PMID- 26789997
OWN - NLM
STAT- MEDLINE
DCOM- 20160607
LR  - 20160202
IS  - 1423-0097 (Electronic)
IS  - 1018-2438 (Linking)
VI  - 168
IP  - 3
DP  - 2015
TI  - Dose-Dependent Immunological Responses after a 6-Month Course of Sublingual House 
      Dust Mite Immunotherapy in Patients with Allergic Rhinitis.
PG  - 182-92
LID - 10.1159/000442467 [doi]
AB  - BACKGROUND: House dust mite (HDM) immunotherapy has proven efficacy in treating 
      allergic rhinitis (AR) symptoms. This trial evaluated the dose-response 
      relationship of SLIToneULTRA(R) HDM mix based on immunological parameters and 
      safety in subjects with moderate-to-severe HDM AR not controlled by symptomatic 
      medication. MATERIALS AND METHODS: A randomized, parallel-group, open-label, 
      clinical trial compared 50/150/300 standard reactivity unit (SRU) doses of 
      SLIToneULTRA(R) HDM mix for 6 months. Subjects had moderate-to-severe HDM AR, 
      positive skin prick and IgE against Dermatophagoides 
      pteronyssinus/Dermatophagoides farinae (DP/DF). The primary end point was change 
      from baseline in the IgE-blocking factor against DP after 6 months. Secondary end 
      points measured changes in the IgE-blocking factor for DP at 3 months and for DF 
      at 3 and 6 months, and in IgG4 and specific IgE to DP/DF after 3 and 6 months. 
      Tolerability was assessed through the evaluation of all adverse events (AEs). 
      RESULTS: A total of 219 subjects were randomized and 196 completed the trial. 
      Dose effect was significant on DP IgE-BF after 6 months (p = 0.018). The change 
      in the DP IgE-blocking factor at a 300-SRU dose was higher than at other doses 
      after 3 (p = 0.008) and 6 (p = 0005) months of treatment. Similar changes were 
      observed for IgG4 and allergen-specific IgE. The number of AEs increased with the 
      dose and were mild-to-moderate, with no severe treatment-related AEs reported. 
      The most frequent AEs were oral/tongue pruritus, mouth oedema and abdominal upper 
      pain. CONCLUSIONS: Data showed a dose-response for immunological markers and 
      safety with a better immunological response for 300 SRU. The highest dose (300 
      SRU daily) was considered as the optimal maintenance dose.
CI  - (c) 2016 The Author(s) Published by S. Karger AG, Basel.
FAU - Didier, Alain
AU  - Didier A
AD  - Department of Respiratory Diseases, Larrey Hospital, Toulouse, France.
FAU - Campo, Paloma
AU  - Campo P
FAU - Moreno, Francisco
AU  - Moreno F
FAU - Durand-Perdriel, Francois
AU  - Durand-Perdriel F
FAU - Marin, Alicia
AU  - Marin A
FAU - Chartier, Antoine
AU  - Chartier A
LA  - eng
SI  - EudraCT/2012-002177-62
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20160121
PL  - Switzerland
TA  - Int Arch Allergy Immunol
JT  - International archives of allergy and immunology
JID - 9211652
RN  - 0 (Antigens, Dermatophagoides)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Adult
MH  - Animals
MH  - Antigens, Dermatophagoides/*immunology
MH  - *Desensitization, Immunologic/adverse effects
MH  - Dose-Response Relationship, Immunologic
MH  - Female
MH  - Humans
MH  - Immunoglobulin E/immunology
MH  - Male
MH  - Rhinitis, Allergic/immunology/*therapy
EDAT- 2016/01/21 06:00
MHDA- 2016/06/09 06:00
CRDT- 2016/01/21 06:00
PHST- 2015/07/09 00:00 [received]
PHST- 2015/11/10 00:00 [accepted]
PHST- 2016/01/21 06:00 [entrez]
PHST- 2016/01/21 06:00 [pubmed]
PHST- 2016/06/09 06:00 [medline]
AID - 000442467 [pii]
AID - 10.1159/000442467 [doi]
PST - ppublish
SO  - Int Arch Allergy Immunol. 2015;168(3):182-92. doi: 10.1159/000442467. Epub 2016 
      Jan 21.