Nonfatal PML in a patient with multiple sclerosis treated with dimethyl fumarate

Baharnoori, Moogeh; Lyons, Jennifer L.; Dastagir, Akram; Koralnik, Igor J.; Stankiewicz, James

doi:10.1212/nxi.0000000000000274

Cited by 43 publications

(20 citation statements)

References 7 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…As of 2013, a FAE‐formulation containing DMF is approved by the U.S. Food and Drug and the European Medicines Agency for the treatment of relapsing‐remitting multiple sclerosis. Four cases have been reported of PML in patients with multiple sclerosis treated with DMF . In response to the reported cases of PML associated with various FAE formulations, the European Medicines Agency has formulated different recommendations to minimize risks for PML during treatment with the DMF formulation in multiple sclerosis and the FAE formulation in psoriasis .…”

Section: Discussionmentioning

confidence: 99%

“…Four cases have been reported of PML in patients with multiple sclerosis treated with DMF. 38 In response to the reported cases of PML associated with various FAE formulations, the European Medicines Agency has formulated different recommendations to minimize risks for PML during treatment with the DMF formulation in multiple Table 3 Summary of lymphocyte counts in published cases of progressive multifocal leukoencephalopathy (PML) associated with fumaric acid ester (FAE) treatment in patients with psoriasis PML associated with fumaric acid esters sclerosis and the FAE formulation in psoriasis. 39 It is of importance to note that there are no clear differences in the DMF formulation used for MS and the DMF formulations in psoriasis as these compounds are identical.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Progressive multifocal leukoencephalopathy associated with fumaric acid esters treatment in psoriasis patients

Balak

Hajdarbegovic

Bramer

et al. 2017

Acad Dermatol Venereol

View full text Add to dashboard Cite

Progressive multifocal leukoencephalopathy is infrequently linked to FAE treatment, but underreporting cannot be excluded. Physicians treating patients with FAEs should be vigilant for the occurrence of PML, and both clinicians and patients should be alert for onset of new neurological symptoms. Periodic monitoring of lymphocyte counts and FAE discontinuation in case of moderate-to-severe lymphocytopenia is recommended to minimize the risk for PML.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Progressive multifocal leukoencephalopathy associated with fumaric acid esters treatment in psoriasis patients

Balak

Hajdarbegovic

Bramer

et al. 2017

Acad Dermatol Venereol

View full text Add to dashboard Cite

show abstract

“…Determine the continuation or suspension of DMF considering the risk and benefit when the lymphocyte count range is 500–800/mm for >6 months PML As of September 2017, five cases of PML that were treated with DMF have been reported globally . The incidence of PML because of DMF treatment was considered to be <0.19/10 000 using data of >260 000 patients who were treated with DMF as of 30 April 2017, worldwide .…”

Section: Four Questions and Answers For Dmf In The 2017 Supplement Ofmentioning

confidence: 99%

“…As of September 2017, five cases of PML that were treated with DMF have been reported globally. [33][34][35][36][37] The incidence of PML because of DMF treatment was considered to be <0.19/10 000 using data of >260 000 patients who were treated with DMF as of 30 April 2017, worldwide. 38 Based on the case reports of PML, patients were aged >50 years, and the lymphocyte count was <500/mm 3 in four of five patients.…”

Section: Pmlmentioning

confidence: 99%

Japanese guidelines for dimethyl fumarate

Niino

Ohashi

Ochi

et al. 2018

Clinical & Exp Neuroim

View full text Add to dashboard Cite

A multicenter, randomized, double‐blind, placebo‐controlled, efficacy and safety study of BG00012 in participants from the Asia–Pacific region and other countries with relapsing–remitting multiple sclerosis (APEX), including Japan, established the efficacy of dimethyl fumarate (DMF) in preventing relapses and disease progression in patients with multiple sclerosis (MS). Consequently, in December 2016, DMF was approved as the second oral disease‐modifying drug for MS in Japan. However, the new Japanese guidelines for MS and neuromyelitis optica published in 2017 did not include DMF. Later, after the committee discussed a guideline for DMF, a supplement of the new guidelines for MS and neuromyelitis optica, which included DMF, was published in June 2018; this supplement comprised the following four clinical questions: (i) is DMF effective in preventing relapses in patients with MS?; (ii) is DMF effective in preventing disease progression in patients with MS?; (iii) how to use DMF?; and (iv) what adverse events does DMF possibly cause? Furthermore, the supplement comprised answers to the questions and comments. Overall, this supplement is anticipated to contribute toward the treatment of Japanese MS patients with DMF.

show abstract

“…Both these drugs have now been associated with PML in patients in both disease groups, prompting updated safety advice from the UK Medicines and Healthcare Products Regulatory Agency in 2016. To date, there are at least six published cases of PML in recipients of FAE and DMF [48,49,[75][76][77][78], which does not enable precise risk-estimate calculations in the absence of a reliable denominator.…”

Section: Therapeutic Monoclonal Antibodiesmentioning

confidence: 99%

Progressive multi-focal leucoencephalopathy – driven from rarity to clinical mainstream by iatrogenic immunodeficiency

Misbah

2017

Clinical and Experimental Immunology

View full text Add to dashboard Cite

SummaryAdvances in immune-mediated targeted therapies have proved to be a doubleedged sword for patients by highlighting the risk of iatrogenic infective complications. This has been exemplified by progressive multi-focal leucoencephalopathy (PML), a hitherto rare devastating viral infection of the brain caused by the neurotrophic JC polyoma virus. While PML achieved prominence during the first two decades of the HIV epidemic, effective anti-retroviral treatment and restitution of T cell function has led to PML being less prominent in this population. HIV infection as a predisposing factor has now been supplanted by T cell immunodeficiency induced by a range of immune-mediated therapies as a major cause of PML. This review focuses on PML in the context of therapeutic immunosuppression and encompasses therapeutic monoclonal antibodies, novel immunomodulatory agents such as Fingolimod and dimethyl fumarate, as well as emerging data on PML in primary immune deficiency.

show abstract

Nonfatal PML in a patient with multiple sclerosis treated with dimethyl fumarate

Cited by 43 publications

References 7 publications

Progressive multifocal leukoencephalopathy associated with fumaric acid esters treatment in psoriasis patients

Progressive multifocal leukoencephalopathy associated with fumaric acid esters treatment in psoriasis patients

Japanese guidelines for dimethyl fumarate

Progressive multi-focal leucoencephalopathy – driven from rarity to clinical mainstream by iatrogenic immunodeficiency

Contact Info

Product

Resources

About