PMID- 25495666
OWN - NLM
STAT- MEDLINE
DCOM- 20150922
LR  - 20150202
IS  - 1398-9995 (Electronic)
IS  - 0105-4538 (Linking)
VI  - 70
IP  - 3
DP  - 2015 Mar
TI  - Safety of sublingual immunotherapy Timothy grass tablet in subjects with allergic 
      rhinitis with or without conjunctivitis and history of asthma.
PG  - 302-9
LID - 10.1111/all.12560 [doi]
AB  - BACKGROUND: Patients with asthma may be more susceptible to adverse events (AEs) 
      with sublingual immunotherapy tablet (SLIT-tablet) treatment, such as severe 
      systemic reactions and asthma-related events. Using data from eight trials of 
      grass SLIT-tablet in subjects with allergic rhinitis with/without conjunctivitis 
      (AR/C), AE frequencies were determined in adults and children with and without 
      reported asthma. METHODS: Data from randomized, double-blind, placebo-controlled 
      trials of Timothy grass SLIT-tablet MK-7243 (2800 BAU/75 000 SQ-T, 
      Merck/ALK-Abello) were pooled for post hoc analyses. Subjects with uncontrolled 
      and severe asthma were excluded from the trials. Frequencies for 
      treatment-emergent AEs (TEAEs), local allergic swelling (mouth or throat), 
      systemic allergic reactions, and asthma-related treatment-related AEs (TRAEs) 
      were calculated. RESULTS: Among adults (n = 3314) and children (n = 881), 24% and 
      31%, respectively, had reported asthma. No serious local allergic swellings or 
      serious systemic allergic reactions occurred in subjects with asthma treated with 
      SLIT-tablet. There was no evidence of increased TEAEs, systemic allergic 
      reactions, or severe local allergic swellings in adults or children with asthma 
      treated with grass SLIT-tablet versus subjects without asthma in or outside of 
      pollen season. There were 6/120 asthma-related TRAEs assessed as severe with 
      grass SLIT-tablet and 2/60 with placebo, without a consistent trend among 
      subjects with and without asthma (5 and 3 events, respectively). CONCLUSIONS: In 
      the AR/C subjects with reported well-controlled mild asthma included in these 
      studies, grass SLIT-tablet did not increase TEAE frequency, severe local allergic 
      swelling, or systemic allergic reactions versus subjects without asthma. There 
      was no indication that treatment led to acute asthma worsening.
CI  - (c) 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
FAU - Maloney, J
AU  - Maloney J
AD  - Merck & Co., Inc., Whitehouse Station, NJ, USA.
FAU - Durham, S
AU  - Durham S
FAU - Skoner, D
AU  - Skoner D
FAU - Dahl, R
AU  - Dahl R
FAU - Bufe, A
AU  - Bufe A
FAU - Bernstein, D
AU  - Bernstein D
FAU - Murphy, K
AU  - Murphy K
FAU - Waserman, S
AU  - Waserman S
FAU - Berman, G
AU  - Berman G
FAU - White, M
AU  - White M
FAU - Kaur, A
AU  - Kaur A
FAU - Nolte, H
AU  - Nolte H
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20150114
PL  - Denmark
TA  - Allergy
JT  - Allergy
JID - 7804028
RN  - 0 (Allergens)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Allergens/administration & dosage/adverse effects/*immunology
MH  - Asthma/*complications
MH  - Conjunctivitis/*complications
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phleum/*adverse effects
MH  - Randomized Controlled Trials as Topic
MH  - Respiratory Function Tests
MH  - Rhinitis, Allergic/*complications/physiopathology/*therapy
MH  - *Sublingual Immunotherapy/adverse effects
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - allergic rhinitis
OT  - asthma
OT  - grass
OT  - safety
OT  - sublingual immunotherapy
EDAT- 2014/12/17 06:00
MHDA- 2015/09/24 06:00
CRDT- 2014/12/16 06:00
PHST- 2014/12/10 00:00 [accepted]
PHST- 2014/12/16 06:00 [entrez]
PHST- 2014/12/17 06:00 [pubmed]
PHST- 2015/09/24 06:00 [medline]
AID - 10.1111/all.12560 [doi]
PST - ppublish
SO  - Allergy. 2015 Mar;70(3):302-9. doi: 10.1111/all.12560. Epub 2015 Jan 14.