Skip to main content
SpringerLink
Log in

Peanut (Arachis hypogaea) allergen powder-dnfp (Palforzia™) in peanut allergy: a profile of its use

  • Adis Drug Q&A
  • Published:
Drugs & Therapy Perspectives Aims and scope Submit manuscript

Abstract

Peanut (Arachis hypogaea) allergen powder-dnfp (Palforzia™; hereafter referred to as PTAH), is the first oral immunotherapy approved in the USA and European Commission for mitigating allergic reactions in children aged 4–17 years with peanut allergy. In the pivotal phase 3 studies in patients with peanut allergy, relative to placebo, PTAH significantly desensitized to peanut protein and reduced severity of allergic reactions to accidental peanut exposure, together with improvements in food allergy-related quality of life. The clinical benefits of PTAH were maintained with continued treatment for up to 2 years. Most adverse events with PTAH, including systemic allergic reactions, were of mild to moderate severity. Frequency and severity of adverse events decreased with continued treatment.

Plain Language Summary

Peanut allergy is a major growing health problem worldwide. Current management of peanut allergy includes strict peanut avoidance and management of acute allergic reactions. With various routes of immunotherapy being investigated as a potential treatment option, peanut (Arachis hypogaea) allergen powder-dnfp (Palforzia™; hereafter referred to as PTAH) is the first oral immunotherapy approved for children aged 4–17 years with peanut allergy. In children with peanut allergy, PTAH increased desensitization to peanut protein and reduced severity of allergic symptoms relative to placebo. Patients treated with PTAH also reported improvements in food allergy-related quality of life. Adverse events seen with PTAH, including systemic allergic reactions, are generally mild or moderate in severity. PTAH is a novel effective treatment option for mitigating allergic symptoms in children with peanut allergy.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Blaiss MS, Tilles S, Petroni D, et al. Current management and use of oral immunotherapy in the United States for patients with peanut allergy. Allergy Asthma Proc. 2019;40(4):214–20.

    Article  CAS  Google Scholar 

  2. Chan ES, Dinakar C, Gonzales-Reyes E, et al. Unmet needs of children with peanut allergy: aligning the risks and the evidence. Ann Allergy Asthma Immunol. 2020;124(5):479–86.

    Article  CAS  Google Scholar 

  3. Blackman AC, Anagnostou A. Identification of goals and barriers to treatment from 92 consecutive consultations with families considering peanut oral immunotherapy. Ther Adv Vaccines Immunother. 2019;7:1–11.

    Google Scholar 

  4. Tanno LK, Clark E, Mamodaly M, et al. Food-induced anaphylaxis morbidity: emergency department and hospitalization data support preventive strategies. Pediatr Allergy Immunol. 2021. https://doi.org/10.1111/pai.13578.

    Article  PubMed  Google Scholar 

  5. Nowak-Wegrzyn A, Hass SL, Donelson SM, et al. The peanut allergy burden study: impact on the quality of life of patients and caregivers. World Allergy Organ J. 2021;14(2):100512.

    Article  Google Scholar 

  6. Licari A, Manti S, Marseglia A, et al. Food allergies: current and future treatments. Medicina (Kaunas). 2019;55(5):120.

    Article  Google Scholar 

  7. Pajno GB, Fernandez-Rivas M, Arasi S, et al. EAACI guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018;73(4):799–815.

    Article  CAS  Google Scholar 

  8. Begin P, Chan ES, Kim H, et al. CSACI guidelines for the ethical, evidence-based and patient-oriented clinical practice of oral immunotherapy in IgE-mediated food allergy. Allergy Asthma Clin Immunol. 2020;16:20.

    Article  CAS  Google Scholar 

  9. Aimmune Therapeutics. Palforzia [peanut (Arachis hypogaea) allergen powder-dnfp] powder for oral administration [US prescribing information]. 2021. https://www.fda.gov/. Accessed 20 Aug 2021.

  10. Aimmune Therapeutics. Palforzia [peanut (Arachis hypogaea) allergen powder-dnfp] powder for oral administration [EU SmPC]. 2020. https://www.ema.europa.eu/. Accessed 20 Aug 2021.

  11. US Food & Drug Administration. Palforzia: Risk Evaluation and Mitigation Strategy (REMS) document. 2020. https://www.accessdata.fda.gov/drugsatfda_docs/rems/Palforzia_2020_07_17_REMS_Full.pdf. Accessed 20 Aug 2021.

  12. European Medicines Agency. Palforzia: public assessment report. 2020. https://www.ema.europa.eu/. Accessed 20 Aug 2021.

  13. Vickery BP, Vereda A, Casale TB, et al. AR101 oral immunotherapy for peanut allergy. N Engl J Med. 2018;379(21):1991–2001.

    Article  Google Scholar 

  14. Hourihane JO, Beyer K, Abbas A, et al. Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial. Lancet Child Adolesc Health. 2020;4(10):728–39.

    Article  Google Scholar 

  15. Vickery BP, Vereda A, Nilsson C, et al. Continuous and daily oral immunotherapy for peanut allergy: results from a 2-year open-label follow-on study. J Allergy Clin Immunol Pract. 2021;9(5):1879-89.e14.

    Article  Google Scholar 

  16. Fernandez-Rivas M, Vereda A, Vickery BP, et al. Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy. Allergy. 2021. https://doi.org/10.1111/all.15027.

    Article  PubMed  Google Scholar 

  17. Bird JA, Spergel JM, Jones SM, et al. Efficacy and safety of AR101 in oral immunotherapy for peanut allergy: results of ARC001, a randomized, double-blind, placebo-controlled phase 2 clinical trial. J Allergy Clin Immunol Pract. 2018;6(2):476-85.e3.

    Article  Google Scholar 

  18. Beyer K, Abbas AS, Brown K, et al. Baseline demographics of >1100 peanut-allergic subjects aged 4–17 years randomised in three double-blind placebo-controlled phase 3 AR101 trials: PALISADE, RAMSES and ARTEMIS [abstract no. PD0548]. Allergy. 2019;74(Suppl 106):301.

    Google Scholar 

  19. Carr W, Vickery BP, Zawadzki R, et al. Estimating the probability of tolerating each challenge dose of peanut protein at exit double-blind, placebo-controlled food challenge: results from a phase 3, randomized, double-blind, placebo-controlled trial (PALISADE) of AR101 [abstract no. 796]. J Allergy Clin Immunol. 2019;143(2 Suppl):AB262.

    Article  Google Scholar 

  20. Yu S, Smith A, Hass S, et al. The risk reduction of accidental exposure-related systemic allergic reactions extrapolated based on food challenge data after 1 year of peanut oral immunotherapy. Adv Ther. 2021;38(8):4321–32.

    Article  CAS  Google Scholar 

  21. Lanser B, Leonard S, Griffin N, et al. Effect of demographics and baseline clinical characteristics on the treatment response to AR101: results from PALISADE [abstract no. 438]. J Allergy Clin Immunol. 2020;145(2 Suppl):AB138.

    Article  Google Scholar 

  22. Bird J, Sher L, Griffin N, et al. Response to AR101 by baseline peanut-specific ige and skin prick test: results from PALISADE [abstract no. P308]. Ann Allergy Asthma Immunol. 2019;123(5 Suppl):S49.

    Article  Google Scholar 

  23. Sharma V, Du Toit G, Fernandez-Rivas M, et al. Treatment satisfaction with AR101 oral immunotherapy for peanut allergy in a European paediatric population [abstract no. 1230]. Allergy. 2020;75(Suppl 109):37–8.

    Google Scholar 

  24. Blumchen K, Hass S, Beyer K, et al. Treatment satisfaction with continued oral immunotherapy for peanut allergy: results after 1, 1.5, and 2 years of daily therapy. In: EAACI hybrid congress 2021. 2021.

  25. Sussman G, Ben-Shoshan M, Cheema A, et al. Extended daily dosing of AR101 for peanut allergy results in higher tolerated doses and continued immunomodulation in subjects aged 4–17 years [abstract no. 59]. Ann Allergy Asthma Immunol. 2019;16(Suppl 1):20–1.

    Google Scholar 

  26. Ohayon J, Sussman G, Ben-Shoshan M, et al. Improvement in disease-specific quality of life for peanut-allergic subjects continuing AR101 therapeutic dosing for an additional 28 weeks [abstract no. 55]. Ann Allergy Asthma Immunol. 2019;16(Suppl 1):19.

    Google Scholar 

  27. Casale T, Burks A, Baker J, et al. Safety of peanut (Arachis hypogaea) allergen powder-dnfp in children and teenagers with peanut allergy: pooled analysis from controlled and open-label phase 3 trials over 3.5 years [abstract no. 335]. J Allergy Clin Immunol. 2021;147(2 Suppl):AB106.

    Article  Google Scholar 

  28. Allergenic Products Advisory Committee Meeting. Peanut, Arachis hypogaea, allergen powder for oral administration (proposed trade name: Palforzia). 2019. https://www.fda.gov/. Accessed 20 Aug 2021.

  29. Shreffler W, Jones S, Fineman S, et al. Identifying demographics and baseline clinical characteristics associated with safety outcomes during AR101 therapy [abstract no. 421]. J Allergy Clin Immunol. 2020;145(2 Suppl):AB132.

    Article  Google Scholar 

  30. Pepper AN, Assa’ad A, Blaiss M, et al. Consensus report from the Food Allergy Research & Education (FARE) 2019 oral immunotherapy for food allergy summit. J Allergy Clin Immunol. 2020;146(2):244–9.

    Article  Google Scholar 

  31. Mustafa SS, Patrawala S. Real world adoption of FDA-approved peanut oral immunotherapy with Palforzia [abstract no. 343]. J Allergy Clin Immunol. 2021;147(2 Suppl):AB108.

    Article  Google Scholar 

Download references

Acknowledgements

The manuscript was reviewed by: M. Erlewyn-Lajeunesse, Southampton Children's Hospital, University Hospitals Southampton NHS Foundation Trust, Southampton, UK; S. Manti, Pediatric Respiratory Unit, Department of Clinical and Experimental Medicine, San Marco Hospital, University of Catania, Catania, Italy; A. Nowak-Wegrzyn, Allergy and Immunology, Department of Pediatrics, NYU Grossman School of Medicine, New York, NY, USA. During the peer review process, Aimmune Therapeutics, the marketing authorization holder of PTAH, was also offered an opportunity to provide a scientific accuracy review of their data. Changes resulting from comments received were made on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand

    Young-A Heo

Authors
  1. Young-A Heo
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Young-A Heo.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Authorship and conflict of interest

Young-A Heo, a salaried employee of Adis International Ltd/Springer Nature and an editor of Drugs & Therapy Perspectives, was not involved in any publishing decisions for the manuscript and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content

Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability

Not applicable.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PPTX 39 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Heo, YA. Peanut (Arachis hypogaea) allergen powder-dnfp (Palforzia™) in peanut allergy: a profile of its use. Drugs Ther Perspect 37, 495–502 (2021). https://doi.org/10.1007/s40267-021-00868-5

Download citation

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40267-021-00868-5

Search

Navigation