Consistent responses with guselkumab treatment in Asian and non-Asian patients with psoriasis: An analysis from VOYAGE 1 and VOYAGE 2

被引:13
|
作者
Reich, Kristian [1 ]
Song, Michael [2 ]
Li, Shu [2 ]
Jiang, Jingzhi [2 ]
Youn, Sang Woong [3 ]
Tsai, Tsen-Fang [4 ,5 ]
Choe, Yong Beom [6 ]
Huang, Yu-Huei [7 ,8 ]
Gordon, Kenneth B. [9 ]
机构
[1] Univ Med Ctr Hamburg Eppendorf, Ctr Translat Res Inflammatory Skin Dis, Skinflammat Ctr, Inst Hlth Serv Res Dermatol & Nursing, Hamburg, Germany
[2] Janssen Res & Dev LLC, Spring House, PA USA
[3] Seoul Natl Univ, Bundang Hosp, Coll Med, Seongnam, South Korea
[4] Natl Taiwan Univ Hosp, Taipei, Taiwan
[5] Natl Taiwan Univ, Coll Med, Taipei, Taiwan
[6] Konkuk Univ, Sch Med, Seoul, South Korea
[7] Chang Gung Mem Hosp, Taoyuan, Taiwan
[8] Chang Gung Univ, Sch Med, Taoyuan, Taiwan
[9] Med Coll Wisconsin, Milwaukee, WI 53226 USA
来源
JOURNAL OF DERMATOLOGY | 2019年 / 46卷 / 12期
关键词
guselkumab; interleukin-23 monoclonal antibody; psoriasis; South Korea; Taiwan; SEVERE PLAQUE PSORIASIS; JAPANESE PATIENTS; IXEKIZUMAB TREATMENT; CHINESE PATIENTS; MODERATE; EFFICACY; SAFETY; ADALIMUMAB; PHASE-3; POPULATION;
D O I
10.1111/1346-8138.15109
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
Guselkumab, an interleukin-23 blocker, was superior to placebo and adalimumab and well-tolerated in phase 3 psoriasis studies (VOYAGE 1 and VOYAGE 2). This analysis evaluated the consistency of response in the Asian subpopulation in VOYAGE 1 and VOYAGE 2. Study designs were identical through week 24; patients were randomized to guselkumab, placebo, or adalimumab. Investigator's Global Assessment (IGA), Psoriasis Area and Severity Index (PASI), safety, and pharmacokinetic and immunogenicity data from VOYAGE 1 and VOYAGE 2 were pooled and compared by race (Asian, n = 199; non-Asian, n = 1630). At week 16, treatment differences between guselkumab and placebo were 78.2 (95% confidence interval [CI], 66.9-89.6) and 76.4 (95% CI, 72.7-80.2) percentage points for IGA 0/1 (score of 0 or 1) and 70.1 (95% CI, 60.0-80.1) and 68.5 (95% CI, 64.9-72.2) percentage points for PASI 90 (>= 90% improvement) in the Asian and non-Asian populations, respectively. Treatment differences between guselkumab and adalimumab were 31.1 (95% CI, 17.7-44.6) and 16.1 (95% CI, 11.2-21.0) percentage points for IGA 0/1 and 24.9 (95% CI, 9.4-40.5) and 23.2 (95% CI, 17.7-28.6) percentage points for PASI 90 in the Asian and non-Asian populations, respectively. Similar results were observed at week 24. Safety was generally similar between populations and among treatment groups. Median serum guselkumab concentrations over time were comparable between the populations. Comparable responses between the Asian and non-Asian populations in this analysis suggest that the overall efficacy, safety, and the resulting benefit/risk analyses from VOYAGE 1 and VOYAGE 2 are applicable to Asian populations.
引用
收藏
页码:1141 / 1152
页数:12
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