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卡泊三醇 0.005%/倍他米松二丙酸酯 0.064%泡沫与卤倍他索 0.01%/他扎罗汀 0.045%乳剂治疗斑块状银屑病的有效性比较和增量成本-反应者分析:匹配调整的间接比较分析。

Effectiveness comparison and incremental cost-per-responder analysis of calcipotriene 0.005%/betamethasone dipropionate 0.064% foam vs. halobetasol 0.01%/tazarotene 0.045% lotion for plaque psoriasis: a matching-adjusted indirect comparative analysis.

机构信息

Dermatology Research and Education Foundation, Irvine, CA, USA.

LEO Pharma, Ballerup, Denmark.

出版信息

J Med Econ. 2020 Jun;23(6):641-649. doi: 10.1080/13696998.2020.1722139. Epub 2020 Mar 2.

DOI:10.1080/13696998.2020.1722139
PMID:31985301
Abstract

The fixed-dose combination foam formulation of calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) has demonstrated efficacy and a favorable safety profile for the treatment of plaque psoriasis. Recently, a topical lotion of the combination of halobetasol 0.01% plus tazarotene 0.045% (HP/TAZ) was approved for treating adult plaque psoriasis. Currently, no head-to-head studies have compared Cal/BD foam with HP/TAZ lotion. Compare the effectiveness and drug incremental cost per responder (ICPR) of Cal/BD foam vs. HP/TAZ lotion in moderate-to-severe plaque psoriasis. An anchor-based, matching-adjusted indirect comparison was conducted for PGA treatment success (Physician's Global Assessment of "clear" or "almost clear," [PGA 0/1] with at least a 2-point improvement) using individual patient data from 3 randomized clinical studies of Cal/BD foam and published data from 2 randomized, Phase 3 clinical studies of HP/TAZ lotion. The number needed to treat and ICPR were also calculated. After reweighting of patients in the Cal/BD foam studies to match summary baseline characteristics of the HP/TAZ lotion study patients and anchoring to vehicle effect, 4 weeks of Cal/BD foam produced a significantly greater rate of treatment success than 8 weeks of HP/TAZ lotion treatment (51.4 vs. 30.7%; treatment difference = 20.7%,  < .001). The number needed to treat with Cal/BD foam was also less than HP/TAZ lotion (1.9 vs. 3.3). Using US wholesale acquisition costs and equal weekly consumption rates, the incremental cost per PGA 0/1 responder relative to vehicle for Cal/BD foam was $3,988 and was 37% lower compared with HP/TAZ lotion ($6,294). The indirect comparison analyses showed that Cal/BD foam was associated with a greater rate of treatment success, lower ICPR, and quicker treatment response than HP/TAZ lotion in adult patients with moderate-to-severe plaque psoriasis.

摘要

卡泊三醇 0.005%加倍他米松二丙酸酯 0.064%(钙/BD)的固定剂量组合泡沫制剂已被证明在治疗斑块状银屑病方面具有疗效和良好的安全性。最近,一种卤倍他索 0.01%加他扎罗汀 0.045%(HP/TAZ)的局部乳膏制剂被批准用于治疗成人斑块状银屑病。目前,尚无头对头研究比较钙/BD 泡沫与 HP/TAZ 乳膏。比较钙/BD 泡沫与 HP/TAZ 乳膏在中重度斑块状银屑病中的有效性和药物增量成本每应答者(ICPR)。使用来自 3 项钙/BD 泡沫随机临床研究和来自 2 项 HP/TAZ 乳膏随机、3 期临床研究的发表数据,基于 PGA 治疗成功(医生的整体评估为“清除”或“几乎清除”[PGA 0/1],至少提高 2 分),进行了基于锚定的、匹配调整的间接比较。还计算了需要治疗的人数和 ICPR。在对钙/BD 泡沫研究中的患者进行重新加权以匹配 HP/TAZ 乳膏研究患者的汇总基线特征并锚定到载体效应后,4 周的钙/BD 泡沫治疗产生的治疗成功率明显高于 8 周的 HP/TAZ 乳膏治疗(51.4%比 30.7%;治疗差异=20.7%,<.001)。用钙/BD 泡沫治疗的需要治疗的人数也少于 HP/TAZ 乳膏(1.9 比 3.3)。使用美国批发采购成本和相等的每周消耗量,与载体相比,钙/BD 泡沫治疗每 PGA 0/1 应答者的增量成本为 3988 美元,比 HP/TAZ 乳膏低 37%(6294 美元)。间接比较分析表明,在中重度斑块状银屑病成年患者中,钙/BD 泡沫与更高的治疗成功率、更低的 ICPR 和更快的治疗反应相关,而 HP/TAZ 乳膏则更低。

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