Efficacy and safety of guselkumab compared with placebo and adalimumab in Korean patients with moderate-to-severe psoriasis:post-hocanalysis from the phase III, double-blind, placebo- and active-comparator-controlled VOYAGE 1/2 trials

被引:6
|
作者
Youn, Sang Woong [1 ,2 ]
Yu, Dae Young [3 ,4 ]
Kim, Tae Yoon [5 ]
Kim, Byung Soo [6 ]
Lee, Seung Chul [7 ]
Lee, Jeung Hoon [8 ]
Choe, Yong-Beom [9 ]
Lee, Joo-Heung [10 ]
Choi, Jee-Ho [11 ]
Roh, Joo Young [12 ]
Jo, Seong Jin [13 ]
Lee, Eun-So [14 ]
Shin, Min Kyung [15 ]
Lee, Min-Geol [16 ]
Jiang, Jingzhi [17 ]
Lee, YoungJa [3 ]
机构
[1] Seoul Natl Univ, Dept Dermatol, Bundang Hosp, 82 Gumi Ro 173 Beon Gil, Seongnam 13620, Gyeonggi, South Korea
[2] Seoul Natl Univ, Coll Med, Seongnam, South Korea
[3] Janssen Korea Ltd, Med Affairs, Seoul, South Korea
[4] Korea Univ, Dept Publ Hlth, Coll Med, Seoul, South Korea
[5] Catholic Univ Korea, Dept Dermatol, Seoul St Marys Hosp, Seoul, South Korea
[6] Pusan Natl Univ, Dept Dermatol, Sch Med, Busan, South Korea
[7] Chonnam Natl Univ Hosp, Dept Dermatol, Gwangju, South Korea
[8] Chungnam Natl Univ Hosp, Dept Dermatol, Daejeon, South Korea
[9] Konkuk Univ, Dept Dermatol, Sch Med, Seoul, South Korea
[10] Sungkyunkwan Univ, Samsung Med Ctr, Dept Dermatol, Sch Med, Seoul, South Korea
[11] Univ Ulsan, Asan Med Ctr, Dept Dermatol, Coll Med, Seoul, South Korea
[12] Gachon Univ, Gil Med Ctr, Dept Dermatol, Coll Med, Incheon, South Korea
[13] Seoul Natl Univ, Dept Dermatol, Coll Med, Seoul, South Korea
[14] Ajou Univ Hosp, Dept Dermatol, Suwon, South Korea
[15] Kyung Hee Univ, Dept Dermatol, Med Ctr, Seoul, South Korea
[16] Yonsei Univ, Severance Hosp, Dept Dermatol, Coll Med, Seoul, South Korea
[17] Janssen Res & Dev LLC, Spring House, PA USA
关键词
Psoriasis; interleukin-23; VOYAGE; 1; 2; MONOCLONAL-ANTIBODY; PLAQUE PSORIASIS; EPIDEMIOLOGY; SECUKINUMAB; USTEKINUMAB; NATIONWIDE; DISEASE;
D O I
10.1080/09546634.2020.1770174
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Background:The phase 3 studies, VOYAGE 1 and 2, were conducted to assess guselkumab in the treatment of patients with moderate-to-severe psoriasis. Objectives:To investigate the efficacy and safety of guselkumab in Korean patients. Methods:The Korean sub-population of VOYAGE 1 and 2 study patients were included in this analysis. Efficacy and safety were evaluated through Weeks 24 and 28, respectively. Results:Of 126 randomized Korean patients, 30, 63, and 33 received placebo, guselkumab, and adalimumab, respectively. At Week 16, guselkumab was superior to placebo in achieving an Investigator's Global Assessment (IGA) score of 0 or 1 (cleared or minimal; 90.5 vs. 20.0%,p<.001) and a Psoriasis Area and Severity Index (PASI) 90 response (71.4 vs. 3.3%,p<.001). At week 24, a significantly higher proportion of guselkumab-treated patients achieved PASI 75 and IGA 0 (clear skin) responses compared to adalimumab-treated patients (PASI 75: 93.7 vs. 66.7%,p<.001; IGA 0: 52.4 vs. 21.2%,p=.004). Through Week 28, guselkumab and adalimumab showed comparable safety profiles. Conclusion:The efficacy and safety of guselkumab in Korean psoriasis patients through 28 weeks were consistent with findings for the overall VOYAGE 1 and 2 study population.
引用
收藏
页码:535 / 541
页数:7
相关论文
共 50 条
  • [21] Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study
    Ohtsuki, Mamitaro
    Kubo, Hiroshi
    Morishima, Hitomi
    Goto, Ryosuke
    Zheng, Richuan
    Nakagawa, Hidemi
    JOURNAL OF DERMATOLOGY, 2018, 45 (09) : 1053 - 1062
  • [22] Risankizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study
    Stephen K. Tyring
    Phoebe Rich
    Yayoi Tada
    Stefan Beeck
    Izabella Messina
    Jie Liu
    Xiaohong Huang
    Stephen Shumack
    Dermatology and Therapy, 2023, 13 : 595 - 608
  • [23] Sustained efficacy of secukinumab in patients with moderate-to-severe palmoplantar psoriasis: 2•5-year results from GESTURE, a randomized, double-blind, placebo-controlled trial
    Gottlieb, A. B.
    Kubanov, A.
    van Doorn, M.
    Sullivan, J.
    Papp, K. A.
    You, R.
    Regnault, P.
    Frueh, J. A.
    BRITISH JOURNAL OF DERMATOLOGY, 2020, 182 (04) : 889 - 899
  • [24] Long-term efficacy and safety of brodalumab in the treatment of psoriasis: 120-week results from the randomized, double-blind, placebo- and active comparator-controlled phase 3 AMAGINE-2 trial
    Puig, Luis
    Lebwohl, Mark
    Bachelez, Herve
    Sobell, Jeffrey
    Jacobson, Abby A.
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2020, 82 (02) : 352 - 359
  • [25] A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
    Cai Lin
    Chen Gen-Hui
    Lu Qian-Jin
    Zheng Min
    Li Yu-Zhen
    Chen Jin
    Zheng Jie
    Zhang Fu-Ren
    Yu Jian-Bin
    Yang Sen
    Li Fu-Qiu
    Xiao Sheng-Xiang
    Sun Qiu-Ning
    Xu Jin-Hua
    Gao Xing-Hua
    Fang Hong
    Gao Tian-Wen
    Hao Fei
    Liu Quan-Zhong
    Tu Ya-Ting
    Li Ruo-Yu
    Wang Bao-Xi
    Deng Dan-Qi
    Zheng Qing-Shan
    Liu Hong-Xia
    Zhang Jian-Zhong
    中华医学杂志英文版, 2020, 133 (24) : 2905 - 2909
  • [26] A double-blind, randomized, placebo- and positive-controlled phase III trial of 1% benvitimod cream in mild-to-moderate plaque psoriasis
    Cai, Lin
    Chen, Gen-Hui
    Lu, Qian-Jin
    Zheng, Min
    Li, Yu-Zhen
    Chen, Jin
    Zheng, Jie
    Zhang, Fu-Ren
    Yu, Jian-Bin
    Yang, Sen
    Li, Fu-Qiu
    Xiao, Sheng-Xiang
    Sun, Qiu-Ning
    Xu, Jin-Hua
    Gao, Xing-Hua
    Fang, Hong
    Gao, Tian-Wen
    Hao, Fei
    Liu, Quan-Zhong
    Tu, Ya-Ting
    Li, Ruo-Yu
    Wang, Bao-Xi
    Deng, Dan-Qi
    Zheng, Qing-Shan
    Liu, Hong-Xia
    Zhang, Jian-Zhong
    CHINESE MEDICAL JOURNAL, 2020, 133 (24) : 2905 - 2909
  • [27] Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: A multicenter, randomized, double-blind, placebo-controlled, Phase 3b study
    Gebauer, Kurt
    Spelman, Lynda
    Yamauchi, Paul S.
    Bagel, Jerry
    Nishandar, Tushar
    Crane, Michael
    Kopeloff, Iris
    Kothekar, Mudgal
    Yao, Siu-Long
    Sofen, Howard L.
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2024, 91 (01) : 91 - 99
  • [28] Efficacy and safety of total glucosides of paeony combined with acitretin in the treatment of moderate-to-severe plaque psoriasis: a double-blind, randomised, placebo-controlled trial
    Chen Yu
    Xueli Fan
    Zhenlu Li
    Xiaoming Liu
    Gang Wang
    European Journal of Dermatology, 2017, 27 : 150 - 154
  • [29] Long-term efficacy and safety of itolizumab in patients with moderate-to-severe chronic plaque psoriasis: A double-blind, randomized-withdrawal, placebo-controlled study
    Dogra, Sunil
    Krupashankar
    Budamakuntla, Leelavathy
    Srinivas, C. R.
    Khopkar, Uday
    Gupta, Sandesh
    Shetty, Narendra
    Pratap, Dasiga Venkata Subrahmanya
    Gopal, M. G.
    Rao, T. Narayana
    Garg, Vijay
    Sumathy, T. K.
    Saraswat, Abir
    Bhat, Ramesh
    Kura, Mahendra
    Pandey, Neeraj
    Shah, Radha
    Krishna, Kotla Sai
    Padmaja, Dalavai
    Manmohan, G.
    Ramakrishnan, M. S.
    Barve, Abhijit
    Montero, Enrique
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2015, 73 (02) : 331 - 333
  • [30] Efficacy and safety of total glucosides of paeony combined with acitretin in the treatment of moderate-to-severe plaque psoriasis: a double-blind, randomised, placebo-controlled trial
    Yu, Chen
    Fan, Xueli
    Li, Zhenlu
    Liu, Xiaoming
    Wang, Gangwang
    EUROPEAN JOURNAL OF DERMATOLOGY, 2017, 27 (02) : 150 - 154