Department of Dermatopharmacology, University of Southampton, Southampton, UK.
Br J Dermatol. 2011 Feb;164(2):387-95. doi: 10.1111/j.1365-2133.2010.10141.x.
A twice-weekly maintenance treatment regimen with tacrolimus ointment for atopic dermatitis (AD) significantly delayed and reduced the number of disease exacerbations over a 12-month period compared with the standard reactive treatment regimen.
To determine the cost-effectiveness of tacrolimus ointment used in the maintenance treatment regimen vs. the standard reactive treatment regimen for the management of moderate and severe AD in adults and children.
Data from two pivotal phase III studies conducted in adults and children receiving 0·1% and 0·03% tacrolimus ointment, respectively, were used to populate a decision-analytic model. The costs and benefits associated with maintenance vs. reactive use of tacrolimus ointment were calculated over a 12-month period based on the clinical and quality of life data from the clinical trials. The analysis was conducted from the perspective of the U.K. National Health Service. Sensitivity analyses were conducted to assess the degree of uncertainty surrounding the results.
For both adults and children with moderate and severe AD, twice-weekly maintenance treatment with tacrolimus ointment was shown to be a more effective and less costly (dominant) treatment regimen than the standard treatment regimen. Sensitivity analyses demonstrated that the model was robust and largely insensitive to changes in model parameters.
Maintenance treatment with tacrolimus ointment for the management of moderate and severe AD provides incremental health benefits at a lower cost compared with the reactive treatment regimen.
与标准反应性治疗方案相比,他克莫司软膏每周两次的维持治疗方案可显著延缓并减少特应性皮炎(AD)患者在 12 个月内的疾病恶化次数。
评估他克莫司软膏维持治疗方案与标准反应性治疗方案相比,在治疗成人和儿童中重度 AD 中的成本效益。
分别使用两项关键性 III 期成人和儿童研究的数据来构建决策分析模型,这些研究中患者分别接受 0·1%和 0·03%他克莫司软膏治疗。根据临床试验的临床和生活质量数据,在 12 个月的时间内计算维持治疗与反应性使用他克莫司软膏的成本和效益。该分析从英国国家医疗服务体系的角度进行。进行敏感性分析以评估结果的不确定性程度。
对于中重度 AD 的成人和儿童患者,与标准治疗方案相比,每周两次的他克莫司软膏维持治疗方案更有效且成本更低(优势方案)。敏感性分析表明,该模型稳健,对模型参数的变化基本不敏感。
与反应性治疗方案相比,他克莫司软膏维持治疗中重度 AD 可提供额外的健康益处,同时成本更低。