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

ABSTRACT: 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.

SUBMITTER: Lou H

PROVIDER: S-EPMC7490724 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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<i>Artemisia Annua</i> sublingual immunotherapy for seasonal allergic rhinitis: A multicenter, randomized trial.

Lou Hongfei H Wang Xueyan X Wei Qingyu Q Zhao Changqing C Xing Zhimin Z Zhang Qinna Q Meng Juan J Zhang Shaoqiang S Zhou Huifang H Ma Ruixia R Zhang Hua H Liu Hui H Xue Weiguo W Wang Chengshuo C Zhang Luo L

The World Allergy Organization journal 20200908 9

<h4>Background</h4><i>Artemisia annua</i> is the most common outdoor aeroallergen throughout Northern China; however, no multicenter study has investigated sublingual immunotherapy (SLIT) as a treatment option for <i>Artemisia annua</i>-induced allergic rhinitis (AR). The aim of this study was to evaluate the efficacy and safety of an innovative SLIT for <i>Artemisia annua</i>-related AR.<h4>Methods</h4>This was a randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trial ...[more]

PMID: 32963688

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Project description:BackgroundAcupuncture has shown beneficial effects for seasonal allergic rhinitis (SAR); however, it is time and cost intensive. We investigated feasibility and effects of self-administered body acupressure as a self-care technique that stimulates acupuncture points with manual pressure in SAR patients.MethodsWe conducted a two-armed randomized controlled exploratory trial to compare effects of self-administered acupressure over 4 weeks at five acupuncture points plus rescue medication (RM) with cetirizine compared to RM alone in SAR patients. Among other outcome parameters, we assessed disease-related quality of life (Rhinitis Quality of Life Questionnaire [RQLQ]), overall SAR symptoms by a visual analogue scale (VAS) and a rescue medication score (RMS) after 4 and 8 weeks.ResultsForty-one SAR patients (mean age 38.5 ± 10.0 years, n = 21, 51.2% women) were randomized. Compared to RM alone (n = 21), acupressure plus RM (n = 20) was associated with relevant improvements after 4 weeks, shown by the difference between groups in adjusted means of RQLQ: - 0.9 points (95% CI - 1.6 to - 0.2; p = 0.011) and VAS overall SAR symptoms: - 21.6 mm (95% CI - 36.3 to - 6.8; p = 0.005). The RMS was lower in the acupressure group than in the control group: 1.9 points (95% CI - 3.8 to - 0.1; p = 0.120). Group differences decreased slightly until week 8. The acupressure was feasible and safe.ConclusionResults of this exploratory study indicate that self-applied acupressure is feasible, may improve disease-specific quality of life and reduce disease-related symptoms as well as anti-allergic medication intake in SAR patients. High-quality confirmatory studies including a sham-control group are needed in the future. Trial registration DRKS-ID: DRKS00014310. Date of registration in DRKS: 2018/04/24. Investigator sponsored/initiated trial (IST/IIT): yes. Ethics approval/approval of the ethics committee: Approved (leading) Ethics Committee No. EA1/033/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin. URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00014310.

Project description:Purpose: Both subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) are effective in reducing symptoms and medication scores and inducing long-term efficacy in patients with allergic rhinitis (AR). However, SLIT has been associated with poor patient adherence. This study investigates the factors impacting dropout rates from SLIT in house dust mite (HDM)-sensitized AR patients. Methods: A retrospective study was performed to analyze dropout rates and reasons in AR patients receiving Dermatophagoides farinae (Der f) SLIT with a follow-up period of 2 years. Results: A total of 719 HDM-sensitized AR patients received Der f-SLIT. Dropout rates increased with time and most occurred after 1 year of SLIT. By month 24, 654 (91%) patients had discontinued SLIT. The dropout rates by month 24 were 100, 90.1, and 91.1% in children <5 years old, children aged 5-18 years old, and adults ≥ 18 years old, respectively. Combination with allergic asthma and mono- or multi-sensitization to other aeroallergens did not affect the dropout rates. The most common self-reported reasons for dropouts were refusal of continuation, dissatisfaction with the efficacy, transition to SCIT, and adverse effects. Refusal of continuation increased with age, whereas transition to SCIT decreased with age. Ninety-seven cases transitioned from SLIT to SCIT, and the transition rates increased with time. Comorbid allergic asthma did not affect the transition rates. However, multi-sensitization was associated with a slightly higher rate of transition to SCIT. The most common reason for the transition was dissatisfaction with the efficacy (54.6%), which was only reported by patients older than 5 years. For children who began SLIT at younger than 5 years old, the most common reason (81.2%) for transition was age reaching 5 years. Conclusions: HDM-SLIT has a very high dropout rate, which is mainly due to refusal of continuation and dissatisfaction with the efficacy. Transitioning from SLIT to SCIT may help keep these patients on AIT and thus increase adherence and long-term efficacy.

Project description:ImportanceSublingual immunotherapy and subcutaneous immunotherapy are effective in seasonal allergic rhinitis. Three years of continuous treatment with subcutaneous immunotherapy and sublingual immunotherapy has been shown to improve symptoms for at least 2 years following discontinuation of treatment.ObjectiveTo assess whether 2 years of treatment with grass pollen sublingual immunotherapy, compared with placebo, provides improved nasal response to allergen challenge at 3-year follow-up.Design, setting, and participantsA randomized double-blind, placebo-controlled, 3-parallel-group study performed in a single academic center, Imperial College London, of adult patients with moderate to severe seasonal allergic rhinitis (interfering with usual daily activities or sleep). First enrollment was March 2011, last follow-up was February 2015.InterventionsThirty-six participants received 2 years of sublingual immunotherapy (daily tablets containing 15 µg of major allergen Phleum p 5 and monthly placebo injections), 36 received subcutaneous immunotherapy (monthly injections containing 20 µg of Phleum p 5 and daily placebo tablets) and 34 received matched double-placebo. Nasal allergen challenge was performed before treatment, at 1 and 2 years of treatment, and at 3 years (1 year after treatment discontinuation).Main outcomes and measuresTotal nasal symptom scores (TNSS; range; 0 [best] to 12 [worst]) were recorded between 0 and 10 hours after challenge. The minimum clinically important difference for change in TNSS within an individual is 1.08. The primary outcome was TNSS comparing sublingual immunotherapy vs placebo at year 3. Subcutaneous immunotherapy was included as a positive control. The study was not powered to compare sublingual immunotherapy with subcutaneous immunotherapy.ResultsAmong 106 randomized participants (mean age, 33.5 years; 34 women [32.1%]), 92 completed the study at 3 years. In the intent-to-treat population, mean TNSS score for the sublingual immunotherapy group was 6.36 (95% CI, 5.76 to 6.96) at pretreatment and 4.73 (95% CI, 3.97 to 5.48) at 3 years, and for the placebo group, the score was 6.06 (95% CI, 5.23 to 6.88) at pretreatment and 4.81 (95% CI, 3.97 to 5.65) at 3 years. The between-group difference (adjusted for baseline) was -0.18 (95% CI, -1.25 to 0.90; [P = .75]).Conclusions and relevanceAmong patients with moderate to severe seasonal allergic rhinitis, 2 years of sublingual grass pollen immunotherapy was not significantly different from placebo in improving the nasal response to allergen challenge at 3-year follow-up.Trial registrationclinicaltrials.gov Identifier: NCT01335139; EudraCT Number: 2010-023536-16.

Dataset Information

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

Publications

<i>Artemisia Annua</i> sublingual immunotherapy for seasonal allergic rhinitis: A multicenter, randomized trial.

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