Persistent severe lymphopenia 5 years after dimethyl fumarate discontinuation

Caldito, Natalia Gonzalez; O’Leary, Shirley; Stüve, Olaf

doi:10.1177/1352458520988149

Cited by 9 publications

(7 citation statements)

References 12 publications

(21 reference statements)

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“…Fifty-three case reports and 10 case series were evaluated using the risk of bias assessment tool. Regarding case reports, 8 studies ( 33 , 37 , 42 , 58 , 67 , 70 , 75 , 81 ) had the highest methodological quality, together with 3 other studies ( 30 , 43 , 56 ) that similarly reported high quality information. For the remaining case reports, the risk of bias evaluation revealed mainly the lack of data on patients’ race and patients’ history presented as timeline.…”

Section: Resultsmentioning

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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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: Resultsmentioning

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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“… 65 , 98 However, only a few cases have been reported of patients experiencing complications from prolonged severe lymphopenia. 65 , 97 , 99 , 100 Age ⩾50 years is another risk factor for PML; however, neither age ⩾50 years nor severe prolonged lymphopenia are absolute identifiers of those at increased risk of PML, with recorded case reports in patients without these characteristics. 95 , 101 – 103 …”

Section: Resultsmentioning

confidence: 99%

Clinical use of dimethyl fumarate in multiple sclerosis treatment: an update to include China, using a modified Delphi method

Gold

Barnett

Chan

et al. 2023

Ther Adv Neurol Disord

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Dimethyl fumarate (DMF) is a widely used oral disease-modifying therapy for multiple sclerosis (MS). Its efficacy and safety profiles are supported by over a decade of experience. Differences exist between Asia and Europe/United States in the prevalence and characteristics of MS; most data for DMF are derived from populations outside Asia. DMF was recently (2021) approved for use in China. The objectives of this review were to evaluate the evidence for DMF’s profile, to provide an update to healthcare providers on current knowledge surrounding its use and to assess the relevance of existing data to use in China. This study used a modified Delphi method based on the insights of a scientific Steering Committee (SC), with a structured literature review conducted to assess the data of DMF. The literature review covered all papers in English (from 01 January 2011 to 21 February 2022) that include ‘dimethyl fumarate’ and ‘multiple sclerosis’, and their MeSH terms, on PubMed, supplemented by EMBASE and Citeline searches. Papers were categorized by topic and assessed for relevance and quality, before being used to formulate statements summarizing the literature on each subject. SC members voted on/revised statements, requiring ⩾80% agreement and ⩽10% disagreement for inclusion. Statements not reaching this level were discussed further until agreement was reached or until there was agreement to remove the statement. A total of 1030 papers were retrieved and used to formulate the statements and evidence summaries considered by the SC members. A total of 45 statements were agreed by the SC members. The findings support the positive efficacy and safety profile of DMF in treating patients with MS. Limited Chinese patient data are an ongoing consideration; however, based on current evidence, the statements are considered applicable to both the global and Chinese populations. DMF is a valuable addition to address unmet MS treatment needs in China. Registration: Not applicable

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“…10%). 1 However, the article by Caldito et al 2 on a patient with DMF-induced grade III lymphopenia, which did not recover over a follow-up period of 5 years (last absolute lymphocyte count (ALC) 0.53 G/l), indicates the possibility of irreversible lymphopenia.…”

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confidence: 99%

Persisting lymphopenia and dimethyl fumarate: A clinical commentary

Diem

Chan

2021

Mult Scler

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Severe prolonged lymphopenia as rare side-effect of dimethyl fumarate is mostly reversible. Caldito et al. report a case of persistent severe lymphopenia over 5 years after discontinuation of dimethyl fumarate. We discuss several clinical implications. Safe withdrawal of disease modifying therapies in terms of reoccurrence of disease activity and drug related adverse events need further attention as our treatment armamentarium continues to grow.

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Persistent severe lymphopenia 5 years after dimethyl fumarate discontinuation

Cited by 9 publications

References 12 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

Clinical use of dimethyl fumarate in multiple sclerosis treatment: an update to include China, using a modified Delphi method

Persisting lymphopenia and dimethyl fumarate: A clinical commentary

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