No evidence of disease activity (NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis: a 36-month real-world study

Assunta Bianco, Massimiliano Mirabella, Paolo Calabresi, Mario Di Filippo, Luca Prosperini, Pietro Annovazzi, Laura Boffa, Maria Chiara Buscarinu, Antonio Gallo, Manuela Matta, Lucia Moiola, Luigina Musu, Paola Perini, Carlo Avolio, Valeria Barcella, Deborah Farina, Elisabetta Ferraro, Simona Pontecorvo, Franco Granella, Luigi M. E. GrimaldiAlice Laroni, Giacomo Lus, Francesco Patti, Eugenio Pucci, Matteo Pasca, Paola Sarchielli, Angelo Ghezzi, Mauro Zaffaroni, Damiano Baroncini, Fabio Buttari, Diego Centonze, Arianna Fornasiero, Marco Salvetti, Renato Docimo, Elisabetta Signoriello, Gioacchino Tedeschi, Antonio Bertolotto, Marco Capobianco, Giancarlo Comi, Eleonora Cocco, Paolo Gallo, Marco Puthenparampil, Roberta Grasso, Valeria Di Francescantonio, Maria Rosaria Rottoli, Alessandra Lugaresi, Giovanna De Luca, Maria Di Ioia, Valeria Di Tommaso, Luca Mancinelli, Giancarlo Di Battista, Ada Francia, Serena Ruggieri, Carlo Pozzilli, Erica Curti, Elena Tsantes, Barbara Palmeri, Caterina Lapicci, Giovanni Luigi Mancardi, Antonio Uccelli, Clara Chisari, Emanuele D’Amico, Elisabetta Cartechini, Anna Maria Repice, Eliana Magnani, Luca Massaccesi, Massimiliano Di Filippo, Maria Di Gregorio

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15 Citazioni (Scopus)

Abstract

In this retrospective, multicenter, real-world study we collected clinical and magnetic resonance imaging (MRI) data of all patients (n = 40) with relapsing-remitting multiple sclerosis (RRMS) treated with alemtuzumab according to a “free-of-charge” protocol available before the drug marketing approval in Italy. Almost all (39/40) started alemtuzumab after discontinuing multiple disease-modifying treatments (DMTs) because of either lack of response or safety concerns. We considered the proportion of alemtuzumab-treated patients who had no evidence of disease activity (NEDA-3) and disability improvement over a 36-month follow-up period. NEDA-3 was defined as absence of relapses, disability worsening, and MRI activity. Disability improvement was defined as a sustained reduction of ≥ 1-point in Expanded Disability Status Scale (EDSS) score. At follow-up, 18 (45%) patients achieved NEDA-3, 30 (75%) were relapse-free, 33 (82.5%) were EDSS worsening-free, and 25 (62.5%) were MRI activity-free. Eleven (27.5%) patients had a sustained disability improvement. We found no predictor for the NEDA-3 status, while the interaction of higher EDSS score by higher number of pre-alemtuzumab relapses was associated with a greater chance of disability improvement (odds ratio 1.10, p = 0.049). Our study provides real-world evidence that alemtuzumab can promote clinical and MRI disease remission, as well as disability improvement, in a significant proportion of patients with RRMS despite prior multiple DMT failures. The drug safety profile was consistent with data available from clinical trials.
Lingua originaleEnglish
pagine (da-a)2851-2860
Numero di pagine10
RivistaJournal of Neurology
Volume265
DOI
Stato di pubblicazionePubblicato - 2018

Keywords

  • Alemtuzumab
  • Multiple sclerosis
  • Outcome measurement

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