Poulin Y, Crowley J J, Langley R G, Unnebrink K, Goldblum O M, Valdecantos W C
Centre Dermatologique du Québec Métropolitain, Québec, Canada.
J Eur Acad Dermatol Venereol. 2014 Jul;28(7):882-90. doi: 10.1111/jdv.12198. Epub 2013 Jun 22.
The Randomized Controlled Evaluation of Adalimumab in Treatment of Chronic Plaque Psoriasis of the Hands and Feet (REACH) trial demonstrated that adalimumab was efficacious and well-tolerated for the treatment of hand and/or foot psoriasis through 28 weeks.
To evaluate the effects of patient baseline characteristics on efficacy of adalimumab treatment of hand and/or foot psoriasis.
Patients with moderate-to-severe chronic plaque psoriasis of the hands and/or feet were randomized 2 : 1 to adalimumab or placebo during the 16 week, double-blind period of REACH. Primary endpoint was percentage of patients achieving Physician's Global Assessment of the hands and/or feet of clear/almost clear at week 16. Post hoc analyses evaluated effects of baseline patient characteristics on the primary endpoint. Patients with nail psoriasis at baseline were assessed for association of Nail Psoriasis Severity Index (NAPSI) 50 response with efficacy outcomes at week 16.
Seventy-two patients (49 adalimumab : 23 placebo) were analysed. Greater percentages of adalimumab-treated patients achieved the primary endpoint vs. placebo across all subgroups. Among 31 patients with nail psoriasis, a greater percentage of adalimumab-treated patients achieved NAPSI 50 (56.5%) vs. placebo (12.5%) at week 16. In adalimumab-treated patients, greater percentages of NAPSI 50 Responders vs. Non-responders achieved the primary endpoint, and had greater improvements in erythema, scaling, induration and fissuring, Dermatology Life Quality Index, and pain scores.
Adalimumab was efficacious in treating chronic plaque psoriasis of the hands and/or feet over 16 weeks, regardless of baseline characteristics. Marked improvement in nail psoriasis among adalimumab-treated patients correlated with significant improvements in skin disease and patient-reported outcomes.
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）试验表明，阿达木单抗在治疗手足银屑病方面有效且耐受性良好，疗程达28周。
评估患者基线特征对阿达木单抗治疗手足银屑病疗效的影响。
在REACH试验的16周双盲期，将中重度手足慢性斑块状银屑病患者按2:1随机分为阿达木单抗组或安慰剂组。主要终点为在第16周时手部和/或足部达到医师整体评估为清除/几乎清除的患者百分比。事后分析评估基线患者特征对主要终点的影响。对基线有甲银屑病的患者评估第16周时甲银屑病严重程度指数（NAPSI）改善50%与疗效结果之间的相关性。
共分析了72例患者（49例阿达木单抗组：23例安慰剂组）。在所有亚组中，接受阿达木单抗治疗的患者达到主要终点的百分比均高于安慰剂组。在31例有甲银屑病的患者中，第16周时接受阿达木单抗治疗的患者达到NAPSI改善50%的百分比（56.5%）高于安慰剂组（12.5%）。在接受阿达木单抗治疗的患者中，达到NAPSI改善50%的患者达到主要终点的百分比高于未达到者，且在红斑、鳞屑、硬结和皲裂、皮肤病生活质量指数及疼痛评分方面改善更大。
无论基线特征如何，阿达木单抗在16周内有效治疗手足慢性斑块状银屑病。阿达木单抗治疗患者的甲银屑病明显改善与皮肤病及患者报告结局的显著改善相关。
