Revicki Dennis A, Menter Alan, Feldman Steven, Kimel Miriam, Harnam Neesha, Willian Mary K
Center for Health Outcomes Research, United BioSource Corporation, Bethesda, Maryland, USA.
Health Qual Life Outcomes. 2008 Oct 2;6:75. doi: 10.1186/1477-7525-6-75.
To evaluate the impact of adalimumab on health-related quality of life (HRQOL) for patients with moderate to severe plaque psoriasis.
Psoriasis is a chronic, inflammatory, immune-mediated disease that has a significant impact on patients' HRQOL. Adalimumab is a fully human monoclonal antibody that blocks tumor necrosis factor, a pro-inflammatory cytokine, and is effective and well-tolerated for patients with moderate to severe psoriasis.
Data were obtained for a secondary analysis of patients in a randomized, controlled Phase III trial evaluating the effect of adalimumab in patients with psoriasis (N = 1,205). Patients with moderate to severe psoriasis were randomized in a 2:1 ratio to adalimumab 80 mg (two 40 mg injections administered subcutaneously at baseline followed by one 40 mg injection every other week from Week 1 to Week 15) or placebo. Short Form-36 (SF-36) Health Survey scores of psoriasis patients were used to assess HRQOL and were compared with United States (US) population norms at baseline and Week 16.
Baseline Physical Component Summary (PCS) scores for the placebo and adalimumab groups were similar to the general US population. Baseline mean Mental Component Summary (MCS) scores were significantly lower for the adalimumab and placebo groups compared with the general population (47.4, 47.7, and 50.8 points, respectively; p < 0.0001). PCS scores at Week 16 for patients receiving adalimumab had improved and were significantly greater than scores for the general US population (52.7 vs 48.9; p < 0.001). Compared with the general US population, MCS scores at Week 16 were similar for patients receiving adalimumab (51.2 vs 50.8; p = 1.000) and lower for patients receiving placebo (50.8 vs 48.7; p < 0.0001).
Psoriasis has a broad impact on patient functioning and well-being. Improvement in skin lesions and joint symptoms associated with adalimumab treatment was accompanied by improvements in HRQOL to levels that were similar to or greater than those of the general US population.
Clinicaltrials.gov NCT00237887.
评估阿达木单抗对中度至重度斑块状银屑病患者健康相关生活质量（HRQOL）的影响。
银屑病是一种慢性、炎症性、免疫介导的疾病，对患者的HRQOL有重大影响。阿达木单抗是一种全人源单克隆抗体，可阻断肿瘤坏死因子（一种促炎细胞因子），对中度至重度银屑病患者有效且耐受性良好。
获取了一项随机对照III期试验中患者的二次分析数据，该试验评估了阿达木单抗对银屑病患者的疗效（N = 1,205）。中度至重度银屑病患者按2:1的比例随机分为接受80 mg阿达木单抗组（基线时皮下注射两次40 mg，随后从第1周开始至第15周每隔一周注射一次40 mg）或安慰剂组。使用银屑病患者的简明健康调查问卷（SF-36）评分来评估HRQOL，并在基线和第16周时与美国人群标准进行比较。
安慰剂组和阿达木单抗组的基线身体成分总结（PCS）评分与美国普通人群相似。与普通人群相比，阿达木单抗组和安慰剂组的基线平均心理成分总结（MCS）评分显著更低（分别为47.4、47.7和50.8分；p < 0.0001）。接受阿达木单抗治疗的患者在第16周时的PCS评分有所改善，且显著高于美国普通人群的评分（52.7对48.9；p < 0.001）。与美国普通人群相比，接受阿达木单抗治疗的患者在第16周时的MCS评分相似（51.2对50.8；p = 1.000），而接受安慰剂治疗的患者的MCS评分更低（50.8对48.7；p < 0.0001）。
银屑病对患者的功能和幸福感有广泛影响。阿达木单抗治疗相关的皮肤病变和关节症状改善伴随着HRQOL的改善，达到了与美国普通人群相似或更高的水平。
Clinicaltrials.gov NCT00237887。
