| Title: |
PERFUSE - A Real-World Study on Rheumatology Patients’ Persistence with Adalimumab Biosimilar SB5 in France: Impacts of Patient Experience |
| Authors: |
Fautrel, Bruno; Salliot, Carine; Bernardeau, Christophe; Maugars, Yves; Coury, Fabienne; Tropé, Sonia; Lafarge, Delphine; Camoin, Armelle; Addison, Janet |
| Contributors: |
CHU Pitié-Salpêtrière AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Centre Hospitalier Regional d'Orléans (CHRO); Polyclinique de Limoges - site François Chénieux Limoges; Regenerative Medicine and Skeleton (RMeS); École nationale vétérinaire, agroalimentaire et de l'alimentation Nantes-Atlantique (ONIRIS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nantes Université - UFR Odontologie (Nantes Univ – UFR Odonto); Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ); Nantes Université (Nantes Univ); Hospices Civils de Lyon (HCL); Association Nationale de Défense contre l'Arthrite Rhumatoide (ANDAR) |
| Source: |
ISSN: 1874-3129 ; The Open Rheumatology Journal ; https://hal.science/hal-05222567 ; The Open Rheumatology Journal, 2025, 19 (1), ⟨10.2174/0118743129328661241128114825⟩. |
| Publisher Information: |
CCSD |
| Publication Year: |
2025 |
| Subject Terms: |
Treatment persistence; PROMs; Biosimilars; Adalimumab; Patient experience; Chronic inflammatory rheumatic disease; [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Description: |
International audience ; AimThis study aimed to provide new insights into patient training and satisfaction using Patient-reported Outcome Measures (PROMs) and their impact on 12-month persistence using SB5 in France.BackgroundSB5 is an EMA-approved adalimumab biosimilar, demonstrating bioequivalence, equivalent efficacy, and similar safety and immunogenicity as the reference biologic.ObjectiveThe purpose of this study was to assess the effect of training practices on SB5 use in rheumatology and patient satisfaction, and measure their impact on 12-month persistence in real life in France.Methods507 eligible patients diagnosed with rheumatoid arthritis (n=116), psoriatic arthritis (n=78), or ankylosing spondylitis (n=313) who were enrolled in the observational PERFUSE study between October 2018 and December 2020 at 25 clinical sites across France were included in this analysis. PROMs were collected 1-month after baseline via an online questionnaire designed with patient associations’ input. Persistence of SB5 use was captured during routine visits. The study (clinical trial NCT03662919) first received regulatory approval from French authorities on March 21, 2018. The final amendment was approved on April 25th, 2019.ResultsTraining on the correct use of SB5 injections was accepted (naive = 92.4%; pre-treated = 82.6%) and appreciated (naive = 95.9%; pre-treated = 97.4%) by patients. Satisfaction scores were high for all subgroups. Higher satisfaction with the injection device was linked to a lower probability of discontinuing treatment (HR=0.87; 95% CI (0.79; 0.96); p |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.2174/0118743129328661241128114825 |
| Availability: |
https://hal.science/hal-05222567; https://hal.science/hal-05222567v1/document; https://hal.science/hal-05222567v1/file/e18743129328661.pdf; https://doi.org/10.2174/0118743129328661241128114825 |
| Rights: |
http://creativecommons.org/licenses/by/ ; info:eu-repo/semantics/OpenAccess |
| Accession Number: |
edsbas.89B26296 |
| Database: |
BASE |