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
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