Outcomes Following Adalimumab Bio-originator to Biosimilar Switch—A Comparison Using Real-world Patient- and Physician-Reported Data in European Countries

Abstract

Introduction The aim of this work is to compare real-world outcomes of patients with rheumatoid arthritis (RA) receiving adalimumab (ADA) bio-originator (non-switchers) to those who had switched from ADA bio-originator to an ADA biosimilar (switchers) on the basis of the hypothesis that these outcomes would differ. Methods Data were drawn from the Adelphi RA Disease Specific Programme™, a point-in-time survey of physicians and their patients in Europe (France, Germany, Italy, Spain, UK) in 2020. Physicians completed a questionnaire for their next ten adult patients with RA, followed by four additional patients who had switched from ADA bio-originator to an ADA biosimilar (switchers). Physician- and patient-reported outcomes (PROs) for switchers and non-switchers were compared by propensity score matching. Results Three hundred and three rheumatologists provided data for 160 non-switchers and 225 switchers, 140 patients provided data; 51 non-switchers, 89 switchers. According to physician-reported disease activity, non-switchers were more likely to improve on their current ADA treatment than switchers (68%, n = 108 vs. 26%, n = 59 p < 0.001) and less likely to worsen (1%, n = 2 vs. 9%, n = 20; p < 0.01). Physician-reported patient adherence was significantly lower amongst switchers versus non-switchers (0.66 vs. 0.78, respectively; p = 0.04). More non-switchers than switchers were reported by their physicians to be consistent in taking their RA medicine ( p < 0.001). Compared with non-switchers, PRO measures indicated quality of life was worse (EQ-5D Visual Analogue Scale: 62.9 vs. 71.9; p < 0.001) and activity impairment was greater (Work Productivity Activity Index: 31.0 vs. 24.4; p = 0.02) for switchers, with trends for poorer health status and greater pain. Conclusions Non-medical switching in RA treatment may lead to unforeseen outcomes that should be considered by health decision-makers. Supplementary Information The online version contains supplementary material available at 10.1007/s40744-022-00526-w.

Patient Experience with the SensoReady® Autoinjector Pen versus a Comparator Device: Results from a Canadian Patient Survey in Rheumatoid Arthritis and Crohn´s Disease

“…Non-medical switching to biosimilars in patients with IMIDs has been associated with the nocebo effect, where patients experience adverse medical outcomes in response to a non-medically necessary change in their therapy due to negative patient perceptions of the new therapy. 27,28 While assessment of the nocebo effect was beyond the scope of the current survey, it appears to have had limited influence on outcomes, although it may explain the preference for the ref-ADL pen in a small number of patients in this survey.…”

Biosimilars for Rheumatoid Arthritis: Riding the 2023 Wave [Podcast]

“… 4 It’s also notable that many biosimilars and biologics have been approved and widely used in Europe for a number of years, providing us with clinical data from real-world use that consistently supports their efficacy and safety. 5–7 [00:04:41.470]…”