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Biosimilar Brenzys comparable to Enbrel in patients with RA
The biosimilar agent Brenzys was shown to have comparable efficacy and safety compared to originator Enbrel after 24 weeks in patients with rheumatoid arthritis, according to recently published research.
Researchers enrolled 596 patients with rheumatoid arthritis (RA) who completed 24 weeks of treatment with either Enbrel (etanercept, Amgen) or Brenzys (etanercept, Samsung Bioepis). Included patients were between 18 and 75 years of age, diagnosed with RA by the 1987 American College of Rheumatology (ACR) criteria within 6 months to 15 years prior to screening, and had active disease in at least six swollen or tender joints and high erythrocyte sedimentation rate (ESR) or high C-reactive protein. Oral glucocorticoids and NSAIDs were permitted in the presence of a stable dose for at least 4 weeks prior to enrollment.
Patients were randomized to either biosimilar etanercept or originator etanercept 1:1 and self-administered 50 mg of the assigned treatment once weekly subcutaneously. Concomitant methotrexate and folic acid were required per treatment protocol.
After 24 weeks, 283 of 299 patients randomized to biosimilar etanercept and 268 of 297 patients randomized to originator etanercept remained enrolled in the ongoing study. In the treatment per-protocol patients, the ACR 20% response rate (ACR20) was met by 78.1% in the biosimilar etanercept group and by 80.3% in the originator etanercept group, and ACR 50 and ACR70 responses were similar in each group. Antidrug antibodies were not developed in 78% of the patients who received biosimilar etanercept or in 81.5% of patients who received originator etanercept comparable safety profile was observed, with similar numbers of adverse events in each group (55.2 vs. 58.2%) upper respiratory tract infection and increased alanine aminotransferase as the most common adverse events. – by Shirley Pulawski
Disclosure: All authors report the receipt of funding from Samsung Bioepis. Please see the full study for a list of all other authors’ relevant financial disclosures.