Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Background
Allergy immunotherapy targets the immunological cause of allergic rhinoconjunctivitis and allergic asthma and has the potential to alter the natural course of allergic disease.
Objective
The primary objective was to investigate the effect of the SQ grass sublingual immunotherapy tablet compared with placebo on the risk of developing asthma.
Methods
A total of 812 children (5-12 years), with a clinically relevant history of grass pollen allergic rhinoconjunctivitis and no medical history or signs of asthma, were included in the randomized, double-blind, placebo-controlled trial, comprising 3 years of treatment and 2 years of follow-up.
Results
There was no difference in time to onset of asthma, defined by prespecified asthma criteria relying on documented reversible impairment of lung function (primary endpoint). Treatment with the SQ grass sublingual immunotherapy tablet significantly reduced the risk of experiencing asthma symptoms or using asthma medication at the end of trial (odds ratio = 0.66, P < .036), during the 2-year posttreatment follow-up, and during the entire 5-year trial period. Also, grass allergic rhinoconjunctivitis symptoms were 22% to 30% reduced (P < .005 for all 5 years). At the end of the trial, the use of allergic rhinoconjunctivitis pharmacotherapy was significantly less (27% relative difference to placebo, P < .001). Total IgE, grass pollen–specific IgE, and skin prick test reactivity to grass pollen were all reduced compared to placebo.
Conclusions
Treatment with the SQ grass sublingual immunotherapy tablet reduced the risk of experiencing asthma symptoms and using asthma medication, and had a positive, long-term clinical effect on rhinoconjunctivitis symptoms and medication use but did not show an effect on the time to onset of asthma.
Allergy immunotherapy targets the immunological cause of allergic rhinoconjunctivitis and allergic asthma and has the potential to alter the natural course of allergic disease.
Objective
The primary objective was to investigate the effect of the SQ grass sublingual immunotherapy tablet compared with placebo on the risk of developing asthma.
Methods
A total of 812 children (5-12 years), with a clinically relevant history of grass pollen allergic rhinoconjunctivitis and no medical history or signs of asthma, were included in the randomized, double-blind, placebo-controlled trial, comprising 3 years of treatment and 2 years of follow-up.
Results
There was no difference in time to onset of asthma, defined by prespecified asthma criteria relying on documented reversible impairment of lung function (primary endpoint). Treatment with the SQ grass sublingual immunotherapy tablet significantly reduced the risk of experiencing asthma symptoms or using asthma medication at the end of trial (odds ratio = 0.66, P < .036), during the 2-year posttreatment follow-up, and during the entire 5-year trial period. Also, grass allergic rhinoconjunctivitis symptoms were 22% to 30% reduced (P < .005 for all 5 years). At the end of the trial, the use of allergic rhinoconjunctivitis pharmacotherapy was significantly less (27% relative difference to placebo, P < .001). Total IgE, grass pollen–specific IgE, and skin prick test reactivity to grass pollen were all reduced compared to placebo.
Conclusions
Treatment with the SQ grass sublingual immunotherapy tablet reduced the risk of experiencing asthma symptoms and using asthma medication, and had a positive, long-term clinical effect on rhinoconjunctivitis symptoms and medication use but did not show an effect on the time to onset of asthma.
Date Issued
2018-02-01
Date Acceptance
2017-06-21
Citation
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 2018, 141 (2), pp.529-538.e13
ISSN
0091-6749
Publisher
MOSBY-ELSEVIER
Start Page
529
End Page
538.e13
Journal / Book Title
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
Volume
141
Issue
2
Copyright Statement
© 2017
The
Authors. Published
by
Elsevier
Inc.
on
behalf
of
the
American
Academy
of
Allergy
,
Asthma
&
Immunology.
This
is
an
open
acces s
article
under
the
CC
BY
-NC-
ND
license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
The
Authors. Published
by
Elsevier
Inc.
on
behalf
of
the
American
Academy
of
Allergy
,
Asthma
&
Immunology.
This
is
an
open
acces s
article
under
the
CC
BY
-NC-
ND
license
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000424410800010&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Allergy
Immunology
Allergy immunotherapy
asthma symptoms
children
disease-modifying treatment
long-term trial
FOLLOW-UP
RHINITIS
CHILDHOOD
RHINOCONJUNCTIVITIS
PAT
IMPACT
RISK
Publication Status
Published
Date Publish Online
2017-07-06