The effects of an anti-IL-13 mAb on cytokine levels and nasal symptoms following nasal allergen challenge

J Allergy Clin Immunol. 2011 Oct;128(4):800-807.e9. doi: 10.1016/j.jaci.2011.05.013. Epub 2011 Jun 29.


Background: IL-13 is a key T(H)2 cytokine that is implicated in allergic responses.

Objective: We evaluated the effects of an anti-IL-13-blocking antibody compared with placebo on repeated nasal allergen challenge responses in hay fever patients out of season.

Methods: We performed a parallel group double-blind study of anti-IL-13 (single dose, 6 mg/kg intravenously, n = 16) and placebo (n = 15), with an additional open label group given a topical nasal corticosteroid (n = 5). Subjects received intranasal timothy grass pollen (Phleum pratense P5 allergen), and serial samples of nasal mucosal lining fluid were taken by using synthetic absorptive matrix and by nasal lavage.

Results: Administration of anti-IL-13 on day 1 resulted in a significant decrease in IL-13 levels in synthetic absorptive matrix eluates compared with placebo (area under the curve 0-8 hours, change from baseline) during the late phase after nasal allergen challenge on day 5 (P < .05) and day 7 (P < .01). There were no apparent effects of anti-IL-13 treatment on nasal lavage eosinophil numbers or total nasal symptom scores versus placebo. However, in a subgroup with high late-phase IL-13 levels at screening, there was a trend for a decrease in total nasal symptom scores after nasal allergen challenge on day 5, when compared with subjects with low IL-13 levels (P < .10). Nasal fluticasone caused suppression of IL-13 (P < .05 on day 5) as well as IL-5 (P < .01 on day 5) levels in the late phase compared with placebo.

Conclusions: Anti-IL-13 had specific pharmacodynamic action in this nasal allergen challenge model, causing profound inhibition of nasal lining fluid IL-13 responses. In addition, there was a possible effect of anti-IL-13 treatment on total nasal symptom scores in a subgroup with high late-phase nasal IL-13 levels at screening.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intranasal
  • Adolescent
  • Adrenal Cortex Hormones / administration & dosage
  • Adult
  • Allergens / administration & dosage*
  • Androstadienes / administration & dosage
  • Anti-Allergic Agents / administration & dosage
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / pharmacokinetics
  • Double-Blind Method
  • Eosinophils / immunology
  • Female
  • Fluticasone
  • Humans
  • Interleukin-13 / antagonists & inhibitors*
  • Interleukin-13 / immunology
  • Male
  • Middle Aged
  • Phleum / immunology
  • Rhinitis, Allergic, Seasonal / blood
  • Rhinitis, Allergic, Seasonal / drug therapy*
  • Rhinitis, Allergic, Seasonal / immunology
  • Therapeutic Irrigation


  • Adrenal Cortex Hormones
  • Allergens
  • Androstadienes
  • Anti-Allergic Agents
  • Antibodies, Monoclonal
  • Interleukin-13
  • Fluticasone