PMID- 30281866
OWN - NLM
STAT- MEDLINE
DCOM- 20190319
LR  - 20200725
IS  - 1399-3038 (Electronic)
IS  - 0905-6157 (Print)
IS  - 0905-6157 (Linking)
VI  - 30
IP  - 1
DP  - 2019 Feb
TI  - Efficacy of house dust mite sublingual tablet in the treatment of allergic 
      rhinoconjunctivitis: A randomized trial in a pediatric population.
PG  - 66-73
LID - 10.1111/pai.12984 [doi]
AB  - BACKGROUND: The efficacy and safety of 300 index of reactivity (IR) tablets of 
      house dust mite (HDM) allergen extracts in Japanese pediatric (5-16 years old) 
      patients with allergic rhinitis (AR) were assessed in a double-blind, randomized, 
      placebo-controlled study (JAPIC CTI-152981). METHODS: Patients were randomized 
      1:1 to HDM sublingual tablets or placebo once daily for 52 weeks. The primary 
      end-point was average adjusted symptom score (AASS; average of daily Rhinitis 
      Total Symptom Scores, comprising sneezing, rhinorrhea, nasal congestion, and 
      nasal pruritus, adjusted for rescue medication use), analyzed during Weeks 48-52 
      (mixed-effects model for repeated measures). RESULTS: Of 438 patients randomized, 
      403 (92%; 193 active, 210 placebo) completed the study. AASS (least-squares [LS] 
      mean [SE]) during Weeks 48-52 was significantly (P = 0.0005) lower in the active 
      group compared with placebo (6.32 [0.20] vs 7.27 [0.19]; relative LS mean 
      difference, -13%). Immunological responses (IgE and IgG4 antibodies specific to 
      antigens of two HDM species) were significantly greater in the active group 
      compared with placebo (P < 0.0001). Almost all patients experienced mild or 
      moderate adverse events (AEs). The most common treatment-related AEs were oral 
      pruritus, mouth edema, throat irritation, and ear pruritus. One patient 
      experienced serious pseudocroup (subglottic laryngitis) that recovered. There 
      were no deaths or anaphylaxis requiring the use of injectable adrenaline. 
      CONCLUSIONS: The HDM tablet significantly improved symptoms of HDM-induced 
      perennial AR and was associated with a significant immunological response. The 
      safety profile in pediatric patients was consistent with that in adults, with no 
      new safety concerns.
CI  - (c) 2018 The Authors. Pediatric Allergy and Immunology Published by John Wiley & 
      Sons Ltd.
FAU - Okamoto, Yoshitaka
AU  - Okamoto Y
AD  - Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of 
      Medicine, Chiba University, Chiba, Japan.
FAU - Fujieda, Shigeharu
AU  - Fujieda S
AD  - Department of Otorhinolaryngology-Head and Neck Surgery, University of Fukui, 
      Fukui, Japan.
FAU - Okano, Mitsuhiro
AU  - Okano M
AD  - Department of Otorhinolaryngology, School of Medicine, International University 
      of Health and Welfare, Narita, Japan.
FAU - Hida, Hideaki
AU  - Hida H
AD  - Biostatistics Center, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Kakudo, Shinji
AU  - Kakudo S
AUID- ORCID: 0000-0003-4050-5153
AD  - Project Management Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Masuyama, Keisuke
AU  - Masuyama K
AD  - Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of 
      Medical Science, University of Yamanashi, Yamanashi, Japan.
LA  - eng
GR  - Shionogi &amp; Co., Ltd./International
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181125
PL  - England
TA  - Pediatr Allergy Immunol
JT  - Pediatric allergy and immunology : official publication of the European Society 
      of Pediatric Allergy and Immunology
JID - 9106718
RN  - 0 (Allergens)
RN  - 0 (Antigens, Dermatophagoides)
SB  - IM
MH  - Adolescent
MH  - Allergens/therapeutic use
MH  - Animals
MH  - Antigens, Dermatophagoides/immunology/*therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Japan
MH  - Male
MH  - Pyroglyphidae/*immunology
MH  - Rhinitis, Allergic/*therapy
MH  - Sublingual Immunotherapy/adverse effects/*methods
MH  - Treatment Outcome
PMC - PMC7379546
OTO - NOTNLM
OT  - SIT: SLIT
OT  - allergens: inhalative allergens
OT  - rhinitis: allergic
OT  - rhinitis: clinical trials
OT  - rhinitis: specific immunotherapy
COIS- YO has received grant and personal fees from Torii, Shionogi, Kyowa Hakko Kirin, 
      Kyorin, Taiho, and Mitsubishi Tanabe; grants from Yamada Bee Farm and Yakult; and 
      personal fees from Stallergenes Greer, GSK, MSD, Sanofi, Thermo Fisher 
      Scientific, Taisyo Toyama, Nippon Zoki, and Otsuka. SF has received grant and 
      personal fees from Shionogi. MO has received personal fees from Torii, Kyorin, 
      Mitsubishi Tanabe, and Shionogi. KM has received grants and personal fees from 
      Torii, Shionogi, Taiho, Sanofi, Merk Serono, Eisai, and Mitsubishi Tanabe, a 
      grant from Tsumura, and personal fees from GSK, MSD, Kyorin, Meiji Seika, Medical 
      Review, Taisho Toyama, and Nihonshinyaku. HH and SK are employees of, and own 
      stock in, Shionogi.
EDAT- 2018/10/04 06:00
MHDA- 2019/03/20 06:00
PMCR- 2020/07/24
CRDT- 2018/10/04 06:00
PHST- 2018/05/06 00:00 [received]
PHST- 2018/08/23 00:00 [revised]
PHST- 2018/09/11 00:00 [accepted]
PHST- 2018/10/04 06:00 [pubmed]
PHST- 2019/03/20 06:00 [medline]
PHST- 2018/10/04 06:00 [entrez]
PHST- 2020/07/24 00:00 [pmc-release]
AID - PAI12984 [pii]
AID - 10.1111/pai.12984 [doi]
PST - ppublish
SO  - Pediatr Allergy Immunol. 2019 Feb;30(1):66-73. doi: 10.1111/pai.12984. Epub 2018 
      Nov 25.