Food, drug, insect sting allergy, and anaphylaxisA randomized, double-blind, placebo-controlled study of omalizumab combined with oral immunotherapy for the treatment of cow's milk allergy
Section snippets
Study design
Subjects 7 to 35 years of age with a history of IgE-mediated CMA were recruited at 3 sites (Mount Sinai, Johns Hopkins, and Stanford). CMA was confirmed by (1) a positive milk skin prick test (SPT) response (wheal ≥3 mm larger than that elicited by the negative control) or a positive milk-specific IgE level (>0.35 kUA/L) and (2) double-blind, placebo-controlled oral food challenge (OFC) reaction to less than 2 g of milk protein. Patients were excluded if there was a history of life-threatening
Study population
Fifty-seven subjects (age, 7-32 years) were randomized between October, 2010, and April, 2012 (Mount Sinai, 29; Johns Hopkins, 23; and Stanford, 5; Fig 1). There were no significant differences between the treatment groups for any baseline characteristic, including age (omalizumab vs placebo: median, 11.7 vs 9.5 years), asthma, other food allergies, milk-specific IgE levels (median, 42.1 vs 38.4 kUA/L), milk SPT responses (median wheal, 8.8 vs 8.5 mm), or milk OFC eliciting dose (median SCD, 20
Discussion
Given that CMA is very prevalent and has the potential to result in severe and even fatal reactions and that cow's milk is ubiquitous in the food supply, safe and effective therapies for those in whom tolerance does not develop naturally is highly desirable, not unlike with other common food allergens, such as egg, peanut, and tree nuts. Although results of previous food OIT studies generally have been encouraging, concerns regarding both safety and long-term efficacy might limit its
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Omalizumab (Xolair) and omalizumab placebo for this trial were kindly provided by Genentech. The study was supported by grant AI-44236 from the National Institute of Allergy and Infectious Diseases and RR-026134 (Mount Sinai) and UL1 TR 001079 (Johns Hopkins) from the National Center for Advancing Translational Sciences, National Institutes of Health; and a supplemental grant from Food Allergy Research and Education.
Disclosure of potential conflict of interest: R. A. Wood has received grants from the National Institutes of Health (NIH); has consultant arrangements with Sanofi and Stallergenes; is employed by Johns Hopkins University; has received royalties from UpToDate; and has received payment for educational presentations from Medscape. J. S. Kim is employed by NorthShore University HealthSystem. R. Lindblad, A. K. Henning, and P. Dawson have received payment to their institution, the Emmes Corporation, from the Food Allergy Initiative and Mount Sinai for serving as the data-coordinating center for the reported clinical trial. H. A. Sampson has received grants from the National Institute of Allergy and Infectious Diseases and Food Allergy Research and Education (FARE); has consultant arrangements with Danone Scientific Advisory Board, Genentech/Novartis, Sanofi, and Allertein Therapeutics; is an unpaid consultant on the DBV Scientific Advisory Board; has received royalties from UpToDate and Elsevier; has stock/stock options in Allertein Therapeutics; and has received honorarium from Thermo Fisher Scientific for being Chair of PhARF Selection Committee. The rest of the authors declare that they have no relevant conflicts of interest.
Trial registration: OIT and Xolair (Omalizumab) in Cow's Milk Allergy, NCT01157117, http://clinicaltrials.gov/show/NCT01157117.