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

Emanuele D'Amico,Aurora Zanghì,Carlo Avolio,Antonio Gallo,Simona Bonavita,Roberta Lanzillo,Maria Buccafusca,Graziella Callari,Giacomo Lus,Patrizia Sola,Franco Granella,Paola Valentino,Massimilano Mirabella,Francesco Patti

doi:10.1016/j.jns.2021.117769

Abstract

The main aim of the study is to evaluate the efficacy and safety profile of Ocrelizumab (OCR), Rituximab (RTX), and Cladribine (CLA), employed as Natalizumab (NTZ) exit-strategies in Relapsing-Remitting Multiple Sclerosis (RRMS) patients at high-risk for progressive multifocal leukoencephalopathy (PML).

Highlights

Natalizumab (NTZ) has improved the possibilities to treat highly active relapsing–remitting forms of multiple sclerosis (RRMS) patients (1).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 brainExtended author information available on the last page of the article infection [2,3,4,5]
Several retrospective studies have investigated the effect of extended interval dose (EID) on reducing PML risk, the reliability of their conclusions is limited by the nonrandomized designs, and the extreme variable definitions of EID [5]
We identified adult relapsing–remitting multiple sclerosis (RRMS) patients who switched from NTZ to OCR, RTX, and CLA from January 1st, 2019, to December 31st, 2019

Summary

Introduction

Natalizumab (NTZ) has improved the possibilities to treat highly active relapsing–remitting forms of multiple sclerosis (RRMS) patients (1).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 brainExtended author information available on the last page of the article infection [2,3,4,5]. 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. 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]. Several retrospective studies have investigated the effect of extended interval dose (EID) on reducing PML risk, the reliability of their conclusions is limited by the nonrandomized designs, and the extreme variable definitions of EID (ranging from 5 to 8 weeks) [5]. A therapeutic switch in patients who respond to NTZ but are exposed to a high PML risk represents an important and increasingly frequent therapeutic challenge in MS clinical practice. Since highly effective drugs have been licensed for the treatment of highly active RRMS, there is

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