Safety and efficacy of natalizumab in children with multiple sclerosis

A. Ghezzi, C. Pozzilli, L. M E Grimaldi, V. Brescia Morra, F. Bortolon, R. Capra, M. Filippi, L. Moiola, M. A. Rocca, M. Rottoli, P. Sarchielli, M. Zaffaroni, G. Comi

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Abstract

Objective: To describe the effect of natalizumab in the treatment of subjects with active multiple sclerosis (MS) treated before the age of 18 years. Methods: Nineteen pediatric subjects with MS (mean age 14.6 ± 2.2 years, mean number of attacks 5.2 ± 1.9 during the pretreatment phase of 27.7 ± 19.7 months, median pretreatment Expanded Disability Status Scale score [EDSS] 2.5, range 1.0-5.0) were treated with natalizumab at the dose of 300 mg every 28 days. After treatment initiation, patients were reassessed clinically every month; brain MRI was performed at baseline and every 6 months. Results: Patients received a median number of 15 infusions (range 6-26). A transient reversible worsening of preexisting symptoms occurred in 1 subject during and following the first infusion. All the patients remained relapse-free during the whole follow-up. The median EDSS decreased from 2.5 to 2.0 at the last visit (p <0.001). EDSS remained stable in 5 cases, decreased by at least 0.5 point in 6 cases, and decreased by at least 1 point in 8 cases. At baseline, the mean number of gadolinium-enhancing lesions was 4.1 (range 1-20). During the follow-up, no gadolinium-enhancing lesions were detected (p = 0.008); 3 patients developed new T2-visible lesions at month 6 scan but the overall number of T2 lesions remained stable during the subsequent follow-up. Transient and mild side effects occurred in 8 patients. Conclusions: Natalizumab was well-tolerated in all subjects. A strong suppression of disease activity was observed in all subjects during the follow-up. Classification of Evidence: This study provides Class IV evidence that natalizumab, 300 mg IV once every 28 days, decreased EDSS scores in pediatric patients with MS over a mean treatment period of 15.2 months.

Original languageEnglish
Pages (from-to)912-917
Number of pages6
JournalNeurology
Volume75
Issue number10
DOIs
Publication statusPublished - Sep 7 2010

ASJC Scopus subject areas

  • Clinical Neurology

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    Ghezzi, A., Pozzilli, C., Grimaldi, L. M. E., Morra, V. B., Bortolon, F., Capra, R., Filippi, M., Moiola, L., Rocca, M. A., Rottoli, M., Sarchielli, P., Zaffaroni, M., & Comi, G. (2010). Safety and efficacy of natalizumab in children with multiple sclerosis. Neurology, 75(10), 912-917. https://doi.org/10.1212/WNL.0b013e3181f11daf