PMID- 28950268
OWN - NLM
STAT- MEDLINE
DCOM- 20171031
LR  - 20220321
IS  - 1423-0097 (Electronic)
IS  - 1018-2438 (Print)
IS  - 1018-2438 (Linking)
VI  - 174
IP  - 1
DP  - 2017
TI  - The SQ House Dust Mite SLIT-Tablet Is Well Tolerated in Patients with House Dust 
      Mite Respiratory Allergic Disease.
PG  - 35-44
LID - 10.1159/000478699 [doi]
AB  - BACKGROUND: The SQ house dust mite (HDM) SLIT-tablet (ALK, Denmark) addresses the 
      underlying cause of HDM respiratory allergic disease, and a clinical effect has 
      been demonstrated for both HDM allergic rhinitis and allergic asthma. Here, we 
      present pooled safety data from an adult population with HDM respiratory allergy, 
      with particular focus on the impact of asthma on the SQ HDM SLIT-tablet 
      tolerability profile. METHODS: Safety data from 2 randomised double-blind, 
      placebo-controlled clinical trials were included: MT-04: 834 adults with HDM 
      allergic asthma not well controlled by inhaled corticosteroids and with HDM 
      allergic rhinitis, and MT-06: 992 adults with moderate-to-severe HDM allergic 
      rhinitis despite the use of allergy pharmacotherapy and with or without asthma. 
      RESULTS: The proportion of subjects experiencing adverse events (AEs) was greater 
      in the active treatment group (12 SQ-HDM; 73% of subjects) compared to placebo 
      (53%). The most common treatment-related AEs were local allergic reactions. No 
      AEs were reported as systemic allergic reactions. Regardless of asthma status, 
      most AEs were mild or moderate (>97% of AEs) and the frequency of serious AEs was 
      low. Subgroup analysis revealed no statistically significant difference in the 
      risk of experiencing moderate or severe treatment-related AEs for subjects with 
      asthma compared to subjects without asthma (p = 0.88). In addition, subjects with 
      partly controlled or uncontrolled asthma were no more likely to experience 
      moderate or severe treatment-related AEs than subjects with controlled asthma (p 
      = 0.42). CONCLUSION: The SQ HDM SLIT-tablet is well tolerated, and the safety 
      profile was comparable for subjects with HDM respiratory allergic disease 
      irrespective of asthma status.
CI  - (c) 2017 The Author(s) Published by S. Karger AG, Basel.
FAU - Emminger, Waltraud
AU  - Emminger W
AD  - Allergy Outpatient Clinic, Vienna, Austria.
FAU - Hernandez, Maria Dolores
AU  - Hernandez MD
FAU - Cardona, Victoria
AU  - Cardona V
FAU - Smeenk, Frank
AU  - Smeenk F
FAU - Fogh, Bodil S
AU  - Fogh BS
FAU - Calderon, Moises A
AU  - Calderon MA
FAU - de Blay, Frederic
AU  - de Blay F
FAU - Backer, Vibeke
AU  - Backer V
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170927
PL  - Switzerland
TA  - Int Arch Allergy Immunol
JT  - International archives of allergy and immunology
JID - 9211652
RN  - 0 (Allergens)
RN  - 0 (Antigens, Dermatophagoides)
RN  - 0 (Placebos)
SB  - IM
MH  - Administration, Sublingual
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Allergens/*administration & dosage
MH  - Animals
MH  - Antigens, Dermatophagoides/*administration & dosage
MH  - Asthma/immunology/*therapy
MH  - Biological Availability
MH  - Dermatophagoides farinae/immunology
MH  - Dermatophagoides pteronyssinus/immunology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Placebos/administration & dosage
MH  - Rhinitis, Allergic/immunology/*therapy
MH  - Sublingual Immunotherapy/*adverse effects/*methods
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5804837
OTO - NOTNLM
OT  - Allergic asthma
OT  - Allergic rhinitis
OT  - Allergy immunotherapy
OT  - House dust mite
OT  - SLIT-tablet
OT  - Safety
EDAT- 2017/09/28 06:00
MHDA- 2017/11/01 06:00
PMCR- 2017/09/27
CRDT- 2017/09/27 06:00
PHST- 2017/02/23 00:00 [received]
PHST- 2017/06/13 00:00 [accepted]
PHST- 2017/09/28 06:00 [pubmed]
PHST- 2017/11/01 06:00 [medline]
PHST- 2017/09/27 06:00 [entrez]
PHST- 2017/09/27 00:00 [pmc-release]
AID - 000478699 [pii]
AID - iaa-0174-0035 [pii]
AID - 10.1159/000478699 [doi]
PST - ppublish
SO  - Int Arch Allergy Immunol. 2017;174(1):35-44. doi: 10.1159/000478699. Epub 2017 
      Sep 27.