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Food Allergy
Published in Praveen S. Goday, Cassandra L. S. Walia, Pediatric Nutrition for Dietitians, 2022
Alison Cassin, Ashley Devonshire, Stephanie Ward, Meghan McNeill
In July 2020, the U.S. Food and Drug Administration (FDA) approved the first therapeutic product for peanut allergy in children ≥4 years of age, Palforzia. The product is a peanut allergen powder for oral immunotherapy, a procedure during which a patient with known food allergy is exposed to their trigger food in small, but increasing quantities over time to try to desensitize them to their food allergen. While this is currently the only approved product, many allergists around the world offer oral immunotherapy to their patients utilizing store-bought products. Oral immunotherapy is not curative, but it has been shown to mitigate risk associated with accidental allergen exposure by raising the threshold for the amount of allergen that induces a response.
Food Allergy
Published in Pudupakkam K Vedanthan, Harold S Nelson, Shripad N Agashe, PA Mahesh, Rohit Katial, Textbook of Allergy for the Clinician, 2021
Neha T Agnihotri, Jialing Jiang, Christopher M Warren, Ruchi S Gupta
Single-food OIT trials on milk, eggs and peanuts are the most common. It is important to consider that these trials varied in maintenance doses. Meglio et al. in the earliest milk OIT study, demonstrated that 71% of subjects with a positive baseline double-blind placebo-controlled food challenge tolerated a daily dosage of 200 mL of cow’s milk following a 6 month desensitization protocol (Meglio et al. 2004). Other studies have also demonstrated that the majority of subjects (67–100%) were able to complete protocol and consume the goal milk dosage daily (Keet et al. 2012, Martorell et al. 2011, Pajno et al. 2010, Salmivesi, et al. 2013, Skripak et al. 2008). Egg and peanut OIT trials have also demonstrated that desensitization can be accomplished among the majority of subjects, approximately 56–100% for eggs (Burks et al. 2012, García Rodríguez et al. 2011, Itoh et al. 2010, Jones et al. 2016, Pérez-Rangel et al. 2017, Vickery et al. 2010) and 62–93% for peanuts (Blumchen et al. 2010, Jones et al. 2009, Anagnostou et al. 2014). Other studies have examined wheat OIT and it also appears to lead to successful desensitization, although these studies were not placebo controlled and some did not have a post-treatment challenge (Kulmala et al. 2018, Pacharn et al. 2014, Rodríguez del Río et al. 2014). While to date OIT has been mostly administered in the private practice setting or via clinical trials of experimental therapies, FDA-approved immunotherapies may be on the horizon, given the completion of phase 3 trials of AR101 (The PALISADE Group of Clinical Investigators 2018) (proposed trade name PALFORZIA™), and recent vote from the FDA Allergenic Products Advisory Committee who found the efficacy and safety data to support its use in peanut allergy OIT.
Pharmacoeconomics of allergy immunotherapy versus pharmacotherapy
Published in Expert Review of Clinical Immunology, 2021
The standard of care for food allergic individuals is the avoidance of the food and carriage of a self-injectable epinephrine treatment in the event of an accidental. Clinical trials investigating oral (POIT) and epicutaneous (EPIT) immunotherapy for peanut allergy have demonstrated improved tolerance. However, in most cases, the tolerance is not maintained after treatment discontinuation. In 2020, the FDA approved the first peanut oral immunotherapy product, Palforzia (Airimmune Therapeutics, Brisbane, California) [86]. An epicutaneous form of peanut immunotherapy, Viaskin™ Peanut Patch (DBV Technologies, Montrouge, France), submitted a Biologics License Application (BLA) in October 2019. The product was granted Fast Track and Breakthrough Therapy designation by the FDA. However, questions regarding the efficacy and the patch’s adhesion to the skin prompted the FDA to cancel the advisory committee meeting convened to discuss approval for the patch’s approval [87].One study performed an economic evaluation of peanut POIT and EPIT from a societal perspective [88]. Microsimulation with Markov modeling evaluated virtual children over an 8-year time horizon. Outcomes included treatment-related adverse effects, anaphylaxis, QALY, and fatalities. The model assumed 35% of those with anaphylaxis due to accidental exposure were hospitalized and all were evaluated in the emergency room. As this analysis predated product approval, the actual product cost was not known.
Oral immunotherapy for food allergy in children: is it worth it?
Published in Expert Review of Clinical Immunology, 2022
Sharanya Nagendran, Nandinee Patel, Paul J Turner
Currently, Palforzia is the only commercial product available for OIT, specifically for peanut allergy. Palforzia is essentially defatted peanut flour which is produced, characterized and aliquoted according to GMP. As might be expected, some clinicians, predominantly in North America but also in the UK, have begun to offer their patients peanut-OIT using peanut flour at the same time as Palforzia was being considered by regulatory authorities. Data published from the USA has demonstrated that this approach is entirely feasible[5]. This has resulted in significant debate as to whether a cheaper, non-pharma grade product or even food should be used for OIT when a commercial, but significantly more expensive pharma-grade product is available (see section 6).