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Uncovering the Burden of Immune-Related Adverse Events in Immunotherapy: Insights from a Nationally Representative Sample

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Abstract

Background

Immune checkpoint inhibitors have shown promising efficacy in multiple malignancies and, therefore, have been increasingly used over the past decade. Clinical data have suggested anti-cancer efficacy associated with immune-related adverse events that could have added healthcare resource utilization and costs.

Objective

We used a nationwide dataset to investigate the association between immune-related adverse events and healthcare resource utilization, charges, and mortality among patients receiving various immune checkpoint inhibitors for indicated cancers.

Methods

We performed a retrospective analysis of the National Inpatient Sample to identify patients hospitalized in the USA for immunotherapy between October 2015 and 2018. Data between patients who developed immune-related adverse events were compared to those who did not. Baseline characteristics, inpatient complications, and associated charges were collected and analyzed between these two groups.

Results

Patients who developed immune-related adverse events in the hospital had high incidences of acute kidney injury, non-septic shock, and pneumonia, and managing these complications significantly contributed to higher healthcare resource utilization. The average charge of admission was highest in patients who developed an infusion reaction, followed by colitis, and adrenal insufficiency. In terms of cancer type, renal cell carcinoma had the highest charges, followed by Merkel cell carcinoma.

Conclusions

Immune checkpoint inhibitor-based regimens have shifted the treatment landscape among multiple malignancies and their use continues to expand. However, a significant proportion of patients still develop severe adverse effects leading to increased healthcare costs and impacting patients’ quality of life. Closer attention should be given to recognizing and managing immune-related adverse events according to guidelines across healthcare facilities and clinical practice settings.

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Author information

Authors and Affiliations

  1. Department of Hematology and Oncology, Henry Ford Hospital, 48202, MI, 2800 W Grand Blvd Detroit, USA

    Rayli Pichardo, Kashmira Wani & Kathren Shango

  2. Cleveland Clinic, Cleveland, OH, USA

    Yazan Abu Omar

  3. Merck & Co, Inc., Kenilworth, NJ, USA

    Ding Wang

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  1. Rayli Pichardo
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Corresponding author

Correspondence to Rayli Pichardo.

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Funding

The HFCI Research American Society of Clinical Oncology Travel Award funded the abstract for this project presented at the American Society of Clinical Oncology 2022 annual meeting.

Conflicts of Interest/Competing Interests

Rayli Pichardo, Yazan Abu Omar, Kashmira Wani, and Kathren Shango have no conflicts of interest that are directly relevant to the content of this article. Ding Wang was a previous employee of Henry Ford Hospital during the conduct of this research, and is currently employed at Merck Research Laboratories and has no financial and non-financial interests to disclose.

Ethics Approval

Institutional review board review and approval were not required as the NIS is a publicly available dataset that contains de-identified patient information.

Consent to Participate

Not applicable.

Consent for Publication

Not applicable.

Availability of Data and Material

The datasets generated and/or analyzed during the current study are available in the Healthcare Cost & Utilization Project-National Inpatient Sample. The Data Use Agreement ("Agreement") governs the disclosure and use of data in the nationwide databases from the Healthcare Cost and Utilization Project, please visit (www.hcup-us.ahrq.gov) for more information on accessing Healthcare Cost and Utilization Project data.

Code Availability

The analysis was performed using STATA and R software. The code is available upon request.

Authors’ Contributions

RP: conceived and designed the analysis, wrote the manuscript. YAO: conceived and designed the analysis, contributed data or analysis tools, performed the analysis. KW: wrote the manuscript. KS: wrote the manuscript. DW: conceived and supervised this research project through its design, data analysis, contributed critical feedbacks, and manuscript writing and its revision.

Supplementary Information

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Supplementary file1 (PDF 165 KB)

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Pichardo, R., Abu Omar, Y., Wani, K. et al. Uncovering the Burden of Immune-Related Adverse Events in Immunotherapy: Insights from a Nationally Representative Sample. Targ Oncol 18, 451–461 (2023). https://doi.org/10.1007/s11523-023-00969-3

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  • DOI: https://doi.org/10.1007/s11523-023-00969-3

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