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One of the most common food allergies worldwide is peanut allergy, a potentially chronic and life-long condition in which the immune system identifies even small amounts of peanut as harmful.1 In the U.S. alone, approximately 1.3 million children between the ages of 4 through 17 years have a peanut allergy.2 Physical symptoms of allergic reactions after peanut exposure can develop within seconds. They can range from hives and digestive discomfort to potentially life-threatening anaphylaxis in which the throat and airways constrict.3 Even with appropriate and prompt treatment, severe reactions can be potentially life-threatening.
No cure is available, so children and their families must strictly avoid peanuts in order to prevent severe reactions. Yet, even with careful avoidance, inadvertent exposures to peanut can occur. In the U.S., one in five peanut-allergic patients visits an emergency room (ER) due to accidental exposure each year.4
In January 2020, the peanut allergy community received welcome news when the U.S. Food and Drug Administration approved the first ever treatment for this condition — PALFORZIA® [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. Approved for children ages 4 to 17, PALFORZIA helps reduce the risk of allergic reactions when used in conjunction with peanut avoidance. This means the medical community can offer peanut-allergic children an approved treatment option beyond avoidance alone. For allergists and parents of children with peanut allergy considering whether the treatment might be an option for them, safety is top of mind.
Now, a new analysis of long-term safety data recently published in the Journal of Allergy and Clinical Immunology provides important insights into the safety profile of PALFORZIA. This information may help facilitate shared decision-making between allergists and families impacted by peanut allergy about whether the treatment could be right for them.
Dr. Thomas B. Casale, an author of the publication, shares key findings from the analysis and discusses how the results can act as an important resource for discussions among allergists and families impacted by peanut allergy. Dr. Casale has extensive experience with peanut allergy management. He is professor of medicine and pediatrics and chief of clinical and translational research in the Division of Allergy and Immunology at the University of South Florida in Tampa. He also serves as the chief medical advisor for FARE (Food Allergy Research and Education) and is the former president of the American Academy of Allergy, Asthma & Immunology (AAAAI).
Q: Can you tell us more about PALFORZIA?
A: PALFORZIA was approved as an oral immunotherapy (OIT) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut for patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. PALFORZIA is used with a structured dosing approach that builds on a century of OIT research. With OIT, the specific allergenic proteins are ingested initially in very small quantities. This is followed by incrementally increasing amounts, resulting in the ability to mitigate allergic reactions to the allergen over time.
PALFORZIA is not indicated for the emergency treatment of allergic reactions, including anaphylaxis, and must always be used in conjunction with a peanut-avoidant diet. PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. For more information, both allergists and families can visit palforziarems.com.
Q: How does PALFORZIA work?
A: PALFORZIA works by helping a child gradually decrease their sensitivity to peanuts over time through OIT. The first part of the process, “Initial Dose Escalation,” takes place in the office and lasts about four hours. The child is given small doses of peanut protein from 0.5 mg to 6 mg. If they can tolerate at least 3 mg, they can move to “Up-Dosing,” which takes about six months, and during which consistent, precise amounts of peanut protein are given every day. After completing the Up-Dosing phase, the child starts taking a “Maintenance” dose every day. The Maintenance phase continues over time to help the child maintain their decreased sensitivity to peanut.
Q: How has PALFORZIA changed the way you treat patients with peanut allergy?
A: Children with peanut allergy have to live with the burden of this condition every day. It restricts their ability, for example, to eat at a restaurant or a friend’s birthday party and even causes some kids to be ostracized and bullied by schoolmates. In fact, a recent study found 31% of children experience bullying related to their food allergies in school.5 For someone with a peanut allergy, the number one management strategy is peanut avoidance, but it’s not always feasible because peanuts are difficult to avoid. Aside from where peanuts are obviously visible, they are often found in baked goods and candy and are the basis of many African, Asian, and Mexican dishes.6 Even foods that do not contain peanuts could be contaminated by peanuts during manufacturing7 or food preparation, putting patients at risk of exposure. Because peanuts are so ubiquitous, a family’s daily life can be dominated by the fear of accidental exposure.
OIT has been offered by allergists in the past and is often referred to as “homebrew OIT.” But it can be risky, because it requires the office staff to measure precise portions and prepare it for the child. As consistency is often an issue, many families and allergists have been hesitant to move forward with this type of OIT.
With PALFORZIA, we now have a rigorously developed, pharmaceutical-grade OIT for peanut allergy, with a well-defined allergen profile to ensure that every dose has been prepared and analyzed for consistency. With safety top of mind for my patients and their families, this new analysis of PALFORZIA — the largest safety data analysis of a single OIT formulation for peanut allergy — provides a great tool for shared decision-making that I encourage allergists to consider when speaking to their patients about PALFORZIA.
Q: What are some key considerations for parents/caregivers when deciding whether PALFORZIA is right for their child?
A: Shared decision-making with patients and families is critically important. The patient and family must be fully vested in PALFORZIA because it requires a mutual commitment to all three phases — Initial Dose Escalation, Up-Dosing, and Maintenance. The family is especially important in supporting and empowering the child to get through the Up-Dosing phase and stay on Maintenance therapy.
As I mentioned, ensuring the safety of the child during the Up-Dosing phase is critical and a big part of the decision whether to move forward with treatment. I assure my patients that, because PALFORZIA up-dosing is administered in the controlled environment of an allergist’s office, where an allergic reaction can be addressed right away, this is very different from experiencing an allergic reaction resulting from an accidental exposure to peanut in an uncontrolled environment.
As the analysis in JACI showed, it is crucial for allergists to contextualize the risk of anaphylactic reactions with PALFORZIA versus an accidental exposure and to consider the risk/benefit of the treatment as perceived by the patient and family. Systemic allergic reactions after accidental exposure are inherently unpredictable and may occur at a time and place where patients and their families are unable to manage the reaction effectively. In comparison, the analysis showed that systemic allergic reactions considered related to PALFORZIA typically occurred near the time of dosing, when the individual and their family are more likely to be prepared and can exert greater control in managing allergic reactions.
Q: What else can you tell us about the recent safety data that were published in JACI and explain why they are important for allergists treating patients with peanut allergy?
A: The JACI findings can be a useful resource for allergists when having discussions with patients and their caregivers about whether treatment with PALFORZIA is right for them, especially if parents are concerned about safety. The JACI publication included clinical data from a pooled analysis of three controlled Phase 3 and two open-label extension trials of PALFORZIA. The published data showed increased desensitization to peanut with continued PALFORZIA treatment and a consistent and manageable safety profile over time. The most frequently reported adverse events were primarily respiratory or gastrointestinal in nature. Most adverse events were mild to moderate and resolved rapidly, and most reactions occurred during Up-Dosing and were less frequent and less severe once patients were on Maintenance therapy.
I would advise allergists to clearly spell out the benefits and risks of this treatment and refer to the JACI data as a resource when discussing the long-term safety of PALFORZIA.
Q: Why is PALFORZIA an important treatment option for the peanut allergy community?
A: With PALFORZIA, children ages 4 to 17 with a peanut allergy have a clinically validated treatment option that can help reduce the risk of severe allergic reactions when used in conjunction with peanut avoidance. For allergists, the approval has made it much more straightforward to offer OIT for their patients with peanut allergy. For the food allergy community, PALFORZIA is a good model for showing there is a path forward for regulatory approval of therapies and immunotherapies for food allergies other than peanut. I hope it opens the door for the approval of other food allergy treatments that could benefit children and adults.
For more information, visit www.PALFORZIApro.com or www.PALFORZIA.com.
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IMPORTANT SAFETY INFORMATION
PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.
- You will receive your first dose in a healthcare setting under the observation of trained healthcare staff.
- You will receive the first dose of all dose increases in a healthcare setting.
- In the healthcare setting, you will be observed for at least 1 hour for signs and symptoms of a severe allergic reaction.
- If you have a severe reaction during treatment, you will need to receive an injection of epinephrine immediately and get emergency medical help right away.
- You will return to the healthcare setting for any trouble tolerating your home doses.
Stop taking PALFORZIA and get emergency medical treatment right away if you have any of the following symptoms after taking PALFORZIA: trouble breathing or wheezing, chest discomfort or tightness, throat tightness, trouble swallowing or speaking, swelling of your face, lips, eyes, or tongue, dizziness or fainting, severe stomach cramps or pain, vomiting, or diarrhea, hives (itchy, raised bumps on skin), or severe flushing of the skin. Because of the risk of severe allergic reactions, PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. Talk to your healthcare provider for more information about the PALFORZIA REMS program and how to enroll.
You should NOT take PALFORZIA if you have uncontrolled asthma, or if you ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.
Tell your doctor if you are not feeling well prior to starting treatment with PALFORZIA. Your doctor may decide to delay treatment until you are feeling better. Also tell your doctor about any medical conditions you have and if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements.
Your doctor may decide that PALFORZIA is not the best treatment if:
- You are unwilling or unable to receive (or self-administer) injectable epinephrine. You have a condition or are taking a medication that reduces the ability to survive a severe allergic reaction.
What are the possible side effects of PALFORZIA?
The most commonly reported side effects of PALFORZIA were: stomach pain, vomiting, feeling sick, itching or burning in the mouth, throat irritation, cough, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itchy skin, hives, and/or itchy ears.
PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.
PALFORZIA can cause stomach or gut symptoms including inflammation of the esophagus (called eosinophilic esophagitis). Symptoms of eosinophilic esophagitis can include:
- Trouble swallowing
- Food stuck in throat
- Burning in chest, mouth, or throat
- Vomiting
- Regurgitation of undigested food
- Feeling sick
For additional information on the possible side effects of PALFORZIA, talk with your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information and Medication Guide, including an Important Warning about anaphylaxis.
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1 Gupta RS, Warren CM, Smith BM, et al. The public health impact of parent-reported childhood food allergies in the United States. Pediatrics. 2018;142(6):e20181235.
2 Mahr, T., Lieberman, J.A., Haselkorn, T., et al. Characteristics of Peanut Allergy Diagnosis in a US Health Care Claims Database (2011-2017). J Allergy Clin Immunol Pract. 2021 9(4),1683-1694.e5. https://doi.org/10.1016/j.jaip.2020.12.020
3American College of Allergy, Asthma & Immunology. https://acaai.org/allergies/types/food-allergies/types-food-allergy/peanut-allergy. Accessed December 20, 2019.
4Gupta RS, Warren CM, Smith BM, et al. The public health impact of parent-reported childhood food allergies in the United States. Pediatrics. 2018;142(6):e20181235.
5Merrill KA, et al. Ann Allergy Asthma Immunol. 2022; 2022; doi:10.1016/j.janai.2022.02.022.
6FARE. Your Food Allergy Field Guide. https://www.arts-cs.org/_theme/files/Student%20Life/Food-Alergy-Field-Guide.pdf. Accessed April 13, 2022.
7https://www.stanfordchildrens.org/en/topic/default?id=peanut-allergy-diet-85-P00028. Accessed April 13, 2022.
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