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J Neurol. 2018 Dec;265(12):2851-2860. doi: 10.1007/s00415-018-9070-x. Epub 2018 Sep 26.

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

Author information

1
Department of Neurosciences, S. Camillo-Forlanini Hospital, C.ne Gianicolense 87, 00152, Rome, Italy. luca.prosperini@gmail.com.
2
MS Centre, S. Antonio Abate Hospital, Gallarate, VA, Italy.
3
Department of Neurosciences, MS Center, Tor Vergata University, Rome, Italy.
4
Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University, S. Andrea Hospital, Rome, Italy.
5
Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
6
Regional MS Centre, S. Luigi Gonzaga Hospital, Orbassano, TO, Italy.
7
Department of Neurology, Institute of Experimental Neurology, Division of Neuroscience, S. Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
8
MS Center, Binaghi Hospital, ASSL Cagliari, ATS regione Sardegna, Cagliari, Italy.
9
Department of Neurosciences, MS Centre, University Hospital, Padua, Italy.
10
Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
11
MS Center, ASST Papa Giovanni XXIII, Bergamo, MI, Italy.
12
Fondazione Policlinico A. Gemelli, IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
13
Department of Neuroscience and Imaging, University "G. d'Annunzio", Chieti, Italy.
14
Neurology Unit, S. Filippo Neri Hospital, Rome, Italy.
15
Department of Neurology and Psychiatry, Sapienza University, Rome, Italy.
16
Department of Medicine and Surgery, University of Parma, Parma, Italy.
17
U.O.C. Neurologia, Fondazione Istituto "G.Giglio, Cefalù, PA, Italy.
18
Department of Neurology, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI) and Center of Excellence for Biomedical Research (CEBR), University of Genoa, Genoa, Italy.
19
Departement of Neurosciences, IRCCS Osp. Policlinico S. Martino, Genoa, Italy.
20
Department of Medical and Surgical Sciences and Advanced Technologies, Neuroscience Section, University of Catania, Catania, Italy.
21
UOC Neurologia Ospedale "A. Murri", ASUR Marche - AV4, Fermo, Italy.
22
Department of Neurofarba, University of Florence, Florence, Italy.
23
Neurology Unit, Osp.e Santa Maria della Misericordia, University of Perugia, Perugia, Italy.

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.

KEYWORDS:

Alemtuzumab; Multiple sclerosis; Outcome measurement

PMID:
30259178
DOI:
10.1007/s00415-018-9070-x

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