Long-term safety of approved biologics for ulcerative colitis

Abstract

Introduction: Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) affecting the large intestine and carrying a heavy burden of morbidity for patients. Conventional treatment is based on mesalamine, corticosteroids, and immunosuppressants. In the last two decades, biologic therapies have revolutionized the treatment of UC, increasing the number of therapeutic options and providing better disease control.

Areas covered: Most biologics have been approved in recent years and long-term data are still scarce. The aim of this review is to summarize safety data on long-term use of biologics in ulcerative colitis. The authors searched the literature up to May 2020 for studies assessing biological drugs' safety in UC with a follow-up longer than one year and present the key findings.

Expert opinion: Biologics long-term safety is consistent with what expected from shorter term studies and no main new concerns emerged from longer follow-up. Real world experience is consistent with clinical trials data. Although comparisons are difficult, safety profiles are not equal among different biologics.

Keywords: Long-term safety; adalimumab; golimumab; infliximab; ulcerative colitis; ustekinumab; vedolizumab.