Comparison of injection site reactions and injection site erythema between ylb113 and etanercept reference product from phase 3 active comparator study (study no. ylb113-002)

Background: YLB113 is an etanercept biosimilar approved in all indications of its etanercept Reference Product (RP). Therapeutic equivalence in terms of clinical efficacy, safety and immunogenicity was previously demonstrated in a pivotal multicenter, double-blind, randomized, parallel-group, active-control, comparative study (YLB113-002) in rheumatoid arthritis (RA) subjects.1,2 Similar incidence of treatment emergent adverse events (TEAEs) was seen in both treatment arms except for injection site reactions (ISRs) and injection site erythema (ISE), both of which were less frequent in subjects treated with YLB113. Objectives: This post-hoc analysis was performed to further evaluate the differences in the incidence of ISRs and ISE during the 24 week treatment when the subjects with RA were treated with 50 mg of YLB113 or RP given once a week as a SC injection along with methotrexate. Methods: Safety analysis set (263 in YLB113 arm and 254 in RP arm) was considered for this analysis. Local reactions at the site of injection were assessed at each of eight study visits. The number of subjects who experienced ISRs and ISE were statistically compared for YLB113 and RP. The risk difference and 95% confidence interval (CI) were computed between arms to understand the magnitude of difference in the incidence of events. The statistical significance of between group difference was tested using chi-square test. Results: The result of this analysis showed a statistically significant difference in the incidences of ISRs and ISE between subjects who received YLB113 and RP. The risk difference between YLB113 and RP arms for ISR was -9.98% (95% CI, WALD -14.81%, -5.15%) and, for ISE it was -7.94% (95% CI, WALD -11.96%, - 3.92%; Table 1). This could be possibly explained by the absence of latex in the syringe needle cap of YLB113.3 Conclusion: YLB113 has shown statistically significant lower incidences of ISRs (P-value References: [1]EULAR Abstract AB0416 (2019). Ann Rheum Dis, volume 78, supplement 2, year 2019, page A1670. [2]Yamanaka H, Kamatani N, Tanaka Y, et al. A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis. Rheumatol Ther. 2020;7(1):149-163. [3]Viatris Etanercept Summary of Product Characteritics May 2020. Disclosure of Interests: Dimitris Stefanidis Employee of: Viatris GmbH Sr. Director, Global Medical Affairs Lead, Immunology Biosimilars, Unmesh G Employee of: Viatris, Juan Sanchez-Burson: None declared, Chirag Shah Shareholder of: As an employee, Shareholder of Lupin LTD, Employee of: Employee of Lupin LTD, Dhananjay Bakhle Shareholder of: As part of Employee Stock Options Plan from Lupin LTD, Employee of: Employee of Lupin LTD