Bogacz-Piaseczyńska Agnieszka, Bożek Andrzej, Krupka-Olek Magdalena, Kawczyk-Krupka Aleksandra, Zalejska-Fiolka Jolanta, Canonica Giorgio Walter
Clinical Department of Internal Diseases, Dermatology and Allergology, Medical University of Silesia, 40-055 Katowice, Poland.
Department of Internal Medicine, Angiology and Physical Medicine, Center for Laser Diagnostics and Therapy, Medical University of Silesia, Batorego 15 Street, 41-902 Bytom, Poland.
Vaccines (Basel). 2024 Sep 13;12(9):1046. doi: 10.3390/vaccines12091046.
Severe atopic dermatitis (AD) is a complex disease requiring systemic treatment. This study aimed to assess the effectiveness of combined therapy consisting of dupilumab and sublingual dust mite allergen immunotherapy (SLIT-HDM) in patients with severe AD and HDM allergies.
Patients diagnosed with severe AD were included in this randomised, placebo-controlled, double-blind 12-month trial; they received SLIT for HDMs and/or dupilumab for 12 months and were compared with patients on cyclosporine. The primary outcomes for the treatment arms were changes in the Eczema Area and Severity Index (EASI), body surface area (%BSA), and Investigator Global Assessment (IsGA) over 12 months. The secondary outcomes were the proportion of patients who achieved IsGA success and reduced medication scores.
Significant improvements were observed in all analysed groups after 12 months of therapy based on the EASI, %BSA, and IsGA. However, the most substantial changes were observed in the groups treated with dupilumab or a combination of SLIT-HDM and dupilumab. Additionally, the proportion of patients who achieved an IsGA reduction was significantly greater in the group receiving combination therapy than in the other groups (9/14 [64% of the group receiving SLIT-HDM] vs. 11/14 [73% of the group receiving dupilumab] vs. 15/17 [88% of the group receiving dupilumab and SLIT-HDM] vs. 7/13 [53% of the group receiving cyclosporine]) ( < 0.05).
In patients with severe AD and HDM allergies, combination treatment with dupilumab and allergen immunotherapy for HDMs may increase the therapeutic benefit over treatment with these methods separately.
重度特应性皮炎（AD）是一种需要全身治疗的复杂疾病。本研究旨在评估度普利尤单抗与舌下尘螨变应原免疫疗法（SLIT-HDM）联合治疗重度AD且对HDM过敏患者的有效性。
诊断为重度AD的患者纳入这项随机、安慰剂对照、双盲的12个月试验；他们接受HDM的SLIT和/或度普利尤单抗治疗12个月，并与接受环孢素治疗的患者进行比较。治疗组的主要结局是12个月内湿疹面积和严重程度指数（EASI）、体表面积（%BSA）以及研究者整体评估（IsGA）的变化。次要结局是达到IsGA成功和降低用药评分的患者比例。
基于EASI、%BSA和IsGA，治疗12个月后所有分析组均观察到显著改善。然而，在接受度普利尤单抗治疗的组或SLIT-HDM与度普利尤单抗联合治疗的组中观察到的变化最为显著。此外，接受联合治疗的组中IsGA降低的患者比例显著高于其他组（9/14 [接受SLIT-HDM组的64%] 对11/14 [接受度普利尤单抗组的73%] 对15/17 [接受度普利尤单抗和SLIT-HDM组的88%] 对7/13 [接受环孢素组的53%]）（P<0.05）。
在重度AD且对HDM过敏的患者中，度普利尤单抗与HDM变应原免疫疗法联合治疗可能比单独使用这些方法治疗具有更大的治疗益处。
