We know how to prescribe natalizumab for multiple sclerosis, but do we know how to withdraw it?

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 The authors concluded that pharmacovigilance on natalizumab must persist after the drug is withdrawn in order to have enough data for adequate recommendations.

Exit Strategies in Natalizumab-Treated RRMS at High Risk of Progressive Multifocal Leukoencephalopathy: a Multicentre Comparison Study

“…However, a long exposure to NTZ treatment in anti-JC virus (JCV)-seropositive patients expose them to a higher risk to develop progressive multifocal leukoencephalopathy (PML), a serious and potentially lethal opportunistic brain infection [2][3][4][5]. To manage PML risk, a magnetic resonance imaging (MRI) monitoring every 3-4 months has been recommended for JCV-seropositive patients on NTZ treatment for more than 18 months [5].…”

Rituximab versus fingolimod after natalizumab in multiple sclerosis patients

“…Currently there is no clear consensus on how to reduce the risk of a sometimes violent return of disease activity in the situation of NTZ discontinuation. 10,11 A frequent choice of disease-modifying therapy (DMT) after NTZ is fingolimod (FGL; Gilenya). Results from a recent register-based study suggest that FGL is more effective than interferon beta/glatiramer acetate in reducing the risk of disease reactivation in this patient group.…”

“…In addition, smaller studies have reported rebound phenomena, with reoccurring disease activity over and beyond that of pretreatment levels, perhaps explained by patients treated in clinical practice having more active disease than those included in RCTs. Currently there is no clear consensus on how to reduce the risk of a sometimes violent return of disease activity in the situation of NTZ discontinuation …”

Exit-strategies in Natalizumab-treated RRMS at high risk of progressive multifocal leukoencephalopathy: A multicentre comparison study

“…However, a long exposure to NTZ treatment in anti-JC virus (JCV)-seropositive patients expose them to a higher risk to develop progressive multifocal leukoencephalopathy (PML), a serious and potentially lethal opportunistic brain infection [2][3][4][5]. To manage PML risk, a magnetic resonance imaging (MRI) monitoring every 3-4 months has been recommended for JCV-seropositive patients on NTZ treatment for more than 18 months [5].…”