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Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis

BACKGROUND: Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese...

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Autores principales: Cai, Lin, Zhang, Jian-Zhong, Yao, Xu, Gu, Jun, Liu, Quan-Zhong, Zheng, Min, Zhang, Shi-Fa, Xu, Jin-Hua, Li, Cheng-Xin, Cheng, Hao, Guo, Qing, Pan, Wei-Li, Li, Shen-Qiu, Li, Ruo-Yu, Guo, Zai-Pei, Song, Zhi-Qi, Li, Shan-Shan, Dong, Xiu-Qin, Wang, Linda, Fu, Rong, Regnault, Pascaline, Charef, Pascal, Mazur, Rafal, Patekar, Manmath
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7647502/
https://www.ncbi.nlm.nih.gov/pubmed/33060370
http://dx.doi.org/10.1097/CM9.0000000000001163
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author Cai, Lin
Zhang, Jian-Zhong
Yao, Xu
Gu, Jun
Liu, Quan-Zhong
Zheng, Min
Zhang, Shi-Fa
Xu, Jin-Hua
Li, Cheng-Xin
Cheng, Hao
Guo, Qing
Pan, Wei-Li
Li, Shen-Qiu
Li, Ruo-Yu
Guo, Zai-Pei
Song, Zhi-Qi
Li, Shan-Shan
Dong, Xiu-Qin
Wang, Linda
Fu, Rong
Regnault, Pascaline
Charef, Pascal
Mazur, Rafal
Patekar, Manmath
author_facet Cai, Lin
Zhang, Jian-Zhong
Yao, Xu
Gu, Jun
Liu, Quan-Zhong
Zheng, Min
Zhang, Shi-Fa
Xu, Jin-Hua
Li, Cheng-Xin
Cheng, Hao
Guo, Qing
Pan, Wei-Li
Li, Shen-Qiu
Li, Ruo-Yu
Guo, Zai-Pei
Song, Zhi-Qi
Li, Shan-Shan
Dong, Xiu-Qin
Wang, Linda
Fu, Rong
Regnault, Pascaline
Charef, Pascal
Mazur, Rafal
Patekar, Manmath
author_sort Cai, Lin
collection PubMed
description BACKGROUND: Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis. METHODS: This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12. RESULTS: A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period. CONCLUSION: Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.
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spelling pubmed-76475022020-11-20 Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis Cai, Lin Zhang, Jian-Zhong Yao, Xu Gu, Jun Liu, Quan-Zhong Zheng, Min Zhang, Shi-Fa Xu, Jin-Hua Li, Cheng-Xin Cheng, Hao Guo, Qing Pan, Wei-Li Li, Shen-Qiu Li, Ruo-Yu Guo, Zai-Pei Song, Zhi-Qi Li, Shan-Shan Dong, Xiu-Qin Wang, Linda Fu, Rong Regnault, Pascaline Charef, Pascal Mazur, Rafal Patekar, Manmath Chin Med J (Engl) Original Articles BACKGROUND: Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis. METHODS: This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12. RESULTS: A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period. CONCLUSION: Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609. Lippincott Williams & Wilkins 2020-11-20 2020-10-14 /pmc/articles/PMC7647502/ /pubmed/33060370 http://dx.doi.org/10.1097/CM9.0000000000001163 Text en Copyright © 2020 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license. http://creativecommons.org/licenses/by-nc-nd/4.0 This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0
spellingShingle Original Articles
Cai, Lin
Zhang, Jian-Zhong
Yao, Xu
Gu, Jun
Liu, Quan-Zhong
Zheng, Min
Zhang, Shi-Fa
Xu, Jin-Hua
Li, Cheng-Xin
Cheng, Hao
Guo, Qing
Pan, Wei-Li
Li, Shen-Qiu
Li, Ruo-Yu
Guo, Zai-Pei
Song, Zhi-Qi
Li, Shan-Shan
Dong, Xiu-Qin
Wang, Linda
Fu, Rong
Regnault, Pascaline
Charef, Pascal
Mazur, Rafal
Patekar, Manmath
Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis
title Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis
title_full Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis
title_fullStr Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis
title_full_unstemmed Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis
title_short Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis
title_sort secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in chinese patients with moderate to severe plaque psoriasis
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7647502/
https://www.ncbi.nlm.nih.gov/pubmed/33060370
http://dx.doi.org/10.1097/CM9.0000000000001163
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