AGA Clinical Practice Guidelines on Crohn's Disease PDF

Gastroenterology 2021;160:2496–2508 CLINICAL PRACTICE GUIDELINES AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing...

Gastroenterology 2021;160:2496–2508 CLINICAL PRACTICE GUIDELINES AGA Clinical Practice Guidelines on the Medical Management of Moderate to Severe Luminal and Perianal Fistulizing Crohn’s Disease Joseph D. Feuerstein,1 Edith Y. Ho,2 Eugenia Shmidt,3 Harminder Singh,4 Yngve Falck-Ytter,5 Shanaz Sultan,3 and Jonathan P. Terdiman,6 on behalf of the American Gastroenterological Association Institute Clinical Guidelines Committee 1 Division of Gastroenterology and Center for Inflammatory Bowel Diseases, Beth Israel Deaconess Medical Center, Boston, Massachusetts; 2Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University, Stanford, California; 3Division of Gastroenterology, University of Minnesota, Minneapolis, Minnesota; 4Section of Gastroenterology, University of Manitoba, Winnipeg, Manitoba, Canada; 5Division of Gastroenterology, Case Western Reserve University, and Veterans Affairs Northeast Ohio Healthcare System, Cleveland, Ohio; and 6Division of Gastroenterology, University of California, San Francisco, San Francisco, California severe as 220–450 and severe >450.8 For this guideline, C rohn’s disease (CD) is a chronic inflammatory bowel disease with substantial morbidity when not adequately controlled.1 Historically, approximately 20% of moderate to severe disease was considered a Crohn’s Dis- ease Activity Index score of 220 or higher. patients with CD were hospitalized every year, and the risk There are a number of different drug classes available of surgery within 1 year of diagnosis was 24%, 36% by 5 for the management of moderate to severe CD, including years, and 47% by 10 years.2 In recent years, outcomes tumor necrosis factor (TNF)–a antagonists (ie, infliximab, have improved, likely because of earlier diagnosis, adalimumab, certolizumab pegol), anti-integrin agents increasing use of biologics, escalation or alteration of (natalizumab, vedolizumab), interleukin 12/23 antagonist therapy based on disease severity, and endoscopic man- (ustekinumab), immunomodulators (thiopurines, metho- agement of colorectal cancer. CD includes multiple trexate), and corticosteroids (prednisone, budesonide).1 In different phenotypes. The Montreal Classification catego- general, most drugs, with the exception of corticosteroids, rizes CD as stricturing, penetrating, inflammatory (non- that are initiated for induction of remission are continued as stricturing and nonpenetrating), and perianal disease.3–5 maintenance therapy. Unless otherwise specified, we do not Each of these phenotypes can present with a range in present separate recommendations for induction and severity from mild to severe disease.6 maintenance of remission. The drugs are listed, in general, This guideline addresses the medical management of in order of US Food and Drug Administration approval. This moderate to severe luminal and fistulizing CD. The Inter- guideline does not address surgical management of mod- national Organization for the Study of Inflammatory Bowel erate to severe CD. Therapeutic drug monitoring to guide Diseases characterizes severe disease as having a high risk the use of biologic therapy has been addressed in a separate for adverse disease-related complications, including sur- American Gastroenterological Association (AGA) guideline gery, hospitalization, and disability, based on a combination and is not included in this guideline.9 of structural damage, inflammatory burden, and impact of quality of life. Contributors to severe disease include large or deep mucosal lesions on endoscopy or imaging, presence Methods of fistula and/or perianal abscess, presence of strictures, This document presents the official recommendations of the AGA on the medical management of moderate to severe luminal prior intestinal resections, particularly of segments >40 cm, CLINICAL PRACTICE GUIDELINES and fistulizing CD in adults. This guideline addresses the presence of a stoma, extensive disease (ileal involvement outpatient medical management of moderate to severe luminal >40 cm, or pancolitis), anemia, elevated C-reactive protein, and fistulizing CD, although we anticipate that most of the and low albumin. With respect to symptoms, patients with recommendations would apply to inpatients as well. severe disease may have at least 10 loose stools per day, daily abdominal pain, presence of anorectal symptoms (eg, anorectal pain, bowel urgency, incontinence, discharge, and Abbreviations used in this paper: AGA, American Gastroenterological tenesmus), systemic corticosteroid use within the prior Association; CD, Crohn’s disease; CI, confidence interval; GRADE, Grading of Recommendations Assessment; Development and Evaluation, year, lack of symptomatic improvement despite prior MCID; minimal clinically important difference, OIS; optimal information exposure to biologics and/or immunosuppressive agents, or size, OR; odds ratio, PICO; population, intervention; comparator, and outcome; PML, progressive multifocal leukoencephalopathy; RCT, ran- significant impact of the disease on activities of daily living.7 domized controlled trial; RR, relative risk; TNF, tumor necrosis factor). Moderate to severe disease can also be defined using the Most current article Crohn’s Disease Activity Index. This standardized disease © 2021 by the AGA Institute assessment score categorizes severity of disease as: remis- 0016-5085/$36.00 sion