Outcomes after fingolimod to alemtuzumab treatment shift in relapsing-remitting MS patients: a multicentre cohort study.


Journal

Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161

Informations de publication

Date de publication:
Oct 2019
Historique:
received: 29 04 2019
accepted: 06 06 2019
revised: 04 06 2019
pubmed: 19 6 2019
medline: 26 2 2020
entrez: 19 6 2019
Statut: ppublish

Résumé

A high reactivation of multiple sclerosis (MS) was reported in patients treated with alemtuzumab after fingolimod. We aimed to understand whether this shift enhanced the risk for reactivation in a real-life cohort. Subjects with relapsing MS, shifting from fingolimod to alemtuzumab were enrolled. We collected the following data: age, sex, disease duration, relapses after fingolimod withdrawal, new T2/gadolinium (Gd)-enhancing lesions in the last magnetic resonance imaging (MRI) during fingolimod and in the first, while on alemtuzumab, lymphocyte counts at alemtuzumab start, and Expanded Disability Status Scale (EDSS) before and after alemtuzumab. We enrolled 77 patients (women 61 (79%); mean age 36.2 years (SD 9.6), and disease duration 12.3 years (SD 6.8) at fingolimod discontinuation; median washout 1.8 months). The annualised relapse rate was 0.89 during fingolimod, 1.32 during washout, and 0.15 after alemtuzumab (p = 0.001). The EDSS changed from a median of 3 (IQR 2-4) at the end of fingolimod to 2.5 after alemtuzumab (IQR 1.5-4) (p = 0.013). The washout length and the lymphocyte count before alemtuzumab were not associated with EDSS change after alemtuzumab (p = 0.59 and p = 0.33, respectively). MRI activity decreased after alemtuzumab compared to that during fingolimod (p = 0.001). At alemtuzumab start, lymphocyte counts were < 0.8 × 10 In our cohort, alemtuzumab reduced relapse, new T2/Gd-enhancing lesions, and EDSS score, as compared to the previous periods (fingolimod/washout). These results were not related to washout length or lymphocyte counts. Therefore, a rapid initiation of alemtuzumab after fingolimod does not seem to be a risk factor for MS reactivation.

Sections du résumé

BACKGROUND BACKGROUND
A high reactivation of multiple sclerosis (MS) was reported in patients treated with alemtuzumab after fingolimod. We aimed to understand whether this shift enhanced the risk for reactivation in a real-life cohort.
METHODS METHODS
Subjects with relapsing MS, shifting from fingolimod to alemtuzumab were enrolled. We collected the following data: age, sex, disease duration, relapses after fingolimod withdrawal, new T2/gadolinium (Gd)-enhancing lesions in the last magnetic resonance imaging (MRI) during fingolimod and in the first, while on alemtuzumab, lymphocyte counts at alemtuzumab start, and Expanded Disability Status Scale (EDSS) before and after alemtuzumab.
RESULTS RESULTS
We enrolled 77 patients (women 61 (79%); mean age 36.2 years (SD 9.6), and disease duration 12.3 years (SD 6.8) at fingolimod discontinuation; median washout 1.8 months). The annualised relapse rate was 0.89 during fingolimod, 1.32 during washout, and 0.15 after alemtuzumab (p = 0.001). The EDSS changed from a median of 3 (IQR 2-4) at the end of fingolimod to 2.5 after alemtuzumab (IQR 1.5-4) (p = 0.013). The washout length and the lymphocyte count before alemtuzumab were not associated with EDSS change after alemtuzumab (p = 0.59 and p = 0.33, respectively). MRI activity decreased after alemtuzumab compared to that during fingolimod (p = 0.001). At alemtuzumab start, lymphocyte counts were < 0.8 × 10
CONCLUSIONS CONCLUSIONS
In our cohort, alemtuzumab reduced relapse, new T2/Gd-enhancing lesions, and EDSS score, as compared to the previous periods (fingolimod/washout). These results were not related to washout length or lymphocyte counts. Therefore, a rapid initiation of alemtuzumab after fingolimod does not seem to be a risk factor for MS reactivation.

Identifiants

pubmed: 31209573
doi: 10.1007/s00415-019-09424-8
pii: 10.1007/s00415-019-09424-8
doi:

Substances chimiques

Immunologic Factors 0
Alemtuzumab 3A189DH42V
Fingolimod Hydrochloride G926EC510T

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

2440-2446

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Auteurs

Jessica Frau (J)

Department of Medical Sciences and Public Health, Multiple Sclerosis Centre, University of Cagliari-ATS Sardegna, Via Is Guadazzonis 2, 09126, Cagliari, Italy. jessicafrauneuro@gmail.com.

Francesco Saccà (F)

NSRO Department Federico II University, Naples, Italy.

Alessio Signori (A)

Section of Biostatistics, Department of Health Sciences, University of Genoa, Genoa, Italy.

Damiano Baroncini (D)

Multiple Sclerosis Centre, ASST Valle-Olona, Gallarate Hospital, Gallarate, VA, Italy.

Giuseppe Fenu (G)

Department of Medical Sciences and Public Health, Multiple Sclerosis Centre, University of Cagliari-ATS Sardegna, Via Is Guadazzonis 2, 09126, Cagliari, Italy.

Pietro Annovazzi (P)

Multiple Sclerosis Centre, ASST Valle-Olona, Gallarate Hospital, Gallarate, VA, Italy.

Marco Capobianco (M)

SCDO Neurologia-Centro di Riferimento Regionale Sclerosi Multipla, AOU San Luigi Gonzaga, Orbassano, TO, Italy.

Elisabetta Signoriello (E)

Multiple Sclerosis Centre Second Division of Neurology, University of Campania Luigi Vanvitelli, Naples, Italy.

Alice Laroni (A)

Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genova, Genoa, Italy.
IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Sara La Gioia (S)

ASST Papa Giovanni XXIII, Bergamo, Italy.

Arianna Sartori (A)

AOU Ospedali Riuniti di Trieste, Trieste, Italy.

Giorgia Teresa Maniscalco (GT)

Neurology and Stroke Unit, A. Cardarelli Hospital, Naples, Italy.

Simona Bonavita (S)

Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.

Marinella Clerico (M)

Clinical and Biological Sciences Department, AOU San Luigi Gonzaga University of Turin, Turin, Italy.

Cinzia Valeria Russo (CV)

NSRO Department Federico II University, Naples, Italy.

Antonio Gallo (A)

Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.

Caterina Lapucci (C)

Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health and Center of Excellence for Biomedical Research, University of Genova, Genoa, Italy.
IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Antonio Carotenuto (A)

NSRO Department Federico II University, Naples, Italy.

Maria Pia Sormani (MP)

Section of Biostatistics, Department of Health Sciences, University of Genoa, Genoa, Italy.

Eleonora Cocco (E)

Department of Medical Sciences and Public Health, Multiple Sclerosis Centre, University of Cagliari-ATS Sardegna, Via Is Guadazzonis 2, 09126, Cagliari, Italy.

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