| アブストラクト | INTRODUCTION: Programmed cell death-1 (PD-1) and programmed cell death ligand-1 (PD-L1) immune checkpoint inhibitors (ICIs) are used for a variety of cancers and are associated with a risk of developing immune-related adverse events, most commonly dermatitis, colitis, hepatitis, and pneumonitis. Immune-mediated hematologic toxicities have been reported, but are less well-described in the literature. Immune thrombocytopenia (ITP) is a rare autoimmune, hematologic adverse event that has been reported with PD-1/PD-L1 inhibitors. METHODS: We performed a retrospective observational analysis of the United States Food and Drug Administration Adverse Event Reporting System (FAERS) data. We searched for cases of ITP reported with exposure to PD-1/PD-L1 inhibitors from initial FDA approval for each agent to September 30, 2022. Disproportionality signal analysis was done by calculating the reporting odds ratio (ROR). Oxaliplatin was used as a positive control for sensitivity analysis as it is an anticancer therapy that has been associated with drug-induced ITP. A systematic review of the PubMed database was also conducted to identify published cases of PD-1/PD-L1 inhibitor-induced ITP. RESULTS: There were 329 reports of ITP with ICIs in the FAERS database that were reviewed for a disproportionality signal, including atezolizumab (n = 27), durvalumab (n = 17), nivolumab (n = 160), and pembrolizumab (n = 125). The ROR was significant for atezolizumab (ROR 5.39, 95 % CI 3.69-7.87), avelumab (ROR 10.32, 95 % CI 4.91-21.69), durvalumab (ROR 7.91, 95 % CI 4.91-12.75), nivolumab (ROR 9.76, 95 % CI 8.34-11.43), and pembrolizumab (ROR 12.6, 95 % CI 10.55-15.06). In our systematic review, we summated 57 cases of ICI-induced ITP. Nivolumab and pembrolizumab had the most reported cases of ITP in the literature. Most cases reported (53 %) included ITP-directed therapies beyond corticosteroids for the management of ICI-induced ITP. CONCLUSION: There is a significant reporting signal of ITP with several ICI agents. Clinicians should be aware of and monitor for signs of this potentially serious adverse event. |
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| ジャーナル名 | International immunopharmacology |
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| 投稿日 | 2024/2/16 |
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| 投稿者 | Moore, Donald C; Elmes, Joseph B; Arnall, Justin R; Strassel, Scott A; Patel, Jai N |
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| 組織名 | Clinical Oncology Pharmacy Manager, Levine Cancer Institute, Atrium Health,;Department of Pharmacy, 1021 Morehead Medical Drive, Charlotte, NC 28204, USA.;Electronic address: Donald.moore1@atriumhealth.org.;Oncology Clinical Staff Pharmacist, Levine Cancer Institute, Atrium Health,;Department of Pharmacy, 100 Medical Park Drive, Concord, NC 28025, USA.;Electronic address: Joseph.Elmes@atriumhealth.org.;Pharmacist Clinical Coordinator - Hematology/Hemophilia, Atrium Health, Specialty;Pharmacy Service, 4400 Golf Acres Drive, Charlotte, NC 28208, USA. Electronic;address: Justin.Arnall@atriumhealth.org.;Atrium Health, Department of Pharmacy, 4400 Golf Acres Drive, Charlotte, NC;28232, USA. Electronic address: Scott.Strassels@atriumhealth.org.;Clinical Pharmacology and Pharmacogenomics, Levine Cancer Institute, Atrium;Health, Department of Cancer Pharmacology and Pharmacogenomics, 1021 Morehead;Medical Drive, Charlotte, NC 28204, USA. Electronic address:;Jai.Patel@atriumhealth.org. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38359661/ |
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