Projects per year
Abstract
Objectives: Etanercept biosimilars show comparable efficacy to their originators among biologic-naïve patients with RA in RCTs. Nationwide guidelines have obligated prescribing of etanercept biosimilars from 2016 resulting in significant cost-savings. This analysis aimed to compare the effectiveness of etanercept originator versus etanercept biosimilar amongst biologic-naïve RA patients treated in routine clinical-practice in the UK.
Methods: Biologic-naïve RA patients starting etanercept in the BSRBR-RA cohort study from 2010 were included. Data collected at start of therapy includes patient demographics and disease activity. Follow-up data includes changes in disease activity and anti-rheumatic therapy. Six and 12-month primary outcomes include Disease Activity Score for 28-joints (DAS28) remission, EULAR response, and minimal clinically important difference (MCID) in function. Etanercept drug survival was assessed using Kaplan-Meier and Cox-regression, including reasons for treatment withdrawal. Multiple imputation accounted for missing data. Propensity-decile adjustment was used to account for confounding-by-indication.
Results: 1806 biologic-naïve RA patients started etanercept: 1009 originator, 797 biosimilar. At six and 12-months, proportion of patients achieving DAS28 remission, and EULAR response were similar between treatments. During follow-up, 19% originator patients switched onto etanercept biosimilar. Patients were censored at time of switch. Patients on originator were no more likely to stop therapy versus biosimilar; 71% originator and 76% biosimilar patients remained on therapy at one-year.
Conclusions: In one of the largest analyses of patients with RA, biologic-naïve RA patients treated with etanercept originator showed similar outcomes versus biosimilar using real-world data. Drug survival, and disease activity after six and 12-months of therapy, was similar between cohorts.
Methods: Biologic-naïve RA patients starting etanercept in the BSRBR-RA cohort study from 2010 were included. Data collected at start of therapy includes patient demographics and disease activity. Follow-up data includes changes in disease activity and anti-rheumatic therapy. Six and 12-month primary outcomes include Disease Activity Score for 28-joints (DAS28) remission, EULAR response, and minimal clinically important difference (MCID) in function. Etanercept drug survival was assessed using Kaplan-Meier and Cox-regression, including reasons for treatment withdrawal. Multiple imputation accounted for missing data. Propensity-decile adjustment was used to account for confounding-by-indication.
Results: 1806 biologic-naïve RA patients started etanercept: 1009 originator, 797 biosimilar. At six and 12-months, proportion of patients achieving DAS28 remission, and EULAR response were similar between treatments. During follow-up, 19% originator patients switched onto etanercept biosimilar. Patients were censored at time of switch. Patients on originator were no more likely to stop therapy versus biosimilar; 71% originator and 76% biosimilar patients remained on therapy at one-year.
Conclusions: In one of the largest analyses of patients with RA, biologic-naïve RA patients treated with etanercept originator showed similar outcomes versus biosimilar using real-world data. Drug survival, and disease activity after six and 12-months of therapy, was similar between cohorts.
| Original language | English |
|---|---|
| Journal | Rheumatology (Print) |
| Publication status | Accepted/In press - 14 Mar 2023 |
Keywords
- Rheumatoid Arthritis
- Biologic therapy
- originator
- biosimilar
- disease activity
- outcomes
- epidemiology
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NIHR Manchester Biomedical Research Centre
Bruce, I., Lord, G., Lennon, R., Black, G., Wedge, D., Morris, A., Hussell, T., Sharrocks, A., Stivaros, S., Buch, M., Gough, J., Kostarelos, K., Thistlethwaite, F., Kadler, K., Barton, A., Hyrich, K., Mcbeth, J., O'Neill, T., Vestbo, J., Simpson, A., Singh, S., Smith, J., Felton, T., Murray, C., Griffiths, C., Cullum, N., Rhodes, L., Warren, R., Paus, R., Dumville, J., Viros Usandizaga, A., Keavney, B., Tomaszewski, M., Allan, S., Body, R., Cartwright, E., Heagerty, A., Kalra, P., Miller, C., Rutter, M., Smith, C., Trafford, A., Evans, D., Crosbie, E., Crosbie, P., Harvie, M., Howell, S., Renehan, A., Dive, C., Blackhall, F., Landers, D., Krebs, M., Cook, N., Clarke, R., Taylor, S., Jorgensen, C., Lorigan, P., Jayson, G., Valle, J., Mccabe, M., Armstrong, A., Freitas, A., Illidge, T., Choudhury, A., Hoskin, P., West, C., Van Herk, M., Faivre-Finn, C., Bristow, R., Kirkby, K., Birtle, A., Mackay, R., Radford, J., Linton, K., Higham, C., Munro, K., Plack, C., Arden Armitage, C., Bruce, I., Moore, D., Saunders, G., Stone, M., Haddock, G., Lewis, S., Elliott, R., Green, J., Lovell, K., Morrison, A., Shaw, J., Bucci, S., Ainsworth, J., Webb, R., Newman, W., Banka, S., Clayton-Smith, J., Payne, K., Moldovan, R., Wynn, R. & Jones, S.
1/12/22 → 30/11/27
Project: Research
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British Society for Rheumatology Rheumatoid Arthritis Register (BSRBR-RA)
Hyrich, K., Watson, K., Mowbray, K., Kearsley-Fleet, L., Lunt, M. & Verstappen, S.
Project: Research
Press/Media
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Etanercept biosimilar, originator produce similar outcomes in rheumatoid arthritis
26/04/23
1 Media contribution
Press/Media: Other
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Etanercept Biosimilar Comparable to Originator in Biologic-Naïve Patients With RA
12/04/23
1 item of Media coverage
Press/Media: Other