PMID- 31954191
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 2213-2201 (Electronic)
VI  - 8
IP  - 4
DP  - 2020 Apr
TI  - Safety of Timothy Grass Sublingual Immunotherapy Tablet in Children: Pooled 
      Analyses of Clinical Trials.
PG  - 1387-1393.e2
LID - S2213-2198(20)30047-7 [pii]
LID - 10.1016/j.jaip.2020.01.008 [doi]
AB  - BACKGROUND: Timothy grass sublingual immunotherapy (SLIT) tablets are indicated 
      for children with allergic rhinitis with or without conjunctivitis. OBJECTIVE: To 
      use pooled analyses to assess the short- and long-term tolerability and safety of 
      timothy grass SLIT-tablet in children. METHODS: Data from 9 double-blinded, 
      randomized European or North American trials that included children with allergic 
      rhinitis with or without conjunctivitis treated up to 3 years with once-daily 
      timothy grass SLIT-tablet or placebo were pooled. RESULTS: In all, 1818 (timothy 
      grass SLIT-tablet, n = 923; placebo, n = 895) subjects were included in the 
      analysis. The frequency of treatment-emergent adverse events (AEs) was 86% in the 
      SLIT-tablet group and 83% in the placebo group, and the frequency of 
      treatment-related AEs (TRAEs) was 59% and 23%, respectively. Most (98%) TRAEs 
      were mild to moderate in severity. The 2 most common TRAEs with SLIT-tablet were 
      oral pruritus (33%) and throat irritation (19%), which had a median onset of 1 
      day and recurrence of 14.5 and 5 days, respectively. In all, 8% of subjects in 
      the SLIT-tablet group and 2% in the placebo group discontinued because of AEs. 
      There were 7 serious AEs assessed as related to SLIT-tablet, 1 systemic allergic 
      reaction (severe with a drop in blood pressure), 3 epinephrine administrations, 
      no eosinophilic esophagitis events, and no serious airway obstructions. The 
      safety profile was similar in subjects across geographic regions and with and 
      without asthma. CONCLUSIONS: Pooled data indicate that short- and long-term 
      timothy grass SLIT-tablet is well tolerated in children, regardless of geographic 
      region. AEs were generally local, mild, and transient allergic reactions.
CI  - Copyright (c) 2020 American Academy of Allergy, Asthma & Immunology. Published by 
      Elsevier Inc. All rights reserved.
FAU - Halken, Susanne
AU  - Halken S
AD  - Hans Christian Andersen Children's Hospital, Odense University Hospital, Odense, 
      Denmark.
FAU - Roberts, Graham
AU  - Roberts G
AD  - The David Hide Asthma and Allergy Research Centre, St Mary's Hospital, Newport 
      Isle of Wight, United Kingdom; NIHR Biomedical Research Centre, University 
      Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; 
      University of Southampton, Southampton, United Kingdom.
FAU - Valovirta, Erkka
AU  - Valovirta E
AD  - Department of Lung Disease and Clinical Allergology, University of Turku and 
      Terveystalo Allergy Clinic, Turku, Finland.
FAU - Nolte, Hendrik
AU  - Nolte H
AD  - ALK-Abello, Horsholm, Denmark. Electronic address: Hendrik.nolte@alk.net.
FAU - Hulstrom, Veronica
AU  - Hulstrom V
AD  - ALK-Abello, Horsholm, Denmark.
FAU - Blaiss, Michael S
AU  - Blaiss MS
AD  - Medical College of Georgia at Augusta University, Augusta, Ga.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20200115
PL  - United States
TA  - J Allergy Clin Immunol Pract
JT  - The journal of allergy and clinical immunology. In practice
JID - 101597220
RN  - 0 (Allergens)
RN  - 0 (Tablets)
SB  - IM
MH  - Allergens
MH  - *Asthma
MH  - Child
MH  - Humans
MH  - Phleum
MH  - Poaceae
MH  - *Rhinitis, Allergic
MH  - *Sublingual Immunotherapy
MH  - Tablets
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Allergic rhinitis
OT  - Children
OT  - Grass
OT  - Immunotherapy
OT  - Safety
OT  - Sublingual
EDAT- 2020/01/19 06:00
MHDA- 2021/05/15 06:00
CRDT- 2020/01/19 06:00
PHST- 2019/08/26 00:00 [received]
PHST- 2019/12/10 00:00 [revised]
PHST- 2020/01/06 00:00 [accepted]
PHST- 2020/01/19 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/01/19 06:00 [entrez]
AID - S2213-2198(20)30047-7 [pii]
AID - 10.1016/j.jaip.2020.01.008 [doi]
PST - ppublish
SO  - J Allergy Clin Immunol Pract. 2020 Apr;8(4):1387-1393.e2. doi: 
      10.1016/j.jaip.2020.01.008. Epub 2020 Jan 15.