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
  • [1] Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparatore-controlled VOYAGE 2 trial
    Reich, Kristian
    Armstrong, April W.
    Foley, Peter
    Song, Michael
    Wasfi, Yasmine
    Randazzo, Bruce
    Li, Shu
    Shen, Y. -K.
    Gordon, Kenneth B.
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2017, 76 (03) : 418 - 431
  • [2] Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial
    Reich, Kristian
    Gooderham, Melinda
    Thaci, Diamant
    Crowley, Jeffrey J.
    Ryan, Caitriona
    Krueger, James G.
    Tsai, Tsen-Fang
    Flack, Mary
    Gu, Yihua
    Williams, David A.
    Thompson, Elizabeth H. Z.
    Paul, Carle
    LANCET, 2019, 394 (10198) : 576 - 586
  • [3] Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparatore-controlled VOYAGE 1 trial
    Blauvelt, Andrew
    Papp, Kim A.
    Griffiths, Christopher E. M.
    Randazzo, Bruce
    Wasfi, Yasmine
    Shen, Yaung-Kaung
    Li, Shu
    Kimball, Alexa B.
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2017, 76 (03) : 405 - 417
  • [4] Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study
    Deodhar, Atul
    Gottlieb, Alice B.
    Boehncke, Wolf-Henning
    Dong, Bin
    Wang, Yuhua
    Zhuang, Yanli
    Barchuk, William
    Xu, Xie L.
    Hsia, Elizabeth C.
    LANCET, 2018, 391 (10136) : 2213 - 2224
  • [5] Efficacy of guselkumab in subpopulations of patients with moderate-to-severe plaque psoriasis: a pooled analysis of the phase III VOYAGE 1 and VOYAGE 2 studies
    Gordon, K. B.
    Blauvelt, A.
    Foley, P.
    Song, M.
    Wasfi, Y.
    Randazzo, B.
    Shen, Y. K.
    You, Y.
    Griffiths, C. E. M.
    BRITISH JOURNAL OF DERMATOLOGY, 2018, 178 (01) : 132 - 139
  • [6] Efficacy and safety of brodalumab in the Korean population for the treatment of moderate to severe plaque psoriasis: A randomized, phase III, double-blind, placebo-controlled study
    Seo, Seong Jun
    Shin, Bong Seok
    Lee, Joo-Heung
    Jeong, Haeyoun
    JOURNAL OF DERMATOLOGY, 2021, 48 (06) : 807 - 817
  • [7] Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: A phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL)
    Tsai, Tsen-Fang
    Ho, Ji-Chen
    Song, Michael
    Szapary, Philippe
    Guzzo, Cynthia
    Shen, Yuang-Kuang
    Li, Shu
    Kim, Kwang-Joong
    Kim, Tae-Yoon
    Choi, Jee-Ho
    Youn, Jai-Il
    JOURNAL OF DERMATOLOGICAL SCIENCE, 2011, 63 (03) : 154 - 163
  • [8] Efficacy and Safety of Adalimumab among Patients with Moderate to Severe Psoriasis with Co-MorbiditiesSubanalysis of Results from a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial
    Alexa B. Kimball
    Arielle G. Bensimon
    Annie Guerin
    Andrew P. Yu
    Eric Q. Wu
    Martin M. Okun
    Yanjun Bao
    Shiraz R. Gupta
    Parvez M. Mulani
    American Journal of Clinical Dermatology, 2011, 12 : 51 - 62
  • [9] Efficacy and Safety of Adalimumab among Patients with Moderate to Severe Psoriasis with Co-Morbidities Subanalysis of Results from a Randomized, Double-Blind, Placebo-Controlled, Phase III Trial
    Kimball, Alexa B.
    Bensimon, Arielle G.
    Guerin, Annie
    Yu, Andrew P.
    Wu, Eric Q.
    Okun, Martin M.
    Bao, Yanjun
    Gupta, Shiraz R.
    Mulani, Parvez M.
    AMERICAN JOURNAL OF CLINICAL DERMATOLOGY, 2011, 12 (01) : 51 - 62
  • [10] Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial
    Yan, Kexiang
    Li, Fuqiu
    Bi, Xiaodong
    Han, Ling
    Zhang, Zhenghua
    Chen, Rixin
    Li, Yuye
    Zhang, Litao
    Wang, Xiaohua
    Li, Linfeng
    Lu, Jianyun
    Xu, Ai'e
    Yang, Sen
    Lu, Yan
    Sun, Jianfang
    Li, Zhiming
    Zhu, Xiaohong
    Jiang, Meiying
    Zhang, Siping
    Wang, Wenqing
    Li, Yanling
    Meng, Zudong
    Li, Hongyi
    Mou, Kuanhou
    Han, Xiuping
    Li, Shanshan
    Chen, Aijun
    Li, Xin
    Liu, Donghua
    Zhang, Chunlei
    Ji, Chao
    Wang, Yu
    Cheng, Hao
    Cui, Xiaojing
    Yao, Xiaoyan
    Bai, Xiaoyan
    Dong, Guangchao
    Xu, Jinhua
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2025, 92 (01) : 92 - 99