Abstract
BackgroundNatalizumab, a highly specific α4-integrin antagonist, , has recently been registered across the Middle East and North Africa region. It improves clinical and magnetic resonance imaging (MRI) outcomes and reduces the rate of relapse and disability progression in relapsing-remitting multiple sclerosis (MS). Natalizumab is recommended for patients who fail first-line disease-modifying therapy or who have very active disease. Progressive multifocal leukoencephalopathy is a rare, serious adverse event associated with natalizumab.We aim to develop regional recommendations for the selection and monitoring of MS patients to be treated with natalizumab in order to guide local neurological societies.MethodsAfter a review of available literature, a group of neurologists with expertise in the management of MS met to discuss the evidence and develop regional recommendations to guide appropriate use of natalizumab in the region.ResultsDisease breakthrough is defined as either clinical (relapse or disability progression) or radiological activity (new T2 lesion or gadolinium-enhancing lesions on MRI), or a combination of both. Natalizumab is recommended as an escalation therapy in patients with breakthrough disease based on its established efficacy in Phase III studies. Several factors including prior immunosuppressant therapy, anti-John Cunningham virus (JCV) antibody status and patient choice will affect the selection of natalizumab. In highly active MS, natalizumab is considered as a first-line therapy for naive patients with disabling relapses in association with MRI activity. The anti-JCV antibody test is used to assess anti-JCV antibody status and identify the risk of PML. While seronegative patients should continue treatment with natalizumab, anti-JCV antibody testing every 6 months and annual MRI scans are recommended as part of patient monitoring. In seropositive patients, the expected benefits of natalizumab treatment have to be weighed against the risks of PML. Clinical vigilance and follow-up MRI scans remain the cornerstone of monitoring. After 2 years of natalizumab therapy, monitoring should include more frequent MRI scans (every 3–4 months) for seropositive patients, and the risk-benefit ratio should be reassessed and discussed with patients.ConclusionsRecommendations have been developed to guide neurologists in the Middle East and North Africa on patient selection for natalizumab treatment and monitoring.
Highlights
Natalizumab, a highly specific α4-integrin antagonist, has recently been registered across the Middle East and North Africa region
Efficacy of natalizumab The goals of multiple sclerosis (MS) treatment have evolved as new therapies have become available
Natalizumab reduced disability progression by 42% sustained at 12 weeks and by 54% sustained at 24 weeks [6], whereas fingolimod performed comparably to interferon (37% reduction sustained at 24 weeks with both) [23,24]
Summary
Natalizumab, a highly specific α4-integrin antagonist, , has recently been registered across the Middle East and North Africa region. It improves clinical and magnetic resonance imaging (MRI) outcomes and reduces the rate of relapse and disability progression in relapsing-remitting multiple sclerosis (MS). Natalizumab, a highly specific α4-integrin antagonist, has recently been registered across the Middle East and North Africa (MENA) region. It is recommended as a single disease-modifying therapy (DMT) in patients with highly active relapsing-remitting MS to prevent relapses and delay progression of disability. Evolving severe relapsing-remitting MS can be defined by at least two disabling relapses in 1 year and at least one Gd-enhancing lesion on brain MRI or a significant increase of T2 burden [5]
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have