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. 2022 Feb;9(1):175-189.
doi: 10.1007/s40744-021-00396-8. Epub 2021 Nov 22.

Fine Comparison of the Efficacy and Safety Between GB242 and Infliximab in Patients with Rheumatoid Arthritis: A Phase III Study

Yanying Liu  1   2 , Shengyun Liu  3 , Lin Liu  4 , Xiaowei Gong  5 , Ju Liu  6 , Lingyun Sun  7 , Xiumei Liu  8 , Lijun Wu  9 , Linjie Chen  10 , Ling Wang  11 , Li Luo  12 , Jinying Lin  13 , Ning Tie  14 , Zhenyu Jiang  15 , Jian Wu  16 , Fuai Lu  17 , Hongsheng Sun  18 , Xiaomei Li  19 , Niansheng Yang  20 , Kexia Chai  21 , Hua Wei  22 , Zhanyun Da  23 , Cheng Zhao  24 , Lie Dai  25 , Youlian Wang  26 , Guixiu Shi  27 , Zhenchun Zhang  28 , Hui Song  29 , Qian Guo  30 , Yingxue Cathy Liu  31 , Zhanguo Li  32
Affiliations

Fine Comparison of the Efficacy and Safety Between GB242 and Infliximab in Patients with Rheumatoid Arthritis: A Phase III Study

Yanying Liu et al. Rheumatol Ther. 2022 Feb.

Abstract

Introduction: This phase III trial (NCT04178850) evaluated the efficacy, safety, and immunogenicity of GB242, an infliximab biosimilar, vs. infliximab (Remicade®) reference product in patients with moderate-to-severe active rheumatoid arthritis (RA) combination with methotrexate (MTX) therapy.

Methods: Patients were randomized in a 1:1 ratio to receive either GB242 or INF (3 mg/kg). Therapeutic equivalence of clinical response according to the American College of Rheumatology 20% (ACR20) response rate at week 30 was declared if the two-sided 95% CI for the treatment difference was within ± 14%. The comparison of GB242 with INF also included the proportion of patients achieving a week 30 ACR 50 response, ACR70 response, change in Disease Activity Score 28 (DAS28), as well as safety and immunogenicity.

Results: A total of 570 subjects were randomized into GB242 (N = 285) or INF (N = 285) and 283 subjects in each group were analyzed. At week 30, the ACR20 was 62.54% for the GB242 group (95% CI 56.62-68.20%) and 56.89% for the INF group (95% CI 50.90-62.74%). The difference between the two groups was 5.65% with a 95% CI of - 2.48 to 13.74. ACR50 response was 37.12% for GB242 and 32.86% for INF at week 30. ACR70 response was 19.79% for GB242 and 16.96% for INF at week 30, respectively. The incidence of treatment-emergent adverse events was comparable (77.4% in GB242 vs. 80.2% in INF) and detection of antidrug antibodies (ADA) to infliximab up to week 30 (60.8% in GB242 vs. 59.4% in INF) was comparable.

Conclusions: GB242 demonstrated equivalent efficacy to INF at week 30. Moreover, GB242 was well tolerated, with a similar immunogenicity and safety profile comparable to INF.

Keywords: Biosimilar; GB242; Infliximab; Rheumatoid arthritis.

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Figures

Fig. 1
Fig. 1
Disposition flow chart of the study population. A total of 905 patients were screened for the study, and 566 eligible patients were randomized into a GB242 group (n = 283) or an infliximab reference product (INF) group (n = 283) to receive 3 mg/kg of GB242 or INF, respectively, coadministered with methotrexate (MTX) and folic acid. The full analysis set (FAS) for GB242 is n = 283 and infliximab reference product (INF) n = 283. The per-protocol set (PPS) for GB242 is n = 237 and INF n = 233
Fig. 2
Fig. 2
ACR20 response pattern over time. INF infliximab reference product
Fig. 3
Fig. 3
American College of Rheumatology (ACR) response rates at week 30. A ACR20, 50 and 70 responses for GB242 and INF in the full analysis set (FAS). B ACR20, 50 and 70 responses for GB242 and infliximab reference product (INF) in the per-protocol set (PPS)
Fig. 4
Fig. 4
DAS28 responses in the per-protocol population. A Mean DAS28 score based on C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) at baseline, weeks 14 and 30 for GB242 and infliximab reference product (INF). B Disease activity classification by DAS28 (CRP). Remission is defined as DAS28 < 2.6, LDA is defined as DAS28 2.6 ≤ to < 3.2, moderate is defined as DAS28 3.2 ≤ to ≤ 5.1, and high is defined as DAS28 > 5.1
Fig. 5
Fig. 5
CD19 response pattern overtime. A Mean CD19 percentage based on DAS28 < 2.6 at weeks 30 for GB242 and infliximab reference product (INF). B Mean CD19 percentage based on DAS28 ≥ 2.6 at weeks 30 for GB242 and INF
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