10 tips to optimize oral immunotherapy for peanut allergy
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A panel of experts has compiled 10 tips to help physicians, patients and their families optimize the use of the oral immunotherapy Palforzia — the first FDA-approved treatment for peanut allergy in children aged 4 to 17 years.
“Introducing novel therapies often requires prescribers to modify practices to maximize treatment effectiveness,” according to S. Shahzad Mustafa, MD, the lead physician of allergy, immunology and rheumatology at Rochester Regional Health in New York.
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Palforzia (Peanut [arachais hypogaea] Allergen Powder-dnfp, Aimmune Therapeutics) — also known as PTAH — is packaged in pull-apart, color-coded capsules of powder that are mixed with a small amount of semisolid food. Because of the risk for anaphylaxis, the peanut powder is only available through the FDA’s Risk Evaluation and Mitigation Strategy (REMS).
Mustafa and colleagues worked with six clinicians from a variety of health care settings who had experience prescribing the immunotherapy to solicit tips regarding its use. Some had been involved in the clinical trials of PTAH.
They received a total of 69 tips. The following 10 were deemed the “most relevant and impactful” to optimize the use of the powder.
Prepare to provide peanut powder
Consider the facilities, staffing requirements, clinical experience, operational processes, space, time and commitment that are needed to administer PTAH and monitor its use, according to Mustafa and colleagues. Kits that contain doses of the powder should also “be stored, refrigerated and administered appropriately.”
“Some offices that do not have the spacing for the dosing visits may not be capable of providing this treatment,” Mustafa told Healio Primary Care. “Or maybe they are just too busy. You have to know if [your practice] is the right setting to do this.”
Assess treatment eligibility
According to Mustafa and colleagues, the powder must only be provided to patients with confirmed peanut allergy.
“Peanut allergy remains over-diagnosed or misdiagnosed in the United States,” Mustafa said. “You want to get the diagnosis right when you are putting someone on indefinite therapy.”
Mustafa and colleagues also wrote that patient-specific factors such as comorbid conditions, concurrent medications, history of severe systemic allergic reactions and psychosocial factors should be considered when ascertaining a patient’s eligibility for the powder.
Utilize shared decision-making
Providers should weigh the possible risks associated with taking PTAH — including stomach pain, vomiting, nausea, itching or burning in the mouth, throat irritation, cough, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itchy skin and/or ears, and hives — alongside the patient’s “expected outcomes,” preferences and values, according to Mustafa and colleagues.
To that end, clinicians should set aside time to answer questions about the treatment before initiating it, the researchers said. Not everyone may be willing to make the time commitment necessary for the treatment, which may indicate to a physician that the treatment is not for that child.
The peanut powder “is not a medication you send to the pharmacy and the patient goes home and takes it,” Mustafa said. “The dosing on the first day consists of a 4-hour visit by the patient, and then every 2 weeks the patient receives another dose that they can take anywhere, from an hour or 2, to administer.”
The powder “is an elective treatment, and every individual with a peanut allergy between 4 to 17 years should have the opportunity to pursue this treatment,” he said in the interview. However, “no treatment works for everyone, and everyone doesn't want the same treatment. That’s why shared decision-making is so important.”
Educate staff, patients and families
Everyone involved in a patient’s care — from medical staff to families — needs to be taught about PTAH, according to Mustafa and colleagues.
For medical staff, this means determining who is the ideal candidate for receiving the peanut powder, understanding the patient’s treatment goals, knowing oral immunotherapy’s pathophysiology, administering and monitoring doses correctly, managing adverse events and securing consent forms from patients and family members, they said. Medical staff should also explain what a patient can do if a dose is missed, if the patient taking the therapy is traveling, and educate them on epinephrine autoinjector use.
“Using a standardized approach, such as checklists, web-based references or video trainings, helps ensure important and essential information is received by all patients,” Mustafa and colleagues wrote.
Create office procedures
Medical staff should work on developing “scheduling practices that are efficient, yet maintain flexibility,” as well as developing a universally followed procedure to receive an insurance provider’s approval for the powder and creating a mechanism for inventory management — such as teaming up with pharmacies authorized to handle drugs in the REMS pathway — according to Mustafa and colleagues.
Staff members should also develop ways to watch and properly handle anaphylactic emergencies and utilize electronic health records to assist in patient tracking, documentation and education.
Manage patient expectations
According to Mustafa and colleagues, the medical staff needs to emphasize that the powder “is not a cure,” and that the risk for anaphylaxis is still possible in those who receive the immunotherapy.
“Continued peanut avoidance, even at the maintenance dose, should be communicated,” Mustafa and colleagues wrote. “Collaborating with other health care providers, such as a dietitian, may assist in managing patient expectations.”
Mustafa also said that patients need to know that the goal of PTAH “is to buffer those with an accidental ingestion from a severe life-threatening reaction.”
Offer guidance on adverse events
Adverse events, such as stomach pain and mouth tingling, are possible with the use of the powder, according to Mustafa and colleagues. “Although most adverse events are mild to moderate in severity, knowledge of potential effects can mitigate treatment-related anxiety.”
Thus, Mustafa and colleagues wrote that staff members should develop ways to manage adverse events to “minimize patient discomfort.” Then, according to Mustafa, “doing everything you can to talk about and learn from side effects.”
Optimize administration, adherence
According to Mustafa and colleagues, establishing “dosing protocols and standard administration methods can assist with PTAH delivery.”
Mustafa and colleagues also wrote that staff members who preemptively talk to patients about disliking the taste of peanuts may improve the patients’ willingness to comply with the treatment regimen. Also, patients should avoid exercise for up to 3 hours after receiving a dose, reducing the risk for adverse reactions that could impact medication adherence.
Remain flexible
“Although the dosage schedule for PTAH has been extensively studied, personalizing treatment to the individual patient is essential,” according to Mustafa and colleagues.
For example, the typical time between updosing visits is 2 weeks, Mustafa said. However, “extending the time between updosing visits, as needed and appropriate,” may increase the tolerability and safety of the peanut powder, Mustafa and colleagues wrote.
Be encouraging, engaging
According to Mustafa and colleagues, staff members must continuously encourage and engage with their patients and family members of patients.
Mustafa and colleagues wrote that staff members should “consider celebrating accomplishments with peanut oral immunotherapy, such as with a graduation ceremony at the completion of updosing, and check in with patients and their families regarding the impact of oral immunotherapy on their lives.”
References:
Mustafa SS, et al. Abstract P112. Presented at: ACAAI Annual Scientific Meeting; Nov. 4-8, 2021; New Orleans (hybrid meeting).
Palforzia [package insert]. Brisbane, CA: Aimmune Therapeutics; 2020.
Perspective
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Edwin H. Kim, MD, MS
Given the complexity of deciding who is eligible for, and would most benefit from, oral immunotherapy for peanut allergy, Mustafa and colleagues have provided a more practical way of interpreting the REMS that the FDA implemented and required as a condition of its approval of Palforzia.
More specifically, Mustafa and colleagues provide, in easy-to-follow terminology, how to find the right patients, preparing these patients and their families and then keeping them on the therapy. On that last point, steps nine and 10 seem particularly important, given how the potential for therapy fatigue must be considered against the risk for significant allergic reactions returning if treatment is not maintained.
Division chief, University of North Carolina School of Medicine Pediatric Allergy & Immunology
Director, University of North Carolina School of Medicine Allergy and Immunology Fellowship Program
Director, University of North Carolina School of Medicine Food Allergy Initiative
Perspective
Back to TopPayal Patel, MD
Although the current management of food allergies remains strict avoidance, we now have an option to mitigate allergic reactions from accidental exposure to peanut. With the FDA approval of the first peanut oral immunotherapy drug, allergists now have an opportunity to offer a treatment to their patients that alleviates anxiety from the risk for anaphylaxis due to an unpredictable peanut ingestion.
Given that Palforzia is the first oral immunotherapy on the market, many allergists will be embarking into this world for the first time. Having guidance from those with extensive experience is beneficial in not only the practical aspects of implementation, but also in anticipation of unforeseen challenges.
The 10 tips shared by Mustafa and colleagues provide a comprehensive overview of considerations prior to initiating Palforzia therapy. The key takeaways are to prepare the facility and staff in providing oral immunotherapy therapy, engage in shared decision-making with the patient after having in-depth education on risks, benefits and practical expectations of this therapy, and adapting treatment approaches with each patient given the nuances of reactions.
Having this guide as a starting point for those engaging in oral immunotherapy for the first time will help successful implementation.
Medical director, Rush University Medical Center South Loop
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