The safety of biological pharmacotherapy for the treatment of ulcerative colitis

Expert Opin Drug Saf. 2017 Apr;16(4):437-443. doi: 10.1080/14740338.2017.1298743. Epub 2017 Mar 10.

Abstract

Biological agents are effective in ulcerative colitis (UC). Currently, 3 anti-TNF agents (infliximab, adalimumab, and golimumab) and 1 anti-integrin agent (vedolizumab) are approved for the treatment of UC. The mechanism of action of biologic agents can also give rise to several side effects, some even serious. It remains uncertain to what extent biologic treatments may be associated with an increased rate of infections, malignancies and other adverse events Areas covered: Our aim is to review the relevant data available in the literature and briefly summarize the safety profile of biological therapy in UC. We performed a literature search using the OVID, MEDLINE, PUBMED and EMBASE databases. Also other relevant sources of safety data were also used. Expert opinion: All biological agents currently used in UC are relatively safe. Accurate prevention measures and screening prior to start such therapies, and regular surveillance programs are strongly recommend to minimize any risk of infections, malignancy and other adverse events related to the use of monoclonal antibodies in UC patients.

Keywords: Infliximab; adalimumab; golimumab; safety; ulcerative colitis; vedolizumab.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / pharmacology
  • Biological Factors / adverse effects
  • Biological Factors / pharmacology
  • Biological Factors / therapeutic use*
  • Colitis, Ulcerative / drug therapy*
  • Colitis, Ulcerative / physiopathology
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / pharmacology
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Integrins / antagonists & inhibitors
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors

Substances

  • Antibodies, Monoclonal
  • Biological Factors
  • Gastrointestinal Agents
  • Integrins
  • Tumor Necrosis Factor-alpha