The biologics of ulcerative colitis

ABSTRACT

Introduction: Tumor necrosis factor α inhibitors dramatically changed the management of moderate-to-severe phenotypes of ulcerative colitis. The recent incoming of vedolizumab, which targets gut-specific leukocyte trafficking, provides a new biologic option for these patients.

Areas covered: This review focuses on the rationale of use, efficacy, and safety profile of all biologics currently approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of ulcerative colitis, including tumor necrosis factor α inhibitors (Infliximab and biosimilars, adalimumab, and golimumab), and the more recent vedolizumab.

Expert opinion: Although biologics have been available in clinical practice for ulcerative colitis for about 15 years, there are several aspects that have not been fully understood yet: we know that they work, but we still don’t know which subsets of patients benefit more, and how to optimize their use. All these unresolved problems are at least partly due to the discrepancy observed between phase II/III clinical trials of all biologics currently used in ulcerative colitis and in clinical practice.

KEYWORDS:

• Adalimumab
• biosimilars
• golimumab
• infliximab
• safety
• ulcerative colitis
• vedolizumab

Article highlights

• The management of ulcerative colitis has dramatically changed over the past fifteen years with the introduction of biologic therapy.

• Biologics that are currently approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of ulcerative colitis include tumor necrosis factor α inhibitors (Infliximab and biosimilars, Adalimumab, and Golimumab), and the more recent Vedolizumab, which targets the gut-specific leukocyte trafficking.

• In developing countries, the limited access to such therapies is still an unresolved issue.

• Although biologics have been available in clinical practice for ulcerative colitis since about 15 years, there are several aspects that have not been fully understood yet: we know that they function, but we still do not know which subsets of patients benefit more.

• A more rigorous methodology should be applied in the future in all studies and/or clinical trials assessing the role of biologics in ulcerative colitis.

This box summarizes key points contained in the article.

Acknowledgments

The authors thank Rossana Sicilia for the English language editing.

Declaration of interest

M Cottone has received financial support for the organization of a second level Master’s degree in Inflammatory Bowel Disease from AbbVie, Merck Sharp and Dohme, Takeda Pharmaceuticals and Sofar S.p.A. S Renna has served as an advisory board member for AbbVie and Merck Sharp and Dohme. He/she also received lecture grants from AbbVie, Merck Sharp and Dohme, Zambon and Takeda Pharmaceuticals. A Orlando has served as an advisory board member for AbbVie, Merck Sharp and Dohme and Takeda Pharmaceuticals. He/she also received lecture grants from AbbVie, Merck Sharp and Dohme, Sofar S.p.A, Chiesi Pharmaceuticals and Takeda Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. FS Macaluso received lecture grants from Merck Sharp and Dohme.

Additional information

Funding

The authors have received no payment for the preparation of their manuscript.