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Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study

OBJECTIVE: PERFUSE is a non-interventional study of 1233 adult patients (rheumatology, n = 496; IBD, n = 737) receiving routine infliximab (IFX) biosimilar SB2 therapy. The aim of this report was to investigate the 12-month persistence, effectiveness and safety outcomes of routine SB2 treatment in p...

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Autores principales: Fautrel, Bruno, Bouhnik, Yoram, Dieude, Philippe, Richette, Pascal, Dougados, Maxime, Freudensprung, Ulrich, Brigui, Amira, Addison, Janet
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10130189/
https://www.ncbi.nlm.nih.gov/pubmed/37122809
http://dx.doi.org/10.1093/rap/rkad031
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author Fautrel, Bruno
Bouhnik, Yoram
Dieude, Philippe
Richette, Pascal
Dougados, Maxime
Freudensprung, Ulrich
Brigui, Amira
Addison, Janet
author_facet Fautrel, Bruno
Bouhnik, Yoram
Dieude, Philippe
Richette, Pascal
Dougados, Maxime
Freudensprung, Ulrich
Brigui, Amira
Addison, Janet
author_sort Fautrel, Bruno
collection PubMed
description OBJECTIVE: PERFUSE is a non-interventional study of 1233 adult patients (rheumatology, n = 496; IBD, n = 737) receiving routine infliximab (IFX) biosimilar SB2 therapy. The aim of this report was to investigate the 12-month persistence, effectiveness and safety outcomes of routine SB2 treatment in patients with chronic inflammatory rheumatic disease. METHODS: Patients with a diagnosis of RA, PsA or axial spondyloarthritis (axSpA) were assigned to one of three study cohorts according to whether SB2 treatment initiated after September 2017 had been the first IFX treatment (IFX naïve) or followed transition from reference IFX (IFX ref) or another IFX biosimilar (IFX bs). Outcomes to month 12 (±2) included persistence (primary outcome), SB2 dose, disease status, immunogenicity and safety. RESULTS: At month 12, persistence on SB2 in IFX-naïve, IFX ref and IFX bs cohorts, respectively, [mean percentage (95% CI)] by indication was as follows: 59% (36.1, 76.2), 75% (57.5, 86.1) and 85% (69.6, 93.0) for RA (n = 98); 64% (34.3, 83.3), 87% (65.6, 95.7) and 83% (60.0, 93.1) for PsA (n = 62); and 56% (44.4, 66.5), 80% (70.8, 86.1) and 80% (72.5, 85.6) for axSpA (n = 336). Disease activity was comparable at baseline and month 12 within the IFX ref and bs subgroups of all cohorts by indication. No immunogenicity concerns or new safety signals were detected. CONCLUSION: SB2 was safe and effective in IFX-naïve patients and in patients transitioned from prior IFX ref or bs. TRIAL REGISTRATION: clinicaltrials.gov, NCT03662919
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spelling pubmed-101301892023-04-27 Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study Fautrel, Bruno Bouhnik, Yoram Dieude, Philippe Richette, Pascal Dougados, Maxime Freudensprung, Ulrich Brigui, Amira Addison, Janet Rheumatol Adv Pract Original Article OBJECTIVE: PERFUSE is a non-interventional study of 1233 adult patients (rheumatology, n = 496; IBD, n = 737) receiving routine infliximab (IFX) biosimilar SB2 therapy. The aim of this report was to investigate the 12-month persistence, effectiveness and safety outcomes of routine SB2 treatment in patients with chronic inflammatory rheumatic disease. METHODS: Patients with a diagnosis of RA, PsA or axial spondyloarthritis (axSpA) were assigned to one of three study cohorts according to whether SB2 treatment initiated after September 2017 had been the first IFX treatment (IFX naïve) or followed transition from reference IFX (IFX ref) or another IFX biosimilar (IFX bs). Outcomes to month 12 (±2) included persistence (primary outcome), SB2 dose, disease status, immunogenicity and safety. RESULTS: At month 12, persistence on SB2 in IFX-naïve, IFX ref and IFX bs cohorts, respectively, [mean percentage (95% CI)] by indication was as follows: 59% (36.1, 76.2), 75% (57.5, 86.1) and 85% (69.6, 93.0) for RA (n = 98); 64% (34.3, 83.3), 87% (65.6, 95.7) and 83% (60.0, 93.1) for PsA (n = 62); and 56% (44.4, 66.5), 80% (70.8, 86.1) and 80% (72.5, 85.6) for axSpA (n = 336). Disease activity was comparable at baseline and month 12 within the IFX ref and bs subgroups of all cohorts by indication. No immunogenicity concerns or new safety signals were detected. CONCLUSION: SB2 was safe and effective in IFX-naïve patients and in patients transitioned from prior IFX ref or bs. TRIAL REGISTRATION: clinicaltrials.gov, NCT03662919 Oxford University Press 2023-04-17 /pmc/articles/PMC10130189/ /pubmed/37122809 http://dx.doi.org/10.1093/rap/rkad031 Text en © The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Fautrel, Bruno
Bouhnik, Yoram
Dieude, Philippe
Richette, Pascal
Dougados, Maxime
Freudensprung, Ulrich
Brigui, Amira
Addison, Janet
Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study
title Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study
title_full Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study
title_fullStr Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study
title_full_unstemmed Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study
title_short Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study
title_sort real-world evidence of the use of the infliximab biosimilar sb2: data from the perfuse study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10130189/
https://www.ncbi.nlm.nih.gov/pubmed/37122809
http://dx.doi.org/10.1093/rap/rkad031
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