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

Autor: Prosperini, L, Annovazzi, P, Boffa, L, Buscarinu, Mc, Gallo, A, Matta, M, Moiola, L, Musu, L, Perini, P, Avolio, C, Barcella, V, Bianco, A, Farina, D, Ferraro, E, Pontecorvo, S, Granella, F, Grimaldi, Lme, Laroni, A, Lus, G, Patti, F, Pucci, E, Pasca, M, Sarchielli, P, Ghezzi, A, Zaffaroni, M, Baroncini, D, Buttari, F, Centonze, D, Fornasiero, A, Salvetti, M, Docimo, R, Signoriello, E, Tedeschi, G, Bertolotto, A, Capobianco, M, Comi, G, Cocco, E, Gallo, P, Puthenparampil, M, Grasso, R, Di Francescantonio, V, Rottoli, Mr, Mirabella, M, Lugaresi, A, De Luca, G, Di Ioia, M, Di Tommaso, V, Mancinelli, L, Di Battista, G, Francia, A, Ruggieri, S, Pozzilli, C, Curti, E, Tsantes, E, Palmeri, B, Lapucci, C, Mancardi, Gl, Uccelli, A, Chisari, C, D'Amico, E, Cartechini, E, Repice, Am, Magnani, E, Massaccesi, L, Calabresi, P, Di Filippo, M, Di Gregorio, M, Italian Alemtuzumab Study, Group.
Přispěvatelé: Prosperini, Luca, Annovazzi, Pietro, Boffa, Laura, Buscarinu, Maria Chiara, Gallo, Antonio, Matta, Manuela, Moiola, Lucia, Musu, Luigina, Perini, Paola, Avolio, Carlo, Barcella, Valeria, Bianco, Assunta, Farina, Deborah, Ferraro, Elisabetta, Pontecorvo, Simona, Granella, Franco, Grimaldi, Luigi M E, Laroni, Alice, Lus, Giacomo, Patti, Francesco, Pucci, Eugenio, Pasca, Matteo, Sarchielli, Paola
Rok vydání: 2018
Předmět:
Adult
Male
medicine.medical_specialty
Neurology
Outcome measurement
Relapsing-Remitting
Follow-Up Studie
Multiple sclerosis
03 medical and health sciences
Immunologic Factor
0302 clinical medicine
Multiple Sclerosis
Relapsing-Remitting
Alemtuzumab
Multiple sclerosis
Outcome measurement
Retrospective Studie
Alemtuzumab
Internal medicine
Medicine
Humans
Immunologic Factors
Multiple sclerosi
030212 general & internal medicine
Female
Follow-Up Studies
Magnetic Resonance Imaging
Retrospective Studies
Treatment Outcome
Neurology (clinical)
Expanded Disability Status Scale
medicine.diagnostic_test
business.industry
Retrospective cohort study
Magnetic resonance imaging
Odds ratio
medicine.disease
alemtuzumab
multiple sclerosis
outcome measurement
neurology
Clinical trial
Settore MED/26 - NEUROLOGIA
business
030217 neurology & neurosurgery
Human
medicine.drug
Zdroj: Journal of neurology. 265(12)
ISSN: 1432-1459
Popis: 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.
Databáze: OpenAIRE
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