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Last month, the FDA released a Briefing Document (link below) outlining a few limitations in the application of the standard clinical trial model to food allergy treatment such as oral immunotherapy (OIT). For example, the FDA notes that “subjecting severely food-allergic individuals to multiple OFCs [oral food challenges] entails risk to the study subjects and recruitment challenges for study sponsors.” The FDA suggests that alternative models should be considered when evaluating OIT and other treatment options for food allergy.

Additionally, the FDA document notes that “[t]olerance has not been demonstrated in any controlled trial of food AIT [allergen immunotherapy, including OIT] to date.” This should not be conflated with any conclusion about the efficacy of OIT generally. It simply refers to the limitations of clinical trials, which typically require 4 phases of study before FDA approval eligibility, a process that can take 10 years or longer and is achieved only 25% of the time. No food allergy treatment has completed a phase 3 or a phase 4 trial. It’s not surprising, therefore, that clinical trials have not yet demonstrated tolerance. We have not had 10 plus-year studies to truly test that model.

It also should be noted that the FDA “does not approve medical foods” as therapy. As a result, FDA policy likely precludes OIT from ever resulting in FDA approval. Lack of FDA approval does not disqualify OIT as a valid and appropriate treatment, however. Many safe and effective medical treatments lack FDA approval yet still are widely used, including allergy shots.

TPIRC’s unique structure addresses the concerns voiced by the FDA. TPIRC’s OIT program is not a clinical trial. Rather, TPIRC integrates research, patient-specific clinical care, and advocacy. TPIRC doctors have nearly a decade of experience in OIT and have achieved an unmatched 99% success rate. Its nearly 1,000 OIT patients have achieved larger maintenance doses than those following other protocols, including more than 300 peanut graduates safely eating at least 60 peanuts daily. The goal of TPIRC’s protocol is to induce immunological tolerance, where IgE = Zero. In fact, there are hundreds of patients whose IgE based numbers have decreased to 0 for various foods and as a result no longer need to ingest these foods on a regular basis. We are demonstrating that food allergy patients can develop desensitization which can drive toward tolerance in a safe, effective, and user-friendly model.

Stay tuned for upcoming news about our doctors’ innovative approach!

http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/AllergenicProductsAdvisoryCommittee/UCM482114.pdf

 
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After treating nearly 700 food allergy OIT patients, a common theme during initial office visits surrounds not just safety but the “risk of reactions” during OIT. Many parents state their child has not had anaphylaxis for years. Others will say reactions occur regularly. Some parents say their children’s allergy testing done at an outside allergist’s office labels them as “high risk” for reactions. This leaves a lot of uncertainty in the discussion.

My discussion with patients and families focuses on the TPIRC model of OIT. The comprehensive nature of analysis not only involves elaborate allergy testing. It also involves a clear evaluation of all allergic systems of the body.   These systems involve the skin, the blood vessels, the lungs, the heart, the liver, and more. It is most important to evaluate all these systems due to the involvement of these systems during different types of allergic reactions. But while all systems are critical, the lungs are one of the most important.

As a board certified pulmonologist, my bias toward excellent lung function prior to starting OIT is based on evidence. A large Australian study published in 2014 brought to light the risk factors of reactions during allergic food exposure. The study, entitled: Safety and clinical predictors of reacting to extensively heated cow’s milk challenge in cow’s milk-allergic children., sought to define the clinical “risk factors” of children allergic to milk who were about to undergo a baked milk challenge. 71 children with confirmed milk protein allergy were set to undergo a baked milk food challenge. Keep in mind the baked milk challenge is not done all at once. It is done in a graded, staged fashion over hours of time with small incremental dose increases. Of the 71 children tested, most passed (51 total, 73%). Of the 27% who did not pass, 4 children actually needed an epinephrine injection to rescue them.

This Australian group studied these 27% who did not pass by comparing them to those who passed and discovered the top “risk factors” associated with having an allergic reaction during food dosing:

  • Any history of asthma, especially asthma requiring preventer therapy (inhaled steroids, singulair)
  • IgE-mediated clinical reactions to more than 3 food groups (separate groups ie nuts, milk, peanut)
  • A history of cow’s milk reactions consistent with severe anaphylaxis

What is the take away message?

If you are considering OIT and your child has the “risk factors” mentioned above, do everything possible to control the lungs before and during treatment. The TPIRC model not only deploys state of the art lung function testing including complete body plethysmography, forced oscillation testing, exhaled nitric oxide and lung clearance index testing. The TPIRC model of OIT ensures patients undergoing OIT are maintained at a normal to super normal level of lung function.

The questions brought forth by this study need to be studied clearly in OIT patients. TPIRC and its OIT model is actively studying these clinical questions and looks forward to publishing its data in 2016.

 

Inderpal Randhawa, MD

 

Reference:

Ann Allergy Asthma Immunol. 2014 Oct;113(4):425-9. doi: 10.1016/j.anai.2014.06.023. Epub 2014 Jul 22.

 
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