Alexis Andrew, McMichael Amy, Soung Jennifer, Choi Olivia, Alkousakis Theodore, Alonso-Llamazares Javier, Shahriari Mona, Rodriguez Adrian O, Bhutani Tina, Chan Daphne, Rowland Katelyn, Sauder Maxwell, Hong H Chih-Ho, Yadav Geeta, Yeung Jensen, Jeyarajah Jenny, Ma Tony, Gao Long-Long, Park-Wyllie Laura, Green Lawrence, Lee Mark, Vashi Neelam, Kindred Chesahna, Grimes Pearl, Taylor Susan C, Desai Seemal R
Department of Dermatology, Weill Cornell Medicine, New York, New York.
Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, North Carolina.
JAMA Dermatol. 2025 Jun 25. doi: 10.1001/jamadermatol.2025.1836.
Data and educational gaps in populations with skin of color contribute to racial and ethnic disparities in psoriasis treatment. Cohort A of the VISIBLE study includes participants with psoriasis who self-identify as belonging to a racial or ethnic category other than White, across the entire skin-tone spectrum.
To evaluate efficacy, quality of life, and adverse event outcomes among participants with moderate to severe psoriasis and skin of color who received guselkumab, 100 mg, for up to 48 weeks.
DESIGN, SETTING, AND PARTICIPANTS: This ongoing phase 3b, randomized clinical trial at 39 sites in the US and Canada enrolled adults with skin of color and moderate to severe psoriasis (body surface area [BSA] ≥10%; Psoriasis Area and Severity Index [PASI] ≥12; Investigator's Global Assessment [IGA] ≥3). Data were collected from August 2022 to June 2024.
Randomized participants (3:1) received guselkumab, 100 mg, at weeks 0 and 4, then every 8 weeks, or placebo with crossover to guselkumab at weeks 16 and 20, then every 8 weeks.
Coprimary end points were IGA score of 0 or 1 (IGA 0/1) and PASI improvement of 90% or more (PASI 90) at week 16 (guselkumab vs placebo). Major secondary end points included IGA 0; PASI 100; percentage changes from baseline in PASI and BSA; changes from baseline in Dermatology Life Quality Index (DLQI) and Psoriasis Symptoms and Signs Diary (PSSD) symptoms; and at least a 4-point reduction in PSSD itch.
Of 103 participants (77 randomized to guselkumab; 26 randomized to placebo), 94 (91.3%) completed 48 weeks of treatment. The mean (SD) age overall was 44.1 (12.9) years, and 74 participants (71.8%) were male. At week 16, coprimary end points were achieved by greater proportions of guselkumab- vs placebo-treated participants (IGA 0/1: 57 of 77 [74.0%] vs 0 of 26; P < .001; PASI 90: 44 of 77 [57.1%] vs 1 of 26 [3.8%]; P < .001); 25 of 77 (32.5%) vs 0 of 26 achieved IGA 0 (P < .001), and 23 of 77 (29.9%) vs 0 of 26 achieved PASI 100 (P = .002). DLQI and PSSD symptoms score least-squares mean changes from baseline were -12.1 (95% CI, -13.1 to -10.9) vs -2.5 (95% CI, -4.4 to -0.6) (P < .001), and -49.4 (95% CI, -54.0 to -44.9) vs -8.2 (95% CI, -15.8 to -0.6) (P < .001), respectively. A 4-point or greater reduction in PSSD itch score was achieved by 48 (66.7%) vs 4 (16.7%) participants with a baseline score of at least 4 (P < .001). Efficacy increased and was maintained through week 48, with guselkumab-randomized participants achieving mean percentage improvements in PASI and BSA of more than 94%, and more than 50% of participants achieving complete clearance. Infections were the most common adverse events in the guselkumab (16 [20.8%]) and placebo (3 [11.5%]) groups through week 16, predominantly upper respiratory tract infection and nasopharyngitis.
In this randomized clinical trial, after 3 doses of guselkumab, significant skin clearance and quality of life improvements were observed in this cohort of participants with moderate to severe psoriasis and skin of color across the range of objectively measured skin tones. Improvements increased and were maintained through week 48.
ClinicalTrials.gov Identifier: NCT05272150.
有色人种群体中的数据和教育差距导致了银屑病治疗中的种族和族裔差异。VISIBLE研究的A队列包括自我认定属于非白人种族或族裔类别的银屑病患者，涵盖整个肤色范围。
评估接受100mg古塞库单抗治疗长达48周的中度至重度银屑病且为有色人种的参与者的疗效、生活质量和不良事件结果。
设计、地点和参与者：这项正在进行的3b期随机临床试验在美国和加拿大的39个地点开展，纳入了患有中度至重度银屑病（体表面积[BSA]≥10%；银屑病面积和严重程度指数[PASI]≥12；研究者整体评估[IGA]≥3）的有色人种成年人。数据收集时间为2022年8月至2024年6月。
随机分组的参与者（3:1）在第0周和第4周接受100mg古塞库单抗治疗，然后每8周一次，或接受安慰剂治疗，并在第16周和第20周交叉接受古塞库单抗治疗，之后每8周一次。
共同主要终点为第16周时IGA评分为0或1（IGA 0/1）以及PASI改善90%或更多（PASI 90）（古塞库单抗与安慰剂对比）。主要次要终点包括IGA 0；PASI 100；PASI和BSA相对于基线的百分比变化；皮肤病生活质量指数（DLQI）和银屑病症状与体征日记（PSSD）症状相对于基线的变化；以及PSSD瘙痒至少降低4分。
103名参与者中（77名随机分配接受古塞库单抗治疗；26名随机分配接受安慰剂治疗），94名（91.3%）完成了48周的治疗。总体平均（标准差）年龄为44.1（12.9）岁，74名参与者（71.8%）为男性。在第16周时，接受古塞库单抗治疗的参与者达到共同主要终点的比例高于接受安慰剂治疗的参与者（IGA 0/1：77名中的57名[74.0%] 对比26名中的0名；P < .001；PASI 90：77名中的44名[57.1%] 对比26名中的1名[3.8%]；P < .001）；77名中的25名（32.5%）对比26名中的0名达到IGA 0（P < .001），77名中的23名（29.9%）对比26名中的0名达到PASI 100（P = .002）。DLQI和PSSD症状评分相对于基线的最小二乘均值变化分别为-12.1（95%置信区间，-13.1至-10.9）对比-2.5（95%置信区间，-4.4至-0.6）（P < .001），以及-49.4（95%置信区间，-54.0至-44.9）对比-8.2（95%置信区间，-15.8至-0.6）（P < .001）。基线评分至少为4分的参与者中，48名（66.7%）对比4名（16.7%）的PSSD瘙痒评分降低了4分或更多（P < .001）。疗效在第48周时增加并维持，随机接受古塞库单抗治疗的参与者的PASI和BSA平均改善百分比超过94%，超过50%的参与者实现了完全清除。在第16周之前，感染是古塞库单抗组（16例[20.8%]）和安慰剂组（3例[11.5%]）中最常见的不良事件，主要为上呼吸道感染和鼻咽炎。
在这项随机临床试验中，在3剂古塞库单抗治疗后，在这组中度至重度银屑病且为有色人种的参与者中，观察到了显著的皮肤清除和生活质量改善，涵盖客观测量的整个肤色范围。改善在第48周时增加并维持。
ClinicalTrials.gov标识符：NCT05272150。
