The introduction and broad use of new immunosuppressive agents, including biologic agents and JAK inhibitors, have revolutionised treatment of inflammatory bowel disease [IBD] in recent decades. With such immunosuppression, the potential for opportunistic infection is a key safety concern. Opportunistic infections pose particular problems for the clinician; they are potentially serious, often difficult to recognise, associated with appreciable morbidity or mortality, and are challenging to treat effectively. The first guideline on opportunistic infections was published in 20091 followed by an update in 2014.2 New evidence in this field and in vaccination strategies for immunosuppressed IBD patients led the European Crohn’s and Colitis Organization [ECCO] to update the previous consensus on opportunistic infections in IBD. The current document is focused on viral, mycobacterial, bacterial, fungal, and parasitic infections and on vaccination strategies for immunosuppressed IBD patients. The target audience includes IBD specialists, gastroenterologists, surgeons, and paediatricians.
To organise this work, 35 PICO [formatted as population, intervention, control, and outcomes] questions were raised by the coordinators, which address clinically relevant questions in opportunistic infections in IBD and in the field of vaccination. These were based on both the previous guidelines from 2009 and 2014 and on new relevant clinical questions in this field. The working group consisted of gastroenterologists, virologists, infectious disease experts, and paediatricians. Each PICO question was assigned to two working group members. As not all relevant clinical questions could be addressed by PICO questions, additional non-PICO questions that covered clinically relevant topics were drafted. In an initial teleconference in October 2019, all participants discussed the PICO and non-PICO questions and agreed on the final set of questions. The questions were classified into four major topics. The working groups then performed a systematic literature search of their topics with the appropriate key words using Medline/Pubmed, the Cochrane database, and their own files. The evidence level [EL] was graded according to the 2011 Oxford Centre for Evidence-Based Medicine [http://www.cebm.net/index]. Provisional guideline statements and recommendations, including supporting text, were then posted on a guideline platform with two subsequent online voting rounds where all participants could vote on the statements for the PICO and non-PICO questions. In the second round of voting, ECCO national representatives also participated in the voting process. The working group members then met over a final web-based video conference in September 2020 to discuss and vote on the statements and recommendations. Consensus was defined as agreement by 80% of participants, termed a consensus statement, and numbered for convenience in the document. Statements that are based on PICO questions are marked with a star [*].
The final document on each topic was written by the workgroup leader and their working party. Statements are intended to be read in context with supporting comments and not read in isolation. To ensure consistency, the statements and recommendations were rearranged and merged in the final manuscript by the coordinators. The final text was critically reviewed by external experts who were not involved in the guideline panel. The final manuscript was edited for consistency of style before being circulated and approved by the participants.
The final manuscript is divided into different sections that follow in a clinically relevant order but are not necessarily reflective of the order of the initial PICO questions. After a section on the definition of risk factors, the following sections focus on specific viral, mycobacterial, bacterial, and fungal infections. This is followed by special situations [such as travel to countries with endemic infections] and vaccination strategies in immunosuppressed IBD patients.
The level of evidence is generally low in some fields, which reflects the paucity of randomised controlled trials. Expert opinion has therefore been included where appropriate.