The Patch versus TPIRC OIT Model: The Difference is Clear
 
 

The Patch vs. TPIRC OIT Model: The Difference is Clear

Patch vs TPIRC OIT (2)
Phase IIB VIPES (Viaskin Peanut’s Efficacy and Safety) trial was conducted in 221 peanut allergy patients (6-55 years with 113 children, 73 adolescents and 35 adults).  The goal of the trial was to see if after 12 months of a “patch” placed on the skin daily, the patient would be able to eat more than 1000 mg of peanut protein or 10 times their baseline dose which made them have anaphylaxis.  The patch started at 50 micrograms then increased to 100 micrograms and finally 250 micrograms.  50% of the patients utilizing the highest dose patch reached the “goal” compared to 25% in the placebo group.  6% of patients dropped out.  No major adverse events were reported.  No epinephrine was used during patch treatment.

To the credit of the company, the study was conducted safely.  However, taking a closer look at the numbers, the graph above shows out of 221 patients in treatment, only half actually reached any benefit.  Of the half who reached a benefit, only a total of 28 patients were able to actually tolerate over 1000 mg of peanut protein.  The Phase III study is planned.

The arguments for the patch:

  • It is on the skin and poses little risk
  • It can be used at a young age
  • It has some effect on the immune system’s “view” of peanut protein

The arguments against the patch:

  • One year of treatment is lengthy
  • Only half the patients receive any kind of “safety” benefit.
  • Even the half who receive the safety benefit, many of them cannot eat over 1000 mg of peanut protein (or 4-5 peanuts)
  • What happens when they stop using the patch? Will just eating a certain “amount” of  peanut continue to help with protection?
  • Is there any long term immune system benefit toward tolerance?

While it looks promising, the details provide the real specifics.  Oral immunotherapy (OIT) utilizes much higher doses of peanut protein.  In fact, unique from any other model of OIT, the TPIRC model is able to treat peanut allergy patients and eventually achieve a very high dose of protein (15,000 to 30,000 mg dose) by mouth safely.  Instead of receiving treatment for one year, patients here receive treatment over 6-12 weeks.  The TPIRC model of food allergy OIT allows the ultimate dose to be safely eaten intermittently typically once every week to monthly.  By achieving these doses, the immune system food allergy profile of each patient shows dramatic shifts toward long term desensitization, clear safety, and free eating of peanuts.

 

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