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.
BACKGROUND: 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. OBJECTIVE: 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). METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRY: ClinicalTrials.gov identifier NCT01708603 (AMAGINE-2); NCT01708629 (AMAGINE-3).
背景：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。
目的：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。
方法：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。
结果：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。
结论：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。
试验注册：ClinicalTrials.gov 标识符 NCT01708603（AMAGINE-2）；NCT01708629（AMAGINE-3）。
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