NDLI: Risk of natalizumab-associated progressive multifocal leukoencephalopathy.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Lee, Sophia Bloomgren, Gary Subramanyam, Meena Goelz, Susan Bozic, Carmen Scanlon, James V. Sandrock, Alfred Natarajan, Amy Plavina, Tatiana Richman, Sandra Hotermans, Christophe
Description	Author Affiliation: Bloomgren G ( Biogen Idec, Weston, MA, USA. gary.bloomgren@biogenidec.com)
Abstract	BACKGROUND: Progressive multifocal leukoencephalopathy (PML) is associated with natalizumab treatment. We quantified the risk of PML in patients with multiple sclerosis, according to the presence or absence of three risk factors: positive status with respect to anti-JC virus antibodies, prior use of immunosuppressants, and increasing duration of natalizumab treatment. METHODS: We used data from postmarketing sources, clinical studies, and an independent Swedish registry to estimate the incidence of PML among natalizumab-treated patients with multiple sclerosis, according to positive or negative status with respect to anti-JC virus antibodies, prior or no prior use of immunosuppressants, and duration of treatment (1 to 24 months vs. 25 to 48 months). Blood samples were available for anti-JC virus antibody testing from 5896 patients with multiple sclerosis and from 54 patients with multiple sclerosis who were treated with natalizumab and in whom PML later developed. RESULTS: As of February 29, 2012, there were 212 confirmed cases of PML among 99,571 patients treated with natalizumab (2.1 cases per 1000 patients). All 54 patients with PML for whom samples were available before the diagnosis were positive for anti-JC virus antibodies. When the risk of PML was stratified according to three risk factors, the risk of PML was lowest among the patients who were negative for anti-JC virus antibodies, with the incidence estimated to be 0.09 cases or less per 1000 patients (95% confidence interval [CI], 0 to 0.48). Patients who were positive for anti-JC virus antibodies, had taken immunosuppressants before the initiation of natalizumab therapy, and had received 25 to 48 months of natalizumab treatment had the highest estimated risk (incidence, 11.1 cases per 1000 patients [95% CI, 8.3 to 14.5]). CONCLUSIONS: Positive status with respect to anti-JC virus antibodies, prior use of immunosuppressants, and increased duration of natalizumab treatment, alone or in combination, were associated with distinct levels of PML risk in natalizumab-treated patients with multiple sclerosis. (Funded by Biogen Idec and Elan Pharmaceuticals.).
ISSN	00284793
Issue Number	20
Volume Number	366
e-ISSN	15334406
Journal	New England Journal of Medicine
Language	English
Publisher	Massachusetts Medical Society (United States)
Publisher Date	2012-05-17
Publisher Place	United States
Access Restriction	Subscribed
Subject Keyword	Antibodies, Monoclonal, Humanized Adverse Effects Antibodies, Viral Blood Immunosuppressive Agents Therapeutic Use JC Virus Immunology Leukoencephalopathy, Progressive Multifocal Chemically Induced Multiple Sclerosis, Relapsing-Remitting Drug Therapy Adolescent Adult Aged Child Drug Therapy, Combination Female Humans Incidence Epidemiology Male Middle Aged Natalizumab Product Surveillance, Postmarketing Registries Risk Factors Young Adult Journal Article Medicine
Content Type	Text
Resource Type	Article
Subject	Medicine

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