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

来源：

JOURNAL OF DERMATOLOGICAL TREATMENT | 2022年 / 33卷 / 01期

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

页码：535 / 541

页数：7

共 50 条

[31] Safety in patients with latent tuberculosis (TB) treated with guselkumab and anti-TB treatments in the phase 3 VOYAGE 1 and 2 trials for moderate-to-severe plaque psoriasis
Puig, L.
Tsai, T. -F.
Bhutani, T.
Uy, J.
Ramachandran, P.
Song, M.
You, Y.
Gooderham, M.
Lebwohl, M.
JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2019, 33 : 41 - 42
[32] Impact of ustekinumab on health-related quality of life in Japanese patients with moderate-to-severe plaque psoriasis: Results from a randomized, double-blind, placebo-controlled phase 2/3 trial
Nakagawa, Hidemi
Schenkel, Brad
Kato, Mai
Kato, Takeshi
Igarashi, Atsuyuki
JOURNAL OF DERMATOLOGY, 2012, 39 (09) : 761 - 769
[33] Consistent safety profile with up to 5 years of continuous treatment with guselkumab: Pooled analyses from the phase 3 VOYAGE 1 and VOYAGE 2 trials of patients with moderate-to-severe psoriasis
Blauvelt, Andrew
Tsai, Tsen-Fang
Langley, Richard G.
Miller, Megan
Shen, Yaung-Kaung
You, Yin
Yang, Ya-Wen
Papp, Kim A.
Puig, Luis
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2022, 86 (04) : 827 - 834
[34] Efficacy and safety of itolizumab, a novel anti-CD6 monoclonal antibody, in patients with moderate to severe chronic plaque psoriasis: Results of a double-blind, randomized, placebo-controlled, phase-III study
Krupashankar, D. S.
Dogra, Sunil
Kura, Mahendra
Saraswat, Abir
Budamakuntla, Leelavathy
Sumathy, T. K.
Shah, Radha
Gopal, M. G.
Rao, T. Narayana
Srinivas, C. R.
Bhat, Ramesh
Shetty, Narendra
Manmohan, G.
Krishna, Kotla Sai
Padmaja, Dalavoi
Pratap, Dasiga Venkata Subrahmanya
Garg, Vijay
Gupta, Sandesh
Pandey, Neeraj
Khopkar, Uday
Montero, Enrique
Ramakrishnan, M. S.
Nair, Pradip
Ganapathi, Prasanna C.
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2014, 71 (03) : 484 - 492
[35] Secukinumab efficacy and safety in Japanese patients with moderate-to-severe plaque psoriasis: Subanalysis from ERASURE, a randomized, placebo-controlled, phase 3 study
Ohtsuki, Mamitaro
Morita, Akimichi
Abe, Masatoshi
Takahashi, Hidetoshi
Seko, Noriko
Karpov, Alexander
Shima, Tomohiro
Papavassilis, Charis
Nakagawa, Hidemi
JOURNAL OF DERMATOLOGY, 2014, 41 (12) : 1039 - 1046
[36] Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis
Strober, B. E.
Crowley, J. J.
Yamauchi, P. S.
Olds, M.
Williams, D. A.
BRITISH JOURNAL OF DERMATOLOGY, 2011, 165 (03) : 661 - 668
[37] Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials
Papp, Kim A.
Armstrong, April W.
Reich, Kristian
Karunaratne, Mahinda
Valdecantos, Wendell
AMERICAN JOURNAL OF CLINICAL DERMATOLOGY, 2016, 17 (01) : 79 - 86
[38] Efficacy and Safety of Toreforant, a Selective Histamine H4 Receptor Antagonist, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results from a Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Frankel, Ellen
Song, Michael
Li, Shu
Jiang, Jingzhi
Thurmond, Robin L.
Randazzo, Bruce
JOURNAL OF DRUGS IN DERMATOLOGY, 2018, 17 (08) : 873 - 879
[39] Safety and efficacy of mirikizumab versus secukinumab and placebo in the treatment of moderate-to-severe plaque psoriasis (OASIS-2): a phase 3, multicentre, randomised, double-blind study
Papp, Kim
Warren, Richard B.
Green, Lawrence
Reich, Kristian
Langley, Richard G.
Paul, Carle
Asahina, Akihiko
Johnson, Lynne
Arora, Vipin
Osuntokun, Olawale
Lebwohl, Mark
LANCET RHEUMATOLOGY, 2023, 5 (09) : E542 - E552
[40] Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: Week 52 results from a phase 3b, randomized, double-blind, placebo-controlled trial
Sofen, Howard L.
Gebauer, Kurt
Spelman, Lynda
Yamauchi, Paul S.
Yao, Siu-Long
Nishandar, Tushar
Kopeloff, Iris
Crane, Michael
Gogineni, Ranga
Kothekar, Mudgal
Bagel, Jerry
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2025, 92 (04) : 816 - 824

← 1 2 3 4 5 →