阿昔替尼与杜比鲁单抗治疗中重度特应性皮炎的每应答者成本分析。

IF 1.8 4区 医学 Q3 DERMATOLOGY Italian Journal of Dermatology and Venereology Pub Date : 2024-09-09 DOI:10.23736/S2784-8671.24.07946-5
Martina Maurelli, Giampiero Girolomoni, Paolo Gisondi
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引用次数: 0

摘要

研究背景JADE COMPARE 是一项多中心、3 期随机、双盲、安慰剂对照试验,目的是比较口服阿罗西替尼 100 或 200 毫克、每 2 周一次皮下注射杜比鲁单抗 300 毫克或安慰剂治疗中重度特应性皮炎(AD)成人患者 16 周的疗效和安全性。目前尚未对这些治疗特应性皮炎的新药进行药物经济学评估。我们的研究目的是利用 JADE COMPARE 试验的数据,比较阿罗西替尼与杜比鲁单抗在 AD 患者中每应答者的成本:每个应答者的成本是用每种疗法的治疗成本乘以所需治疗人数计算得出的,这些数据来自 JADE COMPARE 试验。为期12周的主要终点是研究者总体评估(IGA)0/1和湿疹面积及严重程度指数改善至少75%(EASI75)的应答率。主要次要终点是第2周时的瘙痒反应(定义为瘙痒峰值数字评分量表[PP-NRS;评分范围为0至10]的得分改善≥4分)以及第16周时的IGA和EASI-75反应。每个应答者的成本模型基于意大利国家卫生系统的观点。关于药物成本,采用的是出厂批发价,包括国家法律规定的强制折扣(5% 折扣,再加上折扣结果的 5%)。阿罗西替尼 100 毫克和 200 毫克在意大利的价格是统一的:阿罗西替尼 100 毫克和 200 毫克每应答者的 12 周 IGA 0/1 费用分别为 3955.77 欧元和 2984.94 欧元,而杜比鲁单抗为 7467.96 欧元;每应答者的 12 周 EASI75 费用分别为 2463.30 欧元和 2057.58 欧元,而杜比鲁单抗为 4705.09 欧元。在次要终点方面,阿罗西替尼100毫克和200毫克与杜比鲁单抗相比,每个应答者的费用始终较低,包括PP-NRS(3791.55欧元和2451.22欧元,对6462.65欧元)、第16周IGA 0/1(6931.05欧元和4854.15欧元,对8787.85欧元)和第16周EASI75(3984.75欧元和3381.00欧元,对5197.45欧元):根据JADE COMPARE试验数据,阿罗西替尼每应答者的费用大大低于杜比鲁单抗。该研究结果仅限于 JADE COMPARE 试验的短时间内。
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Cost per responder analysis of abrocitinib versus dupilumab in moderate to severe atopic dermatitis.

Background: The JADE COMPARE was a multicenter, phase 3 randomized, double-blind, placebo-controlled trial with the objective of comparing the 16-week efficacy and safety of oral abrocitinib 100 or 200 mg once daily, dupilumab 300 mg subcutaneous injection every 2 weeks, or placebo in adults with moderate-to-severe atopic dermatitis (AD). Pharmacoeconomic evaluation of these new drugs for AD is lacking. The objective of our study was to compare the cost per responder of abrocitinib versus dupilumab in patients with AD using the data from the JADE COMPARE trial.

Methods: The cost per responder was calculated by multiplying the cost of treatment by the number needed to treat for each therapy, as obtained from the JADE COMPARE trial. The 12-week primary endpoint was the Investigator global assessment (IGA) 0/1 and eczema area and severity index improvement of at least 75% (EASI75) response rate. The key secondary end points were itch response (defined as an improvement of ≥4 points in the score on the Peak Pruritus Numerical Rating Scale [PP-NRS; scores range from 0 to 10]) at week 2 and IGA and EASI-75 responses at week 16. The cost per responder model was based on the perspective of the Italian National Health System. Regarding the costs of drugs, ex-factory wholesale purchase prices were used, including the mandatory discounts according to the national legislation (5% discount, plus a further 5% reduction on the discount result). Abrocitinib 100 mg and 200 mg have flat price in Italy.

Results: The 12-week IGA 0/1 cost per responder was € 3955.77 and € 2984.94 for abrocitinib 100 mg and 200 mg, respectively, versus € 7467.96 for dupilumab; as for 12-week EASI75 the cost were € 2463.30 and € 2057.58 vs. € 4705.09, respectively. As far as the secondary end points, the costs per responder were always lower for abrocitinib 100 and 200 mg compared to dupilumab, including the PP-NRS (€ 3791.55 and € 2451.22, vs. € 6462.65), the IGA 0/1 at week 16 (€ 6931.05 and € 4854.15 vs. € 8787.85) and the EASI75 at week 16 (€ 3984.75 and € 3381.00 vs. € 5197.45).

Conclusions: According to JADE COMPARE trial data, the costs per responder of abrocitinib were considerably lower than dupilumab. The results of the study are limited to the short time frame of JADE COMPARE trial.

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