Study Mixing OIT and Xolair Sees Big Drop in Side Effects
This “clearly appears to show marked benefit of the combination of anti-IgE [omalizumab] with oral immunotherapy,” said Dr. Hugh Sampson, a co-author of the study and director of the Jaffe Food Allergy Institute at New York’s Icahn School of Medicine at Mount Sinai.
Most patients undergoing experimental OIT treatment experience some adverse effects, he told journalists at the American Academy of Allergy Asthma & Immunology (AAAAI) annual meeting. “And somewhere between 5 and 10 percent of those are significant.”
In the Mount Sinai study, 54 study subjects with milk allergy between the ages of 7 and 32 took part. They were divided into two groups: 26 patients received omalizumab by injection over 16 months before and during OIT, while 28 got a placebo shot along with oral therapy for the same period.
Among those taking omalizumab, known by the brand name Xolair, only one person needed epinephrine to halt a reaction during OIT. The placebo group was far more affected, with nine participants requiring 17 epinephrine shots while on the oral therapy.
In OIT, patients are given a tiny amount of an allergen, then increasing amounts with the aim of reaching desensitization to a food (in this case, milk). They are then told to consume a daily “maintenance dose” of the food to retain this new protection.
Omalizumab also reduced the length of time to reach the maintenance level – an average of 26 weeks versus 31 weeks in the placebo group. The injections are often referred to as “anti-IgE” since they prevent or reduce reactions by neutralizing free-roaming IgE antibodies – those that set off allergic symptoms.
Study participants were able to stop the injections once they reached the maintenance level dosing. Sampson says that in two other studies involving omalizumab and OIT, the injections were also successfully stopped. Patients “were able to maintain their maintenance dose of the oral immunotherapy without the omalizumab,” he said.