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April 18, 2019
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 4 to 11 years old who enrolled in the Peanut 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.”
About Arkansas Children’s
Arkansas Children's, Inc. is the only healthcare system in the state solely dedicated to caring for Arkansas' 710,000 children, giving the organization a unique ability to shape the landscape of pediatric care in Arkansas and transform the health of children throughout the region. The private, non-profit organization includes two pediatric hospitals, a pediatric research institute and USDA nutrition center, a philanthropic foundation, a nursery alliance, statewide clinics, and many education and outreach programs.
Arkansas Children’s Hospital (ACH) is a 336-bed, Magnet-recognized facility in Little Rock operating the state’s only Level I pediatric trauma center; the state's only burn center; the state's only Level IV neonatal intensive care unit; the state's only pediatric intensive care unit; the state’s only pediatric surgery program with Level 1 verification from the American College of Surgeons; and the state's only nationally recognized pediatric transport program. Additionally, ACH is nationally ranked by U.S. News & World Report in five pediatric subspecialties (2019-2020): Cardiology & Heart Surgery, Nephrology, Neurology & Neurosurgery, Orthopedics and Pulmonology. Arkansas Children’s Northwest (ACNW), the first and only pediatric hospital in the Northwest Arkansas region, opened in Springdale in early 2018. ACNW operates a 24-bed inpatient unit; a surgical unit with five operating rooms; outpatient clinics offering over 20 subspecialties; diagnostic services; imaging capabilities; occupational therapy services; and Northwest Arkansas' only pediatric emergency department, equipped with 30 exam rooms. Generous philanthropic and volunteer engagement has sustained Arkansas Children's since it began as an orphanage in 1912, and today ensures the system can fundamentally transform the health of children in Arkansas and beyond. To learn more, visit archildrens.org.
About Arkansas Children’s Research Institute
ACRI is a free-standing state-of-the-art pediatric research center which provides a research environment on the ACH campus to foster research and scholarship of faculty members of University of Arkansas for Medical Sciences who are investigating questions relative to development, disease and treatment as it relates to the health of infants, children and adolescents. Physician and biomedical scientist investigators at ACRI and the Arkansas Children's Nutrition Center (ACNC) conduct clinical, basic science, and health services research for the purpose of treating illnesses and preventing disease and thereby, improving the health of the children of Arkansas and beyond.
UAMS is the state’s only health sciences university, with colleges of Medicine, Nursing, Pharmacy, Health Professions and Public Health; a graduate school; hospital; a main campus in Little Rock; a Northwest Arkansas regional campus in Fayetteville; a statewide network of regional campuses; and seven institutes: the Winthrop P. Rockefeller Cancer Institute, Jackson T. Stephens Spine & Neurosciences Institute, Harvey & Bernice Jones Eye Institute, Psychiatric Research Institute, Donald W. Reynolds Institute on Aging, Translational Research Institute and Institute for Digital Health & Innovation. UAMS includes UAMS Health, a statewide health system that encompasses all of UAMS’ clinical enterprise including its hospital, regional clinics and clinics it operates or staffs in cooperation with other providers. UAMS is the only adult Level 1 trauma center in the state. U.S. News & World Report named UAMS Medical Center the state’s Best Hospital; ranked its ear, nose and throat program among the top 50 nationwide; and named six areas as high performing — cancer, colon cancer surgery, heart failure, hip replacement, knee replacement and lung cancer surgery. UAMS has 2,727 students, 870 medical residents and five dental residents. It is the state’s largest public employer with more than 10,000 employees, including 1,200 physicians who provide care to patients at UAMS, its regional campuses, Arkansas Children’s Hospital, the VA Medical Center and Baptist Health. Visit www.uams.edu or www.uamshealth.com. Find us on Facebook, Twitter, YouTube or Instagram.