| アブストラクト | BACKGROUND: Immune checkpoint inhibitors (ICIs) improve cancer survival but can provoke new or worsening autoimmune disease. OBJECTIVES: To explore the association of ICIs with multiple sclerosis (MS) using the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database, and to compare the disproportionality signal of MS with that of other autoimmune neurological adverse events. DESIGN: Secondary analysis of the FAERS database. METHODS: We performed a disproportionality analysis of FAERS between 2003-Q4 and 2024-Q2. Outcomes were MS, myasthenia gravis (MG), Guillain-Barre syndrome (GBS), and autoimmune encephalitis (AIE). A signal required ⩾3 reports, proportional reporting ratio ⩾2, and chi(2) ⩾ 4. RESULTS: There were 48 reports of MS or MS relapse associated with ICIs. The reporting odds ratio (ROR) for MS or MS relapse was 0.09 (95% confidence interval (CI): 0.068-0.12). In comparison, RORs were 21.05 (95% CI: 19.287-22.974) for MG, 8.075 (95% CI: 6.677-9.766) for GBS, and 29.03 (95% CI: 23.564-35.764) for AIE. CONCLUSION: We found no significant safety signal for MS with ICIs, in contrast to MG, GBS, and AIE. This heterogeneity underscores the need for continued pharmacovigilance and mechanistic research. |
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| 組織名 | Saint Luke's Marion Bloch Neuroscience Institute, 4401 Wornall Rd, Kansas City,;MO 64111, USA Department of Neurology, University of Missouri-Kansas City, Kansas;City, MO, USA.;Saint Luke's Marion Bloch Neuroscience Institute, Kansas City, MO, USA.;Saint Luke's Cancer Institute, Kansas City, MO, USA.;Department of Neurology, University of Texas Southwestern Medical Center, Dallas,;TX, USA.;Neurology Section, VA North Texas Health Care System, Dallas, TX, USA.;Peter O'Donnell Jr. Brain Institute, University of Texas Southwestern Medical;Center, Dallas, TX, USA. |
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