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Artif Cells Nanomed Biotechnol. 2019 Dec;47(1):3540-3547. doi: 10.1080/21691401.2019.1640709.

Sublingual immunotherapy of atopic dermatitis in mite-sensitized patients: a multi-centre, randomized, double-blind, placebo-controlled study.

Author information

1
Department of Dermatology, The Second Affiliated Hospital, Zhejiang University School of Medicine , Hangzhou , China.
2
Department of Dermatology, The Fourth Affiliated Hospital, Zhejiang University School of Medicine , Yiwu , China.
3
Department of Dermatology, Huashan Hospital Affiliated to Fudan University , Shanghai , China.
4
Department of Dermatology, Peking University Third Hospital , Beijing , China.
5
Department of Dermatology, Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine , Shanghai , China.
6
Department of Dermatology, The First Affiliated Hospital, Zhejiang University School of Medicine , Hangzhou , China.
7
Department of Dermatology, The First Affiliated Hospital of Soochow University , Suzhou , China.
8
Department of Dermatology, The Second Affiliated Hospital of Kunming Medical University , Kunming , China.
9
Department of Dermatology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology , Wuhan , China.
10
Fudan School of Public Health , Shanghai , China.

Abstract

Allergen-specific immunotherapy is widely used for allergic rhinitis and asthma treatment worldwide. This study explored the efficacy and safety of sublingual immunotherapy (SLIT) with the extracts of Dermatophagoides Farinae (D. farinae Drops) on house dust mites (HDM)-induced atopic dermatitis (AD). 239 patients with HDM-induced AD were recruited and exposure to a multi-centre, randomized, double-blind, and placebo-controlled clinical trials for 36 weeks, which were randomly divided into placebo and sublingual D. farinae Drops groups (high-dose, medium-dose and low-dose), respectively. Statistical analysis was performed in three groups: Full Analysis Set, Per Protocol Set and Safety Set. 48 cases have withdrawn from the study before the end of study. As primary outcomes, significant decreases in scoring atopic dermatitis and total medication score were showed in medium-dose and high-dose D. farinae Drops groups. In the sixth visit, the skin lesion area showed a statistically significant difference between high-dose/medium-dose D. farinae Drops group and placebo group (p < .05). Most adverse events are slight, and no life-threatening adverse drug reaction happened. Our research demonstrates the beneficial effect of SLIT with high or medium dose D. farinae Drops on AD, and the treatment was well tolerated.

KEYWORDS:

Drops; Sublingual immunotherapy; atopic dermatitis; clinical phase II trial

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