Natalizumab wearing-off symptoms : effect of extend interval dosing during Sars-CoV-2 pandemic
© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany..
BACKGROUND: Many patients treated with Natalizumab experience wearing-off symptoms (WoS) towards the end of the administration cycle. During the pandemic we advised and asked patients undergoing treatment with Natalizumab if they wanted to be shifted from a standard interval dosing (StID of 4 weeks) to an extended interval dosing (ExID of 5-6 weeks), regardless of their JCV index. Our main objective was to study prevalence and incidence of WoS when ExID was adopted.
METHODS: We enrolled 86 patients, from May 2020 to January 2021, evaluated at baseline and during a 6 months follow-up with a survey focused on WoS, Fatigue Severity Scale (FSS), Expanded Disability Status Scale (EDSS) and MRI.
RESULTS: Among the 86 patients, 32 (37.2%) reported WoS. Most common one was fatigue (93.7%). Mean EDSS was higher in the group reporting WoS (3.8 WoS vs 3.1 non-WoS, p < 0.05). Sphincterial function was the EDSS item that significantly differed between the WoS group and the non-WoS group (1.4 WoS vs 0.6 non-WoS, p < 0.001). WoS correlate with the FSS scale (p < 0.001).
CONCLUSION: Adopting an extended interval dosing does not result in significantly different occurrence of WoS between the ExID and the StID populations, in our cohort of patients. Interestingly, there is a strong correlation between WoS and a higher EDSS and FSS. Safety and efficacy of Natalizumab with ExID are relatively preserved in our study.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:270 |
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| Enthalten in: |
Journal of neurology - 270(2023), 2 vom: 13. Feb., Seite 595-600 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Magro, Giuseppe [VerfasserIn] |
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| Links: |
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| Themen: |
End of dosing interval symptoms (EDIs) |
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| Anmerkungen: |
Date Completed 01.02.2023 Date Revised 02.02.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s00415-022-11408-0 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM347447686 |
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| 100 | 1 | |a Magro, Giuseppe |e verfasserin |4 aut | |
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| 520 | |a © 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany. | ||
| 520 | |a BACKGROUND: Many patients treated with Natalizumab experience wearing-off symptoms (WoS) towards the end of the administration cycle. During the pandemic we advised and asked patients undergoing treatment with Natalizumab if they wanted to be shifted from a standard interval dosing (StID of 4 weeks) to an extended interval dosing (ExID of 5-6 weeks), regardless of their JCV index. Our main objective was to study prevalence and incidence of WoS when ExID was adopted | ||
| 520 | |a METHODS: We enrolled 86 patients, from May 2020 to January 2021, evaluated at baseline and during a 6 months follow-up with a survey focused on WoS, Fatigue Severity Scale (FSS), Expanded Disability Status Scale (EDSS) and MRI | ||
| 520 | |a RESULTS: Among the 86 patients, 32 (37.2%) reported WoS. Most common one was fatigue (93.7%). Mean EDSS was higher in the group reporting WoS (3.8 WoS vs 3.1 non-WoS, p < 0.05). Sphincterial function was the EDSS item that significantly differed between the WoS group and the non-WoS group (1.4 WoS vs 0.6 non-WoS, p < 0.001). WoS correlate with the FSS scale (p < 0.001) | ||
| 520 | |a CONCLUSION: Adopting an extended interval dosing does not result in significantly different occurrence of WoS between the ExID and the StID populations, in our cohort of patients. Interestingly, there is a strong correlation between WoS and a higher EDSS and FSS. Safety and efficacy of Natalizumab with ExID are relatively preserved in our study | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a End of dosing interval symptoms (EDIs) | |
| 650 | 4 | |a Extended interval dosing (ExID) | |
| 650 | 4 | |a Fatigue | |
| 650 | 4 | |a Multiple sclerosis | |
| 650 | 4 | |a Natalizumab wearing-off symptoms (WoS) | |
| 650 | 7 | |a Natalizumab |2 NLM | |
| 650 | 7 | |a Immunologic Factors |2 NLM | |
| 700 | 1 | |a Barone, Stefania |e verfasserin |4 aut | |
| 700 | 1 | |a Tosto, Federico |e verfasserin |4 aut | |
| 700 | 1 | |a De Martino, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Santange Lo, Domenico |e verfasserin |4 aut | |
| 700 | 1 | |a Manzo, Lucia |e verfasserin |4 aut | |
| 700 | 1 | |a Pascarella, Angelo |e verfasserin |4 aut | |
| 700 | 1 | |a Bruno, Pietro |e verfasserin |4 aut | |
| 700 | 1 | |a Pasquale, Marilisa |e verfasserin |4 aut | |
| 700 | 1 | |a Gambardella, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a Valentino, Paola |e verfasserin |4 aut | |
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