Etanercept biosimilar, originator produce similar outcomes in rheumatoid arthritis
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Key takeaways:
- Originator- and biosimilar-receiving patients with rheumatoid arthritis demonstrated similar disease activity at 6 months and 1 year.
- Both drugs had a similar survival rate at 1 year.
Patients with rheumatoid arthritis who receive an etanercept biosimilar demonstrate similar disease activity and survival outcomes as those who receive the originator product, according to data published in Rheumatology.
“One of the first biologic therapies to be licensed for use in patients with rheumatoid arthritis (RA) was etanercept, a tumor necrosis factor (TNF) inhibitor, in the early 2000s,” Lianne Kearsley-Fleet, PhD, of the University of Manchester, and colleagues wrote. “From 2016, etanercept biosimilars have been available in the U.K., and due to the reduced costs of these therapies, the National Health Service (NHS) commissioning framework set guidelines for at least 90% of new patients to be prescribed the biosimilar product by 2019.”
To investigate the real-world effectiveness of originator etanercept (Enbrel, Amgen) compared with a biosimilar in patients with RA, Kearsley-Fleet and colleagues analyzed data from the British Society for Rheumatology Biologics Register for RA. Patients were included in the analysis if they had RA and were beginning etanercept therapy as a biologic-naïve patient between Jan. 1, 2010, and June 16, 2022. Collected data included the date of therapy initiation, patient characteristics, disease activity and severity measurements, patient-reported outcomes and functional ability scores. Follow-up data was collected every 6 months for 3 years.
Primary outcomes included DAS28 remission, any EULAR response, “good” EULAR responses and minimal clinically important difference in function scores, the researchers wrote. The authors additionally measured drug survival among included patients.
A total of 1,806 patients with RA were included in the analysis. Of those, 1,009 received the originator product while 797 received the biosimilar medication, with 783 taking Benepali (SB4, Samsung Bioepis) and 14 being prescribed Erelzi (etanercept-szzs, Sandoz). At both 6 and 12 months, the proportion of patients who achieved DAS28 remission and EULAR response was similar across both the originator and biosimilar groups, according to the researchers.
Approximately 19% of patients treated with the originator product switched to a biosimilar during the follow-up period. Additionally, 71% of patients receiving the original therapy and 76% of patients receiving the biosimilar therapy were still receiving that therapy at 1 year.
“This is one of the largest analyses of over 1,800 patients with RA starting etanercept as their first biologic from 2010 in a national cohort study,” Kearsley-Fleet and colleagues wrote. “It found patients starting etanercept originator achieved similar treatment response with respect to disease activity and drug survival compared with patients starting etanercept biosimilar.”
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