Use of an anti-IgE humanized monoclonal antibody in ragweed-induced allergic rhinitis

J Allergy Clin Immunol. 1997 Jul;100(1):110-21. doi: 10.1016/s0091-6749(97)70202-1.


Background: Increased serum levels of antigen-specific IgE are often associated with allergic respiratory disorders. RhuMAb-E25, a recombinant humanized monoclonal antibody, decreases free serum IgE by forming biologically inactive immune complexes with free IgE.

Objective: We hypothesized that rhuMAb-E25 would decrease total serum IgE and reduce symptoms.

Methods: Two hundred forty subjects were enrolled into five groups to determine the safety, tolerance, and efficacy of repeated administration of rhuMAb-E25 in adults with ragweed-induced allergic rhinitis and to explore the pharmacodynamic relationship of rhuMAb-E25 and IgE. One hundred eighty-one subjects received an initial intravenous loading dose (day 0, 1 month before ragweed season), followed by administration of rhuMAb-E25 (in mg/kg body weight) of 0.15 mg/kg subcutaneously, 0.15 mg/kg intravenously, or 0.5 mg/kg intravenously on days 7, 14, 28, 42, 56, 70, and 84. A subcutaneous placebo group and an intravenous placebo group were included. The total evaluation time included the 84-day treatment period, followed by a 42-day observation period.

Results: Adverse events were mild, and no differences were observed in the rates between the three active and two placebo treatment groups. Ragweed-specific IgE levels correlated with symptom scores. RhuMAb-E25 decreased serum free IgE levels in a dose- and baseline IgE-dependent fashion. However, only 11 subjects had IgE levels that were suppressed to undetectable levels (< or = 24 ng/ml), a sample too small to demonstrate significant differences and clinical efficacy. Thus the case for efficacy was not proven. Nonetheless, the study confirms that it is safe to repeatedly administer rhuMAb-E25 over a period of months.

Conclusions: Because rhuMAb-E25 decreased serum free IgE in a dose-dependent fashion and because symptom scores correlated with antigen-specific IgE levels, the results suggest that if given in adequate doses, rhuMAb-E25 should be an effective therapy for allergic diseases.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Animals
  • Antibodies, Anti-Idiotypic / adverse effects
  • Antibodies, Anti-Idiotypic / therapeutic use*
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal / pharmacokinetics
  • Antibodies, Monoclonal / pharmacology*
  • Antibody Specificity
  • Demography
  • Double-Blind Method
  • Female
  • Humans
  • Immunization, Passive / adverse effects
  • Immunoglobulin E / immunology*
  • Male
  • Mice
  • Middle Aged
  • Poaceae / immunology
  • Pollen / immunology
  • Recombinant Fusion Proteins / adverse effects
  • Recombinant Fusion Proteins / immunology*
  • Recombinant Fusion Proteins / therapeutic use*
  • Rhinitis, Allergic, Seasonal / etiology*
  • Rhinitis, Allergic, Seasonal / immunology
  • Rhinitis, Allergic, Seasonal / therapy*
  • Severity of Illness Index
  • Skin Tests
  • Titrimetry


  • Antibodies, Anti-Idiotypic
  • Antibodies, Monoclonal
  • Recombinant Fusion Proteins
  • anti-IgE antibodies
  • Immunoglobulin E