PURPOSE OF THE STUDY.
The goal of this study was to assess the safety and efficacy of milk oral immunotherapy (OIT) in milk-allergic children and adults, including high-risk patients.
The study included 280 Israeli patients, ages 4 to 27 years (median age: 7.5 years), with persistent cow’s milk allergy as defined by positive results on skin prick test and/or specific-serum IgE, positive oral food challenge, or history of clinical reaction with accidental exposure in the last 12 months. High-risk patients, including those with a history of anaphylaxis (as defined by involvement of at least 2 organ systems), were not excluded. In fact, 73% had a history of anaphylactic reaction. Patients with uncontrolled asthma were excluded.
Using an open-label individualized treatment program, monthly rounds of OIT were administered by using fresh cow’s milk via a modified challenge-desensitization protocol. All patients were skin tested, with complete blood count and eosinophil counts obtained at the start of the program. The induction phase determined the maximal tolerated starting dose. This phase was performed in the hospital setting, with escalating doses of cow’s milk and observation for reactions with appropriate treatment. By the second day, 98% of patients had exhibited reactions. The third and fourth days were used to repeat the maximum tolerated starting dose and verify that it was safe. During the home dosing phase, the maximum tolerated starting dose was then given twice daily at home for 24 days.
Five patients failed milk OIT during induction, and 15 patients were still being studied. Sixty-two percent of the remaining patients (160 of 260) were able to freely consume milk (>7200 mg), and 25% were able to tolerate smaller amounts, with 85% consuming at least 180 mg of cow’s milk protein or the equivalent of 6 mL of milk. Clinically significant factors (P < .001) for achieving full tolerance to cow’s milk protein included a higher starting dose (odds ratio: 4.6 [for >30 mg]), not requiring epinephrine during induction (odds ratio: 5.2), and lack of nonanaphylactic reactions (odds ratio: 15.6).
This study presents clinical factors that may be helpful in predicting which patients undergoing milk OIT might be able to achieve full consumption of cow’s milk protein.
Challenges exist to prescribing food OIT at this point due to several unresolved issues, and the approach is not currently approved. These challenges include optimal criteria for patient selection, timing and duration of treatment, and the optimal protocol to maximize safety and effectiveness. This study may help with patient selection and risk stratification. Even when subjects were unable to be successfully desensitized, they tolerated a “minimal protective dose.” This approach would offer some protection against accidental ingestions and would greatly increase the quality of life for a number of patients.
- Copyright © 2014 by the American Academy of Pediatrics