Clinical trials for the drug Xolair (omalizumab) found that although it did not work as expected, it did have a surprising effect that could prove useful in future immunotherapy treatments for milk allergies.
The trials were conducted to test omalizumab’s effectiveness as a way to improve oral immunotherapy effectiveness by dampening the allergic reaction to cow’s milk. The desired effect, however, did not prove conclusive in the trials. Instead, researchers found that Xolair was likely reducing the effects of adverse allergic reactions to cow’s milk during the study.
The surprising result opens new avenues for research and potential treatment options using Xolair.
Xolair could help reduce the “build up phase” time during OIT.
During oral immunotherapy, the first phase of treatment is to slowly build a tolerance to very small amounts of the allergen. In the case of milk allergy, this usually means small drops of milk being introduced in controlled circumstances so that adverse reactions can be quickly dealt with by medical staff.
When testing omalizumab in trials, researchers assembled 57 children with milk allergies. Half were given the drug before and during the OIT while the other half were given a placebo. During the build-up phase of the therapy, among those children given Xolair, only one had a severe reaction to milk that required epinephrine. Among the children who did not receive it, eight of them had severe reactions.
Dr. Hugh Sampson, director of the Jaffe Food Allergy Institute at New York’s Icahn School of Medicine at Mount Sinai, who lead the study, believes that this opens a new avenue for research into the drug. He acknowledges the limitations of the study and its interesting and unexpected result, but more work will be required to prove efficacy as an OIT additive.