Safety profile of anti-tumor necrosis factor therapy in inflammatory bowel disease – a single center experience

Abstract

Introduction. The data on the safety profile of anti-tumor necrosis factor (anti-TNF) therapy in real-life patients cohorts with inflammatory bowel disease (IBD) still are lacking. Aim. The aim of the study was to assess the adverse events (AE) of anti-TNF therapy in a single Polish IBD center. Material and methods. Data on the safety of anti-TNF therapy among Crohn’s disease (CD) and ulcerative colitis (UC) patients treated in years 2009–2015 at the Department of Gastroenterology, Human Nutrition and Internal Diseases of Poznań University of Medical Sciences were analyzed. Results. There were 41 AE/188 therapies reported (21.8%) – 39/176 (22.1%) in CD and 2/12 (16.6%) in UC patients. The most common AE were infections – 10.1%, followed by dermatological complications – 2.6%, and infusion allergic reactions – 2.1%. The majority of AE (27/41 – 66%) were treated successfully or resolved without a treatment. The frequency of AE among patients treated with different molecules was similar – 17/85 (20%) in the adalimumab group, 20/91 (21.9%) in the originator infliximab group, and 4/18 (22.2%) in the biosimilar infliximab group. Concomitant treatment seemed not to influence the AE risk. Conclusions. Anti-TNF therapy, which is used among the most severely ill IBD patients, seems to be safe. However, further assessment is needed in real-life patients cohorts, especially to assess the long-term safety of anti-TNF treatment in IBD.

Keywords

• adalimumab
• adverse events
• Crohn’s disease
• infliximab
• ulcerative colitis