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.
基金：
national natural science foundation of China (81630023, 81420108009,
81970850, 81870698, 81400444 and 81470678), China,
National Key R & D Program of China (2018YFC0116800),
China, Chinese Academy of Medical Sciences Innovation
Fund for Medical Sciences (2019-I2M-5-022), China, the
Program for Changjiang Scholars and Innovative Research
Team (IRT13082), China, Beijing Municipal Administration
of Hospitals' Mission Plan (SML20150203), China, Beijing
Municipal Administration of Hospitals’ Youth Program
(QML20150202), China, Beijing Natural Science Foundation
(Z141107002514122), China, Capital Health Development
Foundation (2016-1-2052), China, and Beijing Advanced
Innovation Center for Food Nutrition and Human Health,
Beijing Technology and Business University (BTBU)
(20181045), China, the Public Welfare Development and
Reform Pilot Project (2019-10), China.
