Supplementary Material for: Prospective, Observational, Non-Interventional, Multicentre Study on the Efficacy and Tolerability of a New Calcipotriol/Betamethasone Aerosol Foam (Enstilar®) in Patients with Plaque Psoriasis under Daily Practice Conditions
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<b><i>Background/Aims:</i></b> To assess the efficacy and tolerability of the new aerosol foam of calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g (Cal/BD foam, Enstilar®) in psoriasis vulgaris under daily practice conditions. <b><i>Methods:</i></b> 410 adult psoriasis patients (56% male) from 87 German sites were enrolled in a 4-week, open-label, prospective, non-controlled, observational, non-interventional study. <b><i>Results:</i></b> At baseline, patients presented with a psoriasis severity of mild (41.81%), moderate (49.63%), and severe (8.31%) assessed by an investigator global assessment (IGA). After 4 weeks of treatment, 49% of the patients achieved an IGA of clear/almost clear. The mean affected body surface area was reduced from 12.91 to 7.55%, the PASI from 10.4 to 5.2 (<i>p</i> < 0.0001). 43% of the patients with severe IGA achieved treatment success (IGA = 0/1 and ≥2-step improvement). 93% of the patients did not show any adverse events. <b><i>Conclusion:</i></b> The new Cal/BD foam showed a convincing efficacy and tolerability profile in daily practice, particularly in patients with severer disease manifestations.
<b><i>背景与目的:</i></b> 评估新型卡泊三醇50 μg/g+二丙酸倍他米松0.5 mg/g气溶胶泡沫制剂(Cal/BD泡沫,Enstilar®)在日常临床实践中治疗寻常型银屑病的疗效与耐受性。<b><i>方法:</i></b> 纳入来自德国87家研究中心的410名成年银屑病患者(男性占比56%),开展一项为期4周的开放标签、前瞻性、非对照、观察性非干预研究。<b><i>结果:</i></b> 基线时,经研究者整体评估(investigator global assessment, IGA),患者的银屑病严重程度分布为轻度(41.81%)、中度(49.63%)及重度(8.31%)。经4周治疗后,49%的患者达到IGA评分清除/几乎清除状态。患者平均受累体表面积从12.91%降至7.55%,银屑病面积与严重程度指数(Psoriasis Area and Severity Index, PASI)从10.4降至5.2(p < 0.0001)。43%的重度IGA评分患者实现治疗成功(IGA评分0/1分且较基线提升≥2个等级)。93%的患者未出现任何不良事件。<b><i>结论:</i></b> 这款新型Cal/BD泡沫制剂在日常临床实践中展现出令人信服的疗效与耐受性特征,尤其针对病情较为严重的患者群体。
提供机构:
Karger Publishers
创建时间:
2018-03-02



