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Abstract
Natalizumab is a potent immunosuppressive monoclonal antibody used for the treatment of multiple sclerosis (MS). While definite guidelines for the safety of natalizumab prescriptions are available in all countries, there are no specific recommendations on how to withdraw the drug if the need arises. There are reports describing MS complications after natalizumab infusions were stopped. Most neurologists seem to stop natalizumab treatment according to their idea on how to best carry out the withdrawal. The present study shows the very different manners in which expert neurologists from 14 MS units in Brazil stopped natalizumab in their patients. The authors concluded that pharmacovigilance on natalizumab must persist after the drug is withdrawn in order to have enough data for adequate recommendations.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.
No writing assistance was utilized in the production of this manuscript.
Key issues
Natalizumab is a potent and efficient drug for the treatment of multiple sclerosis.
There are clear guidelines regarding the prescription of natalizumab.
Patients usually do well on natalizumab and withdrawal may mainly be because of possible infections than for insufficient response.
Progressive multifocal leukoencephalopathy caused by JC virus is the most important risk for patients on natalizumab.
Natalizumab withdrawal may cause severe worsening of multiple sclerosis activity.
Natalizumab withdrawal requires pharmacovigilance.
The switch from natalizumab to another drug or procedure does not follow guidelines.
It is imperative that we learn from data and experience in order to provide recommendations on natalizumab withdrawal.