The Journal of Allergy and Clinical Immunology
Volume 122, Issue 6 , Pages 1154-1160 , December 2008

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

  • Justin M. Skripak, MD

      Affiliations

    • Department of Pediatrics, Division of Allergy and Immunology, the Johns Hopkins University School of Medicine, Baltimore, Md
    • ,
  • Scott D. Nash, MD

      Affiliations

    • Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC
    • ,
  • Hannah Rowley, RD

      Affiliations

    • Department of Pediatrics, Division of Allergy and Immunology, the Johns Hopkins University School of Medicine, Baltimore, Md
    • ,
  • Nga H. Brereton, RD

      Affiliations

    • Department of Pediatrics, Division of Allergy and Immunology, the Johns Hopkins University School of Medicine, Baltimore, Md
    • ,
  • Susan Oh, RD

      Affiliations

    • Department of Pediatrics, Division of Allergy and Immunology, the Johns Hopkins University School of Medicine, Baltimore, Md
    • ,
  • Robert G. Hamilton, PhD

      Affiliations

    • Department of Pediatrics, Division of Allergy and Immunology, the Johns Hopkins University School of Medicine, Baltimore, Md
    • ,
  • Elizabeth C. Matsui, MD

      Affiliations

    • Department of Pediatrics, Division of Allergy and Immunology, the Johns Hopkins University School of Medicine, Baltimore, Md
    • ,
  • A. Wesley Burks, MD

      Affiliations

    • Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC
    • ,
  • Robert A. Wood, MD

      Affiliations

    • Department of Pediatrics, Division of Allergy and Immunology, the Johns Hopkins University School of Medicine, Baltimore, Md
    • Corresponding Author InformationReprint requests: Robert A. Wood, MD, CMSC 1102, The Johns Hopkins Hospital, 600 North Wolfe St, Baltimore, MD 21287.

Received 21 July 2008 ,Revised 25 August 2008 ,Accepted 4 September 2008.

  • Image Result

    Study timeline. Key features and overall timeframe are shown. OFC, Oral food challenge.

    Study timeline. Key features and overall timeframe are shown. OFC, Oral food challenge.

  • Image Result

    Change in milk dose threshold. A, Threshold change in active group (P = .002). B, Threshold change in placebo group (P = .16). Change in threshold after open-label active treatment in the placebo grou

    Change in milk dose threshold. A, Threshold change in active group (P = .002). B, Threshold change in placebo group (P = .16). Change in threshold after open-label active treatment in the placebo group is also shown in Fig 2, B (from after placebo to after milk OIT). Change in threshold for active versus placebo groups, P = .0003. Orange bars represent medians. MOIT, Milk OIT.

  • Image Result
    Change in end-point titration skin prick testing. A, Threshold change in active group (P = .03). B, Threshold change in placebo group (P = .03). Change in threshold for active versus placebo groups, P

    Change in end-point titration skin prick testing. A, Threshold change in active group (P = .03). B, Threshold change in placebo group (P = .03). Change in threshold for active versus placebo groups, P = .54. Orange bars represent medians. MOIT, Milk OIT.

  • Image Result
    Change in milk-specific IgE levels. Results are shown before milk OIT (MOIT), at maintenance, and after MOIT for the active group (P = .75; A) and placebo group (P = .46; B). Change in threshold for a

    Change in milk-specific IgE levels. Results are shown before milk OIT (MOIT), at maintenance, and after MOIT for the active group (P = .75; A) and placebo group (P = .46; B). Change in threshold for active versus placebo groups, P = .87. Orange bars represent medians.

  • Image Result
    Change in milk-specific IgG4 levels. Results are shown before milk OIT (MOIT), at maintenance, and after MOIT for the active group (P = .002; A) and placebo group (P = .6; B). Change in threshold for

    Change in milk-specific IgG4 levels. Results are shown before milk OIT (MOIT), at maintenance, and after MOIT for the active group (P = .002; A) and placebo group (P = .6; B). Change in threshold for active versus placebo groups, P = .001. Orange bars represent medians.

 Supported by National Institutes of Health (NIH) training grant no. 5T32 AI07007, the Eudowood Foundation, NIH training grant no. 5T32AI007062-30, and Duke Clinical Research Unit/Clinical and Translational Science Award grant no. 5UL1-RR024128-02.

 Disclosure of potential conflict of interest: A. W. Burks has consulting arrangements with ActoGeniX, NV, Novartis, McNeil Nutritionals, and Mead Johnson; owns stock in Allertein and MastCell, Inc; is on the advisory board for Dannon Co, Probiotics; is on the speakers' bureau for EpiPen/Dey; is on the data-monitoring committee for Genentech; is on an expert panel for Nutricia; has received research support from the National Institutes of Health (NIH), the Food Allergy and Anaphylaxis Network (FAAN), Gerber, and Mead Johnson; has served as an expert witness in food allergy litigation; and has served as a member of the FAAN, the American College of Allergy, Asthma & Immunology, the NIH, Hypersensitivity, Autoimmune, and Immune-mediated Diseases, and the Journal of Allergy and Clinical Immunology. R. A. Wood has received research support from Genentech and is on the advisory board for the FAAN and Dey. The rest of the authors have declared that they have no conflict of interest.

PII: S0091-6749(08)01725-9

doi: 10.1016/j.jaci.2008.09.030

The Journal of Allergy and Clinical Immunology
Volume 122, Issue 6 , Pages 1154-1160 , December 2008

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