Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study.
Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study.
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DOI：
10.1111/jdv.13859
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发表时间：
2017-01
期刊：
影响因子：
--
通讯作者：
Griffiths CE
中科院分区：
文献类型：
--
作者：
Paul C;Stein Gold L;Cambazard F;Kalb RE;Lowson D;Bang B;Griffiths CE
固定复方卡泊三醇50 μg/g（Cal）加倍他赛0.5 mg/g（BD）泡沫已被开发为银屑病患者的新治疗选择。随机、平行组、研究者设盲、III期、12周PSO‐ABLE研究比较了Cal/BD泡沫与Cal/BD凝胶的有效性和安全性。年龄≥18岁的轻度至重度银屑病患者以4：4：1：1的比例随机分配至每日一次Cal/BD泡沫、Cal/BD凝胶、泡沫溶剂或凝胶溶剂组（NCT 02132936）。主要有效性终点是Cal/BD泡沫组第4周与Cal/BD凝胶组第8周时根据医生对疾病严重程度的总体评估（即治疗成功），明确/几乎明确且改善≥ 2级的患者比例。次要疗效终点包括：改良银屑病面积和严重程度指数（mPASI 75）减少至少75%的患者比例和治疗成功时间（TTTS）。全程监测安全性。共463例患者接受随机分组：Cal/BD泡沫（n = 185）、Cal/BD凝胶（n = 188）、泡沫溶剂（n = 47）、凝胶溶剂（n = 43）;总体完成率为90%。Cal/BD泡沫在第4周达到的治疗成功率（38% vs. 22%; P < 0.001）和mPASI 75（52% vs. 35%; P < 0.001）高于Cal/BD凝胶（第8周）。使用Cal/BD泡沫的中位TTTS为6周;由于未达到50%的治疗成功率，因此无法确定Cal/BD凝胶的TTTS（P < 0.001）。14例（7.6%）Cal/BD气雾剂泡沫患者和7例（3.7%）Cal/BD凝胶患者报告了药物不良反应;除Cal/BD气雾剂泡沫的瘙痒（n = 5; 2.7%）和Cal/BD凝胶的银屑病恶化（n = 3; 1.6%）外，所有均为单一事件。Cal/BD气雾剂泡沫在4周后显示出比Cal/BD凝胶治疗8周显著更大的疗效，具有相似的耐受性。
Fixed combination calcipotriol 50 μg/g (Cal) plus betamethasone 0.5 mg/g (BD) foam has been developed as a new treatment option for patients with psoriasis. The randomized, parallel‐group, investigator‐blinded Phase III, 12‐week PSO‐ABLE study compared the efficacy and safety of Cal/BD foam with Cal/BD gel. Patients aged ≥18 years with mild‐to‐severe psoriasis were randomized 4:4:1:1 to once‐daily Cal/BD foam, Cal/BD gel, foam vehicle or gel vehicle (NCT02132936). The primary efficacy endpoint was the proportion of patients who were clear/almost clear with a ≥ 2 grade improvement according to the physician's global assessment of disease severity (i.e. treatment success) at week 4 for Cal/BD foam vs. week 8 for Cal/BD gel. Secondary efficacy endpoints included: proportion of patients achieving at least a 75% reduction in modified psoriasis area and severity index (mPASI75), and time to treatment success (TTTS). Safety was monitored throughout. A total of 463 patients were randomized: Cal/BD foam (n = 185), Cal/BD gel (n = 188), foam vehicle (n = 47), gel vehicle (n = 43); overall completion rate was 90%. Cal/BD foam achieved higher treatment success rates (38% vs. 22%; P < 0.001) and mPASI75 (52% vs. 35%; P < 0.001) by week 4 than Cal/BD gel by week 8. Median TTTS with Cal/BD foam was 6 weeks; this could not be determined for Cal/BD gel as 50% treatment success was not achieved (P < 0.001). Adverse drug reactions were reported in 14 (7.6%) Cal/BD aerosol foam patients and 7 (3.7%) Cal/BD gel patients; all were single events except for itch with Cal/BD aerosol foam (n = 5; 2.7%) and worsening psoriasis with Cal/BD gel (n = 3; 1.6%). Cal/BD aerosol foam showed significantly greater efficacy after 4 weeks, than 8 weeks of treatment with Cal/BD gel, with similar tolerability.
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影响因子：
3.2
作者：
Queille-Roussel, Catherine;Olesen, Martin;Lacour, Jean-Philippe
通讯作者：
Lacour, Jean-Philippe
影响因子：
13.8
作者：
Menter, Alan;Korman, Neil J.;Bhushan, Reva
通讯作者：
Bhushan, Reva
影响因子：
13.8
作者：
Gelfand, JM;Feldman, SR;Margolis, DJ
通讯作者：
Margolis, DJ
影响因子：
3.6
作者：
Douglas, WS;Poulin, Y;Bibby, AJ
通讯作者：
Bibby, AJ
DOI：
10.1111/jdv.13230
发表时间：
2015-12-01
影响因子：
9.2
作者：
Lambert, J.;Hol, C. W.;Vink, J.
通讯作者：
Vink, J.