Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Napoli, Italy.
J Dermatolog Treat. 2022 Nov;33(7):3028-3033. doi: 10.1080/09546634.2022.2102121. Epub 2022 Jul 19.
Special populations (SPs) involve people who require additional consideration in clinical research. Effectiveness of treatment or occurrence of side effects may be different in SPs with respect to not-SPs.
To retrospectively compare the effectiveness and safety of dupilumab in AD treatment of SPs not-SPs.
A 52-weeks retrospective study was performed enrolling patients with a diagnosis of moderate-to-severe AD undergoing treatment with dupilumab at labeled dosage. Patients were divided in Group A (SPs patients) and Group B (not-SPs patients). Disease severity was assessed using Eczema Area Severity Index (EASI), Pruritus-Numerical Rating Scale (P-NRS), and Dermatology Life Quality Index (DLQI) score at baseline and after 4 weeks (W4), W16, W24, and W52.
A total of 263 patients were enrolled and divided in Group A (25) and Group B (238). SPs included history of cancer, severe kidney failure, viral hepatitis, neurological diseases, acquired immunodeficiency syndrome, and transplanted patients. A statistically significant reduction of EASI, DLQI, and P-NRS was assessed in both groups at each follow-up visit ( < .0001), without significant differences between the groups. No differences were recorded for safety.
There are not significant differences between SPs and not-SPs as regards effectiveness and safety of dupilumab in AD management.
特殊人群（SPs）是指在临床研究中需要额外考虑的人群。SPs 与非 SPs 相比，治疗效果或副作用的发生可能有所不同。
回顾性比较 SP 和非 SP 接受度匹鲁单抗治疗 AD 的疗效和安全性。
对接受标签剂量度匹鲁单抗治疗的中重度 AD 患者进行了为期 52 周的回顾性研究。患者分为 A 组（SP 患者）和 B 组（非 SP 患者）。在基线和第 4 周（W4）、第 16 周（W16）、第 24 周（W24）和第 52 周（W52），使用湿疹面积严重程度指数（EASI）、瘙痒数字评分量表（P-NRS）和皮肤病生活质量指数（DLQI）评分评估疾病严重程度。
共纳入 263 例患者，分为 A 组（25 例）和 B 组（238 例）。SP 包括癌症史、严重肾衰竭、病毒性肝炎、神经系统疾病、获得性免疫缺陷综合征和移植患者。两组在每次随访时 EASI、DLQI 和 P-NRS 均有显著降低（ < .0001），但两组间无显著差异。安全性方面无差异。
在 AD 管理中，度匹鲁单抗对 SPs 和非 SPs 的疗效和安全性无显著差异。
