Impacts of Biosimilar Etanercept Are Patient-specific, Not Drug-related

By JC Landry - Last Updated: September 11, 2023

According to an observational cohort study, effects of switching from an originator to biosimilar etanercept depend on the patient and are not specific to the drug itself.

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Patients being treated for rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis either switched from 50 mg originator (ETA) to biosimilar (SB4) etanercept (switchers) or maintained ETA (non-switchers). Non-switchers received 25 mg ETA.

Out of 2,061 ETA-treated patients, 1,621 (79%) switched to SB4. After three months, there were no differences in disease activity. After one year, both groups had similar retention rates—non-switchers, 77% (95% CI: 72% to 82%); switchers, 83% (79% to 87%); and historic cohort, 90% (88% to 92%). Patients in remission had higher retention rates compared to those not in remission, in switchers (crude HR 1.7 [1.3 to 2.2]) and non-switchers (2.4 [1.7 to 3.6]). At follow-up, 7% of switchers (n = 120) returned to ETA. According to the researchers, “Back-switchers’ clinical characteristics were similar to switchers, and reasons for SB4 withdrawal were mainly subjective.”

“We found that a nationwide switch from originator to biosimilar [etanercept] in 1,621 patients with inflammatory arthritis had no negative impact on 3 months’ disease activities, and no major safety events were observed,” the study authors wrote. “Despite mandatory switch recommendations, one in five [etanercept]-treated patients did not switch. In both patient groups, withdrawal was most common in patients not in remission. These real-world data indicate that switch outcomes in routine care are affected by non-specific drug effects and patient-related factors.”

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Sources: Healio Rheumatology, Annals of the Rheumatic Diseases

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