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VIPES extension shows continued peanut tolerance in children
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ATLANTA — A two-year extension of the VIPES trial involving Viaskin Peanut showed that more than 80% of children using the skin patch could tolerate more peanut protein, according to findings presented at the annual meeting of the American Academy of Allergy, Asthma and Immunology.
The two-year continuance study involved 171 patients from year one of the VIPES trial who were divided into a children group and an adolescents/adults group, Hugh Sampson, MD, FAAAAI, department of pediatrics at the Icahn School of Medicine at Mount Sinai, said at a press conference. All extension trial participants received a 250 μg dose of Viaskin Peanut because that dose was deemed the most effective from year one data.
“The median cumulative reactive dose a patient could handle went from 440 milligrams of peanut at the end of that first year, up to 1,440 milligrams at the end of the second year of the extension trial,” Sampson said. “Of this group, 60% had a cumulative reactive dose of 1,000 mg or greater, and 40% had a cumulative reactive dose of 5,000 mg or greater.”
He also stated that the response rate, a ten-fold increase in the baseline eliciting dose, was 83% at the end of the extension trial in the children who received the high dose for the full course of the study.
According to Sampson, the overall study had an “amazing” compliance rate of more than 95%, and that there were neither serious adverse events reported nor use of epinephrine related to treatment in either study.
“The patch is essentially a small compensation chamber that is placed on the skin that has peanut protein on the outer surface. Because of the humidity generated in that hatch area, you get penetration of peanut protein into the epidermal layer,” he said. “Patients put [the patch] on at night or in the morning, it’s taken off 24 hours later and another patch is put on. In children, it’s applied in a rotation in the upper part of the back.”
Over time, the patch lets patients gradually develop a tolerance to peanuts. A phase 3 trial involving the device with approximately 350 participants with a 1-year endpoint and a focus on younger patients is fully enrolled, Sampson said.
The FDA granted Viaskin Peanut breakthrough designation status in April 2015. – by Janel Miller
Reference:
Sampson, HA et al. Abstract L7. Presented at: American Academy of Allergy, Asthma and Immunology Annual Meeting; March 3-6, 2017; Atlanta.
https://www.dbv-technologies.com/en/viaskin-products/viaskin-peanut (accessed 03-05-17)
Disclosure: Sampson works for DBV Technologies. Healio Family Medicine was unable to confirm Sampson’s other disclosures prior to publication. Please see the American Academy of Allergy, Asthma and Immunology Annual Meeting for a list of the other author’s disclosures.