Department of Dermatology, Wake Forest Baptist Medical Center, Medical Center Boulevard, Winston-Salem, NC, 27104, USA.
Innovative Dermatology, Plano, TX, USA.
Am J Clin Dermatol. 2019 Apr;20(2):267-276. doi: 10.1007/s40257-018-0408-z.
Data on treatment outcomes in patients with psoriasis who have skin of color are limited. Brodalumab has shown efficacy in patients with moderate-to-severe plaque psoriasis.
Our objective was to evaluate the efficacy, safety, and health-related quality of life associated with brodalumab in patients with skin of color participating in two phase III, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies (AMAGINE-2/-3).
Patients were self-categorized into racial subgroups (black, Asian, or white) or the non-mutually exclusive ethnic subgroup Hispanic/Latino. Patients were randomized to receive brodalumab 210 mg every 2 weeks (Q2W) or ustekinumab (45 mg in patients weighing ≤ 100 kg and 90 mg in patients weighing > 100 kg) for 52 weeks. Skin clearance was monitored using the Psoriasis Area and Severity Index (PASI) and Static Physician's Global Assessment (sPGA). Treatment-emergent adverse events (TEAEs) were summarized by treatment and racial and ethnic subgroup. Health-related quality of life was assessed using the Dermatology Life Quality Index (DLQI).
During the 12-week induction phase, 613 patients received ustekinumab (black, n = 20; Asian, n = 24; white, n = 551; Hispanic/Latino, n = 68) and 1236 patients received brodalumab 210 mg Q2W (black, n = 36; Asian, n = 39; white, n = 1116; Hispanic/Latino, n = 132). At week 52, a total of 590 patients received continuous ustekinumab (black, n = 19; Asian, n = 23; white, n = 532; Hispanic/Latino, n = 64) and 339 patients were re-randomized to continue receiving brodalumab 210 mg Q2W (black, n = 10; Asian, n = 7; white, n = 308; Hispanic/Latino, n = 40). Among patients who received brodalumab 210 mg Q2W, skin clearance response rates were similar across racial and ethnic subgroups at week 12 and week 52; rates of 75%, 90%, and 100% improvement in PASI from baseline were also higher, as was sPGA score ≤ 1, than in patients who received ustekinumab across all racial and ethnic subgroups. Rates of TEAEs and ≥ 5-point improvement in DLQI score were similar across racial and ethnic subgroups.
Brodalumab 210 mg Q2W is well tolerated and efficacious across diverse racial and ethnic subgroups in patients with psoriasis, including black, Asian, white, and Hispanic/Latino patients.
ClinicalTrials.gov identifier NCT01708603 (AMAGINE-2); NCT01708629 (AMAGINE-3).
有关肤色患者银屑病治疗结果的数据有限。布罗达umab 在中度至重度斑块型银屑病患者中显示出疗效。
我们的目的是评估布罗达umab 在参与两项 III 期、多中心、随机、双盲、安慰剂和阳性对照对照研究（AMAGINE-2/-3）的有色人种患者中的疗效、安全性和与健康相关的生活质量。
患者自我归类为种族亚组（黑人、亚洲人或白人）或非互斥的种族亚组西班牙裔/拉丁裔。患者被随机分配接受布罗达umab 210mg 每 2 周（Q2W）或乌司奴单抗（体重≤100kg 的患者为 45mg，体重>100kg 的患者为 90mg）治疗 52 周。使用银屑病面积和严重程度指数（PASI）和静态医师总体评估（sPGA）监测皮肤清除率。按治疗和种族及族裔亚组总结治疗出现的不良事件（TEAEs）。使用皮肤病生活质量指数（DLQI）评估与健康相关的生活质量。
在 12 周诱导期，613 名患者接受乌司奴单抗治疗（黑人，n=20；亚洲人，n=24；白人，n=551；西班牙裔/拉丁裔，n=68），1236 名患者接受布罗达umab 210mg Q2W 治疗（黑人，n=36；亚洲人，n=39；白人，n=1116；西班牙裔/拉丁裔，n=132）。在第 52 周时，共有 590 名患者接受持续乌司奴单抗治疗（黑人，n=19；亚洲人，n=23；白人，n=532；西班牙裔/拉丁裔，n=64），339 名患者重新随机接受继续接受布罗达umab 210mg Q2W 治疗（黑人，n=10；亚洲人，n=7；白人，n=308；西班牙裔/拉丁裔，n=40）。在接受布罗达umab 210mg Q2W 的患者中，在第 12 周和第 52 周时，各种族和族裔亚组的皮肤清除率反应率相似；基线 PASI 改善 75%、90%和 100%的比例以及 sPGA 评分≤1的比例也高于所有种族和族裔亚组接受乌司奴单抗的患者。TEAEs 发生率和 DLQI 评分改善≥5 分的比例在各种族和族裔亚组中相似。
布罗达umab 210mg Q2W 在银屑病患者中耐受性良好，疗效在不同种族和族裔亚组中相似，包括黑人、亚洲人、白人和西班牙裔/拉丁裔患者。
ClinicalTrials.gov 标识符 NCT01708603（AMAGINE-2）；NCT01708629（AMAGINE-3）。
