Ocrelizumab-related neutropenia: Effects of age, sex and bodyweight using the FDA Adverse Event Reporting System (FAERS)

Hammer, Helly; Kamber, Nicole; Pistor, Maximilian; Diem, Lara; Friedli, Christoph; Chan, A.; Hoepner, Robert; Salmen, Anke

doi:10.1016/j.msard.2022.104015

Cited by 6 publications

(5 citation statements)

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“…Leukopenia,lymphopenia and/or neutropenia 5 -- (100). Studies involving rituximab and evaluating bone marrow functionality found that late-onset neutropenia was induced by the white cell line maturation arrest, which in turn is the result of excessive levels of B-cell activating factor (101,102).…”

Section: Discussionmentioning

confidence: 99%

“…Through the analysis of data reported in the FDA Adverse Event Reporting System (FAERS), Hammer H et al aimed to identify risk factors of neutropenia in patients treated with ocrelizumab. They identified male sex, younger age and lower bodyweight as factors associated with ocrelizumab-related neutropenia ( 100 ). Studies involving rituximab and evaluating bone marrow functionality found that late-onset neutropenia was induced by the white cell line maturation arrest, which in turn is the result of excessive levels of B-cell activating factor ( 101 , 102 ).…”

Section: Discussionmentioning

confidence: 99%

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Disease-modifying therapies and hematological disorders: a systematic review of case reports and case series

Scavone,

Liguori,

Adungba

et al. 2024

Front. Neurol.

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IntroductionDisease modifying therapies (DMTs) used to treat multiple sclerosis (MS) can be associated to the occurrence of hematological disorders. This systematic review aims to provide an overview of these events occurring in real-life conditions, by describing case reports and series published in the literature.MethodsA literature search of all publications up to January 5th 2024 on the Medline and Embase databases was carried out. The results were presented both in the text and in tables.ResultsSixty-seven case reports/series were included in this review, of which more than half related to alemtuzumab, natalizumab and ocrelizumab. The publication date of included studies ranged from 2006 to 2024. The majority of case reports and series described the occurrence of late-onset hematological disorders (events that occurred more than 30 days after the first DMT administration), mainly represented by case of neutropenia, autoimmune hemolytic anemia and immune thrombocytopenia. All cases reported a favorable outcome, apart one case report that described a fatal case. Among included cases, 4 articles, all related to natalizumab, described the occurrence of myeloid disorders in 13 newborns from mother receiving the DMT.DiscussionConsidering the limitations identified in the majority of included studies, further ad hoc studies are strongly needed to better evaluate the hematological disorders of DMTs. Meantime, the strict monitoring of treated patients for the occurrence of these toxicities should be highly recommended.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Disease-modifying therapies and hematological disorders: a systematic review of case reports and case series

Scavone,

Liguori,

Adungba

et al. 2024

Front. Neurol.

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show abstract

“…Eine Auswertung des FDA Adverse Event Reporting System (FAERS) identifizierte 25 Fälle einer LON unter OCR-Therapie (0,8 % der beobachteten Fälle; [ 3 ]). Das ermittelte Risiko liegt damit zwar deutlich unter dem des Auftretens einer LON bei RTX-Gabe (6,5 %; [ 6 ]); dies erscheint allerdings anhand der von RTX bekannten klinischen Inapparenz und der damit verbundenen hohen Dunkelziffer der LON sowie der schlechteren Datenlage zu OCR erklärbar [ 2 , 6 ].…”

Section: Diskussionunclassified

“…Unzureichend verstanden ist außerdem, welche Faktoren das Auftreten einer solchen Komplikation begünstigen. In oben genannter Auswertung des FAERS mit jedoch vergleichsweise geringer Fallzahl trat diese häufiger bei Patienten mit männlichem Geschlecht, höherem Alter und Untergewicht auf [ 3 ]. Inwieweit die vorausgegangene SARS-CoV-2-Infektion des zweiten Patienten relevant für das Auftreten der Lymphopenie war, bleibt ungeklärt.…”

Section: Diskussionunclassified

Ocrelizumab-associated severe neutropenia: an underestimated complication of treatment of multiple sclerosis with anti-CD20 antibodies?

Hess,

Uibel,

Berthele

et al. 2023

Nervenarzt

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Section: Discussionmentioning

confidence: 99%

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Ocrelizumab-related neutropenia: Effects of age, sex and bodyweight using the FDA Adverse Event Reporting System (FAERS)

Cited by 6 publications

References 6 publications

Disease-modifying therapies and hematological disorders: a systematic review of case reports and case series

Disease-modifying therapies and hematological disorders: a systematic review of case reports and case series

Ocrelizumab-associated severe neutropenia: an underestimated complication of treatment of multiple sclerosis with anti-CD20 antibodies?

Data_Sheet_1.docx

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