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Comparative efficacy of subcutaneous versus intravenous natalizumab on annualized relapse rate: A post-hoc analysis of the REFINE study.
Mariottini, Alice; Mealli, Fabrizia; Mattei, Alessandra; Massacesi, Luca.
Afiliación
  • Mariottini A; Department of NEUROFARBA, University of Florence, Florence, Italy; Department of Neurology 2 and Tuscan Region Multiple Sclerosis Referral Centre, Careggi University Hospital, Florence, Italy. Electronic address: alice.mariottini@unifi.it.
  • Mealli F; Department of Statistics Informatics and Applications "Giuseppe Parenti", University of Florence, Florence, Italy; Florence Centre for Data Science, Florence, Italy.
  • Mattei A; Department of Statistics Informatics and Applications "Giuseppe Parenti", University of Florence, Florence, Italy; Florence Centre for Data Science, Florence, Italy.
  • Massacesi L; Department of NEUROFARBA, University of Florence, Florence, Italy; Department of Neurology 2 and Tuscan Region Multiple Sclerosis Referral Centre, Careggi University Hospital, Florence, Italy.
Mult Scler Relat Disord ; 91: 105852, 2024 Aug 27.
Article en En | MEDLINE | ID: mdl-39226723
ABSTRACT

BACKGROUND:

The non-inferiority of the efficacy of subcutaneous (SC) vs intravenous (IV) administration of natalizumab (NTZ) once every 4 weeks in relapsing-remitting multiple sclerosis (RRMS) was recently demonstrated on the primary outcome of the REFINE study, i.e. MRI "combined unique active lesions number" (CUAL). To provide further evidence on the comparative efficacy of the two NTZ formulations, the effect of NTZ-SC vs NTZ-IV on annualized relapse rate (ARR) was investigated re-analysing the REFINE dataset.

METHODS:

Post-hoc analysis of the REFINE study dataset aimed at exploring the non-inferiority of the efficacy of NTZ-SC vs NTZ-IV on ARR, i.e. the main secondary outcome of the REFINE study. Robustness of the non-inferiority analysis on CUAL with respect to the presence of cases from the SC arm who received a rescue treatment, including NTZ-IV, was also assessed by sensitivity analyses. Three non-inferiority margins were selected, corresponding to 25 %, 33 %, and 50 % fractions of the effect size of NTZ-IV vs placebo observed in the AFFIRM study on ARR (i.e. 0.125, 0.170, and 0.250).

RESULTS:

Ninety-nine RRMS patients were included. The mean difference in the effect of NTZ-SC vs NTZ-IV on ARR was close to 0. The lower bound of the 95 % confidence interval (worst case scenario) was -0.119, corresponding to 25 % (p = 0.025) of the effect of NTZ-IV vs placebo on ARR. Sensitivity analyses confirmed the results of the primary non-inferiority analysis on the outcome CUAL.

CONCLUSIONS:

NTZ-SC resulted not inferior to NTZ-IV on ARR for all the non-inferiority margins. The non-inferiority analysis of the efficacy of NTZ-SC vs NTZ-IV on CUAL was demonstrated to be robust with respect to rescued patients.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Mult Scler Relat Disord Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Mult Scler Relat Disord Año: 2024 Tipo del documento: Article Pais de publicación: Países Bajos