A new consensus document provides recommendations for preparing and counseling patients before beginning oral immunotherapy (OIT) to treat food allergies. The recommendations aim to increase the treatment's safety and decrease the potential for allergic reactions.
The document emphasizes the control of comorbidities like asthma, the management of social and behavioral factors such as parental disagreement, and the benefits of OIT. The authors also present evidence-based guidance on contraindications, risk mitigation, and discontinuation of OIT. Finally, they stress the importance of informed consent.
"We are relying on the families [of patients] to have these very, very high levels of responsibility at home" in administering OIT, lead author Douglas P. Mack, MD, a pediatric allergist and assistant clinical professor of pediatrics at McMaster University in Hamilton, Ontario, told Medscape Medical News. "They have no medical training needed to be amateur medical professionals that are managing this procedure."
The consensus statement was published on April 8, 2024, in the Journal of Allergy and Clinical Immunology.
Ranking Contraindications
"Alarmingly, recent surveys have suggested that up to one third of allergists offering OIT do not engage in informed consent," the authors wrote. Indeed, a review of the literature suggested that a sizeable proportion of patients is not being counseled as to how to initiate OIT.
"What was startling was that up to one third of patients were not getting any formal counseling or training," said Mack. "To me, that was shocking. That is what really sparked this."
A 36-member international panel of pediatric allergists, adult allergists, and immunologists developed a consensus document on patient preparation and consent for OIT. They used a Delphi methodology to reach consensus on statements and themes. More than 300 statements were initially proposed from consent forms, processes, and standard operating procedures that are already in use.
Members of the panel ranked contraindications to the initiation of OIT as absolute or relative, with 94.3% reaching consensus on lack of willingness to use epinephrine as an absolute contraindication and 88.9% reaching consensus on uncontrolled asthma being an absolute contraindication to the initiation of OIT. An example of a contraindication that most panelists regarded as relative was language barrier — 82.1% of panelists ranked it as a relative contraindication.
"It is a real strength of this document that we graded the contraindications in a way that has not been performed previously," said Mack. "One of the major contraindications was uncontrolled asthma. We know lots of our patients who have asthma can [follow an OIT regimen]. Uncontrolled asthma was one of our contraindications that almost everybody agreed was absolute."
The panel also reached consensus on OIT alternatives including continued food avoidance (100%). There was also unanimous agreement on the ability to discuss OIT discontinuation any time.
Resource for Families
Commenting on the consensus document for Medscape Medical News, Michael Pistiner, MD, director of food allergy advocacy, education, and prevention at Massachusetts General Hospital for Children in Boston, said that it will support parents and families in informed OIT initiation.
"This is a really helpful and needed resource," said Pistiner. "It not only facilitates clear communication between the medical team and the family, but it also helps with communication by setting clear expectations between the family members, the patient, the parents, and the people who will be caring for the child directly." Pistiner did not participate in drafting the document.
The guidance also "highlights the talking points around risk and potential benefit and clearly outlines what the potential outcomes can be. It then helps remind us of what alternatives to OIT are and what other options are when dealing with the risks of OIT," said Pistiner. "Additionally, it offers various ways to mitigate the risk."
Pistiner described the methodology as sound and noted that panelists covered all the relevant topics that affect the safe initiation of OIT. "They hit upon all the things that I would have wanted to see them hit upon," he said. "I am definitely going to be using the talking points that they have developed. I think that this publication is helpful because it helps a team standardize and streamline those initial conversations that can take up to an hour."
The ranking of contraindications also serves to inform those considering OIT initiation of the possible variables that can increase or decrease the potential for sustained unresponsiveness to an allergen, he said.
"It is nice that the contraindications are clearly called out," said Pistiner. "For someone who is participating in the shared decision-making process, it highlights circumstances that may make OIT less than ideal, more challenging, or unsafe."
As a consultant and advisor for the Asthma and Allergy Foundation of America (AAFA), Pistiner noted that the organization applauds this initiative. "The AAFA is pleased this resource is out there for the families it serves," he said.
The document was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health (NIH) and the National Center for Advancing Translational Sciences of the NIH. Mack has provided consultation and speaker services for DBV Technologies, ALK-Abelló, and Alladapt and is an investigator for DBV and ALK-Abelló. Pistiner has served as a consultant/advisor for AAFA, FARE, kaleo, DBV Technologies, Bryn Pharma, Genentech, Novartis, Aimmune, and Anjo and has received funding from kaleo, the United States Department of Agriculture (USDA)/National Peanut Board, and the USDA/Egg Nutrition Center. He is cofounder of AllergyHome and Allergy Certified Training.