Section of Dermatology, Health Sciences Department, Magna Graecia University, Catanzaro, Italy.
Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.
Clin Drug Investig. 2024 Aug;44(8):629-634. doi: 10.1007/s40261-024-01382-y. Epub 2024 Jul 16.
The estimated prevalence of atopic dermatitis (AD) among adolescents (12-17 years of age) is about 14.8%. AD compromises sleep quality and may be associated with poor scholastic performance, mood disruptions, low self-esteem, and difficulty in building social relationships. Upadacitinib was recently approved by the European Medicines Agency for the treatment of moderate-to-severe AD in patients aged ≥ 12 years who are candidates for systemic treatment. The aim of this real-world study was to determine the effectiveness in disease control and safety of upadacitinib in adolescents aged 12-17 years with moderate-to-severe AD.
This is a retrospective study in adolescents with moderate-to-severe AD treated with upadacitinib 15 mg between July 2022 and February 2024 at six Italian dermatological referral centres. The primary endpoint was to analyse the evolution of the response in terms of absolute Eczema Area and Severity Index (EASI) value, as well as the percentage of patients achieving 75% and 90% improvement in EASI (EASI75 and EASI90) from baseline to weeks (W) 4, 16, 24, and 52. Secondary endpoints included the assessment of treatment efficacy in terms of Numerical Rating Scale (NRS) for pruritus (P-NRS) and sleep (S-NRS), Children's Dermatology Life Quality Index (c-DLQI), and safety.
Thirty-six patients [males: 18 (50%)] were evaluated. A statistically significant improvement of EASI was observed at each timepoint, as stated by a mean percentage reduction from baseline of 72.2% at W4, 82.7% at W16, of 86.4% at W24 (n = 34) and of 92.7% at W52 (n = 18) (p < 0.0001). At W4, 21/36 (58.3%) achieved EASI75 and 12/36 (33.3%) EASI90. At W16, 29/36 (80.5%) achieved EASI75 and 19/36 (52.8%) EASI90. At W24, 32/34 (94.1%) reached EASI75 and 24/34 (70.6%) EASI90. Finally, at W52 all the assessed patients (n = 18) maintained EASI75 and 14/18 (77.7%) reached EASI90. Likewise, a statistically significant reduction of c-DLQI, P-NRS and S-NRS was observed at each timepoint.
Our real-world experience seems to confirm the efficacy and safety of upadacitinib for the long-term treatment of moderate-to-severe AD in adolescents.
青少年（12-17 岁）特应性皮炎（AD）的估计患病率约为 14.8%。AD 会影响睡眠质量，并可能与学习成绩不佳、情绪紊乱、自尊心低下以及难以建立社交关系有关。Upadacitinib 最近已获欧洲药品管理局批准，用于治疗候选全身治疗的中重度 AD 患者。本真实世界研究的目的是确定在 12-17 岁中重度 AD 青少年中，Upadacitinib 在疾病控制和安全性方面的有效性。
这是一项回顾性研究，纳入了 2022 年 7 月至 2024 年 2 月在意大利六家皮肤科转诊中心接受 Upadacitinib 15mg 治疗的中重度 AD 青少年患者。主要终点是分析基于绝对湿疹面积和严重程度指数（EASI）值的反应演变，以及从基线到第 4、16、24 和 52 周时达到 EASI75 和 EASI90（EASI75 和 EASI90）的患者比例。次要终点包括评估瘙痒的数字评定量表（P-NRS）和睡眠（S-NRS）、儿童皮肤病生活质量指数（c-DLQI）以及安全性的治疗效果。
共评估了 36 名患者[男性：18 名（50%）]。从基线的平均百分比降低分别为 72.2%（第 4 周）、82.7%（第 16 周）、86.4%（第 24 周，n=34）和 92.7%（第 52 周，n=18），表明 EASI 在每个时间点均有显著改善（p<0.0001）。在第 4 周时，21/36（58.3%）达到 EASI75，12/36（33.3%）达到 EASI90。在第 16 周时，29/36（80.5%）达到 EASI75，19/36（52.8%）达到 EASI90。在第 24 周时，32/34（94.1%）达到 EASI75，24/34（70.6%）达到 EASI90。最后，在第 52 周，所有评估患者（n=18）均保持 EASI75，14/18（77.7%）达到 EASI90。同样，在每个时间点，c-DLQI、P-NRS 和 S-NRS 均有显著降低。
我们的真实世界经验似乎证实了 Upadacitinib 对青少年中重度 AD 的长期治疗具有疗效和安全性。
