National Expertise Center for Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, the Netherlands.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, the Netherlands.
JAMA Dermatol. 2022 Sep 1;158(9):1048-1056. doi: 10.1001/jamadermatol.2022.3014.
Long-term data on dupilumab drug survival in patients with atopic dermatitis (AD) are scarce. Furthermore, little is known about the factors associated with drug survival of dupilumab in AD.
To describe the drug survival of dupilumab in patients with AD and to identify associated predictors.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study was based on data from the multicenter prospective daily practice BioDay registry, in which 4 university and 10 nonuniversity hospitals in the Netherlands participated. Analysis included patients (age ≥18 years) participating in the BioDay registry with a follow-up of at least 4 weeks. The first patient treated with dupilumab was recorded in the BioDay registry in October 2017; data lock took place in December 2020, and data analysis was performed from October 2017 to December 2020.
Drug survival was analyzed by Kaplan-Meier survival curves and associated characteristics by using univariate and multivariate Cox regression analysis.
A total of 715 adult patients with AD (mean [SD] age, 41.8 [16.0] years; 418 [58.5%] were male) were included with a 1-year, 2-year, and 3-year overall dupilumab drug survival of 90.3%, 85.9%, and 78.6%, respectively. Characteristics associated with shorter drug survival owing to ineffectiveness were the use of immunosuppressant drugs at baseline (hazard ratio [HR], 2.64; 95% CI, 1.10-6.37) and being a nonresponder at 4 weeks (HR, 8.68; 95% CI, 2.97-25.35). Characteristics associated with shorter drug survival owing to adverse effects were the use of immunosuppressant drugs at baseline (HR, 2.69; 95% CI, 1.32-5.48), age 65 years or older (HR, 2.94; 95% CI, 1.10-7.87), and Investigator Global Assessment score of very severe AD (HR, 3.51; 95% CI, 1.20-10.28).
This cohort study demonstrated a good overall 1-year, 2-year, and 3-year dupilumab drug survival. Patients using immunosuppressive therapy at baseline and those with an absence of treatment effect at week 4 tended to discontinue treatment owing to ineffectiveness more frequently. Using immunosuppressant drugs at baseline, older age, and Investigator Global Assessment score of very severe AD were characteristics associated with an increased risk for discontinuation owing to adverse effects. These data provide more insight and new perspectives regarding dupilumab treatment in AD and can contribute to the optimization of patient outcomes.
长期关于度普利尤单抗治疗特应性皮炎(AD)患者药物生存的数据稀缺。此外,关于 AD 患者度普利尤单抗药物生存相关的因素知之甚少。
描述 AD 患者中度普利尤单抗的药物生存情况,并确定相关的预测因素。
设计、地点和参与者:这项队列研究基于多中心前瞻性日常实践 BioDay 登记处的数据,荷兰的 4 所大学医院和 10 所非大学医院参与了这项研究。分析纳入了在 BioDay 登记处至少随访 4 周的年龄≥18 岁的患者。记录了 2017 年 10 月第一个接受度普利尤单抗治疗的患者,数据锁定于 2020 年 12 月,分析时间为 2017 年 10 月至 2020 年 12 月。
通过 Kaplan-Meier 生存曲线分析药物生存情况,并通过单变量和多变量 Cox 回归分析相关特征。
共纳入 715 例 AD 成年患者(平均[标准差]年龄为 41.8[16.0]岁;418[58.5%]为男性),1 年、2 年和 3 年的总体度普利尤单抗药物生存率分别为 90.3%、85.9%和 78.6%。因无效而导致药物生存时间缩短的特征包括基线时使用免疫抑制剂(风险比[HR],2.64;95%CI,1.10-6.37)和 4 周时无应答(HR,8.68;95%CI,2.97-25.35)。因不良反应而导致药物生存时间缩短的特征包括基线时使用免疫抑制剂(HR,2.69;95%CI,1.32-5.48)、年龄≥65 岁(HR,2.94;95%CI,1.10-7.87)和研究者全球评估非常严重 AD 评分(HR,3.51;95%CI,1.20-10.28)。
这项队列研究显示,度普利尤单抗的总体 1 年、2 年和 3 年药物生存率良好。基线时使用免疫抑制治疗的患者和第 4 周时无治疗效果的患者更容易因无效而停止治疗。基线时使用免疫抑制剂、年龄较大和研究者全球评估非常严重 AD 评分是与不良反应相关的停药风险增加的特征。这些数据为 AD 患者的度普利尤单抗治疗提供了更多的见解和新视角,并有助于优化患者结局。