PMID- 27471838
OWN - NLM
STAT- MEDLINE
DCOM- 20171207
LR  - 20240324
IS  - 1398-9995 (Electronic)
IS  - 0105-4538 (Print)
IS  - 0105-4538 (Linking)
VI  - 72
IP  - 3
DP  - 2017 Mar
TI  - House dust mite sublingual tablet is effective and safe in patients with allergic 
      rhinitis.
PG  - 435-443
LID - 10.1111/all.12996 [doi]
AB  - BACKGROUND: House dust mite (HDM) is the major indoor allergen for allergic 
      diseases such as allergic rhinitis (AR) and asthma. Although sublingual 
      immunotherapy is a curative treatment for HDM-induced AR, data from large-scale 
      studies are limited. We evaluated the efficacy and safety of HDM tablets in 
      adolescent and adult patients (aged 12-64 years) with HDM-induced AR with or 
      without intermittent asthma. METHODS: In a double-blind trial in Japan, 968 
      subjects were randomized 1 : 1 : 1 to 300 index of reactivity (IR), 500 IR, or 
      placebo groups. The primary endpoint was the Average Adjusted Symptom Score 
      (AASS) in the last eight weeks of the 52-week treatment. Secondary endpoints 
      included individual nasal and ocular symptom scores, rescue medication use, and 
      the Japanese Rhinoconjunctivitis Quality of Life Questionnaire (JRQLQ) scores. 
      RESULTS: The AASS in the last eight weeks of treatment significantly improved in 
      both the 300 IR and the 500 IR groups compared to that in the placebo group (P < 
      0.001). In the 300 IR group, the onset of action occurred at week 8-10. All four 
      nasal symptoms significantly improved in both active treatment groups; rescue 
      medication use and JRQLQ outcome improved in the 300 IR group. Most adverse 
      events (AEs) were mild, and 16 serious AEs (SAEs) were reported; however, none of 
      them were drug-related. CONCLUSIONS: One-year treatment with 300 IR and 500 IR 
      HDM tablets was effective without major safety concerns. The recommended 
      therapeutic dose for AR is 300 IR.
CI  - (c) 2016 The Authors. Allergy Published by John Wiley & Sons Ltd.
FAU - Okamoto, Y
AU  - Okamoto Y
AD  - Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of 
      Medicine, Chiba University, Chiba, Japan.
FAU - Fujieda, S
AU  - Fujieda S
AD  - Department of Otorhinolaryngology-Head and Neck Surgery, University of Fukui, 
      Fukui, Japan.
FAU - Okano, M
AU  - Okano M
AD  - Department of Otolaryngology-Head and Neck Surgery, Okayama University Graduate 
      School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
FAU - Yoshida, Y
AU  - Yoshida Y
AD  - Biostatistics Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Kakudo, S
AU  - Kakudo S
AD  - Clinical Development Department, Shionogi & Co., Ltd., Osaka, Japan.
FAU - Masuyama, K
AU  - Masuyama K
AD  - Department of Otorhinolaryngology-Head and Neck Surgery, Graduate School of 
      Medical Science, University of Yamanashi, Yamanashi, Japan.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160823
PL  - Denmark
TA  - Allergy
JT  - Allergy
JID - 7804028
RN  - 0 (Allergens)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Tablets)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Allergens/administration & dosage/*immunology
MH  - Animals
MH  - Child
MH  - Female
MH  - Humans
MH  - Immunoglobulin E/blood/immunology
MH  - Immunoglobulin G/blood/immunology
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Pyroglyphidae/*immunology
MH  - Rhinitis, Allergic/diagnosis/*immunology/*therapy
MH  - *Sublingual Immunotherapy/adverse effects/methods
MH  - Tablets
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5324568
OTO - NOTNLM
OT  - Average Adjusted Symptom Score
OT  - allergic rhinitis
OT  - clinical study
OT  - house dust mite
OT  - sublingual immunotherapy tablet
EDAT- 2016/07/30 06:00
MHDA- 2017/12/08 06:00
PMCR- 2017/02/24
CRDT- 2016/07/30 06:00
PHST- 2016/07/26 00:00 [accepted]
PHST- 2016/07/30 06:00 [pubmed]
PHST- 2017/12/08 06:00 [medline]
PHST- 2016/07/30 06:00 [entrez]
PHST- 2017/02/24 00:00 [pmc-release]
AID - ALL12996 [pii]
AID - 10.1111/all.12996 [doi]
PST - ppublish
SO  - Allergy. 2017 Mar;72(3):435-443. doi: 10.1111/all.12996. Epub 2016 Aug 23.