Long-term safety evaluation of natalizumab for the treatment of multiple sclerosis. Issue 8 (3rd August 2017)

• Record Type: Journal Article
• Authors: Clerico, Marinella; Artusi, Carlo Alberto; Di Liberto, Alessandra; Rolla, Simona; Bardina, Valentina; Barbero, Pierangelo; De Mercanti, Stefania Federica; Durelli, Luca
• Is Part Of: Expert opinion on drug safety. Volume 16:Issue 8(2017:Aug.)
• Page Start: 963
• Page End: 972
• Publication Date: 2017-08-03
• Subjects: Multiple sclerosis -- natalizumab -- safety -- progressive multifocal leukoencephalopathy -- long-term safety -- adverse events -- serious adverse event -- John-Cunningham virus; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2017.1346082
• Languages: English
• ISSNs: 1474-0338

Abstract

ABSTRACT: Introduction : Natalizumab is a humanized monoclonal antibody highly effective in relapsing-remitting multiple sclerosis (MS). Important concerns about its safety have been pointed out mainly because of the risk of progressive multifocal leukoencephalopathy (PML), caused by the opportunistic John-Cunningham virus (JCV). Areas covered : This review analyzes all the safety aspects related to the use and safety of natalizumab in MS patients. Other than PML, post-marketing, safety red-flags have been reported, as liver or haematological serious adverse events. Pregnancy evidences will be pointed out. The risk of PML depends on: concomitant or previous immunosuppression, exposure duration, anti–JCV antibody level. In natalizumab-related PML the average survival is 77%; prognostic features and information for the earliest identification of PML have been identified to maximally reduce its incidence, mortality and morbidity. Expert opinion : Natalizumab is a highly effective drug for MS patients but its safety issues represent a relevant limitation and impose strict clinical surveillance of treated patients. Some post-marketing safety red-flags have been pointed out, with higher attention to severe liver failures and limphoma cases. If PML and its consequences are considered the most relevant issues, a continuous surveillance must be maintained also regarding other possible SAEs like liver diseases and malignancies.