| アブストラクト | OBJECTIVE: The current study aims to describe the infection and infestation adverse events that may be associated with the use of ocrelizumab using real-world data. METHODS: Infection and infestation adverse event reports with the generic name ocrelizumab as the primary suspect in the FAERS database from Q4 2003 to Q3 2024 were included in the study. The disproportionality analysis software package OpenVigil 2.1-MedDRA-v24, including the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR) algorithms, was used to determine signal strength of infection and infestation adverse events associated with ocrelizumab. The signal intensity for ROR and PRR was classified as low, medium and strong according to signal strength. RESULTS: The analysis of infection and infestation reports of the drug pharmacovigilance database on the use of ocrelizumab revealed 161 positive signals. The most common adverse event reported was COVID-19 (n=2287, ROR 24.303; PRR 22.681). According to the disproportionality analysis, the top six adverse events with the highest ROR and PRR were encephalitis enteroviral (ROR 101.831; PRR 101.809), meningitis enteroviral (ROR 76.019; PRR 76.005), fallopian tube abscess (ROR 51.225; PRR 51.221), nasal herpes (ROR 45.676; PRR 45.662), neuroborreliosis (ROR 28.563; PRR 28.559) and babesiosis (ROR 25.507; PRR 25.5). CONCLUSION: Ocrelizumab may increase the risk of many infections and infestations, including enterovirus-related central nervous system infections, tick-borne infections, COVID-19-related disorders, genital tract infections and herpes infections, and therefore requires careful monitoring in clinical practice. |
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