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Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial

INTRODUCTION: The aim of this work is to examine the efficacy and safety of prefilled liquid etanercept-biosimilar Yisaipu versus lyophilized Yisaipu in active ankylosing spondylitis (AS) patients. METHODS: This double-blind, phase III trial with non-inferiority design randomized adult patients with...

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Autores principales: Zhao, Dongbao, He, Dongyi, Bi, Liqi, Wu, Huaxiang, Liu, Yi, Wu, Zhenbiao, Li, Yang, Wang, Guochun, Li, Xingfu, Bao, Chunde, Jiang, Lindi, Zhang, Zhiyi, Xiao, Weiguo, Tong, Gang, Wang, Dong, Huang, Feng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7991065/
https://www.ncbi.nlm.nih.gov/pubmed/33559842
http://dx.doi.org/10.1007/s40744-021-00276-1
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author Zhao, Dongbao
He, Dongyi
Bi, Liqi
Wu, Huaxiang
Liu, Yi
Wu, Zhenbiao
Li, Yang
Wang, Guochun
Li, Xingfu
Bao, Chunde
Jiang, Lindi
Zhang, Zhiyi
Xiao, Weiguo
Tong, Gang
Wang, Dong
Huang, Feng
author_facet Zhao, Dongbao
He, Dongyi
Bi, Liqi
Wu, Huaxiang
Liu, Yi
Wu, Zhenbiao
Li, Yang
Wang, Guochun
Li, Xingfu
Bao, Chunde
Jiang, Lindi
Zhang, Zhiyi
Xiao, Weiguo
Tong, Gang
Wang, Dong
Huang, Feng
author_sort Zhao, Dongbao
collection PubMed
description INTRODUCTION: The aim of this work is to examine the efficacy and safety of prefilled liquid etanercept-biosimilar Yisaipu versus lyophilized Yisaipu in active ankylosing spondylitis (AS) patients. METHODS: This double-blind, phase III trial with non-inferiority design randomized adult patients with active AS in a 3:1:1 ratio to receive twice-weekly 25-mg prefilled liquid Yisaipu for a total of 48 injections (group I, n = 330), once-weekly 50-mg prefilled liquid Yisaipu for 24 injections (group II, n = 110), or twice-weekly 25-mg lyophilized Yisaipu for 48 injections (group III, n = 110). Both physicians and patients who received 25-mg twice-weekly lyophilized or liquid Yisaipu were blinded to treatment assignment while patients who received 50-mg once-weekly liquid Yisaipu received treatment in an open-label design. In addition, 90 patients in the PK/PD study were randomized in a 1:1:1 ratio to each group. The primary outcome was the proportion of patients who achieved ASAS20 at week 24. RESULTS: A total of 640 subjects were enrolled. The proportion of patients who attained ASAS20 at week 24 was 85.56% in group I, 85.71% in group II, and 83.45% in group III (group I vs. III, P = 0.545; group II vs. III, P = 0.605). The difference between group I and III was 2.10% (95% CI − 5.06%, 9.27%) and 2.26% (95% CI − 6.21%, 10.73%) between group II and III, meeting the non-inferiority threshold (Δ = − 15%) (P < 0.001). Except for a statistical difference between group I (75.83%) and group III at week 8 (64.75%, P = 0.011), there was no statistical difference in the ASAS20 attainment rate among the three groups at other time points. The incidence of serious adverse events was comparable among the three groups (group I, 2.50%, II, 2.86% and III, 1.43%; P > 0.05). No deaths were reported. CONCLUSIONS: Once-weekly 50-mg or twice-weekly 25-mg prefilled liquid Yisaipu is safe and non-inferior to twice-weekly 25-mg lyophilized Yisaipu. TRIAL REGISTRATION: CTR20130124 and NCT04345458. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-021-00276-1.
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spelling pubmed-79910652021-04-16 Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial Zhao, Dongbao He, Dongyi Bi, Liqi Wu, Huaxiang Liu, Yi Wu, Zhenbiao Li, Yang Wang, Guochun Li, Xingfu Bao, Chunde Jiang, Lindi Zhang, Zhiyi Xiao, Weiguo Tong, Gang Wang, Dong Huang, Feng Rheumatol Ther Original Research INTRODUCTION: The aim of this work is to examine the efficacy and safety of prefilled liquid etanercept-biosimilar Yisaipu versus lyophilized Yisaipu in active ankylosing spondylitis (AS) patients. METHODS: This double-blind, phase III trial with non-inferiority design randomized adult patients with active AS in a 3:1:1 ratio to receive twice-weekly 25-mg prefilled liquid Yisaipu for a total of 48 injections (group I, n = 330), once-weekly 50-mg prefilled liquid Yisaipu for 24 injections (group II, n = 110), or twice-weekly 25-mg lyophilized Yisaipu for 48 injections (group III, n = 110). Both physicians and patients who received 25-mg twice-weekly lyophilized or liquid Yisaipu were blinded to treatment assignment while patients who received 50-mg once-weekly liquid Yisaipu received treatment in an open-label design. In addition, 90 patients in the PK/PD study were randomized in a 1:1:1 ratio to each group. The primary outcome was the proportion of patients who achieved ASAS20 at week 24. RESULTS: A total of 640 subjects were enrolled. The proportion of patients who attained ASAS20 at week 24 was 85.56% in group I, 85.71% in group II, and 83.45% in group III (group I vs. III, P = 0.545; group II vs. III, P = 0.605). The difference between group I and III was 2.10% (95% CI − 5.06%, 9.27%) and 2.26% (95% CI − 6.21%, 10.73%) between group II and III, meeting the non-inferiority threshold (Δ = − 15%) (P < 0.001). Except for a statistical difference between group I (75.83%) and group III at week 8 (64.75%, P = 0.011), there was no statistical difference in the ASAS20 attainment rate among the three groups at other time points. The incidence of serious adverse events was comparable among the three groups (group I, 2.50%, II, 2.86% and III, 1.43%; P > 0.05). No deaths were reported. CONCLUSIONS: Once-weekly 50-mg or twice-weekly 25-mg prefilled liquid Yisaipu is safe and non-inferior to twice-weekly 25-mg lyophilized Yisaipu. TRIAL REGISTRATION: CTR20130124 and NCT04345458. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40744-021-00276-1. Springer Healthcare 2021-02-09 /pmc/articles/PMC7991065/ /pubmed/33559842 http://dx.doi.org/10.1007/s40744-021-00276-1 Text en © The Author(s) 2021 Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Original Research
Zhao, Dongbao
He, Dongyi
Bi, Liqi
Wu, Huaxiang
Liu, Yi
Wu, Zhenbiao
Li, Yang
Wang, Guochun
Li, Xingfu
Bao, Chunde
Jiang, Lindi
Zhang, Zhiyi
Xiao, Weiguo
Tong, Gang
Wang, Dong
Huang, Feng
Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial
title Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial
title_full Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial
title_fullStr Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial
title_full_unstemmed Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial
title_short Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial
title_sort safety and efficacy of prefilled liquid etanercept-biosimilar yisaipu for active ankylosing spondylitis: a multi-center phase iii trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7991065/
https://www.ncbi.nlm.nih.gov/pubmed/33559842
http://dx.doi.org/10.1007/s40744-021-00276-1
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