Anti-JCV antibody index data were collected from anti-JCV antibody–positive MS patients who did not develop PML from 3 natalizumab clinical studies, AFFIRM (n = 359),1 (link) STRATIFY-1 (n = 680),7 (link) and STRATIFY-2 (n = 1,483)6 ; the total number of samples was 5,834. Because PML is an uncommon adverse event in natalizumab-treated patients, PML patient samples were obtained from clinical studies and postmarketing sources (n = 71 as of September 2012); only pre-PML samples available >6 months prior to PML diagnosis were included (total number of samples = 316, collected at a median duration of 4 years prior to PML diagnosis). Patients enrolled in clinical studies provided informed consent for participation. For all other patients, data were collected through standard pharmacovigilance practices.
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Anti-JCV Antibody Index in Natalizumab Patients
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Variable analysis
independent variables
- None explicitly mentioned
- Anti-JCV antibody index
- None explicitly mentioned
- Positive control: Anti-JCV antibody-positive MS patients who did not develop PML from 3 natalizumab clinical studies (AFFIRM, STRATIFY-1, and STRATIFY-2).
- Negative control: PML patient samples obtained from clinical studies and postmarketing sources, only including pre-PML samples available >6 months prior to PML diagnosis.
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