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Managing Risks with Biologics
Benjamin Click1, Miguel Regueiro2
1Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, Cleveland, OH, USA.
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.
Insights
New biologic therapies for inflammatory bowel disease (IBD) like vedolizumab and ustekinumab present unique safety concerns. This review outlines risks and strategies for managing side effects in IBD patients.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Advanced targeted therapies are transforming inflammatory bowel disease (IBD) management.
- Emerging biologic therapies introduce novel safety and side effect profiles.
- Proactive risk assessment is crucial for effective IBD treatment.
Purpose of the Study:
- To review the risks associated with advanced biologic therapies in IBD.
- To discuss potential strategies for mitigating these risks.
- To provide management recommendations for IBD treatment-related complications.
Main Methods:
- Comprehensive review of clinical trial and real-world safety data for IBD therapies.
- Analysis of safety data for vedolizumab, ustekinumab, and tofacitinib.
- Evaluation of new vaccine data (varicella zoster virus, hepatitis B, influenza) in IBD patients.
Main Results:
- Novel safety considerations arise with vedolizumab, ustekinumab, and tofacitinib.
- Updated safety data for anti-tumor necrosis factor agents are presented.
- New vaccine studies offer insights into infection prevention for IBD patients.
Conclusions:
- Understanding risks of new IBD agents is vital for optimal clinical outcomes.
- Implementing mitigating strategies can improve patient safety.
- Effective management of side effects is key to maintaining treatment efficacy in IBD.
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