| アブストラクト | BACKGROUND: Rituximab and ocrelizumab are anti-CD20 monoclonal antibodies that have shown a marked reduction in multiple sclerosis (MS) inflammatory activity. However, their real-world safety profile has not been adequately compared. OBJECTIVE: To investigate the adverse event (AE) profile of rituximab and ocrelizumab reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) database. METHODS: The FAERS database was filtered by indication (MS) and drug (rituximab or ocrelizumab). Disproportionality analyses including but not limited to reporting odds ratio (ROR) were conducted to identify drug-AE associations. A signal was detected if the lower limit of the 95% confidence interval of ROR (ROR025) exceeded 1. RESULTS: There were 623 and 7948 reports for rituximab and ocrelizumab, respectively. The most frequent AEs with rituximab and ocrelizumab were infusion-related reaction (4.82%) and urinary tract infection (10.52%), respectively. The strongest drug-AE association for rituximab and ocrelizumab were ear pruritus (ROR025: 47.53) and oral herpes (ROR025: 38.99), respectively. Ocrelizumab was associated with an almost two times higher frequency of infections than rituximab (21.93% vs 11.05%, respectively). CONCLUSION: This study revealed differences in reporting AEs between rituximab and ocrelizumab. Infections were reported more frequently with ocrelizumab. Although speculative, a potentially different or more extensive B-cell depletion by ocrelizumab might explain these findings. Additional pharmacovigilance studies need to be performed to better characterize differences in the AE profile in B-cell-depleting therapies. |
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| 組織名 | Department of Neurology & Neurotherapeutics, Immunology Graduate Program,;University of Texas Southwestern Medical Center, Dallas, TX, USA.;Department of Neurological Sciences, University of Nebraska Medical Center,;Omaha, NE, USA.;Division of Biostatistics, Washington University School of Medicine, St. Louis,;MO, USA.;University of Texas Southwestern Medical Center, Dallas, TX, USA/Neurology;Section, VA North Texas Health Care System, Dallas, TX, USA. |
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