBD.

Unexpected findings

The current register-based study included a national Danish cohort of 2,817 children with IBD and was conducted by a team of researchers from Karolinska Institutet in Sweden and Statens Serum Institut in Denmark. The researchers compared the risk of serious infections in 618 young patients treated with TNF-α inhibitors with patients who were not treated with TNF-α inhibitors, taking into account potential confounders such as treatment history and comorbidity through advanced statistical modelling.

“Given the statistical precision in the study, a relatively small risk increase of serious infection could be ruled out with high degree of certainty,” says Viktor Wintzell. “However, the findings were unexpected and more studies on larger pediatric populations are needed to further investigate this potential adverse event.”

The study was led by Dr. Björn Pasternak, Associate Professor at the Department of Medicine Solna, Karolinska Institutet. It was funded by the Swedish Research Council, Frimurare Barnhuset Foundation, and the Åke Wiberg Foundation.


“Use of tumour necrosis factor-α inhibitors and the risk of serious infection in paediatric inflammatory bowel disease in Denmark: a nationwide cohort study”, Viktor Wintzell, Henrik Svanström, Mads Melbye, Tine Jess, Ola Olén, Jonas F. Ludvigsson, Björn Pasternak, The Lancet Gastroenterology & Hepatology, online 4 September 2019, doi: 10.1016/S2468-1253(19)30266-3.