Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults

Peter S. Creticos, Jennifer Maloney, David I. Bernstein, Thomas Casale, Amarjot Kaur, Robert Fisher, Nancy Liu, Kevin Murphy, K. Nékám, Hendrik Nolte

Research output: Contribution to journalArticle

91 Citations (Scopus)

Abstract

Background: In North America and Europe, millions of patients experience symptoms of allergic rhinitis with or without conjunctivitis (AR/C) on exposure to ragweed pollen. The disease burden can be significant, with most patients relying on symptomatic medications without disease-modifying potential. However, novel sublingual immunomodulatory treatment options may potentially play an important role if efficacy and side effect profiles allow the convenience of self-administration. Objectives: This study evaluated an allergy immunotherapy tablet (AIT; SCH 39641/MK-3641) for treatment of ragweed-induced AR/C in the first large randomized, double-blind multinational trial of this therapeutic modality for ragweed allergy. Methods: Adults (n = 784) with short ragweed-induced AR/C were randomly assigned to approximately 52 weeks of daily self-administered ragweed AIT of 1.5, 6, or 12 units of Ambrosia artemisiifolia major allergen 1 (Amb a 1-U) or placebo. Subjects could use as-needed allergy rescue medication. Symptoms and medications were recorded daily. The primary efficacy end point was total combined daily symptom/medication score (TCS) during peak ragweed season. Safety was monitored through adverse event diaries maintained through study duration. Results: During peak ragweed season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 9% (-0.76; P = .22), 19% (-1.58; P = .01), and 24% (-2.04; P = .002) compared with placebo. During the entire season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 12% (-0.88; P = .09), 18% (-1.28; P = .01), and 27% (-1.92; P <.001) compared with placebo. Treatment was well tolerated; no systemic allergic reactions occurred. Conclusions: In this trial, ragweed AIT of 12 Amb a 1-U was effective and tolerable with a safety profile that permitted daily self-administration of ragweed allergen immunotherapy.

Original languageEnglish
JournalJournal of Allergy and Clinical Immunology
Volume131
Issue number5
DOIs
Publication statusPublished - May 2013

Fingerprint

Ambrosia
Immunotherapy
Tablets
Hypersensitivity
Randomized Controlled Trials
Self Administration
Placebos
Immunologic Desensitization
Safety
Conjunctivitis
Therapeutics
North America
Allergens

Keywords

  • allergic conjunctivitis
  • allergic rhinitis
  • allergic rhinoconjunctivitis
  • Allergy immunotherapy tablet
  • ragweed pollen
  • specific immunotherapy
  • sublingual immunotherapy

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. / Creticos, Peter S.; Maloney, Jennifer; Bernstein, David I.; Casale, Thomas; Kaur, Amarjot; Fisher, Robert; Liu, Nancy; Murphy, Kevin; Nékám, K.; Nolte, Hendrik.

In: Journal of Allergy and Clinical Immunology, Vol. 131, No. 5, 05.2013.

Research output: Contribution to journalArticle

Creticos, Peter S. ; Maloney, Jennifer ; Bernstein, David I. ; Casale, Thomas ; Kaur, Amarjot ; Fisher, Robert ; Liu, Nancy ; Murphy, Kevin ; Nékám, K. ; Nolte, Hendrik. / Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. In: Journal of Allergy and Clinical Immunology. 2013 ; Vol. 131, No. 5.
@article{36d1782bd74d4220a3c491fffaf15845,
title = "Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults",
abstract = "Background: In North America and Europe, millions of patients experience symptoms of allergic rhinitis with or without conjunctivitis (AR/C) on exposure to ragweed pollen. The disease burden can be significant, with most patients relying on symptomatic medications without disease-modifying potential. However, novel sublingual immunomodulatory treatment options may potentially play an important role if efficacy and side effect profiles allow the convenience of self-administration. Objectives: This study evaluated an allergy immunotherapy tablet (AIT; SCH 39641/MK-3641) for treatment of ragweed-induced AR/C in the first large randomized, double-blind multinational trial of this therapeutic modality for ragweed allergy. Methods: Adults (n = 784) with short ragweed-induced AR/C were randomly assigned to approximately 52 weeks of daily self-administered ragweed AIT of 1.5, 6, or 12 units of Ambrosia artemisiifolia major allergen 1 (Amb a 1-U) or placebo. Subjects could use as-needed allergy rescue medication. Symptoms and medications were recorded daily. The primary efficacy end point was total combined daily symptom/medication score (TCS) during peak ragweed season. Safety was monitored through adverse event diaries maintained through study duration. Results: During peak ragweed season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 9{\%} (-0.76; P = .22), 19{\%} (-1.58; P = .01), and 24{\%} (-2.04; P = .002) compared with placebo. During the entire season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 12{\%} (-0.88; P = .09), 18{\%} (-1.28; P = .01), and 27{\%} (-1.92; P <.001) compared with placebo. Treatment was well tolerated; no systemic allergic reactions occurred. Conclusions: In this trial, ragweed AIT of 12 Amb a 1-U was effective and tolerable with a safety profile that permitted daily self-administration of ragweed allergen immunotherapy.",
keywords = "allergic conjunctivitis, allergic rhinitis, allergic rhinoconjunctivitis, Allergy immunotherapy tablet, ragweed pollen, specific immunotherapy, sublingual immunotherapy",
author = "Creticos, {Peter S.} and Jennifer Maloney and Bernstein, {David I.} and Thomas Casale and Amarjot Kaur and Robert Fisher and Nancy Liu and Kevin Murphy and K. N{\'e}k{\'a}m and Hendrik Nolte",
year = "2013",
month = "5",
doi = "10.1016/j.jaci.2013.03.019",
language = "English",
volume = "131",
journal = "Journal of Allergy and Clinical Immunology",
issn = "0091-6749",
publisher = "Mosby Inc.",
number = "5",

}

TY - JOUR

T1 - Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults

AU - Creticos, Peter S.

AU - Maloney, Jennifer

AU - Bernstein, David I.

AU - Casale, Thomas

AU - Kaur, Amarjot

AU - Fisher, Robert

AU - Liu, Nancy

AU - Murphy, Kevin

AU - Nékám, K.

AU - Nolte, Hendrik

PY - 2013/5

Y1 - 2013/5

N2 - Background: In North America and Europe, millions of patients experience symptoms of allergic rhinitis with or without conjunctivitis (AR/C) on exposure to ragweed pollen. The disease burden can be significant, with most patients relying on symptomatic medications without disease-modifying potential. However, novel sublingual immunomodulatory treatment options may potentially play an important role if efficacy and side effect profiles allow the convenience of self-administration. Objectives: This study evaluated an allergy immunotherapy tablet (AIT; SCH 39641/MK-3641) for treatment of ragweed-induced AR/C in the first large randomized, double-blind multinational trial of this therapeutic modality for ragweed allergy. Methods: Adults (n = 784) with short ragweed-induced AR/C were randomly assigned to approximately 52 weeks of daily self-administered ragweed AIT of 1.5, 6, or 12 units of Ambrosia artemisiifolia major allergen 1 (Amb a 1-U) or placebo. Subjects could use as-needed allergy rescue medication. Symptoms and medications were recorded daily. The primary efficacy end point was total combined daily symptom/medication score (TCS) during peak ragweed season. Safety was monitored through adverse event diaries maintained through study duration. Results: During peak ragweed season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 9% (-0.76; P = .22), 19% (-1.58; P = .01), and 24% (-2.04; P = .002) compared with placebo. During the entire season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 12% (-0.88; P = .09), 18% (-1.28; P = .01), and 27% (-1.92; P <.001) compared with placebo. Treatment was well tolerated; no systemic allergic reactions occurred. Conclusions: In this trial, ragweed AIT of 12 Amb a 1-U was effective and tolerable with a safety profile that permitted daily self-administration of ragweed allergen immunotherapy.

AB - Background: In North America and Europe, millions of patients experience symptoms of allergic rhinitis with or without conjunctivitis (AR/C) on exposure to ragweed pollen. The disease burden can be significant, with most patients relying on symptomatic medications without disease-modifying potential. However, novel sublingual immunomodulatory treatment options may potentially play an important role if efficacy and side effect profiles allow the convenience of self-administration. Objectives: This study evaluated an allergy immunotherapy tablet (AIT; SCH 39641/MK-3641) for treatment of ragweed-induced AR/C in the first large randomized, double-blind multinational trial of this therapeutic modality for ragweed allergy. Methods: Adults (n = 784) with short ragweed-induced AR/C were randomly assigned to approximately 52 weeks of daily self-administered ragweed AIT of 1.5, 6, or 12 units of Ambrosia artemisiifolia major allergen 1 (Amb a 1-U) or placebo. Subjects could use as-needed allergy rescue medication. Symptoms and medications were recorded daily. The primary efficacy end point was total combined daily symptom/medication score (TCS) during peak ragweed season. Safety was monitored through adverse event diaries maintained through study duration. Results: During peak ragweed season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 9% (-0.76; P = .22), 19% (-1.58; P = .01), and 24% (-2.04; P = .002) compared with placebo. During the entire season, ragweed AIT of 1.5, 6, and 12 Amb a 1-U reduced TCS by 12% (-0.88; P = .09), 18% (-1.28; P = .01), and 27% (-1.92; P <.001) compared with placebo. Treatment was well tolerated; no systemic allergic reactions occurred. Conclusions: In this trial, ragweed AIT of 12 Amb a 1-U was effective and tolerable with a safety profile that permitted daily self-administration of ragweed allergen immunotherapy.

KW - allergic conjunctivitis

KW - allergic rhinitis

KW - allergic rhinoconjunctivitis

KW - Allergy immunotherapy tablet

KW - ragweed pollen

KW - specific immunotherapy

KW - sublingual immunotherapy

UR - http://www.scopus.com/inward/record.url?scp=84876906083&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84876906083&partnerID=8YFLogxK

U2 - 10.1016/j.jaci.2013.03.019

DO - 10.1016/j.jaci.2013.03.019

M3 - Article

VL - 131

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

SN - 0091-6749

IS - 5

ER -