Laird Harrison

March 10, 2014

SAN DIEGO — Omalizumab can speed the effects of oral immunotherapy and reduce the adverse effects, a new study shows.

"We'll see what effect this has on long-term tolerance, but it appears, in this double-blind placebo-controlled trial, to show marked benefit," said study investigator Hugh Sampson, MD, professor of pediatrics, allergy, and immunology at Mount Sinai Hospital in New York City.

Dr. Sampson presented the results during a news conference here at the American Academy of Allergy, Asthma & Immunology 2014.

"Most patients who go through oral immunotherapy experience some adverse effects of treatment," said Dr. Sampson. And 5% to 10% of these adverse events are significant, with many patients requiring epinephrine therapy, he explained.

Omalizumab is an immunomodulator currently used to treat severe allergic asthma in people 12 years and older. It works by tying up free immunoglobulin (Ig)E in the blood, which allows patients to be exposed to larger doses of an allergen without reacting, Dr. Sampson explained.

To assess whether omalizumab is of benefit to patients undergoing immunotherapy, Dr. Sampson's team recruited 57 patients 7 to 35 years of age. Allergy to milk was confirmed in all patients with skin tests and milk-specific IgE levels.

The researchers evaluated 26 patients randomly assigned to omalizumab and 28 patients randomly assigned to placebo. The groups were well matched on skin tests, IgE levels, and a number of other allergies.

Investigators started milk immunotherapy after patients had been on the study drug for 4 months. They increased doses to maintenance levels over a period of 22 to 44 weeks.

During the 16-month study period, there was 1 administration of epinephrine in the omalizumab group and 17 administrations in 9 people in the placebo group.

There were fewer adverse events, such as hives, pruritus, runny noses, nausea, and vomiting, in the omalizumab group than in the placebo group, and fewer doses were needed to reach the maintenance dose, resulting in a shorter escalation phase.

Table. Outcomes in the 2 Groups

Median Outcome Omalizumab Group Placebo Group P Value
Dose-related symptoms per subject 5.0 47.5 .0001
Dosing reactions requiring treatment 1.0 12.0 .0003
Weeks in the escalation phase 25.9 30.8 .0100

 

The research to date suggests that patients don't have to continue taking omalizumab indefinitely once their oral immunotherapy is completed, Dr. Sampson reported. "There did not appear to be any rebound effect."

Dr. Sampson said he is optimistic about the approach in general. "If you ask me, it's worth starting people on anti-IgE to reduce the dosing effect. I think the evidence is pretty strong that it does make a difference."

But he added that not all patients need omalizumab or other anti-IgE drugs to successfully complete oral immunotherapy. Although some patients have difficulty attaining maintenance doses, others do so fairly easily.

The researchers are looking for biomarkers such as IgE or basophil level that might identify which patients could benefit most from anti-IgE therapy.

Omalizumab might not work for all patients struggling with immunotherapy, said Wesley Burks, MD, physician in chief at North Carolina Children's Hospital in Chapel Hill.

His team has found that patients taking omalizumab while undergoing oral immunotherapy for peanut allergy had just as many abdominal symptoms as patients who did not take the drug.

Dr. Sampson said he agrees that the therapy might work differently for different food allergens.

This study was funded by the National Institute for Allergy and Infectious Diseases. Dr. Sampson reports relationships with Dannone, ThermoFisher Scientific, Allertein Therapeutics, Regeneron, Novartis, and UpToDate, among others. Dr. Burks has disclosed no relevant financial relationships.

American Academy of Allergy, Asthma & Immunology (AAAAI) 2014: Abstract L19. Presented March 2, 2014.

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