AB1501 SAFETY AND EFFECTIVENESS OF ETANERCEPT BIOSIMILAR LBEC0101 FOR RHEUMATIC DISEASES IN SOUTH KOREA: REAL-WORLD POST-MARKETING SURVEILLANCE DATA
Authors: B. Song, S. H. Kim, S. S. Kim
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> LBEC0101, as the third approved biosimilar of etanercept in Korea, represents an important step in expanding treatment options for autoimmune diseases like axial spondyloarthritis (axSpA), rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis (PsO) and juvenile idiopathic arthritis (JIA). A biosimilar is a biologic medical product that is highly similar to an already approved biological medicine, known as the 'reference product' – in this case, etanercept. <h3>Objectives:</h3> The purpose of this post-marketing surveillance (PMS) study of LBEC0101 is to assess the safety and effectiveness of the biosimilar in the varied conditions of routine clinical practice; to collect long-term data,; and to provide real-world evidence. <h3>Methods:</h3> This prospective, multi-center, open-label, observational, phase IV PMS study was designed to enroll patients with axSpA, RA, PsA, PsO, and JIA (Juvenile idopathic arthritis) in Korea from March 2018 to March 2022. Both etanercept-naïve patients or patients switched from reference etanercept were included. LBEC0101 was administered weekly via subcutaneous injections using pre-filled syringes or autoinjectors. Safety was assessed by the incidence of adverse events (AEs), adverse drug reactions (ADRs) and serious adverse events (SAE). Effectiveness was assessed by the change from baseline of investigator-rated Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) in patients with ankylosing spondylitis (AS), disease activity score-28 (DAS28) in patients with RA, number of tender joints and swollen joints in patient with PsA, number of tender joints, swollen joints, and joints with limited range of motion in patient with JIA. <h3>Results:</h3> In this study, a total of 372 subjects were enrolled, 351 were included in the safety analysis (176 with RA, 164 with AS, 10 with PsA and1 with JIA). The overall incidence of AEs, ADRs and serious AEs were 35.33, 15.67, and 2.56%, respectively. Most common AEs were arthralgia (1.99%), diarrhea (1.99%), rash (1.71%) and pruritis (1.42%). After the administration of the LBEC0101, the study analyzed changes in the Disease Activity Score-28 using Erythrocyte Sedimentation Rate (DAS28-ESR) in patients with RA, -1.54±1.50 in 12 weeks (p=0.0013), -2.02±1.41 in 24 weeks (p&lt;0.0001), and -2.96±1.37 in 52 weeks (p&lt;0.0001). The results showed statistically significant reductions in DAS28-ESR scores at all three time points compared to the baseline. Significant reductions in both tender and swollen joint counts in patients with PsA were also observed. The number of tender joints showed a significant decrease at 12 weeks (-6.33±5.05) and at 52 weeks (-12.67±4.73), with the most pronounced improvement observed at the one-year mark. Similarly, the number of swollen joints significantly decreased at all assessed time points: 12 weeks (-3.67±0.52), 24 weeks (-3.83±1.72), and 52 weeks (-5.67±2.08). In patient with AS, the response rate for a 50% or more reduction in BASDAI score at 12 weeks, 24 weeks, and 52 weeks was consistently high, at 63.54%, 65.12%, and 63.64% respectively. A single juvenile idiopathic arthritis patient showed a significant decrease of -9.00 in the number of tender joints after 24 weeks of treatment. <h3>Conclusion:</h3> This post-marketing surveillance study successfully provided long-term (up to 52 weeks) real-world data on the efficacy and safety of LBEC0101 for treating rheumatoid arthritis and ankylosing spondylitis. While the study observed a higher incidence of adverse events and reactions compared to other studies, these were generally less severe. Factors such as concurrent medications and conditions, including possible links to the COVID-19 vaccine, were considered in the analysis. The study's findings are significant, although direct comparisons with other studies are limited due to the non-head-to-head nature of the research. REFERENCES: NIL. <h3>Acknowledgements:</h3> <b>NIL.</b> <h3>Disclosure of Interests:</h3> <b>None declared.</b>