Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis, University Medical Center Utrecht, Utrecht, The Netherlands.
Division Laboratories, Pharmacy and Biomedical Genetics, Center for Translational Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Allergy. 2022 Nov;77(11):3398-3407. doi: 10.1111/all.15439. Epub 2022 Jul 29.
At present, no real-world studies are available on different dupilumab dosing regimens in controlled atopic dermatitis (AD). The aim of this study was to clinically evaluate a patient-centered dupilumab dosing regimen in patients with controlled AD and to relate this to serum drug levels and serum biomarkers.
Ninety adult AD patients from the prospective BioDay registry were included based on their dupilumab administration interval according to a predefined patient-centered dosing regimen. Group A (n = 30) did not fulfill the criteria for interval prolongation and continued using the standard dupilumab dosage (300 mg/2 weeks), group B (n = 30) prolonged dupilumab interval with 50% (300 mg/4 weeks), and group C (n = 30) prolonged dupilumab interval with 66%-75% (300 mg/6-8 weeks). AD severity score, patient-reported outcomes, serum dupilumab levels, and serum biomarkers were analyzed over time.
Disease severity scores did not significantly change over time during the tapering period in any of the groups. In groups B and C, the Numeric Rating Scale (NRS)-pruritus temporarily significantly increased after interval prolongation but remained low (median NRS-pruritus≤4). Median dupilumab levels remained stable in group A (standard dosage), but significantly decreased in groups B and C (24.1 mg/L (IQR = 17.1-45.6); 12.5 mg/L (IQR = 1.7-22.3)) compared with the levels during the standard dosage (88.2 mg/L [IQR = 67.1-123.0, p < .001]). Disease severity biomarker levels (CCL17/CCL18) remained low in all study groups during the whole observation period.
This study showed that dose reduction was successful in a subgroup of patients with controlled AD by using a patient-centered dosing regimen. These patients showed stable low disease activity and low severity biomarkers over time.
目前，尚无关于控制特应性皮炎（AD）的不同度普利尤单抗剂量方案的真实世界研究。本研究旨在临床评估控制 AD 患者的以患者为中心的度普利尤单抗剂量方案，并将其与血清药物水平和血清生物标志物相关联。
根据预先设定的以患者为中心的剂量方案，根据度普利尤单抗给药间隔，从前瞻性 BioDay 登记处纳入 90 名成年 AD 患者。A 组（n=30）未达到延长间隔的标准，继续使用标准度普利尤单抗剂量（300mg/2 周），B 组（n=30）度普利尤单抗间隔延长 50%（300mg/4 周），C 组（n=30）度普利尤单抗间隔延长 66%-75%（300mg/6-8 周）。分析了 AD 严重程度评分、患者报告的结果、血清度普利尤单抗水平和血清生物标志物随时间的变化。
在任何一组中，在逐渐减少的期间，疾病严重程度评分在整个期间均无明显变化。在 B 组和 C 组中，间隔延长后，数字评定量表（NRS）瘙痒暂时显著增加，但仍较低（中位数 NRS-瘙痒≤4）。A 组（标准剂量）的度普利尤单抗中位数保持稳定，但 B 组和 C 组显著降低（24.1mg/L[IQR=17.1-45.6]；12.5mg/L[IQR=1.7-22.3]）与标准剂量时的水平相比（88.2mg/L[IQR=67.1-123.0，p<0.001]）。在整个观察期间，所有研究组的疾病严重程度生物标志物（CCL17/CCL18）水平均较低。
本研究表明，通过使用以患者为中心的剂量方案，在控制 AD 的患者亚组中成功减少了剂量。这些患者在整个过程中表现出稳定的低疾病活动和低严重程度生物标志物。
