Maurelli Martina, Girolomoni Giampiero, Gisondi Paolo
Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy -
Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.
Ital J Dermatol Venerol. 2024 Dec;159(6):607-611. doi: 10.23736/S2784-8671.24.07946-5. Epub 2024 Sep 9.
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.
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.
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).
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.
JADE COMPARE研究是一项多中心、3期随机、双盲、安慰剂对照试验，旨在比较每日一次口服100或200毫克阿布昔替尼、每2周皮下注射300毫克度普利尤单抗或安慰剂在中度至重度特应性皮炎（AD）成人患者中的16周疗效和安全性。目前缺乏对这些治疗AD新药的药物经济学评价。我们研究的目的是利用JADE COMPARE试验的数据，比较阿布昔替尼与度普利尤单抗在AD患者中的每例缓解者成本。
每例缓解者成本通过将治疗成本乘以每种治疗的需治疗人数来计算，数据来自JADE COMPARE试验。12周主要终点为研究者整体评估（IGA）0/1且湿疹面积和严重程度指数改善至少75%（EASI75）的缓解率。关键次要终点为第2周时的瘙痒缓解（定义为峰值瘙痒数字评定量表[PP-NRS；评分范围为0至10]得分改善≥4分）以及第16周时的IGA和EASI-75缓解。每例缓解者成本模型基于意大利国家卫生系统的视角。关于药物成本，使用出厂批发采购价格，包括根据国家立法的强制折扣（5%折扣，在折扣结果基础上再降低5%）。阿布昔替尼100毫克和200毫克在意大利有固定价格。
12周时，阿布昔替尼100毫克和200毫克每例缓解者的IGA 0/1成本分别为3955.77欧元和2984.94欧元，度普利尤单抗为7467.96欧元；12周时EASI75成本分别为2463.30欧元和2057.58欧元，度普利尤单抗为4705.09欧元。至于次要终点，阿布昔替尼100毫克和200毫克每例缓解者的成本始终低于度普利尤单抗，包括PP-NRS（3791.55欧元和2451.22欧元，度普利尤单抗为6462.65欧元）、第16周时的IGA 0/1（6931.05欧元和4854.15欧元，度普利尤单抗为8787.85欧元）以及第16周时的EASI75（3984.75欧元和3381.00欧元，度普利尤单抗为5197.45欧元）。
根据JADE COMPARE试验数据，阿布昔替尼的每例缓解者成本显著低于度普利尤单抗。本研究结果仅限于JADE COMPARE试验的短时间框架。
