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November 18, 2018
LITTLE ROCK, AR. (Nov. 18, 2018) – A groundbreaking clinical research trial conducted at Arkansas Children’s Research Institute (ACRI) and 65 other sites has produced what could become the first oral immune therapy to treat peanut allergy, and is featured today in the New England Journal of Medicine (NEJM).
The work occurred in the Pediatric Clinical Research Unit at ACRI, under the leadership of Stacie Jones, MD, chief of Allergy & Immunology at ACH and a professor of Pediatrics in the University of Arkansas for Medical Sciences (UAMS) College of Medicine. Jones, who also holds the Dr. and Mrs. Leeman King Chair in Pediatric Allergy, is included as an author of the NEJM manuscript.
The study is the largest oral immunotherapy trial ever conducted, with nearly 500 participants between the ages of 4 and 17. Children were enrolled in the Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization (PALISADE) study at 66 sites across 10 countries if they reacted to a food challenge of approximately one third of a peanut.
Participants took gradually increasing amounts of either peanut powder or a placebo over six months. The study participants and their doctors didn’t know which they received until the blinded study period ended.
The manuscript in NEJM shows that 67 percent of the children who received the study treatment tolerated the equivalent of about two peanuts by the study’s conclusion. That’s compared to just 4 percent of the participants who received the placebo.
“This provides hope to families that there is going to be a treatment in the future for their children with peanut allergy,” Jones said. “For the first time, they have reassurance and encouragement that a peanut allergy may one day be treatable.”
Currently, the millions of children across the globe who have peanut allergy have no approved treatment options, and rely on diet restriction and rescue injections when they encounter life-threatening reactions.
“For the first time, we’re seeing potential that it doesn’t have to be that way,” Jones said.
She had a warning for families, though.
“It’s very important that this study happened in food allergy centers that had experience with food allergic patients and anaphylaxis to keep those patients safe,” Jones said. “This is not something that can be replicated safely outside that environment.”
Indeed, 12 percent of the children who participated in the study dropped out because they experienced reactions or other problems. Overall, 20 percent of those initially enrolled quit the study.
The research culminates years of extensive research on peanut allergy among children in Arkansas with global impact. The first peanut oral immunotherapy studies in the nation, published in 2009, were performed at Arkansas Children’s Research Institute and Duke University Medical Center.
Since the original concept studies and the more recent publications, Aimmune Therapeutics, based in California, has indicated they will seek U.S. Food & Drug Administration approval for the treatment.
About Arkansas Children’s
Arkansas Children’s, Inc. is the only health care system in the state solely dedicated to caring for children, which allows the organization to uniquely shape the landscape of pediatric care in Arkansas. The system includes a 336-bed hospital in Little Rock with the state’s only pediatric Level 1 Trauma Center, burn center, Level 4 neonatal intensive care and pediatric intensive care, and research institute as well as a nationally-recognized transport service. It is one of the 25 largest children’s hospitals in the United States and is nationally ranked by U.S. News World & Report in cardiology/heart surgery, neurology/neurosurgery, nephrology and pulmonology. Arkansas Children’s Northwest in Springdale includes 233,613 square feet of inpatient beds, emergency care, clinic rooms and diagnostic services. Arkansas Children’s also blankets the state with outreach programs that include telemedicine, mobile health and school-based health solutions. A private nonprofit, Arkansas Children’s boasts an internationally renowned reputation for medical breakthroughs and intensive treatments, unique surgical procedures and forward-thinking research and is committed to providing every child with access to the best care available, regardless of location or resources. Founded as an orphanage, Arkansas Children’s has championed children by making them better today and healthier tomorrow for more than 100 years. For more info, visit www.archildrens.org.
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.