Croom Katherine F, McCormack Paul L
Wolters Kluwer Health/Adis, Auckland, New Zealand.
Am J Clin Dermatol. 2009;10(1):43-50. doi: 10.2165/0128071-200910010-00008.
Adalimumab is a recombinant, human, IgG1 monoclonal antibody specific for tumor necrosis factor. The clinical efficacy and safety of adalimumab (40 mg administered subcutaneously every other week) in patients with moderate-to-severe chronic plaque psoriasis have been demonstrated in several randomized, double-blind clinical trials, including the pivotal trials REVEAL (n = 1212) and CHAMPION (n = 271). Based on these trials, adalimumab was significantly more effective than placebo and methotrexate at relieving the signs and symptoms of psoriasis after 16 weeks of treatment, as assessed by the percentage of patients achieving a 75% improvement from baseline in Psoriasis Area and Severity Index. Based on open-label extension studies of up to 2 years' duration, the efficacy of adalimumab was sustained over the long term. Of patients who had responded to 33 weeks of treatment with adalimumab in REVEAL, patients randomized to remain on adalimumab for an additional 19 weeks of treatment were significantly less likely to experience loss of an adequate response than patients who were transferred to placebo. Compared with placebo or methotrexate, adalimumab was associated with significantly greater improvements in dermatology-specific and general measures of health-related quality of life in patients with plaque psoriasis. Adalimumab was generally well tolerated in trials in patients with plaque psoriasis, and the adverse-event profile was similar to that associated with its use in rheumatoid arthritis.
阿达木单抗是一种重组人IgG1单克隆抗体,对肿瘤坏死因子具有特异性。在包括关键试验REVEAL(n = 1212)和CHAMPION(n = 271)在内的多项随机双盲临床试验中,已证明阿达木单抗(每两周皮下注射40 mg)治疗中重度慢性斑块状银屑病患者的临床疗效和安全性。基于这些试验,在治疗16周后,根据银屑病面积和严重程度指数较基线改善75%的患者百分比评估,阿达木单抗在缓解银屑病体征和症状方面明显比安慰剂和甲氨蝶呤更有效。基于长达2年的开放标签扩展研究,阿达木单抗的疗效长期维持。在REVEAL试验中,对阿达木单抗治疗33周有反应的患者中,随机分配继续接受阿达木单抗额外治疗19周的患者比转用安慰剂的患者出现疗效丧失的可能性显著降低。与安慰剂或甲氨蝶呤相比,阿达木单抗使斑块状银屑病患者的皮肤病特异性和与健康相关生活质量的总体指标有显著更大改善。在斑块状银屑病患者的试验中,阿达木单抗总体耐受性良好,不良事件谱与其在类风湿关节炎中的使用相关情况相似。