PMID- 37990117
OWN - NLM
STAT- MEDLINE
DCOM- 20240215
LR  - 20240405
IS  - 1365-2222 (Electronic)
IS  - 0954-7894 (Linking)
VI  - 54
IP  - 2
DP  - 2024 Feb
TI  - Tolerability of sublingual versus vestibular allergy immunotherapy tablet 
      administration: A randomized pilot study.
PG  - 120-129
LID - 10.1111/cea.14427 [doi]
AB  - BACKGROUND: Local application site reactions are common with sublingual allergy 
      immunotherapy (AIT)-tablets for the treatment of allergic rhinitis/conjunctivitis 
      (AR/C) and occasionally lead to treatment discontinuation. Because of the lower 
      mast cell density in the vestibular mucosa than the sublingual area, vestibular 
      AIT-tablet administration may result in fewer adverse events (AEs). This pilot 
      study evaluated the tolerability of the vestibular administration route of 
      AIT-tablets compared with the sublingual route in adult subjects with AR/C. 
      METHODS: Adults (n = 164) aged 18-65 years with AR/C treated with daily birch 
      pollen, grass pollen, ragweed pollen or house dust mite AIT in tablet form were 
      randomized 1:1 to vestibular or sublingual administration for 28 days, followed 
      by 28 days of sublingual administration only. The primary endpoint was the 
      severity (mild, moderate, severe) of local treatment-related adverse events 
      (TRAEs) during the first 28 days of treatment. RESULTS: During the first 28 days, 
      the percentage of subjects in the vestibular and sublingual groups reporting mild 
      TRAEs were 55.6% versus 50.6%, respectively; moderate TRAEs were 27.2% versus 
      30.1%; and severe TRAEs were 12.3% versus 6.0% (p = .16). In the vestibular 
      group, 95.1% of the subjects experienced at least one TRAE during the first 
      period versus 81.9% in the sublingual group (p = .01) and discontinuation rates 
      due to AEs were higher (12.3% vs. 3.6%). CONCLUSION: The frequencies of subjects 
      experiencing severe TRAEs, at least one TRAE, and discontinuations due to AEs at 
      the initiation of AIT-tablets were numerically higher with vestibular 
      administration than sublingual administration. Sublingual administration should 
      remain the standard of care for subjects treated with AIT-tablets for AR/C.
CI  - (c) 2023 John Wiley & Sons Ltd.
FAU - Simard, Marie-Lee
AU  - Simard ML
AD  - Clinique Specialisee en Allergie de la Capitale, Quebec, Quebec, Canada.
FAU - Novak, Natalija
AU  - Novak N
AD  - Clinic and Polyclinic for Dermatology and Allergology, University Hospital Bonn, 
      Bonn, Germany.
FAU - Drolet, Jean-Philippe
AU  - Drolet JP
AD  - Clinique Specialisee en Allergie de la Capitale, Quebec, Quebec, Canada.
FAU - Joly, Marie-Claude
AU  - Joly MC
AD  - Clinique Specialisee en Allergie de la Capitale, Quebec, Quebec, Canada.
FAU - Nolte, Hendrik
AU  - Nolte H
AD  - ALK, Bedminster, New Jersey, USA.
FAU - Wuestenberg, Eike
AU  - Wuestenberg E
AD  - ALK-Abello A/S, Horsholm, Denmark.
AD  - Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine (and 
      University Hospital) Carl Gustav Carus, Technische Universitat Dresden, Dresden, 
      Germany.
FAU - Gagnon, Remi
AU  - Gagnon R
AD  - Clinique Specialisee en Allergie de la Capitale, Quebec, Quebec, Canada.
LA  - eng
GR  - ALK/
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20231121
PL  - England
TA  - Clin Exp Allergy
JT  - Clinical and experimental allergy : journal of the British Society for Allergy 
      and Clinical Immunology
JID - 8906443
RN  - 0 (Tablets)
RN  - 0 (Allergens)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Pilot Projects
MH  - *Rhinitis, Allergic, Seasonal/therapy
MH  - Administration, Sublingual
MH  - Treatment Outcome
MH  - *Conjunctivitis, Allergic
MH  - *Rhinitis, Allergic/therapy
MH  - *Sublingual Immunotherapy/adverse effects
MH  - Tablets
MH  - Allergens
OTO - NOTNLM
OT  - allergic rhinoconjunctivitis
OT  - house dust mite
OT  - pollen
OT  - sublingual immunotherapy tablet
OT  - vestibular
EDAT- 2023/11/22 06:43
MHDA- 2024/02/15 06:43
CRDT- 2023/11/22 00:48
PHST- 2023/09/28 00:00 [received]
PHST- 2023/11/08 00:00 [accepted]
PHST- 2024/02/15 06:43 [medline]
PHST- 2023/11/22 06:43 [pubmed]
PHST- 2023/11/22 00:48 [entrez]
AID - 10.1111/cea.14427 [doi]
PST - ppublish
SO  - Clin Exp Allergy. 2024 Feb;54(2):120-129. doi: 10.1111/cea.14427. Epub 2023 Nov 
      21.