Managing Risks with Biologics

  • Benjamin Click
  • Miguel RegueiroEmail author
Inflammatory Bowel Disease (S Hanauer, Section Editor)
Part of the following topical collections:
  1. Topical Collection on Inflammatory Bowel Disease


Purpose of Review

With a rapidly evolving complement of advanced targeted therapies in inflammatory bowel disease, additional safety and side effect concerns emerge. It is the purpose of this review to consider various risks with biologic therapies in inflammatory bowel disease and discuss mitigating strategies.

Recent Findings

Two recently approved monoclonal antibodies (vedolizumab and ustekinumab) and a Janus kinase inhibitor small molecule (tofacitnib) have introduced a number of novel safety and risk considerations. We review the clinical trial and real-world safety data to date on these agents as well as review new data and considerations with anti-tumor necrosis factor agents. New vaccines for varicella zoster virus, hepatitis B virus, and high-dose influenza have been studied, and we discuss the clinical importance of these findings. Lastly, we make management recommendations in the event of particular side effects or complications.


Understanding the risks of new agents in inflammatory bowel disease, potential mitigating strategies, and management considerations is important to achieving and maintaining clinical outcomes in IBD patients.


Crohn’s disease Ulcerative colitis Biologics Infection Safety 


Compliance with Ethical Standards

Conflict of Interest

Miguel Regueiro reports personal fees from Abbvie, Janssen, UCB, Takeda, Pfizer, Seres, and Allergan, outside the submitted work. Miguel Regueiro serves as a consultant and advisory boards for Abbvie, Janssen, UCB, Takeda, Miraca, Pfizer, Celgene, and Amgen. He also receives research support from Abbvie, Janssen, and Takeda.

Benjamin Click declares no conflict of interest.

Human and Animal Rights and Informed Consent

This article does not contain any studies with human or animal subjects performed by any of the authors.


Papers of particular interest, published recently, have been highlighted as: • Of importance

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© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Department of Gastroenterology, Hepatology and NutritionCleveland ClinicClevelandUSA

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