Biologic oral immunotherapy for peanut allergy could impact incidence of severe reactions
The FDA’s Allergenic Products Advisory Committee recently voted in support of AR101, an investigational biologic oral immunotherapy for peanut allergy in children and teenagers, bringing it one step closer to approval.
Peanut allergy affects more than 1.7 million children in the United States, according to Stephen Tilles, MD, senior director of medical affairs at Aimmune Therapeutics, AR101’s manufacturer.
“Peanut allergens are often hidden and can be difficult to spot,” he said in an interview. “As a result, reactions can be sudden and unpredictable, and their severity can vary each time.”
Tilles explained that avoiding peanuts completely is a challenging strategy in the real world.
“Accidental exposures are inevitable, and one accident can potentially be fatal,” he said.
Gradually increasing doses of AR101 can desensitize patients to peanut over a period of about 6 months or longer, according to Aimmune. Then, the patient continues to take a daily therapeutic dose to maintain desensitization.
According to the company, the therapy is designed to reduce the incidence and severity of allergic reactions, including anaphylaxis, after accidental exposure to peanut in patients aged 4 through 17 years who have a confirmed diagnosis of peanut allergy.
However, the therapy poses some safety concerns, cautioned Matthew Greenhawt, MD, director of the Food Challenge and Research Unit at Children’s Hospital Colorado.
“Nearly every AR101 trial participant had an adverse event directly related to treatment at some point. Specifically, 14% of patients had systemic allergic reactions and 15% had to use epinephrine. One in five study participants dropped out of their respective study for various reasons,” he told Healio Primary Care.
In addition, Greenhawt noted that a recent meta-analysis published in The Lancet showed that the risk for anaphylaxis was approximately fivefold higher with AR101.
“However, oral immunotherapy is a very important treatment modality that patients may want to consider, and there is good evidence that the majority that go into an oral immunotherapy protocol achieve desensitization,” he said. “The issue is risk vs. benefit, lifestyle/convenience, and what a family or patient will trade off in consideration of other options.”
Tilles explained that although primary care physicians and pediatricians are the first point of care for patients with food allergies, “it will be important for them to work with an experienced allergist to determine if AR101 is an appropriate treatment strategy.”
Aimmune intends to create programs that facilitate pediatrician and PCP referrals regarding AR101 to allergists and provide allergists with resources, according to Tilles.
Brian Vickery, MD, founding director of the Food Allergy Center at Children’s Healthcare of Atlanta, said patients who cannot take AR101 should not give up hope.
“While AR101 is a step forward for some patients with peanut allergy, it is not a perfect for everyone with the condition,” Vickery, who is a former employee of Aimmune and a scientific advisory board member for that company, as well as medical director for the Palisade trial that examined peanut oral immunotherapy, told Healio Primary Care.
“PCPs and allergists whose patients do not benefit from this treatment need to be reassured that AR101 helped open the floodgates on food allergy research and that there is a whole pipeline of products behind it,” he said in an interview.
The full FDA’s decision on AR101 is expected by the end of January, according to an Aimmune spokesperson. – by Janel Miller
Disclosures: Greenhawt reports numerous ties to the industry. Tilles is an employee of Aimmune Therapeutics. Vickery reports serving as a scientific advisory board member and clinical investigator for Aimmune; being a clinical investigator for DBV; and chief medical advisor for patient experience for Food Allergy Research and Education.