Curta Inc., 113 Cherry St, PMB 45802, Seattle, WA, 98116, USA.
CHOICE Institute, University of Washington, Seattle, WA, USA.
Am J Clin Dermatol. 2023 Jan;24(1):109-117. doi: 10.1007/s40257-022-00734-8. Epub 2022 Oct 20.
Atopic dermatitis is a chronic inflammatory skin disease that can negatively impact work productivity and daily activities. Ruxolitinib cream, a Janus kinase inhibitor, demonstrated efficacy and safety in patients with atopic dermatitis in two phase III studies (TRuE-AD1 and TRuE-AD2).
This post hoc analysis sought to describe the effects of ruxolitinib cream on work productivity and activity impairment from pooled data from the phase III studies, to estimate indirect costs due to atopic dermatitis, and to estimate the incremental cost savings with ruxolitinib cream versus vehicle cream.
Patients in both studies were ≥ 12 years old with atopic dermatitis for ≥ 2 years, an Investigator's Global Assessment score of 2 or 3, and a 3-20% affected body surface area at baseline. Patients were randomized 2:2:1 to receive ruxolitinib cream (0.75% or 1.5%) or vehicle cream for 8 weeks. Patient self-reported productivity in the efficacy-evaluable population was assessed at weeks 2, 4, and 8 using the Work Productivity and Activity Impairment Questionnaire-Specific Health Problem version 2.0. Statistical significance for the two doses versus vehicle was calculated using an analysis of covariance. Work Productivity and Activity Impairment overall work impairment scores were converted to a model of costs per employed patient due to lost productivity and incremental cost savings from ruxolitinib cream treatment using a human capital approach.
Of 1249 patients enrolled (median age, 32 years; female sex, 61.7%), 1208 were included in the efficacy-evaluable population. Patients applying 0.75% or 1.5% ruxolitinib cream had significant changes in overall work impairment (- 17.9% [0.75% strength] and - 15.0% [1.5% strength] vs - 5.7% for vehicle; p < 0.0001 for both) and daily activity impairment (- 20.6% [0.75% strength] and - 21.5% [1.5% strength] vs - 10.6% for vehicle; p < 0.0001 for both). These corresponded to estimated lost productivity costs in 2021 US dollars of $1313 (0.75% strength) and $1242 (1.5% strength) versus $2008 (vehicle) over the 8-week trial period. Compared with a patient receiving vehicle, incremental annual indirect cost savings were estimated to be $5302 with 0.75% ruxolitinib cream and $4228 with 1.5% ruxolitinib cream.
Ruxolitinib cream therapy is associated with improved work productivity and daily activity compared with vehicle and is estimated to reduce the indirect cost burden on the patient.
ClinicalTrials.gov identifiers: NCT03745638 (registered 19 November, 2018) and NCT03745651 (registered 19 November, 2018).
特应性皮炎是一种慢性炎症性皮肤病，可对工作生产力和日常活动产生负面影响。罗沙司他乳膏，一种 Janus 激酶抑制剂，在两项 III 期研究（TRuE-AD1 和 TRuE-AD2）中显示了对特应性皮炎患者的疗效和安全性。
本事后分析旨在从 III 期研究的汇总数据中描述罗沙司他乳膏对工作生产力和活动障碍的影响，估算特应性皮炎导致的间接成本，并估算与载体乳膏相比使用罗沙司他乳膏的增量成本节约。
两项研究的患者年龄均≥12 岁，特应性皮炎病史≥2 年，研究者整体评估（IGA）得分为 2 或 3，基线时受累体表面积为 3%~20%。患者随机 2:2:1 接受罗沙司他乳膏（0.75%或 1.5%）或载体乳膏治疗 8 周。在疗效可评估人群中，使用特定健康问题工作生产力和活动障碍问卷 2.0 版本，在第 2、4 和 8 周评估患者的自我报告工作生产力。使用协方差分析计算两个剂量与载体相比的统计学意义。使用人力资本方法，将工作生产力和活动障碍的整体工作障碍评分转换为因生产力下降而导致的每位就业患者的成本模型，以及罗沙司他乳膏治疗的增量成本节约。
共纳入 1249 例患者（中位年龄 32 岁；女性占 61.7%），1208 例患者纳入疗效可评估人群。应用 0.75%或 1.5%罗沙司他乳膏的患者整体工作障碍（分别为-17.9%[0.75%强度]和-15.0%[1.5%强度]与载体相比为-5.7%；均<0.0001）和日常活动障碍（分别为-20.6%[0.75%强度]和-21.5%[1.5%强度]与载体相比为-10.6%；均<0.0001）均有显著改善。这些对应于在 2021 年以美元计的估计生产力损失成本，0.75%罗沙司他乳膏治疗组为 1313 美元，1.5%罗沙司他乳膏治疗组为 1242 美元，而载体组为 2008 美元。与接受载体治疗的患者相比，0.75%罗沙司他乳膏治疗组估计每年间接成本节省为 5302 美元，1.5%罗沙司他乳膏治疗组为 4228 美元。
与载体相比，罗沙司他乳膏治疗可提高工作生产力和日常活动能力，并估计减轻患者的间接成本负担。
ClinicalTrials.gov 标识符：NCT03745638（于 2018 年 11 月 19 日注册）和 NCT03745651（于 2018 年 11 月 19 日注册）。
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