A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy

Justin M. Skripak, Scott D. Nash, Hannah Rowley, Nga H. Brereton, Susan Oh, Robert G Hamilton, Elizabeth C. Matsui, A. Wesley Burks, Robert A Wood

Research output: Contribution to journalArticle

Abstract

Background: Orally administered, food-specific immunotherapy appears effective in desensitizing and potentially permanently tolerizing allergic individuals. Objective: We sought to determine whether milk oral immunotherapy (OIT) is safe and efficacious in desensitizing children with cow's milk allergy. Methods: Twenty children were randomized to milk or placebo OIT (2:1 ratio). Dosing included 3 phases: the build-up day (initial dose, 0.4 mg of milk protein; final dose, 50 mg), daily doses with 8 weekly in-office dose increases to a maximum of 500 mg, and continued daily maintenance doses for 3 to 4 months. Double-blind, placebo-controlled food challenges; end-point titration skin prick tests; and milk protein serologic studies were performed before and after OIT. Results: Nineteen patients, 6 to 17 years of age, completed treatment: 12 in the active group and 7 in the placebo group. One dropped out because of persistent eczema during dose escalation. Baseline median milk IgE levels in the active (n = 13) versus placebo (n = 7) groups were 34.8 kUa/L (range, 4.86-314 kUa/L) versus 14.6 kUa/L (range, 0.93-133.4 kUa/L). The median milk threshold dose in both groups was 40 mg at the baseline challenge. After OIT, the median cumulative dose inducing a reaction in the active treatment group was 5140 mg (range 2540-8140 mg), whereas all patients in the placebo group reacted at 40 mg (P = .0003). Among 2437 active OIT doses versus 1193 placebo doses, there were 1107 (45.4%) versus 134 (11.2%) total reactions, with local symptoms being most common. Milk-specific IgE levels did not change significantly in either group. Milk IgG levels increased significantly in the active treatment group, with a predominant milk IgG4 level increase. Conclusions: Milk OIT appears to be efficacious in the treatment of cow's milk allergy. The side-effect profile appears acceptable but requires further study.

Original languageEnglish (US)
Pages (from-to)1154-1160
Number of pages7
JournalThe Journal of Allergy and Clinical Immunology
Volume122
Issue number6
DOIs
StatePublished - Dec 2008

Fingerprint

Milk Hypersensitivity
Immunotherapy
Milk
Placebos
Milk Proteins
Skin Test End-Point Titration
Immunoglobulin E
Immunoglobulin G
Active Immunotherapy
Food
Eczema
Therapeutics

Keywords

  • Cow's milk
  • desensitization
  • food allergy
  • IgE
  • oral immunotherapy
  • prognosis
  • tolerance

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. / Skripak, Justin M.; Nash, Scott D.; Rowley, Hannah; Brereton, Nga H.; Oh, Susan; Hamilton, Robert G; Matsui, Elizabeth C.; Burks, A. Wesley; Wood, Robert A.

In: The Journal of Allergy and Clinical Immunology, Vol. 122, No. 6, 12.2008, p. 1154-1160.

Research output: Contribution to journalArticle

Skripak, Justin M. ; Nash, Scott D. ; Rowley, Hannah ; Brereton, Nga H. ; Oh, Susan ; Hamilton, Robert G ; Matsui, Elizabeth C. ; Burks, A. Wesley ; Wood, Robert A. / A randomized, double-blind, placebo-controlled study of milk oral immunotherapy for cow's milk allergy. In: The Journal of Allergy and Clinical Immunology. 2008 ; Vol. 122, No. 6. pp. 1154-1160.
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AU - Rowley, Hannah

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AU - Oh, Susan

AU - Hamilton, Robert G

AU - Matsui, Elizabeth C.

AU - Burks, A. Wesley

AU - Wood, Robert A

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N2 - Background: Orally administered, food-specific immunotherapy appears effective in desensitizing and potentially permanently tolerizing allergic individuals. Objective: We sought to determine whether milk oral immunotherapy (OIT) is safe and efficacious in desensitizing children with cow's milk allergy. Methods: Twenty children were randomized to milk or placebo OIT (2:1 ratio). Dosing included 3 phases: the build-up day (initial dose, 0.4 mg of milk protein; final dose, 50 mg), daily doses with 8 weekly in-office dose increases to a maximum of 500 mg, and continued daily maintenance doses for 3 to 4 months. Double-blind, placebo-controlled food challenges; end-point titration skin prick tests; and milk protein serologic studies were performed before and after OIT. Results: Nineteen patients, 6 to 17 years of age, completed treatment: 12 in the active group and 7 in the placebo group. One dropped out because of persistent eczema during dose escalation. Baseline median milk IgE levels in the active (n = 13) versus placebo (n = 7) groups were 34.8 kUa/L (range, 4.86-314 kUa/L) versus 14.6 kUa/L (range, 0.93-133.4 kUa/L). The median milk threshold dose in both groups was 40 mg at the baseline challenge. After OIT, the median cumulative dose inducing a reaction in the active treatment group was 5140 mg (range 2540-8140 mg), whereas all patients in the placebo group reacted at 40 mg (P = .0003). Among 2437 active OIT doses versus 1193 placebo doses, there were 1107 (45.4%) versus 134 (11.2%) total reactions, with local symptoms being most common. Milk-specific IgE levels did not change significantly in either group. Milk IgG levels increased significantly in the active treatment group, with a predominant milk IgG4 level increase. Conclusions: Milk OIT appears to be efficacious in the treatment of cow's milk allergy. The side-effect profile appears acceptable but requires further study.

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