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

World Allergy Organization Journal

Xueyan Wang¹  Qingyu Wei²  Changqing Zhao³  Hongfei Lou⁴  Luo Zhang⁴  Juan Meng⁵  Hua Zhang⁶  Shaoqiang Zhang⁷  Qinna Zhang⁸  Chengshuo Wang⁹  Zhimin Xing^1,10  Weiguo Xue^1,11  Huifang Zhou^1,12  Hui Liu^1,13  Ruixia Ma^1,14 

[1] Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, 100005, China;Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China;Department of Allergy, No. 202 Hospital of PLA (General Hospital of Northern Theater Command), Shenyang 110003, China;Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100730, China;Department of Otolaryngology Head and Neck Surgery, First Hospital of Shanxi Medical University, Taiyuan, 030001, China;Department of Otolaryngology Head and Neck Surgery, General Hospital of Ningxia Medical University, Yinchuan 750004, China;Department of Otolaryngology, West China Hospital, Sichuan University, Chengdu, 610041, China;Department of Otorhinolaryngology, Peking University People's Hospital, Beijing, 100044, China;Department of Otorhinolaryngology, Qingdao Municipal Hospital, Qingdao, 266011, China;Department of Otorhinolaryngology, Second Hospital of Shanxi Medical University, Taiyuan, 030001, China;Department of Otorhinolaryngology, Shanxi Provincial People's Hospital, Xi'an, 710068, China;Department of Otorhinolaryngology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China;Department of Otorhinolaryngology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830011, China;Department of Otorhinolaryngology, Tianjin Medical University General Hospital, Tianjin, 300052, China;

关键词: Sublingual immunotherapy;    Allergic rhinitis;    Artemisia annua;    Efficacy;    Safety;   

DOI  :  

来源: DOAJ

【 摘 要 】

Background: 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. Methods: 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. Results: 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 < 0.0001 in full analysis set [FAS]; 1.49 ± 0.52 vs 1.95 ± 0.46, P < 0.0001 in per protocol set [PPS]); representing a 22.3% and 23.6% reduction, respectively, relative to placebo. In specifically Artemisia annua monosensitized patients, mean daily CSMRS reductions were demonstrated as 24.1% and 27.0% in the FAS and PPS populations, respectively, when comparing the active treatment to placebo treatment. Similarly, SLIT decreased dTNSS in peak pollen period by 19.0% in FAS and 22.3% in PPS, respectively, relative to placebo. In coincidence, dRMS in peak pollen period was reduced by 22.0% in FAS and 26.0% in PPS. 65.8% patients in SLIT group experienced treatment-related AEs, none of which was serious. Conclusion: This study indicates that SLIT with Artemisia annua drops is an effective and safe treatment option in Chinese patients with Artemisia Annua-induced AR.

【 授权许可】

Unknown