Real-World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort.
Extended interval dosing
Multiple sclerosis
Natalizumab
Real-world evidence
Journal
Neurology and therapy
ISSN: 2193-8253
Titre abrégé: Neurol Ther
Pays: New Zealand
ID NLM: 101637818
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
09
11
2022
accepted:
19
01
2023
medline:
11
2
2023
pubmed:
11
2
2023
entrez:
10
2
2023
Statut:
ppublish
Résumé
Natalizumab, a therapy for relapsing-remitting multiple sclerosis (RRMS), is associated with a risk of progressive multifocal leukoencephalopathy (PML). Over the last several years, practitioners have used off-label extended interval dosing (EID) of natalizumab to reduce PML risk, despite the absence of a large-scale efficacy evaluation. We conducted a retrospective, multicenter cohort study among adults with RRMS receiving stable standard interval dosing (SID), defined as a ≥ 12-month consecutive period of ≥ 11 natalizumab infusions/year in France. We compared the 12-month risk difference of remaining relapse-free (primary endpoint) between patients who switched to EID (≤ 9 natalizumab infusions) and those who remained on SID, with a noninferiority margin of - 11%. We used propensity score methods such as inverse probability treatment weighting (IPTW) and 1:1 propensity score matching (PSM). Secondary endpoints were annualized relapse rate, disease progression, and safety. Baseline characteristics were similar between patients receiving EID (n = 147) and SID (n = 156). The proportion of relapse-free patients 12 months postbaseline was 142/147 in the EID (96.6%) and 144/156 in the SID group (92.3%); risk difference (95% CI) 4.3% (- 1.3 to 9.8%); p < 0.001 for non-inferiority. There were no significant differences between relapse rates (0.043 vs. 0.083 per year, respectively; p = 0.14) or Expanded Disability Status Scale mean scores (2.43 vs. 2.72, respectively; p = 0.18); anti-JC virus index values were similar (p = 0.23); and no instances of PML were reported. The comparisons using IPTW (n = 306) and PSM (n = 204) were consistent. These results support the pertinence of using an EID strategy for RRMS patients treated with natalizumab. gov identifier (NCT04580381).
Identifiants
pubmed: 36763307
doi: 10.1007/s40120-023-00440-5
pii: 10.1007/s40120-023-00440-5
pmc: PMC10043118
doi:
Banques de données
ClinicalTrials.gov
['NCT04580381']
Types de publication
Journal Article
Langues
eng
Pagination
529-542Informations de copyright
© 2023. The Author(s).
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