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Safety Considerations with the Use of Corticosteroids and Biologic Therapies in Mild-to-Moderate Ulcerative Colitis

Cross, Raymond K. MD, MS

doi: 10.1097/MIB.0000000000001261
Clinical Review Articles

Background: The risk of corticosteroid-associated adverse events can limit the use of systemic corticosteroids. Oral, topically acting, second-generation corticosteroids that deliver drug to the site of inflammation, and biologic therapies, are effective treatment alternatives. The aim of this review was to evaluate the safety and tolerability of topically acting corticosteroids and biologic therapies versus oral systemic corticosteroids for ulcerative colitis (UC).

Methods: The PubMed database was searched for clinical and observational trials, systematic reviews, and case reports/series published between January 1950 and September 30, 2016. Search terms used included “corticosteroids,” “beclomethasone dipropionate,” “budesonide,” “infliximab,” “adalimumab,” “golimumab,” and “vedolizumab” in combination with “ulcerative colitis” or “inflammatory bowel disease.”

Results: A total of 582 studies were identified from PubMed searches. Only 1 direct comparative trial for oral topically acting corticosteroids and systemic corticosteroids was available, and no comparative trials versus biologic therapies were identified. In patients with mild-to-moderate UC, short-term (4–8 wk) oral beclomethasone dipropionate or oral budesonide multimatrix system demonstrated safety profiles comparable with placebo with few corticosteroid-related adverse events reported. Based on long-term data in patients with moderate-to-severe UC, biologics have a generally tolerable adverse event profile, although infections, infusion reactions, and autoimmune disorders were frequently reported.

Conclusions: Second-generation corticosteroids, beclomethasone dipropionate and budesonide multimatrix system, exhibited a favorable safety profile in patients with mild-to-moderate UC. For biologics, which are only indicated in moderate-to-severe UC, additional studies are needed to further ascertain the benefit to risk profile of these agents in patients with mild-to-moderate disease (see Video Abstract, Supplemental Digital Content,

Article first published online 8 September 2017.

Division of Gastroenterology and Hepatology, Department of Medicine, University of Maryland School of Medicine, Baltimore, Maryland.

Address correspondence to: Raymond K. Cross, MD, MS, MSTF, 685 West Baltimore Street, Baltimore, MD 21201 (e-mail:

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (

Technical editorial and medical writing support was provided, under the direction of the author, by Mary Beth Moncrief, PhD, and Jillian Gee, PhD, Synchrony Medical Communications, LLC, West Chester, PA. Funding for this support was provided by Salix Pharmaceuticals, Raleigh, NC. Salix Pharmaceuticals did not actively contribute to the content of this article but reviewed for scientific accuracy.

R. K. Cross, receives fees for consulting and participation in advisory boards from AbbVie Inc., Janssen, Takeda, and UCB, and receives research funding from AbbVie Inc.

Received March 03, 2017

Accepted June 23, 2017

© Crohn's & Colitis Foundation
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