Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD)

Abstract

Inflammatory bowel diseases are chronic conditions of unknown etiology, showing a growing incidence and prevalence in several countries, including Italy. Although the etiology of Crohn's disease and ulcerative colitis is unknown, due to the current knowledge regarding their pathogenesis, effective treatment strategies have been developed. Several guidelines are available regarding the efficacy and safety of available drug treatments for inflammatory bowel diseases. Nevertheless, national guidelines provide additional information adapted to local feasibility, costs and legal issues related to the use of the same drugs. These observations prompted the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) to establish Italian guidelines on the safety of currently available treatments for Crohn's disease and ulcerative colitis. These guidelines discuss the use of aminosalicylates, systemic and low bioavailability corticosteroids, antibiotics (metronidazole, ciprofloxacin, rifaximin), thiopurines, methotrexate, cyclosporine A, TNFα antagonists, vedolizumab, and combination therapies. These guidelines are based on current knowledge derived from evidence-based medicine coupled with clinical experience of a national working group.

Postoperative outcomes in vedolizumab‐treated Crohn's disease patients undergoing major abdominal operations

“…The pivotal GEMINI studies demonstrated both the efficacy and safety of vedolizumab in achieving clinical relevant endpoints in Crohn's disease patients who were either naïve to or had previously failed therapy with TNFα‐antagonists . Several additional reports have demonstrated safety and efficacy with vedolizumab, offering a promising alternative to the anti‐TNFα class of biologic therapy. Interestingly, despite the noted safety, the GEMINI studies suggest that patients with Crohn's disease, unlike ulcerative colitis, may have an increased number of infectious complications with taking vedolizumab …”

Unmet Medical Needs in the Management of Ulcerative Colitis: Results of an Italian Delphi Consensus

“…Indeed, a wide range of pharmacological agents is used to manage UC, and given their diversity are associated with a broad range of adverse effects and safety concerns. In this regard, guidance for their use with a focus on safety has been developed based on current knowledge and clinical experience [45]. Conventional agents are associated with a number of safety concerns with the possibility of the involvement of multiple organ systems [45], and both conventional and biological agents may carry an additional concern of malignancy [45, 46].…”

The Intricate Link among Gut “Immunological Niche,” Microbiota, and Xenobiotics in Intestinal Pathology

“…Importantly, it has been shown that antibiotics may be used even to maintain IBD remission [ 89 ]. Among xenobiotics, rifaximin seems to influence remission in both CD and UC [ 90 ].…”