Oral peanut immunotherapy largely safe in kids, teens

The peanut allergen powder-dnfp (PTAH), a daily oral immunotherapy that helps avoid allergic reactions, has an acceptable safety profile in children and adolescents, a recent study has found. Most side effects are mild or moderate and wane over time.

The present data represent pooled analysis of three controlled phase 3 trials and two open-label extension phases. A total of 944 participants who had received at least one PTAH dose were included, with a median duration of exposure of around 49 weeks.

Most participants (n=853; 90.4 percent) experienced at least one treatment-related adverse event. In general, these side effects were mild (n=497; 52.6 percent) or moderate (n=332; 35.2 percent) in intensity. Only 24 participants (2.5 percent) developed severe adverse events, while 80 eventually discontinued PTAH use due to side effects.

Adjusting for exposure, adverse events during updosing had an occurrence rate of 76.4 events per participant-year of exposure (PYE). Meanwhile, side effects deemed related to the treatment occurred at a rate of 58.7 events per PYE.

Overall, mild systemic allergic reactions occurred at an exposure-adjusted rate of 0.12 events per PYE, while moderate and severe reactions had corresponding rates of 0.11 and 0.01 events per PYE.

“The safety profile of PTAH was characterized in a pooled population of highly sensitized and/or highly reactive peanut-allergic individuals and was consistent across trials, manageable, and improved over time,” the researchers said. “These findings can be used by allergists, patients, and their families to facilitate a risk/benefit discussion as is done with other allergen immunotherapies utilized by allergists in everyday practice.”