Peanut Allergen Powder-dnfp: A Novel Oral Immunotherapy to Mitigate Peanut Allergy

Abstract

Objective: To review data on efficacy and safety of peanut allergen powder-dnfp (PAP; Palforzia), a novel oral immunotherapy for peanut allergy, a common food allergy. Data Sources: A PubMed/CINAHL search in English was performed from inception to June 30, 2020, using the search words peanut allergy, desensitization, ARA101, and peanut oral immunotherapy. Study Selection and Data Extraction Quantification: Published phase 2 and 3 clinical trials, documents presented to the Food and Drug Administration, and supplemental study documentation were reviewed. Articles evaluated PAP’s pharmacology, pharmacokinetics, mechanism of action, efficacy, and safety. Data Synthesis: PAP was efficacious and safe for treatment of peanut allergy in mostly Caucasian children, 4 to 17 years old. A key phase III clinical trial showed a statistically significant difference (primary end point) between PAP 600 mg and placebo groups (67.2% vs 4%; P < 0.001). During initial dose escalation and updosing phases, gastrointestinal and respiratory tract allergic reactions (ARs) were more common in the PAP group. More epinephrine rescue was used in the PAP group. Relevance to Patient Care and Clinical Practice: Oral immunotherapy for desensitization of peanut allergy was shown to reduce the severity of reactions if accidental allergen exposure occurs. Risk evaluation and mitigation strategy certification is required for pharmacies, health care providers, and clinics. More data in real-world populations will enhance its effectiveness. Conclusions: In patients 4 to 17 years old, PAP mitigated ARs, including anaphylaxis, that may occur with accidental peanut exposure. Although there are risks, it was efficacious in more than two-thirds of participants in phase 2 and phase 3 efficacy trials.

Food allergy and hypersensitivity reactions in children and adults—A review

“…The most studied and successful is OIT. The safety and efficacy of clinical protocols for OIT toward various common allergens are currently being investigated [159,160] and implemented in clinical practice [161,162]. OIT towards peanut is the most studied, which leads to immunological changes with decreased IgE-and increased IgG4-ab to peanut.…”

Tolerogenic Nano-/Microparticle Vaccines for Immunotherapy

“…Despite the effectiveness in mice, oral tolerance in human clinical trials is widely discouraging. Palforzia, made up of powdered peanut protein extract, remains to be the only oral desensitization therapy to treat peanut allergy approved by FDA . Besides the high cost and up to 6-month treatment period, the possibility of anaphylaxis has not been proven to be excluded, and long-term efficacy has not been accomplished. − That makes it difficult to depend on harnessing the oral-route tolerance approach only for the nanoparticle-based tolerance induction to translate into clinics.…”

Allergenicity of peanut allergens and its dependence on the structure

“…AR101 (contains defatted roasted peanut flour) is a kind of oral biologic drug that delivers a target daily maintenance dose of 300 mg of peanut protein with a characterized profile (Vickery et al., 2018) and results in increased serum levels of peanut‐specific IgG4 in treated patients as well as decreased peanut‐specific IgE/IgG4 (O'BHourihane et al., 2020). It was subsequently named as peanut allergen powder‐dnfp (PAP, Palforzia) and has been proved to be a novel OIT to mitigate peanut allergy in individuals aged 4−17 years by the Food and Drug Administration (Dougherty et al., 2021).…”