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

Massimiliano Mirabella, Matteo Lucchini, Aurora Zanghì, Antonio Gallo, Carlo Avolio, Rocco Capuano, Maria Petracca, Simona Bonavita, Roberta Lanzillo, Diana Ferraro, Erica Curti, Maria Buccafusca, Graziella Callari, Stefania Barone, Giuseppe Pontillo, Gianmarco Abbadessa, Valeria Di Francescantonio, Elisabetta Signoriello, Giacomo Lus, Patrizia SolaFranco Granella, Paola Valentino, Francesco Patti, Emanuele D'Amico

Risultato della ricerca: Contributo in rivistaArticolo in rivistapeer review

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). This is a multicentre, retrospective, real-world study on consecutive RRMS patients from eleven tertiary Italian MS centres, who switched from NTZ to OCR, RTX, and CLA from January 1st, 2019, to December 31st, 2019. The primary study outcomes were the annualized relapse rate (ARR) and magnetic resonance imaging (MRI) outcome. Treatment effects were estimated by the inverse probability treatment weighting (IPTW), based on propensity-score (PS) approach. Additional endpoint included confirmed disability progression (CDP) as measured by Expanded Disability Status Scale and adverse events (AEs). Patients satisfying predefined inclusion and exclusion criteria were 120; 64 switched to OCR, 36 to RTX, and 20 to CLA. Patients from the 3 groups did not show differences for baseline characteristics, also after post hoc analysis. The IPTW PS-adjusted models revealed that patients on OCR had a lower risk for ARR than patients on CLA (ExpBOCR 0.485, CI 95% 0.264-0.893, p=0.020). This result was confirmed also for 12-month MRI activity (ExpBOCR 0.248 CI 95% 0.065-0.948, p=0.042). No differences were found in other pairwise comparisons (OCR vs RTX and RTX vs CLA) for the investigated outcomes. AEs were similar among the 3 groups. Anti-CD20 drugs were revealed to be effective and safe options as NTZ exit strategies. All investigated DMTs showed a good safety profile.
Lingua originaleEnglish
pagine (da-a)N/A-N/A
RivistaNeurotherapeutics
Volume2021
DOI
Stato di pubblicazionePubblicato - 2021

Keywords

  • Cladribine
  • Disease activity
  • Rituximab
  • Natalizumab
  • Ocrelizumab
  • Exit strategy

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