| Title: |
Real-world evidence of the use of the infliximab biosimilar SB2: data from the PERFUSE study |
| Authors: |
Fautrel, Bruno; Bouhnik, Yoram; Dieude, Philippe; Richette, Pascal; Dougados, Maxime; Freudensprung, Ulrich; Brigui, Amira; Addison, Janet |
| Contributors: |
Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP); Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Hôpital Beaujon AP-HP; AP-HP - Hôpital Bichat - Claude Bernard Paris; Physiopathologie et Epidémiologie des Maladies Respiratoires (PHERE (UMR_S_1152 / U1152)); Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité); Service de Rhumatologie CHU Lariboisière; Hôpital Lariboisière-Fernand-Widal APHP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Université Paris Cité (UPCité); Centre for Research in Epidemiology and Statistics; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE); Service de rhumatologie CHU Cochin; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin AP-HP |
| Source: |
EISSN: 2514-1775 ; Rheumatology Advances in Practice ; https://hal.sorbonne-universite.fr/hal-04087107 ; Rheumatology Advances in Practice, 2023, 7, ⟨10.1093/rap/rkad031⟩ |
| Publisher Information: |
CCSD; British Society for Rheumatology; Oxford University Press |
| Publication Year: |
2023 |
| Subject Terms: |
axial spondyloarthritis; psoriatic arthritis; rheumatoid arthritis; switch; infliximab; biosimilar; NCT03662919 SB2; Trial registration: clinicaltrials.gov; Trial registration: clinicaltrials.gov NCT03662919 SB2 biosimilar infliximab switch rheumatoid arthritis psoriatic arthritis axial spondyloarthritis; [SDV]Life Sciences [q-bio] |
| Description: |
International audience ; Objective: PERFUSE is a non-interventional study of 1233 adult patients (rheumatology, n ¼ 496; IBD, n ¼ 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 naı ¨ve) or followed transition from reference IFX (IFX ref) or another IFX biosimilar (IFX bs). Outcomes to month 12 (62) included persistence (primary outcome), SB2 dose, disease status, immunogenicity and safety. Results: At month 12, persistence on SB2 in IFX-naı ¨ve, 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 ¼ 98); 64% (34.3, 83.3), 87% (65.6, 95.7) and 83% (60.0, 93.1) for PsA (n ¼ 62); and 56% (44.4, 66.5), 80% (70.8, 86.1) and 80% (72.5, 85.6) for axSpA (n ¼ 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-naı ¨ve patients and in patients transitioned from prior IFX ref or bs. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1093/rap/rkad031 |
| Availability: |
https://hal.sorbonne-universite.fr/hal-04087107; https://hal.sorbonne-universite.fr/hal-04087107v1/document; https://hal.sorbonne-universite.fr/hal-04087107v1/file/rkad031.pdf; https://doi.org/10.1093/rap/rkad031 |
| Rights: |
info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.F8BA4649 |
| Database: |
BASE |