Leonardi Craig, Langley Richard G, Papp Kim, Tyring Stephen K, Wasel Norman, Vender Ronald, Unnebrink Kristina, Gupta Shiraz R, Valdecantos Wendell C, Bagel Jerry
Central Dermatology, 1034 S Brentwood Blvd, Ste 600, St Louis, MO 63117, USA.
Arch Dermatol. 2011 Apr;147(4):429-36. doi: 10.1001/archdermatol.2010.384. Epub 2010 Dec 20.
To determine the efficacy, safety, and sustainability of response to adalimumab therapy for moderate to severe chronic plaque psoriasis involving hands and/or feet.
Sixteen-week, randomized, double-blind, placebo-controlled evaluation of adalimumab therapy for moderate to severe chronic plaque psoriasis involving the hands and/or feet with a 12-week open-label extension (Randomized Controlled Evaluation of Adalimumab in Treatment of Chronic Plaque Psoriasis of the Hands and Feet [REACH]).
Multicenter outpatient study in the United States and Canada.
Patients with chronic plaque psoriasis on the hands and/or feet with a Physician's Global Assessment of hands and/or feet (hfPGA) score of "moderate" or above.
Patients were randomized 2:1 to adalimumab (80 mg at week 0, then 40 mg every other week starting at week 1) or to matching placebo.
Percentage of patients achieving an hfPGA score of "clear" or "almost clear" at week 16.
Seventy-two patients (adalimumab [n = 49];placebo [n = 23]) were evaluated. Baseline percentages of patients with moderate and severe hfPGA scores were 76% and 24%, respectively, for the adalimumab group and 74% and 26%, respectively, for the placebo group. At week 16, 31% and 4% of patients randomized to adalimumab and placebo, respectively, achieved an hfPGA score of clear or almost clear (P = .01). At week 28, 80% of the hfPGA clear or almost clear response was maintained from week 16 (25% for patients randomized to adalimumab). Adverse events in both groups were generally mild to moderate. In both periods combined, nasopharyngitis (27% and 13% for adalimumab- and placebo-treated patients, respectively) was most frequently reported.
Adalimumab is efficacious and well tolerated for treatment of chronic plaque psoriasis of hands and/or feet, with efficacy largely maintained to 28 weeks. Trial Registration clinicaltrials.gov Identifier: NCT00735787.
确定阿达木单抗治疗累及手部和/或足部的中度至重度慢性斑块状银屑病的疗效、安全性及反应的可持续性。
一项为期16周的随机、双盲、安慰剂对照评估，用于评估阿达木单抗治疗累及手部和/或足部的中度至重度慢性斑块状银屑病，并进行为期12周的开放标签延长期研究（阿达木单抗治疗手足慢性斑块状银屑病的随机对照评估[REACH]）。
美国和加拿大的多中心门诊研究。
手部和/或足部患有慢性斑块状银屑病且医生对手部和/或足部的整体评估（hfPGA）评分为“中度”或以上的患者。
患者按2:1随机分组，分别接受阿达木单抗（第0周80mg，然后从第1周开始每隔一周40mg）或匹配的安慰剂治疗。
在第16周时达到hfPGA评分为“清除”或“几乎清除”的患者百分比。
共评估了72例患者（阿达木单抗组[n = 49]；安慰剂组[n = 23]）。阿达木单抗组中度和重度hfPGA评分患者的基线百分比分别为76%和24%，安慰剂组分别为74%和26%。在第16周时，随机分配至阿达木单抗组和安慰剂组的患者中，分别有31%和4%的患者达到了hfPGA评分为清除或几乎清除（P = 0.01）。在第28周时，80%在第16周时达到hfPGA清除或几乎清除反应的患者维持了该反应（随机分配至阿达木单抗组的患者为25%）。两组的不良事件一般为轻度至中度。在两个阶段合并时，最常报告的是鼻咽炎（阿达木单抗治疗组和安慰剂治疗组分别为27%和13%）。
阿达木单抗治疗手部和/或足部慢性斑块状银屑病有效且耐受性良好，疗效在很大程度上维持至28周。试验注册 clinicaltrials.gov标识符：NCT00735787。
