PALFORZIA at 3 Years: New Data Show Sustained Peanut Immunotherapy Benefit, Safety

Author(s):

A discussion on continued research into the first regulated treatment for pediatric peanut allergy.

Video highlights

0:50 Introduction
2:18 Patient demographics
3:46 Study outcomes
6:35 Interpretations
8:29 Breakdown of reaction types
13:45 Family and clinician confidence
16:36 Realistic immunotherapy goals
18:30 Extended assessment

A new study presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2021 Virtual Sessions this week showed pooled controlled and open-label data from phase 3 trials indicate sustained benefit and safety of oral peanut immunotherapy for the reduction of pediatric peanut allergy reactions.

The data, which collected up to 3.5 years of outcomes associated with Aimmune Therapeutics’ AR101 (PALFORZIA), showed the first peanut allergen powder regulated as a food immunotherapy by the US Food and Drug Administration (FDA) was feasible as a 300 mg dose for a majority (83%) of phase 3 patients.

The assessment of patients aged 4-17 years old also showed 74% of the 150 participants to discontinue treatment due to adverse events had done so in the first 6 months. At trial’s end, two-thirds (66.9%) of patients reached 1 year of immunotherapy; 38% reached 2 years; and 8.3% reached 3 years.

In an interview with HCPLive during AAAAI 2021, lead study author Thomas Casale, MD, professor of medicine at the University of South Florida, broke down the study’s details, and provided outlooks for extended observation.

As PALFORZIA becomes more widely prescribed, investigators are interested in reaching trial marks of four-, even five-year outcomes.

“Do people have sustained unresponsiveness, where we could stop the trial for a period of time, and they would be fine?” Casale prosed.

Casale also discussed the influence of COVID-19 on the need for bettered food allergy protection—the pandemic’s effect could come in various factors associated with anaphylaxis risks.

“If you’re on a fixed income and you’ve lost your job, try to get food from a food bank that are guaranteed to not have the allergens that you’re allergic to. It’s much harder,” Casale said. “And if you do have an allergic reaction, you’re much less likely to go to the emergency department out of fear of getting COVID-19.

An additional observed benefit from the three-plus year data: Casale and colleagues found the adverse events reported by patient families were largely expected, minor in severity, and easily managed by trained and informed clinicians and parents overseeing administration.

“That provides a degree of comfort,” Casale explained. “That’s way different than sending your child to a birthday party, they eat a cookie they didn’t know has peanuts. Now when they have an allergic reaction, nobody is there that recognizes it, nobody is there with epinephrine, no one knows what to do.”