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Omalizumab, oral immunotherapy combination significantly improved milk allergy

SAN DIEGO — Omalizumab plus oral immunotherapy yielded significantly favorable benefits for the treatment of milk allergies compared with placebo, according to data presented at a press conference here.

“I think we felt that it met what we call the ‘eyeball test’ – you don’t need many statistics to see the difference, but they were significantly different,” Hugh A. Sampson, MD, FAAAAI, said during a press conference at the American Academy of Allergy, Asthma & Immunology annual meeting. “With this, we concluded that the use of omalizumab compared with placebo decreased markedly the adverse dosing symptoms, treatment requirements for adverse reactions due to the dosing, including the use of epinephrine; that the time to achieve maintenance was also markedly reduced.”

 

Hugh A. Sampson

Researchers randomly assigned 57 milk-allergic individuals (aged 7 to 32 years) to either blinded omalizumab or placebo for 16 months, according to abstract data.

An open-label milk oral immunotherapy began four months after the initiation of either treatment arm. From weeks 22 to 40, the researchers increased maintenance to 3.84 g of milk protein per day, according to data. Of the 57 included in the study, three patients withdrew due to adverse reactions related to oral immunotherapy dosing.

Significant differences were observed between the omalizumab (n=28) group and placebo (n=29) groups relating to dose-related symptoms per patient during the titration and maintenance period through 16 months (median number of symptoms: 5 vs. 47.5; P=.0001), dosing reactions that required treatment (median: 1 vs. 12; P=.0003), and a need for epinephrine (once in one omalizumab patient vs. 17 times in nine placebo patients), according to data.

They also reported significantly fewer doses required to reach maintenance dosage in patients randomly assigned to omalizumab compared with placebo (median: 198 vs. 224.5; P=.01), which resulted in a shorter escalation period with those assigned to omalizumab (25.9 vs. 30.8 weeks; P=.01), according to data.

“Going forward, we’ll see what effects this has on long-term tolerance. Clearly, it appears in this double blind, placebo controlled trial, there is a marked safety benefit of the combination of omalizumab with oral immunotherapy,” Sampson said. – By Samantha Costa

For more information:

Sampson HA. #L19. Presented at the American Academy of Allergy, Asthma & Immunology annual meeting; Feb. 28-March 4, 2014; San Diego.

Disclosure: Sampson reports financial ties with Dannone, ThermoFisher Scientific, Allertein Therapeutics, LLC, NIAID, NIH, Regeneron, UCB, Novartis, UpToDate and other organizational conflicts of interest.