First Patients Receive Aimmune Therapeutics Palforzia Peanut Allergy Treatment
The first US patients with peanut allergy were treated with Aimmune Therapeutic’s Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) the company announced in a statement. The oral immunotherapy treatment (OIT) was approved by the FDA in January and is the first treatment approved for peanut allergy patients.
Palforzia aims to alleviate allergic reactions, including anaphylaxis. Patients initially ingest allergenic proteins in very small amounts, then the amounts gradually increase, allowing them to tolerate allergic reactions over time.
Specialty pharmacies have begun shipping initial OIT assay kits to allergists for in-office administration to patients ages 4 to 17 who have a confirmed diagnosis of peanut allergy. Dosage escalation and maintenance also take place during an office visit and can be continued in patients 4 years of age and older.
The treatment must be administered in person, but Joel Hartman, MD, of Allergy Partners of the Piedmont, emphasized that the process doesn’t have to be intrusive to daily workflow. “We have a day cut out where we do oral immunotherapy in and among our normal workflow,” Hartman said on an Aimmune conference call. “What we’ve found is that most doctors have the tools and resources they need” to administer the treatment. However, in the wake of the COVID-19 pandemic, physicians on call stressed that they are trying to minimize non-emergency office visits at this time.
Currently, the treatment is only available through a restricted program under an FDA-mandated Risk Assessment and Mitigation Strategy (REMS), due to the risk of anaphylaxis. “Only prescribers, healthcare facilities, pharmacies and patients certified and enrolled in the REMS program can prescribe, receive, dispense or administer Palforzia,” according to the company.
The REMS site was launched at the end of February, and since then more than 600 allergists have been certified to prescribe the treatment. “Our field team continues to meet with allergists to provide guidance and information on the REMS process to help other physicians and practices become certified and to provide training on how to safely integrate Palforzia into their practices,” said Jayson Dallas, MD, President and CEO. CEO of Aimmune. Certified distributors are listed here.
This announcement comes after additional data was released this week on Palforzia. The data was originally scheduled to be presented at the 2020 annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI), which was canceled due to the novel coronavirus.
An analysis of ARC004, the open-label follow-up trial of the 52-week Peanut Allergy Oral Immunotherapy Study of the AR101 Trial for Desensitization in Children and Adults (PALISADE), shows that treatment results in increased desensitization, better tolerance and continued immunomodulation after 18 and 24 months of treatment.
Specifically, the researchers found that “patients tolerated more peanut protein, had fewer adverse events, and continued immunomodulation – changes in the body’s immune system – as evidenced by reductions in blood levels peanut-specific immunoglobulin (IgE) levels after an additional 56 weeks of daily treatment with palforzia.”
Follow-up testing yielded additional results:
- The ability to tolerate cumulative doses of peanut protein was maintained or improved between PALISADE and ARC004, after an additional 28 or 56 weeks of treatment.
- An increased number of patients in both cohorts tolerated peanut protein doses greater than 300 mg during the ARC004 exit food challenge compared to the PALISADE exit food challenge.
- 80.8% of patients completing the trial in Cohort 3a were able to tolerate 2000 mg (or 3443 cumulative) of peanut protein (equivalent to approximately 12 peanuts) after 56 weeks of continuous treatment.
- In Cohort 1 (28 weeks of additional daily dosing), 49% of patients tolerated 2000 mg, suggesting progressive desensitization to peanut protein over time during palforzia treatment.
- With continued daily dosing beyond one year, the number of associated adverse events per patient-year of exposure fell by 59% and 85% in cohorts 1 and 3a, respectively, of PALISADE to ARC004, and no deaths or life-threatening adverse events were observed. observed.
- Although all patient subgroups showed clinically significant therapeutic effects with palforzie, trends toward desensitization rates greater than 70% were observed for some variables, including female gender and lack of a history of asthma or anaphylaxis.
Regarding patient access to treatment, the company said, “Aimmune will provide resources to patients and families who, after consultation with their physician, wish to seek treatment for palforzia. These resources will include educational materials, a dedicated call center, a co-payment program for eligible patients, and a patient assistance program to provide palforzia to eligible patients free of charge.
About 1 million children in the United States are affected by peanut allergy, and only 1 in 5 children will outgrow it, according to Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. Since there is no cure for the allergy, living with the disease can lead to significant burdens for patients and caregivers.
“As physicians or clinicians caring for patients, we understand how this diagnosis obviously affects the patient, but also caregivers and the whole family,” said Anna Nowak-W&grzyn, MD, PhD, professor of pediatrics at the New York University School of Medicine, in an interview with The American Journal of Managed Care®. “Food allergy is a really unique disease, in the sense that you’re not sick all the time. But you live with the potential for a life-threatening catastrophic event every minute, every second of your life, so it’s really very unique. Regarding the results of the most recent palforzia trials, Nowak-Wøgrzyn, (included in the Aimmune appeal) said: “This is very, very important… This is a major win for children and caregivers.”
Aimmune hopes to alleviate these burdens in part through the use of palforzia, which will alleviate the environmental risk factors children face. “Additional studies…further reinforce the daily burden of living with peanut allergy and suggest that treatment with palforzia may improve its emotional and social impact on adolescents and caregivers,” said Daniel Adelman, MD, chief medical officer of ‘Aimmune Therapeutics.