PMID- 32963688 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220417 IS - 1939-4551 (Print) IS - 1939-4551 (Electronic) IS - 1939-4551 (Linking) VI - 13 IP - 9 DP - 2020 Sep TI - Artemisia Annua sublingual immunotherapy for seasonal allergic rhinitis: A multicenter, randomized trial. PG - 100458 LID - 10.1016/j.waojou.2020.100458 [doi] LID - 100458 AB - 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. CI - (c) 2020 The Author(s). FAU - Lou, Hongfei AU - Lou H AD - Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100730, China. AD - Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, 100005, China. FAU - Wang, Xueyan AU - Wang X AD - Department of Allergy, Beijing Shijitan Hospital, Capital Medical University, Beijing, 100038, China. FAU - Wei, Qingyu AU - Wei Q AD - Department of Allergy, No. 202 Hospital of PLA (General Hospital of Northern Theater Command), Shenyang 110003, China. FAU - Zhao, Changqing AU - Zhao C AD - Department of Otorhinolaryngology, Second Hospital of Shanxi Medical University, Taiyuan, 030001, China. FAU - Xing, Zhimin AU - Xing Z AD - Department of Otorhinolaryngology, Peking University People's Hospital, Beijing, 100044, China. FAU - Zhang, Qinna AU - Zhang Q AD - Department of Otolaryngology Head and Neck Surgery, First Hospital of Shanxi Medical University, Taiyuan, 030001, China. FAU - Meng, Juan AU - Meng J AD - Department of Otolaryngology, West China Hospital, Sichuan University, Chengdu, 610041, China. FAU - Zhang, Shaoqiang AU - Zhang S AD - Department of Otorhinolaryngology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China. FAU - Zhou, Huifang AU - Zhou H AD - Department of Otorhinolaryngology, Tianjin Medical University General Hospital, Tianjin, 300052, China. FAU - Ma, Ruixia AU - Ma R AD - Department of Otolaryngology Head and Neck Surgery, General Hospital of Ningxia Medical University, Yinchuan 750004, China. FAU - Zhang, Hua AU - Zhang H AD - Department of Otorhinolaryngology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, 830011, China. FAU - Liu, Hui AU - Liu H AD - Department of Otorhinolaryngology, Shanxi Provincial People's Hospital, Xi'an, 710068, China. FAU - Xue, Weiguo AU - Xue W AD - Department of Otorhinolaryngology, Qingdao Municipal Hospital, Qingdao, 266011, China. FAU - Wang, Chengshuo AU - Wang C AD - Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100730, China. AD - Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, 100005, China. FAU - Zhang, Luo AU - Zhang L AD - Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, 100730, China. AD - Beijing Key Laboratory of Nasal Diseases, Beijing Institute of Otolaryngology, Beijing, 100005, China. AD - Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, 100730, China. LA - eng PT - Journal Article DEP - 20200908 PL - United States TA - World Allergy Organ J JT - The World Allergy Organization journal JID - 101481283 PMC - PMC7490724 OTO - NOTNLM OT - Allergic rhinitis OT - Artemisia annua OT - Efficacy OT - Safety OT - Sublingual immunotherapy COIS- All authors declare no financial or commercial conflicts of interest. EDAT- 2020/09/24 06:00 MHDA- 2020/09/24 06:01 PMCR- 2020/09/08 CRDT- 2020/09/23 06:34 PHST- 2020/05/05 00:00 [received] PHST- 2020/08/03 00:00 [revised] PHST- 2020/08/13 00:00 [accepted] PHST- 2020/09/23 06:34 [entrez] PHST- 2020/09/24 06:00 [pubmed] PHST- 2020/09/24 06:01 [medline] PHST- 2020/09/08 00:00 [pmc-release] AID - S1939-4551(20)30361-6 [pii] AID - 100458 [pii] AID - 10.1016/j.waojou.2020.100458 [doi] PST - epublish SO - World Allergy Organ J. 2020 Sep 8;13(9):100458. doi: 10.1016/j.waojou.2020.100458. eCollection 2020 Sep.