Overview

Crohn's disease is characterized by chronic inflammation that can occur anywhere in the gastrointestinal tract, but most often affects the small bowel and colon. Typical symptoms include abdominal pain, chronic diarrhea, and gastrointestinal bleeding. Crohn's disease affects between 400,000 and 600,000 North Americans. Ten percent of Crohn's disease patients are children under the age of 17 years. The clinical management of Crohn's disease is complicated. Practice guidelines for Crohn's disease recommend that clinicians take into account the disease location, severity, complications, and extra-intestinal manifestations when choosing a treatment strategy. However, no universal treatment strategy exists. The lack of consensus about the best treatment strategy can result in confusion and frustration for the Crohn's disease patient as well as practitioners who treat Crohn's disease patients. Medications are the preferred treatment for Crohn's disease with surgical interventions reserved for complications of disease or evidence of dysplasia. Medical therapy in Crohn's disease targets intestinal inflammation with the intent of altering the natural history of the disease. Corticosteroids and aminosalicylates such as sulfasalazine have been used since the 1950s. Immunomodulators (6-mercaptopurine, azathioprine, and methotrexate) have been used for the treatment of Crohn's disease since the 1970s, although use of these medications was not routine until the 1990s. The first biologic tumor necrosis factor (TNF)-alpha inhibitor, infliximab, was approved by the Food and Drug Administration (FDA) for the treatment of Crohn's disease in adults in 1998. The FDA-approved monoclonal antibodies against TNF-alpha inhibitor also include adalimumab and certolizumab pegol. Another biologic agents used for the treatment of Crohn's disease include natalizumab, a monoclonal antibody against cellular adhesion molecule that is FDA-approved for Crohn's disease in adults. Our recent systematic review addressed several Key Questions in the management of Crohn's disease. In that review, we identified several important gaps in the Evidence. We used the population, intervention, comparison, outcome, timing, setting (PICOTS) framework to identify gaps from the evidence in relationship to the populations, interventions, comparisons, outcomes, timing, and settings relevant to treatments for Crohn's disease. Several gaps related to the target population (children, non-white, and risk stratification based on patient characteristics). Other gaps related to interventions and comparisons of interest (step up versus top down treatment and head to head comparisons within and between treatment classes), outcomes of interest (mucosal healing, and patient-reported symptoms), or a timing issue (remission beyond 2 years). The objective of this report is to identify and prioritize existing gaps in the synthesized literature pertaining to pharmacological induction and maintenance of remission for patients with Crohn's disease by engaging stakeholders using a modified Delphi method.

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