Methods of treating inflammatory and autoimmune diseases with natalizumab

摘要

Natalizumab is a safe and efficacious treatment for inflammatory and autoimmune diseases, such as multiple sclerosis, Crohn's Disease, and rheumatoid arthritis. Rare occurrences of progressive multifocal leucoencephalopathy during treatment suggest the possibility that it may be related to natalizumab treatment. Monitoring for JCV and informing caregivers and patients about the manifestations of progressive multifocal leucoencephalopathy can improve the safety of natalizumab therapy.

主权项

1. A method of treating a patient with an inflammatory or autoimmune disease comprising the steps of:
(a) testing the patient for the presence of anti-JC virus (JCV) antibodies by a method consisting of measuring the presence of anti-JCV antibodies in the serum or plasma of a blood sample from the patient; (b) initiating treatment of the patient tested in step (a) by administering natalizumab to the patient in the event the sample is negative for anti-JCV antibodies; (c) testing the patient treated in step (b) for indicators of progressive multifocal leukoencephalopathy (PML) by detecting the presence of JCV in the patient's cerebrospinal fluid, or detecting clinical and/or radiologic symptoms of PML in said patient, and (d) further administering natalizumab to the patient in the absence of indicators of PML or discontinuing natalizumab treatment in the presence of indicators of PML.