期刊
MULTIPLE SCLEROSIS JOURNAL
卷 19, 期 8, 页码 1106-1112出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/1352458512471878
关键词
Multiple sclerosis; adolescence; childhood; natalizumab
资金
- Sanofi-Aventis
- Biogen Idec
- Merck Serono
- Bayer Schering Pharma
- Teva Pharmaceuticals Industries Ltd
- Genzyme Corporation
- Novartis
- Eisai Inc.
- Ministero della Salute of Italy
- Schering
- Sanofi Aventis
- Teva
- Biogen Domp
- Associazione Italiana Sclerosi Multipla
- Italian Ministry of Health
- Genmab A/S
- Pharmaceutical Industries Ltd
- Fondazione Italiana Sclerosi Multipla
Background: Limited information is available on the use of natalizumab (NA) in pediatric multiple sclerosis (ped-MS) patients. Objective: The purpose of this study was to describe the long-term effects of NA in a large cohort of active ped-MS patients. Methods: Patients with definite ped-MS were treated with NA if in the previous year they had experienced at least two relapses or a severe relapse with incomplete recovery while on immunomodulating treatment, or at least two relapses and new magnetic resonance imaging (MRI) lesions regardless of any prior treatment. Results: The study included 55 patients (mean age: 14.4 years, mean number of relapses: 4.4, pre-treatment mean disease duration: 25.5 months). They received a median number of 26 infusions. Three relapses occurred during the follow-up, one female patient continued to deteriorate in cognitive functioning. Mean Expanded Disability Status Scale (EDSS) scores decreased from 2.7 to 1.9 at the last visit (p<0.001). During the follow-up the majority of patients remained free from MRI activity. Transient and mild clinical adverse events occurred in 20 patients. Mild hematological abnormalities occurred in seven patients. Anti-JCV antibodies were detected in 20/51 tested patients. Conclusions: NA was well tolerated in all patients. A strong suppression of disease activity was observed in the majority of patients during the follow-up.
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