Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: The importance of allergen-specific serum IgE

Linda S. Cox, Thomas B. Casale, Anjuli S. Nayak, David I. Bernstein, Peter Socrates Creticos, Laurence Ambroisine, Michel Melac, Robert K. Zeldin

Research output: Contribution to journalArticle

Abstract

Background: Previous trials have demonstrated the efficacy, safety, and optimal dosage of the 5-grass pollen sublingual tablet for adults and children with grass pollen-induced allergic rhinoconjunctivitis. Objectives: We sought to evaluate the efficacy and safety of 300 index of reactivity (IR) 5-grass pollen sublingual tablet in US adults. Methods: Adults with grass pollen allergy and Rhinoconjunctivitis Total Symptom Scores of 12 or greater (scale, 0-18) during the previous grass pollen season were randomized in a double-blind, placebo-controlled study to receive 300IR 5-grass pollen sublingual tablet or placebo starting 4 months before and continuing through the pollen season. The primary efficacy end point was the daily Combined Score (CS; scale, 0-3), which integrates symptoms and rescue medication use. Results: Four hundred seventy-three participants were randomized. The mean daily CS over the pollen period was significantly lower in the active treatment group versus the placebo group (least-squares mean difference: -0.13; 95% CI, -0.19 to -0.06; P =.0003; relative reduction: 28.2%; 95% CI, 13.0% to 43.4%). In placebo-treated participants, the daily CS least-squares mean was 0.32 in the subgroup with baseline timothy grass-specific serum IgE of less than 0.1 kU/L (n = 23) and 0.46 in those with baseline timothy grass-specific serum IgE of 0.1 kU/L or greater (n = 204). The most frequent reported adverse events were oral pruritus, throat irritation, and nasopharyngitis. There were no reports of anaphylaxis, and no actively treated participant received epinephrine. Conclusion: In US adults with grass pollen-induced allergic rhinoconjunctivitis, preseasonal and coseasonal treatment with 300IR 5-grass pollen sublingual tablet demonstrated clinically meaningful efficacy, especially in study subjects with measurable timothy grass-specific serum IgE. Use of 300IR 5-grass pollen sublingual tablet was safe and well tolerated. A requirement for a measurable level of allergen-specific serum IgE should be considered in future studies in this field.

Original languageEnglish (US)
Pages (from-to)1327-1334
Number of pages8
JournalThe Journal of Allergy and Clinical Immunology
Volume130
Issue number6
DOIs
StatePublished - Dec 2012

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Pollen
Allergens
Immunoglobulin E
Poaceae
Phleum
Serum
Placebos
Least-Squares Analysis
Tablets
Nasopharyngitis
Safety
Seasonal Allergic Rhinitis
Anaphylaxis
Pruritus
Pharynx
300IR 5-grass pollen allergen
Epinephrine
Therapeutics

Keywords

  • allergic rhinoconjunctivitis
  • allergy
  • combined score
  • Double-blind
  • grass pollen
  • grass-specific IgE
  • placebo-controlled trial
  • specific immunotherapy
  • sublingual immunotherapy tablet

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study : The importance of allergen-specific serum IgE. / Cox, Linda S.; Casale, Thomas B.; Nayak, Anjuli S.; Bernstein, David I.; Creticos, Peter Socrates; Ambroisine, Laurence; Melac, Michel; Zeldin, Robert K.

In: The Journal of Allergy and Clinical Immunology, Vol. 130, No. 6, 12.2012, p. 1327-1334.

Research output: Contribution to journalArticle

Cox, Linda S. ; Casale, Thomas B. ; Nayak, Anjuli S. ; Bernstein, David I. ; Creticos, Peter Socrates ; Ambroisine, Laurence ; Melac, Michel ; Zeldin, Robert K. / Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study : The importance of allergen-specific serum IgE. In: The Journal of Allergy and Clinical Immunology. 2012 ; Vol. 130, No. 6. pp. 1327-1334.
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AU - Bernstein, David I.

AU - Creticos, Peter Socrates

AU - Ambroisine, Laurence

AU - Melac, Michel

AU - Zeldin, Robert K.

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N2 - Background: Previous trials have demonstrated the efficacy, safety, and optimal dosage of the 5-grass pollen sublingual tablet for adults and children with grass pollen-induced allergic rhinoconjunctivitis. Objectives: We sought to evaluate the efficacy and safety of 300 index of reactivity (IR) 5-grass pollen sublingual tablet in US adults. Methods: Adults with grass pollen allergy and Rhinoconjunctivitis Total Symptom Scores of 12 or greater (scale, 0-18) during the previous grass pollen season were randomized in a double-blind, placebo-controlled study to receive 300IR 5-grass pollen sublingual tablet or placebo starting 4 months before and continuing through the pollen season. The primary efficacy end point was the daily Combined Score (CS; scale, 0-3), which integrates symptoms and rescue medication use. Results: Four hundred seventy-three participants were randomized. The mean daily CS over the pollen period was significantly lower in the active treatment group versus the placebo group (least-squares mean difference: -0.13; 95% CI, -0.19 to -0.06; P =.0003; relative reduction: 28.2%; 95% CI, 13.0% to 43.4%). In placebo-treated participants, the daily CS least-squares mean was 0.32 in the subgroup with baseline timothy grass-specific serum IgE of less than 0.1 kU/L (n = 23) and 0.46 in those with baseline timothy grass-specific serum IgE of 0.1 kU/L or greater (n = 204). The most frequent reported adverse events were oral pruritus, throat irritation, and nasopharyngitis. There were no reports of anaphylaxis, and no actively treated participant received epinephrine. Conclusion: In US adults with grass pollen-induced allergic rhinoconjunctivitis, preseasonal and coseasonal treatment with 300IR 5-grass pollen sublingual tablet demonstrated clinically meaningful efficacy, especially in study subjects with measurable timothy grass-specific serum IgE. Use of 300IR 5-grass pollen sublingual tablet was safe and well tolerated. A requirement for a measurable level of allergen-specific serum IgE should be considered in future studies in this field.

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