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Oral Immunotherapy (OIT) For the Treatment of Peanut Allergy – A Message from Allergist & Immunologist, Jinlin Du, MD

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A peanut allergy is one of the most common food allergies, affecting approximately 1 million children in the U.S.  Since food allergies have no cure and can only be managed with strict dietary avoidance, oral immunotherapy (OIT) offers a new approach for treating IgE-mediated food allergies including peanut allergies. This form of treatment has become increasingly popular in recent years.  As of January 31, 2020, the Food and Drug Administration (FDA) approved its first drug ever, Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigate allergic reactions to peanut.  It is likely that this may be the beginning of a new era of food allergy treatment landscape. 

What is oral immunotherapy (OIT)?

  • Oral immunotherapy (OIT) refers to feeding an allergic individual an increasing amount of an allergen, such as peanuts, gradually with the goal of increasing the threshold that triggers a reaction.
  • OIT is not a curative therapy.  The goal of OIT is to mitigate the accidental ingestion of the allergen. 
  • Patients that receive OIT need to continue allergen (peanut) avoidance and carry the EpiPen in case of emergencies.

What is the current standard care for treatment of food allergy?

  • Food allergen avoidance
  • Carry the auto-injectable EpiPen (epinephrine) at all times

What is the difference between oral food challenge (OFC) vs oral immunotherapy (OIT)?

  • Oral food challenge (OFC) refers to ingesting a food that a person either has an inconclusive allergy diagnosis or to rule out if there is an allergy, by gradually increasing amounts under  medical supervision to accurately diagnose or rule out a true food allergy.
  • OFC is more of a test when food allergy is in question.  Once confirmed, a patient may be able to either eat or has to avoid the food in question. 

What are the indications for peanut OIT?

  • Patients who have a confirmed diagnosis of peanut allergy and are between 4-7 years old are candidates for OIT.

When should peanut OIT not be used? In patients with:

  • Uncontrolled asthma
  • History of eosinophilic esophagitis or other eosinophilic gastrointestinal disease

Who can prescribe peanut OIT (Palforzia)?

  • Palforzia can only be prescribed by certified healthcare providers who are enrolled in the FDA required Risk Evaluation and Mitigation Strategy (REMS) program, complete with training staff who can monitor, identify and manage anaphylaxis.

What is Palforzia Risk Evaluation and Mitigation Strategy (REMS) program?                           

  • Due to the risk of anaphylaxis, Palforzia is only available through this advisory registry program.
  • It requires:
    1.  Patient must be enrolled in the program;
    2. patient, parent or guardian must be educated on the need for monitoring with Initial Dose Escalation and first dose of each Up-Dosing level and how to recognize the signs and symptoms of anaphylaxis;
    3. patient must continue dietary peanut avoidance;
    4. patient must carry the EpiPen at all times.

Is Crystal Run’s Allergy Department REMS certified?

  • Yes. We are currently providing this service at our 95 Crystal Run Road location in Middletown  only.

How often is a peanut dosage  escalated (up-dosed)?

  • Treatment with Palforzia consists of three phase: Initial Dose Escalation, Up-Dosing, and Maintenance.  The initial Dose Escalation is completed on a single day. The Up-Dosing phase consists of 11 increasing dose levels and occurs over 5 months.
  • Upon completion of the Up-Dosing phase, it is required to be on daily maintenance (unless decide otherwise).

How effective is OIT?

  • More than 2/3 of patients,67.2% tolerated a 600mg dose (up to 2 peanuts)  6 months into a 300mg daily maintenance dose of Palforzia vs 4.0% of placebo recipients.

What are the common side effects of OIT?

  • The most commonly reported side effects of Palforzia include but are not limited to abdominal pain, vomiting, nausea, tingling in the mouth, mouth and eye itching, cough, throat irritation, hives, wheezing, shortness of breath and anaphylaxis.

What you should know, before considering OIT?

  • Palforzia is a long-term commitment of daily medications.  Peanut OIT can occur over several months to years and possibly indefinitely.
  • It is extremely time consuming, in particular during the Initial Dose Escalation and Up-Dosing phases.  Bi-weekly office visits with safety and tolerability assessments are required.
  • There is other interference or restrictions on daily life due to safety precautions when dosing at home.

What other OIT has been approved for the treatment of food allergies?

  • To date, peanut OIT product, Palforzia is the only one available.  Others such as egg, walnut, and milk are still being tested, and are not currently approved by the FDA.

If your child has a peanut allergy, it’s important to discuss the option of OIT with their pediatrician. A pediatrician can determine if the patient may be a good candidate and refer you to an allergist & immunologist for treatment. Visit crystalrunhealthcare.com to learn more about our allergy and immunology department.  

 

Jinlin Du, MD, FAAAAI, FACAAI, is an Allergist and Immunologist. He earned his Medical Degree from Hubei Medical University and completed his Residency in Pediatrics at Marshall University School of Medicine in Huntington, WV. He completed Fellowship-training in Allergy & Immunology at University of Medicine & Dentistry of New Jersey in Newark, NJ. He is Board Certified in both Pediatrics and Allergy & Immunology. Dr. Du sees patients in Middletown and Rock Hill.