The findings of a retrospective study indicate that successive switching from reference to 2 different biosimilars was not associated with clinically significant changes in disease activity and function in patients with inflammatory rheumatic diseases.
The effect of successive multiple switching from reference biologic to its biosimilars on disease activity and function has not been evaluated. A retrospective study assessed the effectiveness and safety of systematic nonmedical switching from reference etanercept to biosimilar etanercept (SB4) followed by switch to another biosimilar etanercept (GP2015) in adult patients with inflammatory rheumatic diseases in a real-life setting; these data were presented at the American College of Rheumatology Convergence 2020 meeting.
This retrospective study included adult patients with inflammatory rheumatic diseases, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), or axial spondyloarthritis (AS) in a tertiary center, who had been treated with reference etanercept and had been subsequently switched for nonmedical reasons to 2 etanercept biosimilars between February 2017 and December 2017. Changes from baseline to week 12 in clinical outcomes such as disease activity, function, and adverse events (AEs) were identified; the primary outcome was change in disease activity and function at week 12 after the second switch.
A total of 100 patients were included in the analysis; these patients were switched twice to etanercept biosimilars over a follow-up period of 21.1 ± 7.4 months. Of these, 54 patients had a diagnosis of RA, 27 patients had AS, and 19 patients had PsA. The mean age of the study population was 54.3 years (standard deviation, 15.1), and 46% were male.
The retention rate after switch from reference etanercept to the second etanercept biosimilar was 89% (approximately 6 months after second switch). A total of 4 patients switched back to reference etanercept and 4 patients received another treatment modality. A total of 14 AEs were reported in 8 patients. At week 12, no change was seen in disease activity scores and function scores across the 2 switches and across patient cohorts of RA, AS, and PsA.
These real-world data indicate that successive switches from reference to 2 different biosimilars resulted in no major changes in disease activity and function in patients with inflammatory rheumatic diseases.
Reference
Kiltz U, et al. Arthritis Rheumatol. 2020;72(suppl 10):Abstract 573.