PMID- 32030780 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20210514 IS - 1398-9995 (Electronic) IS - 0105-4538 (Linking) VI - 75 IP - 8 DP - 2020 Aug TI - Artemisia annua-sublingual immunotherapy for seasonal allergic rhinitis: A randomized controlled trial. PG - 2026-2036 LID - 10.1111/all.14218 [doi] AB - BACKGROUND: Artemisia annua is an important autumnal pollen allergen for seasonal allergic rhinitis (SAR) in northern China. To date, no study has investigated allergen immunotherapy with A annua. We aimed to investigate the efficacy and mechanisms underlying A annua-sublingual immunotherapy (SLIT). METHODS: This was a randomized, double-blind, placebo-controlled phase III clinical trial involving 71 SAR patients, randomized to SLIT with A annua extract (n = 47) or placebo (n = 24) for 32 weeks. Total nasal symptom score (TNSS; primary clinical end point) was evaluated at baseline (peak pollen phase (PPP) in the previous year), initiation of A annua-SLIT, 1st PPP during SLIT, end of SLIT and 2nd PPP during follow-up. Blood samples and nasal secretions were collected at beginning and after SLIT for assessment of T cells and inflammatory mediators. Safety was assessed according to adverse events (AEs) reported. RESULTS: Artemisia annua-SLIT significantly reduced TNSS to a greater level from baseline (from 9.45 +/- 1.68 to 6.16 +/- 2.27) than placebo (from 9.29 +/- 2.09 to 9.05 +/- 2.40) at the 1st PPP (P < .001) and sustained the improvement in symptoms throughout to the 2nd PPP. Preseasonal A annua-SLIT for 16 weeks significantly decreased Th2 cells, increased nTreg and Tr1 cells in blood; and increased cystatin 1 (CST1) in nasal secretion after 16 and 32 weeks compared with pretreatment. Overall, 17/47 patients experienced mild local AEs and 2 patients mild systemic AEs, after A annua-SLIT. CONCLUSION: Artemisia annua-SLIT is an efficacious and safe treatment in patients with A annua SAR. CI - (c) 2020 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd. FAU - Lou, Hongfei AU - Lou H AUID- ORCID: 0000-0002-8553-812X AD - Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. AD - Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China. FAU - Huang, Yanran AU - Huang Y AUID- ORCID: 0000-0001-5755-7684 AD - Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. AD - Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China. FAU - Ouyang, Yuhui AU - Ouyang Y AUID- ORCID: 0000-0002-5946-0779 AD - Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China. AD - Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. FAU - Zhang, Yuan AU - Zhang Y AUID- ORCID: 0000-0003-1080-4267 AD - Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China. AD - Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. FAU - Xi, Lin AU - Xi L AUID- ORCID: 0000-0003-0028-6873 AD - Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China. AD - Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. FAU - Chu, Xiaohan AU - Chu X AUID- ORCID: 0000-0001-6045-175X AD - Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. AD - Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China. FAU - Wang, Yang AU - Wang Y AUID- ORCID: 0000-0003-1231-7278 AD - Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China. FAU - Wang, Chengshuo AU - Wang C AUID- ORCID: 0000-0003-0646-5135 AD - Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. AD - Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China. FAU - Zhang, Luo AU - Zhang L AUID- ORCID: 0000-0002-0910-9884 AD - Department of Otolaryngology Head and Neck Surgery, Beijing TongRen Hospital, Capital Medical University, Beijing, China. AD - Beijing Key Laboratory of Nasal Disease, Beijing Institute of Otolaryngology, Beijing, China. AD - Department of Allergy, Beijing TongRen Hospital, Capital Medical University, Beijing, China. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20200223 PL - Denmark TA - Allergy JT - Allergy JID - 7804028 RN - 0 (Allergens) SB - IM MH - Allergens MH - *Artemisia annua MH - China MH - *Conjunctivitis, Allergic MH - Desensitization, Immunologic MH - Double-Blind Method MH - Humans MH - *Rhinitis, Allergic, Seasonal/therapy MH - *Sublingual Immunotherapy MH - Treatment Outcome OTO - NOTNLM OT - Artemisia annua OT - allergen immunotherapy (AIT) OT - allergic rhinitis OT - efficacy OT - safety EDAT- 2020/02/08 06:00 MHDA- 2021/05/15 06:00 CRDT- 2020/02/08 06:00 PHST- 2019/08/11 00:00 [received] PHST- 2019/11/17 00:00 [revised] PHST- 2019/12/08 00:00 [accepted] PHST- 2020/02/08 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/02/08 06:00 [entrez] AID - 10.1111/all.14218 [doi] PST - ppublish SO - Allergy. 2020 Aug;75(8):2026-2036. doi: 10.1111/all.14218. Epub 2020 Feb 23.