Artemisia Annua sublingual immunotherapy for seasonal allergic rhinitis: A multicenter, randomized trial

• Published in: The World Allergy Organization journal 2020-09, Vol.13 (9), p.100458-100458, Article 100458
• Main Authors: Lou, Hongfei, Wang, Xueyan, Wei, Qingyu, Zhao, Changqing, Xing, Zhimin, Zhang, Qinna, Meng, Juan, Zhang, Shaoqiang, Zhou, Huifang, Ma, Ruixia, Zhang, Hua, Liu, Hui, Xue, Weiguo, Wang, Chengshuo, Zhang, Luo
• Format: Article
• Language: English
• Subjects: Activities of daily living; Allergens; Allergic rhinitis; Allergies; Artemisia annua; Clinical trials; Efficacy; Hay fever; Histamine; Immunotherapy; Pollen; Population; Rhinitis; Safety; Seasons; Steroids; Sublingual immunotherapy
• ISSN: 1939-4551; 1939-4551
• DOI: 10.1016/j.waojou.2020.100458

Artemisia annua is the most common outdoor aeroallergen throughout Northern China; however, no multicenter study has investigated sublingual immunotherapy (SLIT) as a treatment option for Artemisia annua-induced allergic rhinitis (AR). The aim of this study was to evaluate the efficacy and safety of an innovative SLIT for Artemisia annua-related AR. This was a randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial conducted in China (NCT XXX). A total of 702 Artemisia annua-sensitized eligible patients were randomized in a ratio of 2:1 to receive Artemisia annua-SLIT or placebo. The treatment lasted 32 weeks; including 5-weeks up-dosing phase and 27-weeks maintenance phase. The primary endpoint was the daily combined score of medication and rhinoconjunctivitis symptom (CSMRS), and secondary endpoints were daily total nasal symptom score (dTNSS) and daily rescue medication score (dRMS) during peak pollen period. Safety of treatment was evaluated according to adverse events (AEs) experienced. Mean daily CSMRS was significantly improved during the peak pollen period in the SLIT group compared with the placebo group (1.46 ± 0.47 vs 1.88 ± 0.42, P