Long-Term Efficacy and Dose-Finding Trial of Japanese Cedar Pollen Sublingual Immunotherapy Tablet

Gotoh, Minoru; Yonekura, Syuji; Imai, Toru; Kaneko, Shinya; Horikawa, Eiji; Konno, Akiyoshi; Okamoto, Yoshitaka; Okubo, Kimihiro

doi:10.1016/j.jaip.2018.11.044

Cited by 67 publications

(53 citation statements)

References 34 publications

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“…The rate and severity of AEs observed in this study in this study are in accordance with those reported in other SLIT studies. One recent study investigating the long-term efficacy of Japanese cedar pollen SLIT in AR patients sensitized to Japanese cedar pollen has demonstrated a cumulative AEs incidence rate of 93.0% within 8 weeks of treatment, 35 which was comparable to the 91.5% AEs rate observed in the present clinical trial. The percentage of subjects who reported drug-related AEs in the present was 65.8% in Artemisia annua SLIT group, which was lower than the 84.9% of subjects experiencing AEs in the 5-grass-pollen SLIT study in Europe, 18 but higher than the 12% of subjects experiencing AEs to ragweed sublingual-liquid immunotherapy trial in North America.…”

Section: Discussionsupporting

confidence: 83%

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

Lou

Wang

Wei³

et al. 2020

World Allergy Organization Journal

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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.

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Section: Discussionsupporting

confidence: 83%

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

Lou

Wang

Wei³

et al. 2020

World Allergy Organization Journal

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“…The use of prescription databases has indicated that the productspecific efficacy demonstrated in double-blind, placebocontrolled, randomized trials translates into real life 142 . Evidence of efficacy of AIT has been demonstrated for grass, birch (covering the homologous group of Betulaceae tree pollen), ragweed and Cryptomeria japonica pollen 143,144 , as well as house dust mites 145 , whereas less evidence is available for other types of pollen, animal dander or moulds. Only regulated, standardized allergen extracts that have demonstrated efficacy and safety should be used for AIT 138,146,147 .…”

Section: Allergen-specific Immunotherapymentioning

confidence: 99%

Allergic rhinitis

Bousquet

Antó

Bachert

et al. 2020

Nat Rev Dis Primers

463

385

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“…Recently, a higher dose SLIT tablet (5000 JAU) has become available and may be more effective than the lower dosage of 2000 JAU. 10,11 In our current study, we compared metachromatic cell, eosinophil and neutrophil numbers in nasal swabs of SLIT subjects and untreated subjects in preseason and in season. There were significant differences in total Mc number between SLIT patients and untreated patients in preseason (P = .014) and in season (P = .00001).…”

Section: Discussionmentioning

confidence: 99%

“…[4][5][6][7][8][9] Recently, a SLIT tablet for JCP has been used to establish efficacy in a double blind, placebo controlled study and is increasingly widely used. 10,11 Various mechanisms have been proposed to explain the effectiveness of SLIT. In local targeted mucosae, transforming growth factor β (TGF-β) and Foxp3(+) were induced by interleukin 10 (IL10), and immunoglobulin G1 (IgG1) and IgG4 antibodies to pollen antigen produced by SLIT.…”

Section: Introductionmentioning

confidence: 99%

Decreased numbers of metachromatic cells in nasal swabs in Japanese cedar pollinosis following sublingual immunotherapy

Otsuka

Matsune

et al. 2020

Immunity Inflam & Disease

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Background and Objective: Nasal symptoms were reduced following allergenspecific sublingual immunotherapy (SLIT) for allergic rhinitis. The mechanisms underlying the effectiveness of SLIT for Japanese cedar pollinosis are poorly understood. We studied changes in the numbers of metachromatic cells, eosinophils, and neutrophils following SLIT for Japanese cedar pollinosis. Methods: Nasal swabs were taken in the preseason (n = 32) and in pollinosis season (n = 49) from subjects given sublingual drop immunotherapy for an average duration of 1.5 years. The numbers of metachromatic cells (mast cells and basophils), eosinophils and neutrophils were determined and compared with those from untreated subjects in preseason (n = 65) and in season (n = 54). Results: SLIT subjects had a significantly reduced frequency of moderate to most severe symptoms in comparison to untreated subjects in preseason (P < .001, the Mann-Whitney U test), and (P < .00001) in season. Metachromatic cell counts in nasal swabs of SLIT subjects in preseason and in season were lower than those of untreated subjects (P = .014, the Mann-Whitney U test) and (P = .00001) respectively. Eosinophil numbers in SLIT subjects were not significantly different than in untreated subjects in both preseason (P = .29) and in season (P = .09). However, when SLIT subjects in season were divided into those with greater than or equal to 1.5 years, or <1.5 years of SLIT duration, the degree of eosinophilia in those with SLIT greater than or equal to 1.5 years was significantly lower (P = .011) than in untreated patients, but not in those with SLIT less than 1.5 years (P = .9). There were no significant differences in neutrophil numbers in nasal swabs between untreated and SLIT subjects in preseason and in season. Conclusion: One of mechanisms underlying the effectiveness of sublingual drop immunotherapy for Japanese cedar pollinosis is a reduction of the number

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Long-Term Efficacy and Dose-Finding Trial of Japanese Cedar Pollen Sublingual Immunotherapy Tablet

Cited by 67 publications

References 34 publications

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

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

Allergic rhinitis

Decreased numbers of metachromatic cells in nasal swabs in Japanese cedar pollinosis following sublingual immunotherapy

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