Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis.
Adult
Alemtuzumab
/ administration & dosage
Drug-Related Side Effects and Adverse Reactions
Female
Follow-Up Studies
Humans
Immunologic Factors
/ administration & dosage
Magnetic Resonance Imaging
Male
Multiple Sclerosis, Relapsing-Remitting
/ diagnostic imaging
Pneumonia
/ chemically induced
Severity of Illness Index
Thrombocytopenia
/ chemically induced
Thyroiditis
/ chemically induced
Alemtuzumab
Efficacy
Real-life
Safety
Journal
Journal of neurology
ISSN: 1432-1459
Titre abrégé: J Neurol
Pays: Germany
ID NLM: 0423161
Informations de publication
Date de publication:
Jun 2019
Jun 2019
Historique:
received:
04
02
2019
accepted:
05
03
2019
revised:
04
03
2019
pubmed:
14
3
2019
medline:
18
12
2019
entrez:
14
3
2019
Statut:
ppublish
Résumé
No postmarketing randomised clinical trials are available about alemtuzumab, and real-world data are limited. We aimed to analyse the efficacy and safety of alemtuzumab in a single-centre cohort of patients with relapsing-remitting MS. Patients who took alemtuzumab were enrolled. We collected the following data: age, sex, MS history, expanded disability status scale (EDSS), relapses, magnetic resonance imaging (MRI) parameters after alemtuzumab, and adverse events. EDSS scores before alemtuzumab and at the last follow-up were compared by Wilcoxon test. Time to first relapse was analysed after dividing the cohort on the basis of previous treatment. Ninety patients were enrolled [women 74.4%; naïve 7; mean follow-up 27 months (SD 23)]. The EDSS was reduced from a median of 2.5 (IQR 1.5-4) before alemtuzumab to 2.0 (IQR 1.5-3.5) after (p = 0.025). The time to first relapse was shorter in patients shifting from a second-line therapy (p = 0.011). Over 2 years, 43.7% had no evidence of disease activity. We observed infusion-related reactions in 95.5% patients, including 11.1% with pneumonitis, thyroiditis in 11%, and thrombocytopenia in 3.3%. We confirmed the clinical and MRI efficacy of alemtuzumab in the clinical setting and the frequency of infusion-related reactions. Compared with that in clinical trials, higher number of patients developed pneumonitis during infusion.
Sections du résumé
BACKGROUND
BACKGROUND
No postmarketing randomised clinical trials are available about alemtuzumab, and real-world data are limited. We aimed to analyse the efficacy and safety of alemtuzumab in a single-centre cohort of patients with relapsing-remitting MS.
METHODS
METHODS
Patients who took alemtuzumab were enrolled. We collected the following data: age, sex, MS history, expanded disability status scale (EDSS), relapses, magnetic resonance imaging (MRI) parameters after alemtuzumab, and adverse events. EDSS scores before alemtuzumab and at the last follow-up were compared by Wilcoxon test. Time to first relapse was analysed after dividing the cohort on the basis of previous treatment.
RESULTS
RESULTS
Ninety patients were enrolled [women 74.4%; naïve 7; mean follow-up 27 months (SD 23)]. The EDSS was reduced from a median of 2.5 (IQR 1.5-4) before alemtuzumab to 2.0 (IQR 1.5-3.5) after (p = 0.025). The time to first relapse was shorter in patients shifting from a second-line therapy (p = 0.011). Over 2 years, 43.7% had no evidence of disease activity. We observed infusion-related reactions in 95.5% patients, including 11.1% with pneumonitis, thyroiditis in 11%, and thrombocytopenia in 3.3%.
CONCLUSIONS
CONCLUSIONS
We confirmed the clinical and MRI efficacy of alemtuzumab in the clinical setting and the frequency of infusion-related reactions. Compared with that in clinical trials, higher number of patients developed pneumonitis during infusion.
Identifiants
pubmed: 30863891
doi: 10.1007/s00415-019-09272-6
pii: 10.1007/s00415-019-09272-6
doi:
Substances chimiques
Immunologic Factors
0
Alemtuzumab
3A189DH42V
Types de publication
Journal Article
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
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