Safety of approved peanut allergy therapy in children
Published: December 28, 2021
Peanut allergy is among the most common food allergy found in children and adolescents in the United States. Those with a peanut allergy and their families commonly experience a decrease in quality of life. Until recently, management of peanut allergy solely relied on peanut avoidance and emergency medication when an allergic reaction occurs. Peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; Palforzia) is an oral immunotherapy that is approved by both the US Food and Drug Administration and the European Commission for use in individuals aged 4-17 years with a confirmed diagnosis of peanut allergy. PTAH uses peanut allergen powder to reduce frequency and severity of allergic reactions occurring due to accidental exposure to peanut.
In a recent research article in The Journal of Allergy and Clinical Immunology (JACI), Brown et al. summarized and analyzed PTAH safety in participants aged 4-17 years from three controlled phase 3 and two open-label extension trials who had received approximately up to 2 years of treatment. Inclusion criteria varied across studies but required that participants had a clinical history of peanut allergy with a positive peanut skin prick test, elevated peanut-specific IgE levels, and/or dose-limiting symptoms during an oral food challenge with peanut protein at the time of screening. All participants included in the analysis received at least one dose of active drug or placebo. Drug or placebo was administered in three dosing phases in these trials: the initial dose escalation; updosing, when the dose was progressively increased to reach the maintenance dosing; and maintenance dosing, with a 300 mg daily dose. Doses were adjusted or interrupted based on prespecified criteria and the judgment of the investigator. The investigators analyzed the pooled safety findings of these five trials to characterize the safety of PTAH up to 2 years of treatment. This analysis was conducted to aid clinicians, patients, and families in informed, shared decision-making when considering immunotherapy with PTAH.
The participants’ median age was 9 years, and most were white with multiple co-morbid allergic diseases. Among the 944 individuals who received at least one dose of PTAH, about 90% experienced one or more treatment-related adverse event during the whole treatment duration. The reported adverse events were primarily respiratory (eg, throat irritation) or gastrointestinal (eg, nausea, abdominal pain) in nature.
Across the total treatment length, 53% of individuals reported adverse events related to treatment with highest severity of mild, 35% experienced related adverse events with a highest severity of moderate, and <3% with a highest severity of severe. The rate of adverse events leading to treatment discontinuation and the use of epinephrine was higher in individuals treated with PTAH versus placebo, but was low overall (11.8% vs 2.4% for adverse events leading to discontinuation; 9.5% vs 4.5% for epinephrine use). Individuals experienced more adverse events associated with treatment earlier in therapy, and the rates of these waned over time as individuals progressed through therapy. The safety profile of PTAH was predictable, manageable, and consistent across trials.
In summary, the manageable safety profile of PTAH improved over time as individuals progressed through therapy. These data can aid patients and families considering treatment with PTAH.
The Journal of Allergy and Clinical Immunology (JACI) is an official scientific journal of the AAAAI and is the most-cited journal in the field of allergy and clinical immunology.
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