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04-07-2022 | Magnetic Resonance Imaging | Original Article

Long-term follow-up (up to 11 years) of an Italian pediatric MS cohort treated with Natalizumab: a multicenter, observational study

Authors: Damiano Baroncini, Angelo Ghezzi, Clara Guaschino, Lucia Moiola, Massimo Filippi, Antonio Ianniello, Carlo Pozzilli, Roberta Lanzillo, Vincenzo Brescia-Morra, Monica Margoni, Paolo Gallo, Graziella Callari, Luigi Grimaldi, Giacomo Lus, Massimiliano Calabrese, Marta Simone, Girolama Alessandra Marfia, Sarah Rasia, Daniela Cargnelutti, Giancarlo Comi, Mauro Zaffaroni, MS Study Group of the Italian Neurological Society

Published in: Neurological Sciences | Issue 11/2022

Abstract

Background

Natalizumab (NAT) has a strong impact on disease activity of aggressive pediatric multiple sclerosis (MS), with no difference in safety profile compared to adult MS. However, available data are limited by short follow-up.

Our aim was to report long-term follow-up data (up to 11 years) of a large Italian pediatric MS cohort treated with NAT.

Materials and methods

We retrospectively collected data of pediatric MS patients treated with NAT included in a previous study and prospectively followed in Italian MS centers. We compared disease activity pre, during, and post-NAT and we performed survival analyses of time to evidence of disease activity (EDA) during NAT, time to reach EDA post-NAT, and time to NAT discontinuation.

Results

Ninety-two patients were included from 19 MS centers in Italy. At NAT initiation, cohort’s characteristics were as follows: 55 females; 14.7 ± 2.4 (mean ± SD) years of age; 34 naïve to disease modifying therapies; 1-year pre-NAT annualized relapse rate (ARR): 2.2 ± 1.2; EDSS (median [IQR]): 2.5 [2.0–3.0]; gadolinium-enhancing lesions: 2 [1–5]; 41 JCV positives. During NAT treatment (61.9 ± 35.2 mean infusions), ARR lowered to 0.08 ± 0.23 (p < 0.001), EDSS score to 1.5 [1.0–2.5] at last infusion (p < 0.001), and 51% patients had EDA (21% after 6 months of rebaseline). No serious adverse events were reported. Forty-nine patients discontinued NAT, mainly due to PML concern; the majority (29/49) had disease reactivation in the subsequent 12 months, of which three with a clinical rebound.

Conclusion

NAT treatment maintains its high efficacy for a long time in pediatric MS patients, with no new safety issues.

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Title: Long-term follow-up (up to 11 years) of an Italian pediatric MS cohort treated with Natalizumab: a multicenter, observational study
Authors: Damiano Baroncini
Angelo Ghezzi
Clara Guaschino
Lucia Moiola
Massimo Filippi
Antonio Ianniello
Carlo Pozzilli
Roberta Lanzillo
Vincenzo Brescia-Morra
Monica Margoni
Paolo Gallo
Graziella Callari
Luigi Grimaldi
Giacomo Lus
Massimiliano Calabrese
Marta Simone
Girolama Alessandra Marfia
Sarah Rasia
Daniela Cargnelutti
Giancarlo Comi
Mauro Zaffaroni
MS Study Group of the Italian Neurological Society
Publication date: 04-07-2022
Publisher: Springer International Publishing
Keywords: Magnetic Resonance Imaging
Magnetic Resonance Imaging
Multiple Sclerosis
Natalizumab
Published in: Neurological Sciences / Issue 11/2022
Print ISSN: 1590-1874
Electronic ISSN: 1590-3478
DOI: https://doi.org/10.1007/s10072-022-06211-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Long-term follow-up (up to 11 years) of an Italian pediatric MS cohort treated with Natalizumab: a multicenter, observational study

Abstract

Background

Materials and methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Materials and methods

Results

Conclusion

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