title: Effect of anti-IgE therapy in patients with peanut allergy.
abstract: BACKGROUND
  Peanut-induced anaphylaxis is an IgE-mediated condition that is estimated to affect 1.5 million people and cause 50 to 100 deaths per year in the United States. TNX-901 is a humanized IgG1 monoclonal antibody against IgE that recognizes and masks an epitope in the CH3 region of IgE responsible for binding to the high-affinity Fc(epsilon) receptor on mast cells and basophils.
  
  
  METHODS
  We conducted a double-blind, randomized, dose-ranging trial in 84 patients with a history of immediate hypersensitivity to peanut. Hypersensitivity was confirmed and the threshold dose of encapsulated peanut flour established by a double-blind, placebo-controlled oral food challenge at screening. Patients were randomly assigned in a 3:1 ratio to receive either TNX-901 (150, 300, or 450 mg) or placebo subcutaneously every four weeks for four doses. The patients underwent a final oral food challenge within two to four weeks after the fourth dose.
  
  
  RESULTS
  From a mean base-line threshold of sensitivity of 178 to 436 mg of peanut flour in the various groups, the mean increases in the oral-food-challenge threshold were 710 mg in the placebo group, 913 mg in the group given 150 mg of TNX-901, 1650 mg in the group given 300 mg of TNX-901, and 2627 mg in the group given 450 mg of TNX-901 (P<0.001 for the comparison of the 450-mg dose with placebo, and P for trend with increasing dose <0.001). TNX-901 was well tolerated.
  
  
  CONCLUSIONS
  A 450-mg dose of TNX-901 significantly and substantially increased the threshold of sensitivity to peanut on oral food challenge from a level equal to approximately half a peanut (178 mg) to one equal to almost nine peanuts (2805 mg), an effect that should translate into protection against most unintended ingestions of peanuts.
authors.affiliation: National Jewish Medical and Research Center, Denver, USA.
authors.forename: Donald Y M
authors.initials: DY
authors.lastname: Leung
authors.forename: Hugh A
authors.initials: HA
authors.lastname: Sampson
authors.forename: John W
authors.initials: JW
authors.lastname: Yunginger
authors.forename: A Wesley
authors.initials: AW
authors.lastname: Burks
authors.forename: Lynda C
authors.initials: LC
authors.lastname: Schneider
authors.forename: Cornelis H
authors.initials: CH
authors.lastname: Wortel
authors.forename: Frances M
authors.initials: FM
authors.lastname: Davis
authors.forename: John D
authors.initials: JD
authors.lastname: Hyun
authors.forename: William R
authors.initials: WR
authors.lastname: Shanahan
mesh_terms: D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D008297:Male; D008875:Middle Aged; D021183:Peanut Hypersensitivity / Q000188:drug therapy* / Q000276:immunology
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007074:Immunoglobulin G; D007073:Immunoglobulin E; C472419:talizumab