A decade of infliximab: The Austrian evidence based consensus on the safe use of infliximab in inflammatory bowel disease

Abstract

Infliximab (IFX) has tremendously enriched the therapy of inflammatory bowel diseases (IBD) and other immune mediated diseases. Although the efficacy of IFX was undoubtedly proven during the last decade numerous publications have also caused various safety concerns. To summarize the immense information concerning adverse events and safety issues the Austrian Society of Gastroenterology and Hepatology launched this evidence based consensus on the safe use of IFX which covers the following topics: infusion reactions and immunogenicity, skin reactions, opportunistic infections (including tuberculosis), non-opportunistic infections (bacterial and viral), vaccination, neurological complications, hepatotoxicity, congestive heart failure, haematological side effects, intestinal strictures, stenosis and bowel obstruction (SSO), concomitant medication, malignancy and lymphoma, IFX in the elderly and the young, mortality, fertility, pregnancy and breast feeding. To make the vast amount of information practicable for routine application the consensus was finally condensed into a checklist for a safe use of IFX which consists of two parts: issues to be addressed prior to anti-TNF therapy and issues to be addressed during maintenance. Both parts are further divided into obligatory and facultative items.

Anti-TNFα et tuberculose

“…Il était encore 2 à 4 fois plus important sous anti-TNFα. Au cours de la maladie de Crohn, le risque semble similaire même si l'incidence de TB chez les malades sans anti-TNFα n'a pas été étudiée [6][7][8].…”

“…Certains facteurs de risque associés à un plus grand risque de développer une TB sous anti-TNFα ont pu être identifiés d'après différents travaux, telle qu'une dose élevée d'INF > 3 mg/kg [6]. En revanche, l'association à d'autres immunosuppresseurs ne semblait pas être accompagnée de sur-risque, d'après une méta-analyse colligeant 5 études et totalisant 1 026 cas de maladie de Crohn [7].…”

A review of liver disorders in inflammatory bowel disease (IBD)

“…Methotrexate impairs DNA synthesis via inhibition of dihydrofolate reductase and also blocks T cell activation and expression Interfere with the activity of TNF α -leads to precipitation of "denovo autoimmune hepatitis", cholestasis and direct hepatocellular necrosis 13,106 Chronic hepatitis B reactivation or hepatitis C reactivation Cholestasis…”

“…Interfere with the activity of TNF α -leads to precipitation of "denovo autoimmune hepatitis", cholestasis and direct hepatocellular necrosis 13,106 Hepatosplenic T-cell lymphoma of intercellular adhesion molecules [120]. It is indicated for use in the maintenance of the clinical remission of steroid dependent CD patients [121].…”

“…Nonalcoholic fatty liver disease (NAFLD), however, is its most common manifestation. Liver toxicity arising from IBD-related medications is also common [9][10][11][12][13][14][15], as is hepatitis B reactivation, secondary to the use of immunosuppressive agents, including biologics. Given the high risk implicated for these agents, regular hepatitis B screening has been suggested for this subgroup.…”