Disproportionality signal of progressive multifocal leukoencephalopathy: monoclonal antibodies versus other immunosuppressants

Piccinni, Carlo; Sacripanti, Chiara; Poluzzi, Elisabetta; Ponti, Fabrizio De

doi:10.1002/pds.3414

Cited by 5 publications

(2 citation statements)

References 6 publications

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“…PML is not mentioned in the French SPC for all the other drugs ( Table ). Our results are consistent with data reported in the literature , except for oxaliplatin not evidenced in the WHO ADR database . All these drugs have been associated with other concomitant cytotoxic agents or immunosuppressive drugs, except for one case with fludarabine in a hematological patient (lymphoma).…”

Section: Discussionsupporting

confidence: 91%

Drug-induced progressive multifocal leukoencephalopathy: a case/noncase study in the French pharmacovigilance database

Colin

Favrelière

Quillet

et al. 2016

Fundam Clin Pharmacol

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Progressive multifocal leukoencephalopathy (PML) is an often fatal demyelinating disease of the central nervous system. As effective treatment is unavailable, identification of all drugs that could be associated with PML is essential. The objective of this study was to investigate the putative association of reports of PML and drugs. We used the case/noncase method in the French PharmacoVigilance database (FPVD). Cases were reports of PML in the FPVD between January 2008 and December 2015. Noncases were all other reports during the same period. To assess the association between PML and drug intake, we calculated an adverse drug report odds ratio (ROR) with its 95% confidence interval. We have studied the delay of onset of PML for each drug concerned. Among the 101 cases of PML, 39 drugs were mentioned as suspect. The main therapeutic classes suspected with significant ROR were antineoplastic agents (n = 85), immunosuppressants (n = 67), and corticosteroids. A latent interval from the time of drug initiation to the development of PML is established: the median time to onset was 365 days (123-1095 days). The onset of PML is highly variable and differs among drug classes [from 1 to 96 months (IQR: 39.0-126)]. An association between PML and some immunosuppressant drugs was found as expected, but also with antineoplastic agents and glucocorticoids. An important delay of PML onset after stopping treatment is suspected and should alert prescribers. Prescribers but also patients should be informed about the potential associations with all these drugs. Monitoring could be necessary for many drugs to early detect PML.

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Section: Discussionsupporting

confidence: 91%

Drug-induced progressive multifocal leukoencephalopathy: a case/noncase study in the French pharmacovigilance database

Colin

Favrelière

Quillet

et al. 2016

Fundam Clin Pharmacol

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“…JCV infection is frequently acquired during childhood; afterwards, the virus persists in the body in a latent state, replicating at low levels only episodically (Hou and Major, 2000;Khalili et al, 2008). PML, which was initially diagnosed mainly in patients with AIDS or lymphoproliferative disease (Calabrese et al, 2007), is now also observed during therapy with a variety of immunomodulating drugs, natalizumab being the most frequently implicated, especially in patients without an underlying predisposing condition (Carson et al, 2009;Schmedt et al, 2012;Piccinni et al, 2013). As of September 2, 2014, the overall incidence of PML in natalizumabtreated patients is 3.72 per 1000 patients (http://www.biogenidecinternational.com/tysabri.aspx?ID=4763; accessed October 24, 2014).…”

Section: Known Predictive Markers For Natalizumab-related Pmlmentioning

confidence: 99%

Immunological biomarkers identifying natalizumab-treated multiple sclerosis patients at risk of progressive multifocal leukoencephalopathy

Serana

Chiarini

Sottini

et al. 2014

Journal of Neuroimmunology

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Drug-Induced Progressive Multifocal Leukoencephalopathy: A Comprehensive Analysis of the WHO Adverse Drug Reaction Database

et al. 2015

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Disproportionality signal of progressive multifocal leukoencephalopathy: monoclonal antibodies versus other immunosuppressants

Cited by 5 publications

References 6 publications

Drug-induced progressive multifocal leukoencephalopathy: a case/noncase study in the French pharmacovigilance database

Drug-induced progressive multifocal leukoencephalopathy: a case/noncase study in the French pharmacovigilance database

Immunological biomarkers identifying natalizumab-treated multiple sclerosis patients at risk of progressive multifocal leukoencephalopathy

Drug-Induced Progressive Multifocal Leukoencephalopathy: A Comprehensive Analysis of the WHO Adverse Drug Reaction Database

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