2015
DOI: 10.1056/nejmc1413724
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PML in a Patient without Severe Lymphocytopenia Receiving Dimethyl Fumarate

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Cited by 140 publications
(111 citation statements)
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“…Two phase 3 studies have shown that dimethyl fumarate is effective at significantly reducing relapse rate and the number of new or enlarging T2-hyperintense lesions [109,110]. Though the safety profile was initially thought to be favorable, other than flushing and gastrointestinal disturbance, reports of PML in the setting of dimethyl fumarate have been released [111,112]. An open-label, randomized, activecontrolled study of dimethyl fumarate versus IFN-β1a (30 μg once weekly) in pediatric patients with MS (CONNECT) is currently recruiting.…”
Section: Dimethyl Fumaratementioning
confidence: 99%
“…Two phase 3 studies have shown that dimethyl fumarate is effective at significantly reducing relapse rate and the number of new or enlarging T2-hyperintense lesions [109,110]. Though the safety profile was initially thought to be favorable, other than flushing and gastrointestinal disturbance, reports of PML in the setting of dimethyl fumarate have been released [111,112]. An open-label, randomized, activecontrolled study of dimethyl fumarate versus IFN-β1a (30 μg once weekly) in pediatric patients with MS (CONNECT) is currently recruiting.…”
Section: Dimethyl Fumaratementioning
confidence: 99%
“…95,105 MRI based monitoring for early PML detection is appropriate not only for patients taking natalizumab, but also for other DMDs, including alemtuzumab, 106 rituximab 107 and dimethyl fumarate. [108][109][110] The value of MRI for treatment monitoring goes beyond PML detection. Other opportunistic infections leading to encephalitis (such as varicella zoster) can also develop in patients with MS, as has been shown during or after treat ment with fingolimod, a sphingosine 1 phosphate receptor modulator approved for MS treatment.…”
Section: Detection Of Adverse Effectsmentioning
confidence: 99%
“…One patient from an extension of one of the phase II studies developed PML after long-term low lymphocyte counts, suggesting that lymphocyte counts could be a risk marker [23]. A recent case of PML in DMF in RR-MS, however, apparently developed the infection in the absence of low lymphocyte counts, thus questioning their relevance for risk management [24]. These cases are certainly of concern but in light of the large number of treated patients worldwide, DMF is generally still viewed as a very useful and safe first-line DMT and has become one of the most commonly prescribed DMTs in RR-MS [25,26].…”
Section: Dimethyl Fumaratementioning
confidence: 99%