Adverse reactions of immune checkpoint inhibitors combined with glucocorticoids: a pharmacovigilance analysis of drug-drug interactions | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Adverse reactions of immune checkpoint inhibitors combined with glucocorticoids: a pharmacovigilance analysis of drug-drug interactions Zhen Zhang, Tao Gao, Linpei Li, Xiaoning Tan, Puhua Zeng This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6637692/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract This study investigated the risks of drug-drug interaction (DDI) between immune checkpoint inhibitors (ICIs) and glucocorticoids (GCs) using the FDA Adverse Event Reporting System (FAERS) data from 2004 to 2024. A total of 2,279,969 adverse event reports were analyzed, employing several methods to find key DDI. Three main types of adverse events showed clear signals: metabolism and nutrition disorders (ROR=2.49), gastrointestinal disorders (ROR=1.42), and investigations (ROR=1.35). PD-1/PD-L1 inhibitors combined with GCs had the higher risks than CTLA-4 inhibitors. This study shows doctors should watch closely for high blood sugar and gut problems in patients taking PD-1/PD-L1 inhibitors with GCs. Preclinical trials and robust clinical studies are required to explore the mechanisms and relationships underlying interactions, thus improving understanding of DDI associated with this combination therapy. drug-drug interaction immune checkpoint inhibitors glucocorticoids FAERS PD-1/PD-L1 Full Text Additional Declarations No competing interests reported. Tables 1 to 5 are available in the Supplementary Files section. Supplementary Files table.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6637692","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":535715481,"identity":"2329f293-32dc-4664-8b6c-4b6c92020961","order_by":0,"name":"Zhen Zhang","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABDUlEQVRIiWNgGAWjYDACCTB5gIGBvQHKAAM2YrTwHGBsIFGLRAKRWuRnNz97+OXPHTlzyefPH/Mw3MkzOH46geFD2WEG/tkNWLUwzjlmbizD88zYcnaOYTMPw7NigzO5GxhnnDvMIHHnAFYtzBIJZtISEocTN9zOYQRqATJu8G5g5m07zGAgkYBVC5tE+jdpCYPD9RtuHn+I0PIXjxYeiRwzyQ8JhxMMbjAYIrQw4tEiIZFTJs1w4LDhhjM5hjPnGBxOnAn0y8Gec+k8Ejewa5Gfkb5N8sefw/IGx48/+PCm4nBi3/GzGx/8KLOW45+BXQs4CHjgTAMIdQDkZJzqgYDxBz7ZUTAKRsEoGAUAUXNmxDd9dJsAAAAASUVORK5CYII=","orcid":"","institution":"Hunan Academy of Chinese Medicine","correspondingAuthor":true,"prefix":"","firstName":"Zhen","middleName":"","lastName":"Zhang","suffix":""},{"id":535715482,"identity":"809eb4c7-55ae-47e8-83a5-26748248a956","order_by":1,"name":"Tao Gao","email":"","orcid":"","institution":"Hunan University of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Tao","middleName":"","lastName":"Gao","suffix":""},{"id":535715483,"identity":"eb8a3c5f-7ebb-47f0-b7bd-f0fb62c704fa","order_by":2,"name":"Linpei Li","email":"","orcid":"","institution":"Hunan Academy of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Linpei","middleName":"","lastName":"Li","suffix":""},{"id":535715484,"identity":"23134e6f-ad20-4442-936b-bfde6f36010a","order_by":3,"name":"Xiaoning Tan","email":"","orcid":"","institution":"Hunan Academy of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Xiaoning","middleName":"","lastName":"Tan","suffix":""},{"id":535715485,"identity":"e15fe220-4bf2-4184-9e0d-6b08e5025141","order_by":4,"name":"Puhua Zeng","email":"","orcid":"","institution":"Hunan Academy of Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Puhua","middleName":"","lastName":"Zeng","suffix":""}],"badges":[],"createdAt":"2025-05-11 05:08:16","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6637692/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6637692/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":94594830,"identity":"57675540-f2b7-4ea4-994a-acce2d011061","added_by":"auto","created_at":"2025-10-28 18:30:36","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":520833,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6637692/v1_covered_9221f52c-6a38-4b31-9554-adabfdb465e2.pdf"},{"id":94574132,"identity":"cabd1470-40f8-461e-869a-3954e5519ae0","added_by":"auto","created_at":"2025-10-28 18:08:40","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":59076,"visible":true,"origin":"","legend":"","description":"","filename":"table.docx","url":"https://assets-eu.researchsquare.com/files/rs-6637692/v1/b1a11bc8820ec6af6916c1f6.docx"}],"financialInterests":"\u003cp\u003eNo competing interests reported.\u003c/p\u003e\n\u003cp\u003eTables 1 to 5 are available in the Supplementary Files section.\u003c/p\u003e","formattedTitle":"Adverse reactions of immune checkpoint inhibitors combined with glucocorticoids: a pharmacovigilance analysis of drug-drug interactions","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
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