Method of Risk Management for Patients Undergoing Natalizumab Treatment
AssigneeSeedlings Life Science Ventures, LLC
InventorsKeith H. Rubin, Steven Glazer
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Abstract
Progressive multifocal leukoencephalopathy (PML) has been identified in patients taking natalizumab (NMAB) for the treatment of multiple sclerosis (MS). This patent application provides a novel method of patient screening and monitoring intended to decrease the risk of PML and other opportunistic central nervous system (CNS) diseases in patients undergoing MS therapy with NMAB, and proposes a novel method of screening and monitoring intended to decrease the risk of opportunistic disease processes of the CNS during the treatment of other medical disorders with NMAB.
Claims19
A method of reducing risk associated with administration of natalizumab to a patient comprising:
- before initiating natalizumab treatment, obtaining an MRI image of the patient's brain establishing a baseline MRI image;
- initiating natalizumab treatment in the absence of evidence of potential opportunistic disease from the MRI image;
- after a predetermined time and before administering a subsequent natalizumab dosage, obtaining a subsequent MRI image of the patient's brain and comparing the subsequent MRI image with the previous MRI image;
- continuing natalizumab treatment in the absence of evidence of potential opportunistic disease in the subsequent MRI image, or
- withholding natalizumab treatment if evidence of potential opportunistic disease is detected in the subsequent MRI image.
A method of reducing a risk associated with administration of natalizumab to a patient undergoing such treatment comprising:
- screening the patient for potential progressive multifocal leukoencephalopathy (PML) by obtaining and examining an MRI image of the brain,
- determining the presence of evidence of potential PML by reference to the MRI image;
- withholding natalizumab treatment if the presence of evidence of potential PML is detected;
- or
- continuing natalizumab treatment in the absence of evidence of potential PML.
A method of reducing risk associated with administration of natalizumab to a patient comprising:
- obtaining an MRI image of the patient's brain establishing a baseline MRI image;
- after a predetermined time and before administering a subsequent natalizumab dosage, obtaining a subsequent MRI image of the patient's brain and comparing the subsequent image with the previous image;
- continuing natalizumab treatment in the absence of evidence of potential opportunistic disease in the subsequent image, or
- if evidence of potential opportunistic disease is detected in the MRI image, obtaining a sample of the patient's cerebrospinal fluid (CSF);
- testing the CSF sample for the presence of a precursor of the opportunistic disease;
- and
- withholding natalizumab treatment if the precursor is present in the CSF sample or continuing natalizumab treatment if the precursor is not present in the CSF sample.
Dependencies are inferred from the claim text.