The push for a therapy to treat peanut allergy continues as an international clinical trial conducted in part at Arkansas Children’s Research Institute (ACRI) is highlighted in a manuscript in the Journal of the American Medical Association (JAMA). The study features the work of allergy specialists at ACRI and the University of Arkansas for Medical Sciences (UAMS).
Patients at Arkansas Children’s Hospital were among 356 participants in a study conducted at 31 sites in five countries examining the effectiveness of a peanut skin patch patients wore daily for a year. The children ages four to 11 years old who enrolled in thePeanut EPIT Efficacy and Safety trial (PEPITES) either wore a Viaskin peanut patch, which exposed them to 250 micrograms of peanut protein daily, or a placebo.
More patients who were exposed to the peanut patch increased their consumption of peanut protein during food challenges when compared to consumption levels defined at study entry than did those who received the placebo – a treatment difference of 21.7%.
Stacie M. Jones, MD, chief of Allergy & Immunology at ACH and a professor of pediatrics in the UAMS College of Medicine, says the study’s results give parents hope that options are on the horizon, but also act as a stark reminder of the daily threats of living without a proven treatment.
“We see that some children do respond to this therapy, and that gives us hope that we are honing in on a possibility that will change children’s lives,” said Jones, who is included as an author of the JAMA manuscript. “It’s imperative that we continue to study potential solutions like this patch because every opportunity gets us closer to a day when the accidental exposure to a tiny amount of peanut doesn’t have to be a child’s worst nightmare.”
While the researchers found the 21.7% treatment difference to be a statistically significant outcome, the result did not meet the prescribed lower bound of the confidence interval criteria for a positive trial result, as recommended by the U.S. Food and Drug Administration.
“We know that some children saw a change in their protection level through this patch, which is encouraging,” Jones said. “The study also showed that the patch is a safe therapy with minimal side effects, though it isn’t without risks.”
Patients in both the treatment group and placebo group experienced itching, redness, and swelling as common side effects. Serious reactions such as anaphylaxis occurred in 4.2% of the peanut-patch group and 5.1% of the placebo-patch group.
“It’s very important that studies like this happen in food allergy centers with experience keeping those patients safe,” Jones said. “This is not something that can be replicated safely outside that environment as we continue our journey toward an effective therapy for peanut allergy.”