J Pediatr Gastroenterol Nutr. 2022 Dec 1;75(6):731-736. doi: 10.1097/MPG.0000000000003630.Epub 2022 Sep 29.

Medea Salzmann ¹, Thea von Graffenried ², Franziska Righini-Grunder ³, Christian Braegger ⁴, Johannes Spalinger ^1 3, Susanne Schibli ¹, Alain Schoepfer ⁵, Andreas Nydegger ², Valérie Pittet ⁶, Christiane Sokollik ¹; Swiss IBD Cohort Study Group

Author information

¹From the Division of Pediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.

²the Division of Pediatric Gastroenterology, Centre Hospitalier Universitaire Vaudois [CHUV] and University of Lausanne, Lausanne, Switzerland.

³the Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Children's Hospital LUKS, Lucerne, Switzerland.

⁴the Division of Pediatric Gastroenterology, Hepatology, and Nutrition, University Children's Hospital Zurich, Zurich, Switzerland.

⁵the Division of Gastroenterology and Hepatology, Centre Hospitalier Universitaire Vaudois [CHUV] and University of Lausanne, Lausanne, Switzerland.

⁶the Department of Epidemiology and Health Systems, Center for Primary Care and Public Health - University of Lausanne, Lausanne, Switzerland.

Abstract

Objectives: Inflammatory bowel disease (IBD) requires long-term drug therapy in most patients, posing a risk for adverse drug events with the need for discontinuation. In this study, we investigated adverse events (AE) necessitating drug discontinuation in pediatric and adolescent IBD patients.

Methods: We used data prospectively collected from IBD patients below the age of 18 enrolled in the Swiss Inflammatory Bowel Disease Cohort Study (SIBDCS), namely demographic variables, medical characteristics, drug treatments, and related AE. We analyzed the frequency, type, and risk factors for AE necessitating drug discontinuation.

Results: A total of 509 pediatric IBD patients fulfilled the inclusion criteria of which 262 (51.5%) were diagnosed with Crohn disease (CD), 206 (40.5%) with ulcerative colitis (UC), and 41 (8%) with IBD-unclassified (IBD-U). In total, 132 (25.9%) presented with at least 1 drug-related AE that required drug cessation. Immunomodulators [methotrexate 29/120 (24.2%), azathioprine 57/372 (15.3%)] followed by tumor necrosis factor (TNF)-alpha antagonists [adalimumab 8/72 (11.1%), infliximab 22/227 (9.7%)] accounted for the highest proportions of AE necessitating treatment discontinuation. Treatment schemes with at least 3 concomitant drugs significantly amplified the risk for development of drug-related AE [odds ratio = 2.50, 95% confidence interval (1.50-4.17)] in all pediatric IBD patients.

Conclusions: Drug-related AE necessitating discontinuation are common in pediatric and adolescent IBD patients. Caution needs to be taken in the case of concomitant drug use.