Nettis E, Ferrucci S M, Ortoncelli M, Pellacani G, Foti C, Di Leo E, Patruno C, Rongioletti F, Argenziano G, Macchia L, Tavecchio S, Napolitano M, Ribero S, Bonzano L, Romita P, Di Bona D, Nisticò S P, Piras V, Calabrese G, Detoraki C, Carbonara M, Fabbrocini G
Department of Emergency and Organ Transplantation, School and Chair of Allergology and Clini-cal Immunology, University of Bari - Aldo Moro, Bari, Italy.
UOC Dermatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Università degli Studi di Milano, Milan, Italy.
J Investig Allergol Clin Immunol. 2022 Apr 19;32(2):124-132. doi: 10.18176/jiaci.0641. Epub 2020 Aug 26.
Dupilumab has proven to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, real-world experience with dupilumab in a broader population is limited.
The study population comprised adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at 10 Italian teaching hospitals. We analyzed physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index [DLQI]), and serological markers (IgE and eosinophil count) after 16 weeks.
We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median (IQR) change from baseline to 16 weeks of treatment in the EASI score was -87.5 (22.0) (P<.001). The EASI-50, EASI-75, and EASI-90 response rates were 98.1%, 81.5%, and 50.8% after 16 weeks. At 16 weeks, 93.0% of the patients had achieved a 4-point or higher improvement in DLQI from baseline. During treatment with dupilumab, 12.2% of the patients developed conjunctivitis, and total IgE decreased significantly (P<.001). Interestingly, in the multivariate logistic regression model, the risk of developing dupilumab-related conjunctivitis was associated with early onset of AD (OR, 2.25; 95%CI, 1.07-4.70; P=.03) and presence of eosinophilia (OR, 1.91; 95%CI, 1.05-3.39; P=.03).
This is the broadest real-life study in AD patients treated with dupilumab to date. We observed more significant improvements induced by dupilumab in adult patients with moderate-to-severe AD than those reported in clinical trials.
在临床试验中,度普利尤单抗已被证明是治疗中度至重度特应性皮炎(AD)患者的有效药物。然而,度普利尤单抗在更广泛人群中的真实世界经验有限。
研究人群包括在10家意大利教学医院接受度普利尤单抗治疗的中度至重度AD成年患者,定义为湿疹面积和严重程度指数(EASI)评分24或更高。我们分析了16周后医生报告的结局指标(EASI)、患者报告的结局指标(瘙痒和睡眠评分、皮肤病生活质量指数[DLQI])以及血清学标志物(IgE和嗜酸性粒细胞计数)。
我们纳入了543例中度至重度AD患者。两名患者(0.4%)停止治疗。从基线到治疗16周,EASI评分的中位数(IQR)变化为-87.5(22.0)(P<0.001)。16周后,EASI-50、EASI-75和EASI-90缓解率分别为98.1%、81.5%和50.8%。在16周时,93.0%的患者DLQI较基线改善了4分或更高。在度普利尤单抗治疗期间,12.2%的患者出现结膜炎,总IgE显著降低(P<0.001)。有趣的是,在多变量逻辑回归模型中,发生度普利尤单抗相关结膜炎的风险与AD的早发(OR,2.25;95%CI,1.07-4.70;P=0.03)和嗜酸性粒细胞增多症的存在(OR,1.91;95%CI,1.05-3.39;P=0.03)相关。
这是迄今为止在接受度普利尤单抗治疗的AD患者中开展的最广泛的真实世界研究。我们观察到,度普利尤单抗在中度至重度AD成年患者中引起的改善比临床试验中报告的更为显著。