Peanut allergen powder yields fewer epinephrine-treated reactions vs. other treatments
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Key takeaways:
- 3.8% of patients using Peanut (Arachis hypogaea) Allergen Powder-dnfp had an epinephrine-treated reaction.
- In other studies, 7.6% of patients using other treatments experienced reactions.
Patients experienced fewer reactions that required epinephrine during oral immunotherapy with peanut allergen powder compared with other immunotherapy methods, according to a study published in Annals of Allergy, Asthma & Immunology.
Children treated with Peanut (Arachis hypogaea) Allergen Powder-dnfp (PTAH; Palforzia, Aimmune Therapeutics) during five phase 2 and 3 clinical trials showed increases in the maximum tolerated dose of peanut protein during double-blind, placebo-controlled food challenges and a 100-fold increase in median highest tolerated dose of peanut protein after 12 months.
Occurrences of epinephrine treated reactions (ETRs) were also half of those reported in other clinical trials using alternative peanut OIT methods, Michele Jara, DSc, MPH, senior director, risk management and epidemiology at Aimmune Therapeutics, a Nestlé Health Science company, and colleagues wrote.
Researchers explained that peanut allergy affects 1% to 2% of the U.S. population, often manifesting in childhood and including lifelong hypersensitivity. Symptoms can vary across those with the allergy, but in severe cases anaphylaxis can occur even when exposed to trace amounts.
Peanut OIT aims to reduce the risk for severe reactions and induce tolerance through incremental exposure in people with the allergy. Previous studies have shown that during peanut OIT, the risk for ETRs is typically less than 1 in 1,000 doses.
PTAH is the first peanut OIT approved to mitigate allergic reactions such as anaphylaxis, according to researchers. Treatment can be initiated in children aged 4 to 17 years and continued in those aged 4 years and older. Doses are delivered by mixing the PTAH into a semi-solid food, with the first dose at each level given under clinical supervision.
Dosing occurs in three steps. The initial dose escalation involves single-day administration of five escalating divided doses of 0.5 mg to 6 mg. Up-dosing includes once-daily dosing at 11 dose levels increasing from 3 mg to 300 mg according to tolerability, with a minimum of 2 weeks at each dose level. Maintenance comprises once-daily doses of 300 mg.
There were 2,501 patients treated with PTAH, and of these, 2,382 (99.2%) completed initial dose escalation and proceeded to up-dosing. By the cutoff date, 1,127 (45.1%) reached maintenance dosing.
There were 94 (3.8%) ETR cases reported across all doses, and 46 cases (1.8%) were anaphylactic reactions. ETRs were more frequent during dose escalations (3.2%), including 15 (0.6%) in the initial dose escalation phase and 66 (2.7%) in the up-dosing phase, vs. maintenance (n = 11; 1%).
The anaphylactic reactions included eight (0.3%) during initial dose escalation, 31 (1.2%) during the up-dosing phase and five (0.4%) during maintenance.
This occurrence of ETRs was half of the 7.6% reported in a recent meta-analysis of 26 clinical trials using other peanut OIT methods.
The authors speculated that their low ETR rate could be due to their 300 mg maintenance dose, compared with other studies using 2,000 mg to 3,000 mg doses. They chose a 300 mg dose due to a previous study showing that it yielded similar efficacy and also a better adverse event profile.
The authors also emphasized that the PTAH manufacturing process is tightly controlled for predictable and consistent Ara h 1, Ara h 2 and Ara h 6 profiles. Also, the authors reported that since the commercial availability of PTAH in March 2020, no new safety concerns have been identified.
Perspective
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These findings are not surprising, as allergic reactions requiring epinephrine are felt to be relatively uncommon during food OIT.
The findings from the study mirror our clinical experience. Although allergic reactions are common during OIT, particularly gastrointestinal side effects, reactions requiring treatment with epinephrine are uncommon.
Despite being the first FDA-approved product for the management of any food allergy, due to a variety of reasons, PTAH is rarely used in clinical practice. Clinical use of this therapy has been low since 2020, and it is likely to become used even less with the emergence of other food therapies, including omalizumab (Xolair; Genentech, Novartis) for any food allergy in individuals aged older than 1 year.
OIT is generally well tolerated, with epinephrine-requiring allergic reactions being uncommon.
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