We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Long-term follow-up (up to 11 years) of an Italian pediatric MS cohort treated with Natalizumab: a multicenter, observational study.
- Authors
Baroncini, Damiano; Ghezzi, Angelo; Guaschino, Clara; Moiola, Lucia; Filippi, Massimo; Ianniello, Antonio; Pozzilli, Carlo; Lanzillo, Roberta; Brescia-Morra, Vincenzo; Margoni, Monica; Gallo, Paolo; Callari, Graziella; Grimaldi, Luigi; Lus, Giacomo; Calabrese, Massimiliano; Simone, Marta; Marfia, Girolama Alessandra; Rasia, Sarah; Cargnelutti, Daniela; Comi, Giancarlo
- 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.
- Subjects
ITALY; NATALIZUMAB; SCIENTIFIC observation; MULTIPLE sclerosis; JOHN Cunningham virus
- Publication
Neurological Sciences, 2022, Vol 43, Issue 11, p6415
- ISSN
1590-1874
- Publication type
Article
- DOI
10.1007/s10072-022-06211-8