dc.contributor.author	Fernandez-Rivas, Montserrat
dc.contributor.author	Vereda, Andrea
dc.contributor.author	Vickery, Brian P.
dc.contributor.author	Sharma, Vibha
dc.contributor.author	Nilsson, Caroline
dc.contributor.author	Muraro, Antonella
dc.contributor.author	Hourihane, Jonathan O'B.
dc.contributor.author	DunnGalvin, Audrey
dc.contributor.author	du Toit, George
dc.contributor.author	Blumchen, Katharina
dc.contributor.author	Beyer, Kirsten
dc.contributor.author	Smith, Alex
dc.contributor.author	Ryan, Robert
dc.contributor.author	Adelman, Daniel C.
dc.contributor.author	Jones, Stacie M.
dc.contributor.funder	Aimmune Therapeutics	en
dc.date.accessioned	2022-09-20T15:09:59Z
dc.date.available	2022-09-20T15:09:59Z
dc.date.issued	2021-07-28
dc.date.updated	2022-09-20T14:42:53Z
dc.description.abstract	Background: The benefit of daily administration of Peanut (Arachis hypogaea) Allergen Powder-dnfp (PTAH)-formerly AR101-has been established in clinical trials, but limited data past the first year of treatment are available. This longitudinal analysis aimed to explore the impact of continued PTAH therapeutic maintenance dosing (300 mg/day) on efficacy, safety/tolerability, and food allergy-related quality of life.Methods: We present a subset analysis of PALISADE-ARC004 participants (aged 4-17 years) who received 300 mg PTAH daily for a total of similar to 1.5 (Group A, n = 110) or similar to 2 years (Group B, n = 32). Safety assessments included monitoring the incidence of adverse events (AEs), accidental exposures to food allergens, and adrenaline use. Efficacy was assessed by double-blind, placebo-controlled food challenge (DBPCFC); skin prick testing; peanut-specific antibody assays; and Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM) scores.Results: Continued maintenance with PTAH increased participants' ability to tolerate peanut protein: 48.1% of completers in Group A (n = 50/104) and 80.8% in Group B (n = 21/26) tolerated 2000 mg peanut protein at exit DBPCFC without dose-limiting symptoms. Immune biomarkers showed a pattern consistent with treatment-induced desensitization. Among PTAH-continuing participants, the overall and treatment-related exposure-adjusted AE rate decreased throughout the intervention period in both groups. Clinically meaningful improvements in FAQLQ and FAIM scores over time suggest a potential link between increased desensitization as determined by the DBPCFC and improved quality of life.Conclusions: These results demonstrate that daily PTAH treatment for peanut allergy beyond 1 year leads to an improved safety/tolerability profile and continued clinical and immunological response.	en
dc.description.status	Peer reviewed	en
dc.description.version	Published Version	en
dc.format.mimetype	application/pdf	en
dc.identifier.citation	Fernandez-Rivas, M., Vereda, A., Vickery, B. P., Sharma, V., Nilsson, C., Muraro, A., Hourihane, J. O'B., DunnGalvin, A., du Toit, G., Blumchen, K., Beyer, K., Smith, A., Ryan, R., Adelman, D. C. and Jones, S. M. (2021) 'Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy', Allergy, 77(3), pp. 991-1003. doi: 10.1111/all.15027	en
dc.identifier.doi	10.1111/all.15027	en
dc.identifier.eissn	1398-9995
dc.identifier.endpage	1003	en
dc.identifier.issn	0105-4538
dc.identifier.issued	3	en
dc.identifier.journaltitle	Allergy	en
dc.identifier.startpage	991	en
dc.identifier.uri	https://hdl.handle.net/10468/13622
dc.identifier.volume	77	en
dc.language.iso	en	en
dc.publisher	John Wiley & Sons, Inc.	en
dc.rights	© 2021, Aimmune Therapeutics. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.	en
dc.rights.uri	https://creativecommons.org/licenses/by-nc/4.0/	en
dc.subject	Desensitization	en
dc.subject	Food allergy	en
dc.subject	Oral immunotherapy	en
dc.subject	Peanut allergy	en
dc.subject	Quality of life	en
dc.title	Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy	en
dc.type	Article (peer-reviewed)	en

Open-label follow-on study evaluating the efficacy, safety, and quality of life with extended daily oral immunotherapy in children with peanut allergy

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