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Journal of Neurology

, Volume 267, Issue 1, pp 100–105 | Cite as

No evidence of disease activity including cognition (NEDA-3 plus) in naïve pediatric multiple sclerosis patients treated with natalizumab

  • Monica MargoniEmail author
  • Francesca Rinaldi
  • Alice Riccardi
  • Silvia Franciotta
  • Paola Perini
  • Paolo Gallo
Original Communication

Abstract

Background

Pediatric-onset multiple sclerosis (POMS) is characterized by high inflammatory activity, aggressive course and early development of physical and cognitive disability. A highly effective early treatment must be considered in POMS.

Objective

To evaluate safety and efficacy of natalizumab (NTZ) in naïve POMS.

Methods

20 naïve POMS (13F, 7 M; mean age: 13.8 ± 2.7 years) were treated with NTZ for at least 24 months (mean number of infusions: 42 ± 20). No evidence of disease activity (NEDA)-3 plus status, i.e., no relapse, no disease progression (EDSS score), no radiological activity and no cognitive decline, was evaluated.

Results

After 2 years of NTZ treatment, a significant reduction in the mean EDSS score (p < 0.0001) was observed in the whole cohort. During the follow-up, evidence of disease activity on MRI was observed in two patients (10%) and a mild decline in cognition was observed in other two. No patient had clinical relapse. At the time of last visit NEDA-3 plus status was maintained in 16 (80%) patients. No major adverse event was observed.

Conclusion

Early treatment of aggressive POMS with NTZ proved to be highly effective in achieving and maintaining the NEDA-3 plus status. Our data support the use of NTZ as first treatment choice in POMS.

Keywords

Pediatric-onset multiple sclerosis Natalizumab NEDA-3 plus 

Notes

Compliance with ethical standards

Conflicts of interest

Monica Margoni reports grants from Teva, grants from Genzyme Sanofi, grants from Merck Serono, grants from Biogen Idec, grants and personal fees from Novartis, during the conduct of the study. Francesca Rinaldi reports grants from Almirall, grants and personal fees from Teva, grants and personal fees from Genzyme Sanofi, grants and personal fees from Merck Serono, grants and personal fees from Biogen Idec, grants from Novartis, during the conduct of the study. Alice Riccardi has nothing to disclose. Silvia Franciotta has nothing to disclose. Paola Perini reports grants and personal fees from Merck Serono, grants and personal fees from Biogen Idec, grants and personal fees from Genzyme Sanofi, grants and personal fees from Bayer Schering Pharma, grants and personal fees from Novartis, grants and personal fees from Teva, during the conduct of the study. Paolo Gallo reports grants and personal fees from Merck Serono, grants and personal fees from Biogen Idec, grants and personal fees from Genzyme Sanofi, grants and personal fees from Bayer Schering Pharma, grants and personal fees from Novartis, grants and personal fees from Teva, grants from University of Padua, Department of Neurosciences DNS, grants from Veneto Region of Italy, grants from Italian Association for Multiple Sclerosis (AISM), grants from Italian Ministry of Public Health, during the conduct of the study.

Ethical standards

This study was approved by the local Ethics Committee and was performed according to the Declaration of Helsinki. Participants received an explanatory statement and gave their written informed consent to participate in the study.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Multiple Sclerosis Centre of the Veneto Region (CeSMuV)University Hospital of PaduaPaduaItaly
  2. 2.Padova Neuroscience Centre (PNC)University of PaduaPaduaItaly
  3. 3.Department of NeurosciencesMedical School, University of PaduaPaduaItaly

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