Ibba Luciano, Falcidia Costanza, Di Giulio Sara, Bianco Matteo, Valenti Mario, Facheris Paola, Narcisi Alessandra, Costanzo Antonio, Gargiulo Luigi
Dermatology Unit, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy.
Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20072 Milan, Italy.
J Clin Med. 2025 Apr 24;14(9):2953. doi: 10.3390/jcm14092953.
Atopic dermatitis (AD) is a chronic pruritic inflammatory disease affecting children and adults. Upadacitinib and abrocitinib are selective Janus kinase 1 inhibitors approved for the treatment of moderate-to-severe AD. Although their efficacy and safety are described in phase 3 clinical trials, real-world data are limited. We aimed to evaluate the effectiveness and safety of upadacitinib and abrocitinib treatment in a real-life adult population with moderate-to-severe AD throughout an extended observation period. This retrospective observational study was conducted by analyzing data from the electronic records of IRCCS Humanitas Research Hospital from January 2023 to December 2024. Patients were administered either upadacitinib (15 or 30 mg) or abrocitinib (100 or 200 mg). Effectiveness was evaluated by using clinician-reported scores (Investigator Global Assessment [IGA] and Eczema Area and Severity Index [EASI]) and patient-reported outcomes (peak pruritus numerical rating scale [PP-NRS]) at weeks 8, 16, 32 and 52. Statistical significance was set at a probability value (-value) < 0.05. Adverse events were also collected. In total, 129 patients were included in the study, and 84 of them reached 52 weeks. At week 52, the EASI 75, 90, and 100 responses were 88.9%, 70.8%, and 54.2% for upadacitinib, and 100%, 91.7%, and 75% for abrocitinib. An IGA score equal to 0 or 1 at 52 weeks was achieved by 84.7% of patients treated with upadacitinib and 100% of those receiving abrocitinib. A four-point reduction from baseline PP-NRS was reported by 86.1% for upadacitinib and by 83.3% of patients for abrocitinib after one year of follow-up. Our study showed comparable or even higher effectiveness outcomes in terms of EASI 75, EASI 90, and EASI 100 at week 52 compared to phase-3 clinical trials, with no new safety concerns, supporting the real-world effectiveness of abrocitinib and upadacitinib in moderate-to-severe AD.
特应性皮炎（AD）是一种影响儿童和成人的慢性瘙痒性炎症性疾病。乌帕替尼和阿布昔替尼是已获批用于治疗中度至重度AD的选择性Janus激酶1抑制剂。尽管它们的疗效和安全性在3期临床试验中有描述，但真实世界的数据有限。我们旨在评估在一个延长的观察期内，乌帕替尼和阿布昔替尼治疗中度至重度AD的成年真实患者群体的有效性和安全性。这项回顾性观察性研究通过分析IRCCS胡马纳塔斯研究医院2023年1月至2024年12月电子记录中的数据进行。患者接受乌帕替尼（15或30毫克）或阿布昔替尼（100或200毫克）治疗。在第8周、16周、32周和52周，通过临床医生报告的评分（研究者整体评估[IGA]和湿疹面积及严重程度指数[EASI]）以及患者报告的结果（峰值瘙痒数字评定量表[PP-NRS]）评估有效性。统计学显著性设定为概率值（P值）<0.05。还收集了不良事件。该研究共纳入129例患者，其中84例达到52周。在第52周时，乌帕替尼的EASI 75、90和100反应率分别为88.9%、70.8%和54.2%，阿布昔替尼分别为100%、91.7%和75%。接受乌帕替尼治疗的患者中有84.7%在52周时IGA评分为0或1，接受阿布昔替尼治疗的患者这一比例为100%。随访一年后，乌帕替尼组86.1%的患者和阿布昔替尼组83.3%的患者报告PP-NRS较基线降低了4分。我们的研究表明，与3期临床试验相比，在第52周时，在EASI 75、EASI 90和EASI 100方面的有效性结果相当甚至更高，且没有新的安全问题，支持阿布昔替尼和乌帕替尼在中度至重度AD中的真实世界有效性。
