Mease Philip J, Gladman Dafna D, Ritchlin Christopher T, Ruderman Eric M, Steinfeld Serge D, Choy Ernest H S, Sharp John T, Ory Peter A, Perdok Renee J, Weinberg Mark A
Seattle Rheumatology Associates, Swedish Medical Center, Seattle, Washington 98104, USA.
Arthritis Rheum. 2005 Oct;52(10):3279-89. doi: 10.1002/art.21306.
Adalimumab, a fully human, anti-tumor necrosis factor monoclonal antibody, was evaluated for its safety and efficacy compared with placebo in the treatment of active psoriatic arthritis (PsA).
Patients with moderately to severely active PsA and a history of inadequate response to nonsteroidal antiinflammatory drugs were randomized to receive 40 mg adalimumab or placebo subcutaneously every other week for 24 weeks. Study visits were at baseline, weeks 2 and 4, and every 4 weeks thereafter. The primary efficacy end points were the American College of Rheumatology 20% improvement (ACR20) response at week 12 and the change in the modified total Sharp score of structural damage at week 24. Secondary end points were measures of joint disease, disability, and quality of life in all patients, as well as the severity of skin disease in those patients with psoriasis involving at least 3% of body surface area.
At week 12, 58% of the adalimumab-treated patients (87 of 151) achieved an ACR20 response, compared with 14% of the placebo-treated patients (23 of 162) (P < 0.001). At week 24, similar ACR20 response rates were maintained and the mean change in the modified total Sharp score was -0.2 in patients receiving adalimumab and 1.0 in those receiving placebo (P < 0.001). Among the 69 adalimumab-treated patients evaluated with the Psoriasis Area and Severity Index (PASI), 59% achieved a 75% PASI improvement response at 24 weeks, compared with 1% of the 69 placebo-treated patients evaluated (P < 0.001). Disability and quality of life measures were also significantly improved with adalimumab treatment compared with placebo. Adalimumab was generally safe and well-tolerated.
Adalimumab significantly improved joint and skin manifestations, inhibited structural changes on radiographs, lessened disability due to joint damage, and improved quality of life in patients with moderately to severely active PsA.
评估全人源抗肿瘤坏死因子单克隆抗体阿达木单抗治疗活动性银屑病关节炎（PsA）时相较于安慰剂的安全性和疗效。
中度至重度活动性PsA且对非甾体抗炎药反应欠佳的患者被随机分组，每两周皮下注射40mg阿达木单抗或安慰剂，共24周。研究访视时间点为基线、第2周和第4周，此后每4周一次。主要疗效终点为第12周时美国风湿病学会（ACR）20%改善（ACR20）反应以及第24周时改良总Sharp结构损伤评分的变化。次要终点为所有患者关节疾病、残疾和生活质量的指标，以及银屑病累及体表面积至少3%的患者的皮肤病严重程度。
第12周时，接受阿达木单抗治疗的患者中有58%（151例中的87例）达到ACR20反应，而接受安慰剂治疗的患者中这一比例为14%（162例中的23例）（P<0.001）。第24周时，维持了相似的ACR20反应率，接受阿达木单抗治疗的患者改良总Sharp评分的平均变化为-0.2，接受安慰剂治疗的患者为1.0（P<0.001）。在69例接受银屑病面积和严重程度指数（PASI）评估的阿达木单抗治疗患者中，59%在24周时达到PASI改善75%的反应，而接受评估的69例安慰剂治疗患者中这一比例为1%（P<0.001）。与安慰剂相比，阿达木单抗治疗还显著改善了残疾和生活质量指标。阿达木单抗总体上安全且耐受性良好。
阿达木单抗显著改善了中度至重度活动性PsA患者的关节和皮肤表现，抑制了X线片上的结构改变，减轻了关节损伤导致的残疾，并改善了生活质量。
