Safety and Efficacy Evaluation of Perkinra in Comparison With Kineret in Systemic Juvenile Idiopathic Arthritis Patients Publisher



Az Mirzaee Azadeh ZEINAB ; S Sadeghi SETAYESH ; R Shiari REZA ; V Ziaee VAHID ; A Karagah AMIRHOSSEIN ; R Sinaei REZA ; Sh Hajiani Ghotbabadi Shabnam HAJIANI ; F Tahghighi FATEMEH ; Mr Fathi Mohammad REZA ; A Shirvai ARMIN
Source: Biomedical and Biotechnology Research Journal Published:2024

Abstract

Background: Systemic juvenile idiopathic arthritis (sJIA) is marked with arthritis and several features of systemic inflammation, including fever, rashes, hepatosplenomegaly, lymphadenopathy, and serositis. Interleukin-1 receptor blockers have been used as one of the most effective biologics for the treatment of resistant types of disease. The main purpose of this study was to evaluate the safety and efficacy of PerkinRA in comparison with Kineret in patients with sJIA. Methods: This was a double-blind, randomized clinical trial conducted on 72 patients with sJIA. The patients were enrolled based on the 2018 International League of Associations for Rheumatology criteria and were treated at the outpatient clinic of Mofid Children's Hospital, Pediatric Medical Center, and four other centers between February 2020 and March 2021. Patients were randomly assigned in a 1:1 ratio to one of two treatment groups: one group received PerkinRA (manufactured by Persis Gene, n = 36), while the other group received Kineret (manufactured by SOBI, n = 36). The primary outcome measure was the proportion of patients achieving an American College of Rheumatology (ACR) 30, ACR 50, and ACR 70 response. Secondary outcomes included changes in vital signs, incidence of adverse events, clinical laboratory assessments, and findings from physical examinations. These parameters were evaluated at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after the first injection, and the two treatment groups were compared. Results: A total of 35 patients in the PerkinRA group and 32 patients in the Kineret group were included in the final analysis. The results showed no clinically significant differences between the two treatment groups. Patients in both the PerkinRA and Kineret groups achieved similar proportions of ACR 30, ACR 50, and ACR 70 responses over the 6-month evaluation period. Conclusion: Based on the findings of this study, the two investigational medications, PerkinRA and Kineret, demonstrated comparable efficacy in the treatment of sJIA. The two treatment groups showed no significant differences in the primary and secondary outcomes assessed. Therefore, it can be concluded that PerkinRA and Kineret are noninferior to each other for the management of sJIA. © 2024 Elsevier B.V., All rights reserved.