Inhibitory effects of an anti-IgE antibody E25 on allergen-induced early asthmatic response

Am J Respir Crit Care Med. 1997 Jun;155(6):1835-40. doi: 10.1164/ajrccm.155.6.9196083.


Inhaled allergens, acting through IgE-dependent mechanisms, are important triggers of asthma symptoms and inducers of airway hyperresponsiveness and airway inflammation. The effect of anti-IgE recombinant humanized monoclonal antibody-E25 (rhuMAb-E25) on the provocation concentration of allergen causing a 15% fall in FEV1 (allergen PC15) during the allergen-induced early asthmatic response (EAR) was assessed in a multicenter, randomized, double-blind, parallel group study. Ten of 11 allergic asthmatic subjects randomized to receive intravenous rhuMAb-E25, 2 mg/kg on study day 0 and 1 mg/kg on Days 7, 14, 28, 42, 56, and 70 completed the study; nine received intravenous placebo. The allergen PC15 was measured on Days -1, 27, 55, and 77 and methacholine PC20 on Days -2, 42, and 76. rhuMAb-25 was well tolerated and only one patient (active group) was withdrawn because of a generalized urticarial rash after the first dose. Compared with baseline values (Day -1), the median allergen PC15 on Days 27, 55, and 77 were increased by 2.3, 2.2, and 2.7 doubling doses (delta log PC15/0.3) respectively with rhuMAb-E25 and -0.3, +0.1, and -0.8 doubling doses with placebo (p < or = 0.002). Methacholine PC20 improved slightly after rhuMAb-E25, this change becoming statistically significant on Day 76 (p < 0.05); no change was observed in the placebo group. Mean serum-free IgE fell by 89% after rhuMAb-E25 while there was no significant change after placebo. The inhibitory effects of rhuMAb-E25 on allergen-induced EAR suggest that it may be an effective, novel antiallergic treatment for asthma.

Publication types

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

MeSH terms

  • Adult
  • Allergens / immunology*
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / analysis
  • Antibodies, Monoclonal / therapeutic use*
  • Asthma / immunology*
  • Asthma / therapy*
  • Double-Blind Method
  • Female
  • Humans
  • Hypersensitivity, Immediate / immunology*
  • Hypersensitivity, Immediate / therapy*
  • Immunoglobulin E / analysis
  • Immunoglobulin E / immunology*
  • Male
  • Methacholine Chloride
  • Middle Aged


  • Allergens
  • Antibodies, Monoclonal
  • Methacholine Chloride
  • Immunoglobulin E