Pediatric patients with peanut allergy who received the oral immunotherapy drug AR101 (PALFORZIA; Aimmune) were more likely to have a systemic allergic reaction to the therapy if they had peanut-specific immunoglobulin E, a history of peanut-related anaphylaxis, or were of a certain age or ethnicity, according to recent research from an abstract released for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.
Wayne G. Shreffler, MD, PhD, Chief, Pediatric Allergy & Immunology Director, and Food Allergy Center Principal Investigator at the Center for Immunology and Inflammatory Diseases at Massachusetts General Hospital in Boston, and colleagues performed an analysis of participants enrolled in the PALISADE and RAMSES trials, where patients between 4 years and 17 years old were treated with AR101 or placebo in an escalating-dose for up to 6 months. There were 709 participants in both trial who received AR101, and 292 participants who received placebo.
Shreffler and colleagues examined whether factors such as gender, age, race, region, peanut-related anaphylaxis history, presence of multiple food allergies, peanut-specific IgE, skin prick test wheal diameter, as well as conditions such as atopic dermatitis, allergic rhinitis, or asthma impacted the rate of systemic allergic reactions.
Patients who received AR101 therapy had a higher rate of any systemic allergic reaction (12.4%) compared with patients who received placebo (4.5%). A history of anaphylaxis (odds ratio, 2.18; 95% confidence interval, 1.31-3.63), being from a European region compared with North America (OR, 2.12; 95% CI, 1.19-3.77), age between 12 years and 17 years old compared with age between 4 years and 11 years old (OR, 2.08; 95% CI, 1.37-3.16), and peanut-specific IgE ≥70 k UA/L compared with 70 k UA/L (OR, 1.70, 95% CI, 1.09-2.63) were predictive factors for increased risk of systemic allergic reaction. These results remained consistent when age and peanut-specific IgE were modified to be continuous variables, researchers said. Other potential risk factors appeared to carry no additional risk of systemic allergic reaction.
Shreffler and colleagues noted that these highlighted risk factors could help clinicians weigh the benefits and risks of using this treatment for pediatric patients with peanut allergy.“Peanut allergy has a profound impact on patients and their families, and we are committed to working with the food allergy community to gather important data that can help further illuminate the burden of this common food allergy and inform research that can lead to treatment options,” Daniel Adelman, MD, Chief Medical Officer of Aimmune, stated in a press release.