Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy

Erkka Valovirta; Thomas H Petersen; Teresa Piotrowska; Mette K Laursen; Jens S Andersen; Helle F Sørensen; Rabih Klink; GAP investigators; Eva-Maria Varga; Isidor Huttegger; Lone Agertoft; Susanne Halken; Inger Merete Jørgensen; Lars G Hansen; Roswitha Cronjäger; Kirsten Skamstrup Hansen; Thomas Houmann Petersen; Sune Rubak; Rajiv Sood; Adam Fox; Adnan Custovic

doi:10.1016/j.jaci.2017.06.014

Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy

Erkka Valovirta, Thomas H Petersen, Teresa Piotrowska, Mette K Laursen, Jens S Andersen, Helle F Sørensen, Rabih Klink, GAP investigators, Eva-Maria Varga, Isidor Huttegger, Lone Agertoft, Susanne Halken, Inger Merete Jørgensen, Lars G Hansen, Roswitha Cronjäger, Kirsten Skamstrup Hansen, Thomas Houmann Petersen, Sune Rubak, Rajiv Sood, Adam FoxAdnan Custovic

Department of Clinical Medicine

147 Citations (Scopus)

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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.

Original language	English
Journal	The Journal of allergy and clinical immunology
Volume	141
Issue number	2
Pages (from-to)	529-538.e13
ISSN	0091-6749
DOIs	https://doi.org/10.1016/j.jaci.2017.06.014
Publication status	Published - Feb 2018

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1-s2.0-S0091674917310886-mainFinal published version, 3.04 MBLicence: CC BY-NC-ND

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Valovirta, E., Petersen, T. H., Piotrowska, T., Laursen, M. K., Andersen, J. S., Sørensen, H. F., Klink, R., GAP investigators, Varga, E-M., Huttegger, I., Agertoft, L., Halken, S., Jørgensen, I. M., Hansen, L. G., Cronjäger, R., Hansen, K. S., Houmann Petersen, T., Rubak, S., Sood, R., ... Custovic, A. (2018). Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy. The Journal of allergy and clinical immunology, 141(2), 529-538.e13. https://doi.org/10.1016/j.jaci.2017.06.014

Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy. / Valovirta, Erkka; Petersen, Thomas H; Piotrowska, Teresa et al.

In: The Journal of allergy and clinical immunology, Vol. 141, No. 2, 02.2018, p. 529-538.e13.

Research output: Contribution to journal › Journal article › Research › peer-review

Valovirta, E, Petersen, TH, Piotrowska, T, Laursen, MK, Andersen, JS, Sørensen, HF, Klink, R, GAP investigators, Varga, E-M, Huttegger, I, Agertoft, L, Halken, S, Jørgensen, IM, Hansen, LG, Cronjäger, R, Hansen, KS, Houmann Petersen, T, Rubak, S, Sood, R, Fox, A & Custovic, A 2018, 'Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy', The Journal of allergy and clinical immunology, vol. 141, no. 2, pp. 529-538.e13. https://doi.org/10.1016/j.jaci.2017.06.014

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title = "Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy",

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.",

author = "Erkka Valovirta and Petersen, {Thomas H} and Teresa Piotrowska and Laursen, {Mette K} and Andersen, {Jens S} and S{\o}rensen, {Helle F} and Rabih Klink and {GAP investigators} and Eva-Maria Varga and Isidor Huttegger and Lone Agertoft and Susanne Halken and J{\o}rgensen, {Inger Merete} and Hansen, {Lars G} and Roswitha Cronj{\"a}ger and Hansen, {Kirsten Skamstrup} and {Houmann Petersen}, Thomas and Sune Rubak and Rajiv Sood and Adam Fox and Adnan Custovic",

year = "2018",

month = feb,

doi = "10.1016/j.jaci.2017.06.014",

language = "English",

volume = "141",

pages = "529--538.e13",

journal = "Journal of Allergy and Clinical Immunology",

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T1 - Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy

AU - Valovirta, Erkka

AU - Petersen, Thomas H

AU - Piotrowska, Teresa

AU - Laursen, Mette K

AU - Andersen, Jens S

AU - Sørensen, Helle F

AU - Klink, Rabih

AU - GAP investigators

AU - Varga, Eva-Maria

AU - Huttegger, Isidor

AU - Agertoft, Lone

AU - Halken, Susanne

AU - Jørgensen, Inger Merete

AU - Hansen, Lars G

AU - Cronjäger, Roswitha

AU - Hansen, Kirsten Skamstrup

AU - Houmann Petersen, Thomas

AU - Rubak, Sune

AU - Sood, Rajiv

AU - Fox, Adam

AU - Custovic, Adnan

PY - 2018/2

Y1 - 2018/2

N2 - 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.

AB - 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.

U2 - 10.1016/j.jaci.2017.06.014

DO - 10.1016/j.jaci.2017.06.014

M3 - Journal article

C2 - 28689794

SN - 0091-6749

VL - 141

SP - 529-538.e13

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

IS - 2

ER -

Results from the 5-year SQ grass sublingual immunotherapy tablet asthma prevention (GAP) trial in children with grass pollen allergy

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