Association of Vonoprazan with Increased Reporting of Cholangitis in Patients Treated with Immune Checkpoint Inhibitors

Overview

This study investigates the association between vonoprazan and increased reporting of cholangitis in patients treated with immune checkpoint inhibitors (ICIs) using VigiBase data.

Background

Immune checkpoint inhibitors have revolutionized cancer treatment but are associated with immune-related adverse events, including hepatobiliary toxicities. Cholangitis, a severe form of hepatobiliary toxicity, is less common but clinically significant.

Data Highlights

No numerical data or trial data were provided in the source material.

Key Findings

• Vonoprazan may be associated with increased reporting of cholangitis in ICI-treated patients.
• Cholangitis is characterized by a cholestatic pattern of liver injury.
• Previous studies have identified other medications, such as PPIs, that alter reporting patterns of immune-related adverse events.
• The study utilized VigiBase, which contains over 40 million reports from more than 170 countries, for its analysis.
• Vonoprazan's pharmacologic profile raises questions about its hepatobiliary safety compared to traditional PPIs.

Clinical Implications

Monitoring for hepatobiliary adverse events is essential in patients treated with vonoprazan.

Conclusion

Further investigation into the safety profile of vonoprazan in the context of immune checkpoint inhibitor therapy is warranted.

Related Resources & Content

1. Kawakami et al., 2017 -- Nivolumab-related cholangitis in patients with nonsmall cell lung cancer
2. ESMO Clinical Practice Guideline -- Management of toxicities from immunotherapy
3. Nature Reviews Gastroenterology & Hepatology -- Immune-mediated liver injury from checkpoint inhibitors
4. Journal of Gastroenterology — Assessment of Pancreatic Damage in Patients Undergoing Treatment with Immune Checkpoint Inhibitors: A Retrospective Multicenter Analysis
5. Drugs - Real World Outcomes — Association Between PCSK9 Inhibitors and Adverse Events Related to Infections: A Study Utilizing WHO VigiBase Data
6. The ASCO Post — Pharmacovigilance Study of Pancytopenia in Patients Receiving PARP Inhibitors
7. FDA Label for VOQUEZNA (vonoprazan) tablets
8. Management of toxicities from immunotherapy: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up☆
9. Immune-mediated liver injury from checkpoint inhibitors: mechanisms, clinical characteristics and management | Nature Reviews Gastroenterology & Hepatology
10. Prospective study of patients with immune checkpoint inhibitor-induced hepatitis; characterization of liver injury, outcome of therapy, and management of steroid-unresponsive and steroid-dependent hepatitis | Journal for ImmunoTherapy of Cancer
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15. Clinical Characteristics and Predictive Factors of Immune-Mediated Cholangitis: A Large Single-Center Retrospective Observational Study | MDPI
16. Helicobacter pylori Eradication Therapy–Associated Drug-Induced Liver Injury in a Patient With Primary Biliary Cholangitis - PMC
17. Alimentary Pharmacology & Therapeutics | Pharmacology Journal | Wiley Online Library
18. Acid suppressants reduce the therapeutic effect of immune checkpoint inhibitors and increase the risk of acute kidney injury: a meta-analysis - PubMed
19. Potassium-competitive acid blocker has more negative impacts on clinical outcomes in patients with non-small cell lung cancer treated with checkpoint inhibitors than those of proton pump inhibitors - PubMed