At the end of the third year, 83.3% of children, who were between ages 6 to 11 years at study entry, showed improvement in the amount of peanut protein they could tolerate compared to 53.6% after the first year of the trial.
Atlanta, GA (PRWEB) March 05, 2017
After the success of the yearlong double-blind, placebo controlled randomized Phase IIb trial for a peanut patch, known as Viaskin® Peanut, researchers continued the trial two more years in an open label extension to ascertain the effect of long-term treatment.
The peanut patch is a form of epicutaneous immunotherapy that allows the patient’s immune system to be exposed to the allergen by applying a patch to their skin. In essence, the patch helps patients slowly build up tolerance to peanuts.
The initial study met its primary efficacy endpoint at 12 months, after which 171 patients were rolled-over into the extended study for 2 more years. They were treated with the 250 μg peanut patch, which was determined to be the most effective dose at the end of the first year of the study. At the end of the third year, 83.3% of children, who were between ages 6 to 11 years at study entry, showed improvement in the amount of peanut protein they could tolerate compared to 53.6% after the first year of the trial. The amount of peanut they could ingest during food challenges increased after three years of treatment.
At study entry, the median cumulative reactive dose a patient could handle was 44 milligrams of peanut protein. Patients who completed all three years of the trial could ingest a median cumulative reactive dose of 1,440 milligrams.
“Long-term treatment with Viaskin® Peanut shows a progressive improvement with time in peanut desensitization thresholds of peanut-allergic children and has been well tolerated,” said Hugh A. Sampson, MD, FAAAAI. “The peanut patch could become an effective treatment for potentially deadly peanut allergy.”
The overall compliance was over 95% and no serious adverse events related to Viaskin® Peanut were reported. The dropout rate of the trial for adverse events was 2.3%.
Viaskin® Peanut is a product of DBV Technologies.
To learn more about the results after the first year of the Phase IIb trial, food allergy or the AAAAI Annual Meeting, visit aaaai.org. Research presented at the AAAAI Annual Meeting is published in an online supplement to The Journal of Allergy and Clinical Immunology.
The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has more than 6,900 members in the United States, Canada and 72 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist.