PERFUSE - A Real-World Study on Rheumatology Patients’ Persistence with Adalimumab Biosimilar SB5 in France: Impacts of Patient Experience

Aim This 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. Background SB5 is an EMA-approved adalimumab biosimilar, demonstrating bioequivalence, equivalent efficacy, and similar safety and immunogenicity as the reference biologic. Objective The 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. Methods 507 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. Results Training 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 <0.05), as was a worse perception of the illness assessed using the B-IPQ (HR=1.03; (1.00; 1.05); p <0.05). Moreover, a significantly higher proportion of ePRO (electronic Patient-reported Outcomes) respondents (n=221/507) remained on SB5 at 12 months than non-respondents (66.4% (59.3; 72.5) vs . 48.7% (42.4; 54.8); p <0.05). Conclusion Lower initial satisfaction may serve as a useful indicator for identifying individuals at a higher risk of non-persistence. This could provide a basis for recommending the standardization of patient information practices throughout France, particularly for pre-treated patients.