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Neurology. 2010 Sep 7;75(10):912-7. doi: 10.1212/WNL.0b013e3181f11daf.

Safety and efficacy of natalizumab in children with multiple sclerosis.

Author information

  • 1Centro Studi Sclerosi Multipla, Via Pastori 4, Ospedale di Gallarate, Gallarate, Italy. angelo.ghezzi@aogallarate.it

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.

PMID:
20820002
[PubMed - indexed for MEDLINE]
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