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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., (© 2020 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd.)

Introduction: Artemisia is a major kind of grass pollen in Northern China that can cause multiple kinds of common allergic diseases, such as allergic rhinitis (AR), conjunctivitis, or asthma. Recently, Artemisia annua Allergens Sublingual Immunotherapy Drops have been proved effective and safe for treating seasonal AR (SAR) with or without allergic conjunctivitis patients and were available in China. We sought to further investigate the different intervention times of A. annua-sublingual immunotherapy (SLIT) for evaluating efficacy and safety in patients with SAR. Methods: A total of 88 subjects aged 18–52 years with SAR were enrolled and randomized into the SLIT group and control group. Forty-five patients received a course of SLIT with A. annua extracts along with pharmacotherapy as SLIT group and 43 patients only used symptomatic drugs as control group. Furthermore, SLIT group was randomly divided into 12–13 weeks' pre-seasonal treatment group and 8–9 weeks' pre-seasonal treatment group to receive different duration of SLIT before pollen season. Monosensitized and polysensitized groups were also the subgroups of SLIT group according to the sensitization status of patients. The combined symptom and medication score (CSMS), total nasal symptom score (TNSS), total medication score (TMS), visual analog score (VAS) were evaluated during the peak pollen phase in 2020 and 2021, respectively. Safety was assessed according to adverse events (AEs) reported. Results: Compared to control group, CSMS, TNSS, TMS, VAS were significantly improved during the course of SLIT (p < 0.001). Besides, clinical improvement in nasal symptoms and reduction of medication use was also observed in SLIT group, compared to the baseline value (p < 0.001). Meanwhile, we observed that there was no significant difference between monosensitized group (n = 8) and polysensitized group (n = 29), as well as 12–13 weeks' preseasonal treatment group (n = 20) and 8–9 weeks' pre-seasonal treatment group (n = 17) belonging to the SLIT group in clinical efficacy (p > 0.05). No severe systemic AEs were reported. Conclusions: This study proved that A. annua-SLIT can provide equivalent efficacy and safety for SAR patients under the circumstance of accepting the pre-seasonal treatment of 8–9 or 12–13 weeks, regardless of monosensitization or polysensitization. [ABSTRACT FROM AUTHOR]