EFFICACY, SAFETY AND IMMUNOLOGICAL RESPONSE WITH SQ HOUSE DUST MITE SUBLINGUAL IMMUNOTHERAPY-TABLET BY BODY WEIGHT IN CHILDREN

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  • Sato Sakura
    Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital
  • Hata Hiroki
    Torii Pharmaceutical Co., Ltd
  • Kobayashi Satoko
    Torii Pharmaceutical Co., Ltd
  • Asaumi Tomoyuki
    Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital
  • Yanagida Noriyuki
    Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital
  • Azuma Ryuji
    Torii Pharmaceutical Co., Ltd
  • Ohashi-Doi Katsuyo
    Torii Pharmaceutical Co., Ltd
  • Ebisawa Motohiro
    Department of Allergy, Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital

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Other Title
  • 小児におけるダニ舌下免疫療法用錠剤の有効性，安全性及び免疫学的応答に対する体重の影響の検討
  • ショウニ ニ オケル ダニ ゼッカ メンエキ リョウホウヨウ ジョウザイ ノ ユウコウセイ,アンゼンセイ オヨビ メンエキガクテキ オウトウ ニ タイスル タイジュウ ノ エイキョウ ノ ケントウ

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Abstract

<p>Background: Sublingual immunotherapy-tablet (SLIT-tablet) treatment includes the same dose regardless of the patients' age or body weight. We investigated the efficacy, safety and immunological response of SQ house dust mite (HDM) SLIT-tablet treatment in relation to body weight in children.</p><p>Methods: Total combined rhinitis score (TCRS), adverse events (AEs), adverse drug reactions (ADRs) and immunological response (IgE, IgG4) were evaluated post hoc in three subgroups (body weight < 30kg, 30-44kg, ≥ 45kg) of patients from a clinical trial for Japanese children with HDM allergic rhinitis (JapicCTI-152953).</p><p>Results: No apparent differences in TCRS were observed between the three subgroups. No differences in the frequency or nature of AEs were detected between the subgroups but the incidence of ADRs was decreased in the lower body weight subgroup. The most common ADRs occurred locally in the oral cavity and were categorized as mild. The levels of HDM specific IgE and IgG4 were increased compared to baseline in all subgroups.</p><p>Conclusion: There were no influences of body weight for efficacy, safety, and immunological response in treatment with SQ HDM SLIT-tablet. These results indicated that SLIT dosage in children is same as adults without any concern in safety.</p>

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