De Backer Marc, Morren Marie-Anne, Boonen Hugo, Boyden Bert, Vertruyen Andre, Lecomte Pascal, Paquay Catherine, Lesaffre Emmanuel, Lambert Julien
Novartis Pharma, Vilvoorde, Belgium.
Dermatology. 2008;217(2):156-63. doi: 10.1159/000136654. Epub 2008 Jun 5.
For reimbursement purposes of pimecrolimus cream 1%, the Belgian authorities asked to document its consumption, its topical corticosteroid-sparing effect and quality of life within the routine clinical practice.
We aimed to address the 3 queries of the Belgian authorities.
An open-label, observational, multicentre, 1-year study under drug prescription was performed.
A total of 416 consecutive patients were enrolled in 49 centres. The mean annual amount of prescribed pimecrolimus cream 1% per patient was 120.8 g (SD = 117.0), with an estimated consumption of 104.4 g (SD = 117.6). The median annual amount prescribed was 90.0 g [interquartile range (IQR) = 45-150] and the estimated consumption 63.6 g (IQR = 32.4-132). Topical corticosteroids had been used before the study in 81.7% of the population. With pimecrolimus cream 1% during the study, 83.3% of the previous corticosteroid users stated less topical corticosteroid use than before and 36% of them did not apply topical corticosteroids at all during the study. The mean improvements compared to baseline in Parents' Index Quality of Life-Atopic Dermatitis and Quality of Life Index-Atopic Dermatitis scores were 34.5% (SD = 84.3) and 31.2% (SD = 70.8), respectively. The median improvements were 50.0% (IQR = 12.5-85.7%) and 46.4% (IQR = 0.0-85.0%), respectively.
In routine practice the consumption of pimecrolimus cream 1% is relatively low, with corticosteroid-sparing effect, improvement in quality of life and good tolerability.
为了确定1%吡美莫司乳膏的报销标准,比利时当局要求记录其在常规临床实践中的使用情况、局部皮质类固醇节省效应和生活质量。
我们旨在回答比利时当局提出的3个问题。
开展了一项开放标签、观察性、多中心、为期1年的药物处方研究。
49个中心共纳入416例连续患者。每位患者每年开具的1%吡美莫司乳膏平均量为120.8 g(标准差=117.0),估计消耗量为104.4 g(标准差=117.6)。每年开具量的中位数为90.0 g[四分位间距(IQR)=45 - 150],估计消耗量为63.6 g(IQR = 32.4 - 132)。81.7%的患者在研究前使用过局部皮质类固醇。在研究期间使用1%吡美莫司乳膏后,83.3%之前使用皮质类固醇的患者表示局部皮质类固醇的使用量比以前减少,其中36%的患者在研究期间完全未使用局部皮质类固醇。与基线相比,父母特应性皮炎生活质量指数和特应性皮炎生活质量指数评分的平均改善分别为34.5%(标准差=84.3)和31.2%(标准差=70.8)。中位数改善分别为50.0%(IQR = 12.5 - 85.7%)和46.4%(IQR = 0.0 - 85.0%)。
在常规实践中,1%吡美莫司乳膏的消耗量相对较低,具有节省皮质类固醇的作用,可改善生活质量且耐受性良好。