Study: Biosimilar Etanercept Shows Equivalence With Reference Product for Rheumatoid Arthritis

Biosimilar etanercept (Sunshine Guojian Pharmaceutical) showed similar therapeutic outcomes compared with etanercept (Enbrel; Amgen) specific to rheumatoid arthritis.

Biosimilar etanercept (Sunshine Guojian Pharmaceutical Co Ltd) showed equivalence with reference etanercept (Enbrel; Amgen), according to results of a new clinical trial (NCT04079374). In previous studies, the biosimilar and reference product have shown similar therapeutic outcomes, but there were only a few studies for the comparison as treatment for rheumatoid arthritis (RA).¹

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The open-label, randomized study evaluated the efficacy and safety of the biosimilar and reference product as subcutaneous injections at 25 mg twice weekly for 24 weeks in combination with methotrexate for patients with RA. The study was 49 to 52 total weeks, including screening up to 4 weeks, treatment of 24 weeks, follow-up post-treatment for 4 weeks, and evaluation of the study after 52 weeks post-initiation.²

Investigators included patients aged 18 to 75 years with a diagnosis of moderate-to-high activity RA, functional class I, II, or III, 6 or more painful and swollen joints, and those who received methotrexate 7.5 mg to 20 mg per week for at least 12 weeks (and the dose and route of administration was not changed for 4 weeks before starting the study drug.) Patients were excluded if they had known hypersensitivity to etanercept, other rheumatic diseases, autoimmune diseases, connective tissue diseases, or immunodeficiency, or septic arthritis within 12 months before screening, acute or frequent recurrent chronic, local, or generalized infection.Patients were recruited and enrolled in the study at 17 sites in Ukraine between March 27, 2019, and December 28, 2020.^1,2

The primary outcome was at least a 20% improvement from baseline in American College of Rheumatology (ACR) 20 criteria response for tender joint, swollen joint, and 3 of the 5 core set measures: Health Assessment Questionnaire-Disability Index, c-reactive protein, Patient’s Assessment of Arthritis Pain-Visual Analog Scale, Patient’s Global Assessment of Disease Activity-Visual Analog Scale, and Physician’s Global Assessment of Disease Activity-Visual Analog Scale. Secondary outcomes included at least a 50% improvement from baseline of ACR50, ACR70 responders, number of individuals who achieved remission and low disease activity, changes in activity index by Disease Activity Score 28 (DAS28), and change in functional state of patients according to the Health Assessment Questionnaire, according to the clinical trial information.²

About The Trial

Title: Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel

ClinicalTrials.gov ID: NCT04079374

Sponsor: Joint Stock Company "Farmak"

Completion Date: December 2023

There were 156 individuals (79 received the biosimilar, 77 received the reference product) who completed the 24-week treatment and were followed up post-treatment, according to the study authors. Approximately 82.3% of patients in the biosimilar group and 90.9% in the reference product group achieved ACR20, according to the results of the study. For secondary end points, the differences between patients taking the biosimilar and those reference product at weeks 4, 8, 12, and 24 were not statistically significant, ranging from 6.3% to 53.2% and 3.9% to 57.1%, respectively. The study authors found that ACR70 responses were similar with 1.3% to 29.1% and 0% to 26%, respectively.¹

Furthermore, there were no statistically significant differences in changes of DAS28 between both groups. In the biosimilar group, 35 individuals experienced 189 mild adverse events (AEs), while 14 experienced 25 moderate AEs. There was only 1 patient with a severe AE. For the reference product, there were 31 patients with 246 mild AEs, 19 patients with 30 moderate AEs, and 2 individuals with 2 severe AEs.¹

REFERENCES

1. Pekhenko V, Udovitskiy V, Barbukho O. Efficacy, safety and immunogenicity of the biosimilar etanercept compared to the reference formulation original etanercept in patients with rheumatoid arthritis: An open-label, randomized, comparative, multicenter study. Medicine (Baltimore). 2024;103(30):e39060. doi:10.1097/MD.0000000000039060

2. Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel. ClinicalTrials.gov identification: NCT04079374. Updated February 3, 2021. Accessed August 19, 2024. https://clinicaltrials.gov/study/NCT04079374