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Current Allergy and Asthma Reports

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01.12.2020 | Immunotherapy and Immunomodulators ( B Vickery, Section Editor)

Oral Immunotherapy for Food Allergy—a US Regulatory Perspective

verfasst von: Kathleen Hise, Ronald L. Rabin

Erschienen in: Current Allergy and Asthma Reports | Ausgabe 12/2020

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Abstract

The recent approval of Palforzia for treatment of peanut allergy by the US Food and Drug Administration (USFDA) predicts that additional products for oral immunotherapy (OIT) are on the horizon. In this article, the authors review the legal framework by which the USFDA regulates products for OIT of food allergy and the clinical data that demonstrated that the safety and effectiveness profile of Palforzia supported approval and conclude with a discussion of oral food challenge (OFC) as a clinical endpoint to demonstrate safety and effectiveness of OIT products.

Patriarca C, Romano A, Venuti A, Schiavino D, di Rienzo V, Nucera E, et al. Oral specific hyposensitization in the management of patients allergic to food. Allergol Immunopathol (Madr). 1984;12(4):275–81.

Buchanan AD, Green TD, Jones SM, Scurlock AM, Christie L, Althage KA, et al. Egg oral immunotherapy in nonanaphylactic children with egg allergy. J Allergy Clin Immunol. 2007;119(1):199–205.CrossRef

Burks AW, Jones SM, Wood RA, Fleischer DM, Sicherer SH, Lindblad RW, et al. Oral immunotherapy for treatment of egg allergy in children. N Engl J Med. 2012;367(3):233–43.CrossRef

Keet CA, et al. The safety and efficacy of sublingual and oral immunotherapy for milk allergy. J Allergy Clin Immunol. 2012;129(2):448–55 455 e1–5.CrossRef

Thyagarajan A, Varshney P, Jones SM, Sicherer S, Wood R, Vickery BP, et al. Peanut oral immunotherapy is not ready for clinical use. J Allergy Clin Immunol. 2010;126(1):31–2.CrossRef

•• Guidance for Clinical Investigators, Sponsors, and IRBs. Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND, F.D.A. US DHHS, 2013. Informs prospective investigators of clinical studies that require approval from the FDA under an IND.

• Chinthrajah RS, et al. Development of a tool predicting severity of allergic reaction during peanut challenge. Ann Allergy Asthma Immunol. 2018;121(1):69–76 e2 An interesting study showing that immunologic markers can predict severity of an allergic reaction during OIT.CrossRef

• Christensen MJ, et al. Exercise lowers threshold and increases severity, but wheat-dependent, exercise-induced anaphylaxis can be elicited at rest. J Allergy Clin Immunol Pract. 2018;6(2):514–20 First of two studies that show that OIT results can depend on physiologic factors.CrossRef

• Dua S, et al. Effect of sleep deprivation and exercise on reaction threshold in adults with peanut allergy: a randomized controlled study. J Allergy Clin Immunol. 2019;144(6):1584–1594 e2. Second of two studies that show that OIT results can depend on physiologic factors.

10.

• Komarow HD, et al. Impulse oscillometry in the evaluation of diseases of the airways in children. Ann Allergy Asthma Immunol. 2011;106(3):191–9 Same as Reference 9.CrossRef

11.

Yanagida N, Sato S, Nagakura KI, Asaumi T, Ebisawa M. Oral food challenge using different target doses and time intervals between doses. Curr Opin Allergy Clin Immunol. 2018;18(3):222–7.CrossRef

Titel: Oral Immunotherapy for Food Allergy—a US Regulatory Perspective
verfasst von: Kathleen Hise
Ronald L. Rabin
Publikationsdatum: 01.12.2020
Verlag: Springer US
Erschienen in: Current Allergy and Asthma Reports / Ausgabe 12/2020
Print ISSN: 1529-7322
Elektronische ISSN: 1534-6315
DOI: https://doi.org/10.1007/s11882-020-00973-x

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Oral Immunotherapy for Food Allergy—a US Regulatory Perspective

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Neu im Fachgebiet HNO

HNO-Op. auch mit über 90?

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Bilateraler Hörsturz hat eine schlechte Prognose

„Nur wer sich gut aufgehoben fühlt, kann auch für Patientensicherheit sorgen“

Update HNO