Ortonne Jean-Paul, Shear Neil, Shumack Stephen, Henninger Eric
Serono International S.A. Geneva, Switzerland.
BMC Dermatol. 2005 Dec 16;5:13. doi: 10.1186/1471-5945-5-13.
Chronic psoriasis can negatively affect patients' lives. Assessing the impact of treatment on different aspects of a patient's health-related quality of life (HRQOL) is therefore important and relevant in trials of anti-psoriasis agents. The recombinant humanized IgG1 monoclonal antibody efalizumab targets multiple T-cell-dependent steps in the immunopathogenesis of psoriasis. Efalizumab has demonstrated safety and efficacy in several clinical trials, and improves patients' quality of life.
To evaluate the impact of efalizumab on HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis, including a large cohort of High-Need patients for whom at least 2 other systemic therapies were unsuitable because of lack of efficacy, intolerance, or contraindication.
A total of 793 patients were randomized in a 2:1 ratio to receive efalizumab 1 mg/kg/wk (n = 529) or placebo (n = 264) for 12 weeks. The study population included 526 High-Need patients (342 efalizumab, 184 placebo). The treatment was evaluated by patients using the HRQOL assessment tools Short Form-36 (SF-36) and Dermatology Life Quality Index (DLQI). Other patient-reported assessments included the Psoriasis Symptom Assessment (PSA), a visual analog scale (VAS) for itching, and the Patient's Global Psoriasis Assessment (PGPA).
Efalizumab was associated with improvements at Week 12 from baseline in patient-reported outcomes, both in the total study population and in the High-Need cohort. Among all efalizumab-treated patients, the DLQI improved by 5.7 points from baseline to Week 12, relative to an improvement of 2.3 points for placebo patients (P < .001). Corresponding improvements in DLQI in the High-Need cohort were 5.4 points for efalizumab compared to 2.3 for placebo (P < .001). Improvements from baseline on the SF-36, PSA, PGPA, and itching VAS at Week 12 were also significantly greater in efalizumab-treated patients than for placebo.
A 12-week course of efalizumab improved HRQOL and other patient-reported outcomes in patients with moderate to severe plaque psoriasis. The benefits of efalizumab therapy in High-Need patients were similar to those observed in the total study population, indicating that the beneficial impact of efalizumab on QOL is consistent regardless of disease severity, prior therapy, or contraindications to previous therapies.
慢性银屑病会对患者生活产生负面影响。因此，在抗银屑病药物试验中，评估治疗对患者健康相关生活质量（HRQOL）不同方面的影响具有重要意义且相关。重组人源化IgG1单克隆抗体依法利珠单抗作用于银屑病免疫发病机制中多个T细胞依赖步骤。依法利珠单抗在多项临床试验中已证明其安全性和有效性，并能改善患者生活质量。
评估依法利珠单抗对中度至重度斑块状银屑病患者HRQOL及其他患者报告结局的影响，包括一大批高需求患者，这些患者因疗效不佳、不耐受或禁忌而至少有2种其他全身治疗方法不适用。
总共793例患者按2:1比例随机分组，接受12周的依法利珠单抗1mg/kg/周（n = 529）或安慰剂（n = 264）治疗。研究人群包括526例高需求患者（342例接受依法利珠单抗治疗，184例接受安慰剂治疗）。患者使用HRQOL评估工具简明健康调查问卷（SF-36）和皮肤病生活质量指数（DLQI）对治疗进行评估。其他患者报告的评估包括银屑病症状评估（PSA）、瘙痒视觉模拟量表（VAS）和患者整体银屑病评估（PGPA）。
在整个研究人群和高需求队列中，依法利珠单抗治疗12周后患者报告结局较基线均有所改善。在所有接受依法利珠单抗治疗的患者中，从基线到第12周，DLQI改善了5.7分，而安慰剂组患者改善了2.3分（P < .001）。高需求队列中，依法利珠单抗组DLQI相应改善5.4分，安慰剂组为2.3分（P < .001）。在第12周时，依法利珠单抗治疗的患者在SF-36、PSA、PGPA和瘙痒VAS方面较基线的改善也显著大于安慰剂组。
依法利珠单抗12周疗程改善了中度至重度斑块状银屑病患者的HRQOL及其他患者报告结局。依法利珠单抗治疗高需求患者的益处与整个研究人群中观察到的相似，这表明无论疾病严重程度、既往治疗或既往治疗的禁忌情况如何，依法利珠单抗对生活质量的有益影响是一致的。
