A year after the FDA blessed Roche and Novartis’ Xolair (omalizumab) as the first medicine to reduce allergic reactions that can occur from accidental exposure to certain foods, the companies have presented data indicating Xolair may be more effective than oral immunotherapy (OIT) in treating food allergies.

Stage 2 of the NIH-sponsored phase 3 OUtMATCH trial—the first head-to-head study of Xolair versus OIT—met its primary endpoint, Roche's Genentech said in a Sunday press release.

The trial showed that 36% of those on Xolair as a monotherapy could withstand 2,000 mg of peanut protein—roughly eight peanuts—and two other allergens from a group that included milk, eggs and wheat without having an allergic reaction.

In the OIT group, 19% of participants experienced the same result.

OIT is a treatment in which allergenic food is gradually introduced to patients to desensitize the immune system.

Stage 2 of the study included 117 patients with a median age of 7 who moved on from Stage 1, which backed last year’s FDA nod for Xolair. 

All the patients in Stage 2 received open-label Xolair for eight weeks and then were randomized to receive OIT or placebo for eight weeks, along with Xolair treatment during this stage.

After that, the OIT group received placebo injections for 44 more weeks, while the other group continued with Xolair and placebo. The patients then were then tested with allergenic foods. 

There was a 30% rate of serious adverse events (AEs) in the OIT group and none in the Xolair arm. Because of the AEs, there was a 22% discontinuation rate in the OIT group. Additionally, AEs that needed to be treated with epinephrine were more common the in OIT group (37%) than in the Xolair arm (7%).

“These findings equip healthcare providers with valuable data on omalizumab and oral immunotherapy, enabling them to continue to address the diverse needs and treatment goals of their food allergy patients,” R. Sharon Chinthrajah, M.D., the OUtMATCH co-lead study investigator and professor of medicine at Stanford, said in a release.

The data were presented Sunday in San Diego at the American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting.

The companies also presented preliminary results from Stage 3 of the OUtMATCH study, which showed that patients who discontinued use of Xolair were able to introduce allergenic foods, though many had to eventually return to avoiding the foods because of adverse events.

Xolair, which was developed by Roche subsidiary Genentech, was originally approved to treat asthma in 2003. It was endorsed in February of last year for those age 1 and older with IgE-mediated food allergies, a classification that includes 160 foods, the most common of which are peanuts, milk, eggs, wheat, soy and tree nuts.

Xolair is not designed to allow patients to freely eat these foods. It just helps them avoid severe reactions, including anaphylaxis, a life-threatening condition that can happen immediately as the immune system releases chemicals that can cause the body to go into shock.

There are 3.4 million children in U.S. who have food allergies and more than 40% of them have had at least one severe reaction, according to Genentech. Food reactions cause approximately 30,000 emergency room visits each year in the U.S.