Paediatric Sublingual Immunotherapy Trial Safety Update: Presented at AAAAI
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Paediatric Sublingual Immunotherapy Trial Safety Update: Presented at AAAAI

By Carole VanSickle Ellis

NEW ORLEANS -- March 3, 2010 -- In an interim analysis designed to understand the safety, efficacy, and potential mechanisms behind the development of desensitisation and tolerance in peanut-allergic children, sublingual immunotherapy (SLIT) trials appear safe in children allergic to peanuts.

The study was presented here at the 2010 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on February 27.

According to the researchers, the prevalence of peanut allergies is on the rise in the United States, with 1.1% of children having a peanut allergy. It is also the most common source of anaphylaxis in emergency rooms. Therefore, it is important not only to investigate treatment, but also to insure that these investigations can be completed successfully and safely for the children.

For the study, John Andrew Bird, MD, Duke University Medical Center in Durham, North Carolina, and colleagues placed 13 children (median age, 4 years and 10 months) with peanut allergies into 2 groups: a peanut SLIT group (n = 7) or a placebo group (n = 6).

The SLIT group received doses ranging from an initial dose of 0.25 mcg peanut to bi-weekly dosing of 100 mcg peanut by the end of 4 months. Wheal diameters were measured at baseline and 4 months into the testing, and the group also took peanut-specific immunoglobulin (Ig)E, IgG, and IgG4 tests at the initiation and again 4 months in. Titrated skin prick tests were also conducted at both points in time. Families also kept daily symptom diaries.

Sneezing, skin itching, lip swelling, mild urticaria, and nonspecific abdominal pain were the most reported symptoms. Placebo cohorts and SLIT patients reported the same types of symptoms with no significant differences in volume of the reports.

At 4 months there was no significant change from baseline values for the treatment group compared with the placebo group for peanut-specific IgE, IgG, or wheal diameter (P > .99).

Other SLIT studies have focused on dosages, techniques, and methods of administering the protocol. This study focused specifically on safety and symptoms, although efficacy and potential mechanisms were also evaluated.

Although there were no significant immunologic changes, the researchers were not surprised since SLIT dosages were very small and the period of time of testing was fairly short. However, other studies that have been ongoing for longer periods of time have indicated changes in immunology, so this study does not rule out SLIT as a viable treatment option for patients with peanut allergies.

“This is early, preliminary data in a 5-year study with a large number of patients,” said Dr. Bird. “Next year these patients will be up to maintenance dosing and we have a series of food challenges to better evaluate the effectiveness of the process.”

[Presentation title: Double-Blinded Placebo Controlled Sublingual Immunotherapy (SLIT) Trial for Peanut Allergy. Abstract 78]



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