Walnut oral immunotherapy for desensitisation of walnut and additional tree nut allergies (Nut CRACKER): a single-centre, prospective cohort study

Elizur, Arnon; Appel, Michael Y.; Nachshon, Liat; Levy, Michael B.; Epstein‐Rigbi, Naama; Pontoppidan, Bo; Lidholm, Jonas; Goldberg, Michael R.

doi:10.1016/s2352-4642(19)30029-x

Cited by 81 publications

(111 citation statements)

References 35 publications

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“…This recommendation is based on the principle of nonmaleficence It is supported by a large amount of consistent clinical evidence indicating that there is a risk of anaphylactic reactions during OIT [22][23][24]. A proportion of these reactions occur outside the healthcare setting [29,32,36,[38][39][40]. This is coherent with data from consultations.…”

Section: Box 6: Recommendations For the Safe Provision Of Oit Ethicalmentioning

confidence: 81%

“…There is no convincing evidence of a clinically significant difference between food allergens in terms of safety and efficacy outcomes in OIT for the treatment of IgEmediated food allergy. Therefore, all recommendations in these CPGs are generally applicable to all food allergens, unless there is specific evidence to demonstrate otherwise This recommendation is based on the principle of equity of eligibility It is supported by large amount of consistent clinical evidence, considering the absence of demonstrated lack of efficacy or of a consistent safety issue for any specific food despite a large number of clinical studies for a variety of foods [22][23][24][29][30][31][32][33][34][35][36][37][38]. Level of evidence: HIGH It is also supported by the lack of biological plausibility that the mechanism of OIT would differ from one allergen to another.…”

Section: Ethical Imperative Data or Other Considerations In Support mentioning

confidence: 99%

“…Whether or not the outcomes (i.e. desensitization, continued consumption or sustained unresponsiveness) are worth pursuing remains patients' prerogative, in line with the principle of patient autonomy It is supported by a large amount of consistent clinical evidence, which includes three metaanalyses [22][23][24] (together covering 31 published OIT controlled clinical trials), three additional RCTs [31,34,39] and two non-randomized controlled clinical trials (CCTs) [36,38], five large case series in clinical practice (N > 150) [29,30,32,33,40], and two smaller case series [35,37]. This body of evidence includes 10 RCTs rated as being at low risk of bias [34,[41][42][43][44][45][46][47][48][49] and is coherent with data from consultations.…”

Section: Ethical Imperative Data or Other Considerations In Support mentioning

confidence: 99%

“…Whether or not the outcomes (i.e. desensitization, continued consumption or sustained unresponsiveness) are worth pursuing remains patients' prerogative, in line with the principle of patient autonomy It is supported by a moderate amount of consistent clinical evidence, from three long-term, 2-arm follow-up studies of RCTs (high risk of bias due to open-label; mean follow-up 2.5 to 5 years; completeness of follow-up: 77 to 90%) [50][51][52], three large case series in clinical practice (N ≥ 145) (moderate risk of bias using the IHE tool due to single-center, retrospective design; median follow-up: 1.5 to 6.5 years; completeness of follow-up: 83 to 99%) [33,53,54], and four smaller single-arm, follow-up studies (N = 43 to 100) at low to high risk of bias (completeness of follow-up: 82 to 100%) [35][36][37]55]. This is coherent with data from consultations.…”

Section: Ethical Imperative Data or Other Considerations In Support mentioning

confidence: 99%

“…• 0 to 18% of patients discontinued due to adverse events during the build-up and 0 to 5.3% during the maintenance phase of OIT for peanut, 40 egg, 55 137 sesame, 38 or walnut 36 or wheat 34 allergy. In one wheat study, 23% of patients discontinued during the build-up and 26% during the maintenance phase; however, discontinuations due to severe reactions declined from 7.0% to 2.6% (case series: N=100 build-up, 77 maintenance 35 ) 143 for these patients, doses were reduced or dose increases deferred or suspended; in long-term follow-up, they were more likely to fail OIT (P=0.04) and less likely to reach full desensitization (P<0.001) compared to patients who did not have such symptoms 144…”

mentioning

confidence: 99%

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CSACI guidelines for the ethical, evidence-based and patient-oriented clinical practice of oral immunotherapy in IgE-mediated food allergy

Bégin

Chan

Kim

et al. 2020

Allergy Asthma Clin Immunol

136

118

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Background: Oral immunotherapy (OIT) is an emerging approach to the treatment of patients with IgE-mediated food allergy and is in the process of transitioning to clinical practice.Objective: To develop patient-oriented clinical practice guidelines on oral immunotherapy based on evidence and ethical imperatives for the provision of safe and efficient food allergy management. Materials and methods:Recommendations were developed using a reflective patient-centered multicriteria approach including 22 criteria organized in five dimensions (clinical, populational, economic, organizational and sociopolitical). Data was obtained from: (1) a review of scientific and ethic literature; (2) consultations of allergists, other healthcare professionals (pediatricians, family physicians, nurses, registered dieticians, psychologists, peer supporters), patients and caregivers; and patient associations through structured consultative panels, interviews and on-line questionnaire; and (3) organizational and economic data from the milieu of care. All data was synthesized by criteria in a multicriteria deliberative guide that served as a platform for structured discussion and development of recommendations for each dimension, based on evidence, ethical imperatives and other considerations. Results:The deliberative grid included 162 articles from the literature and media reviews and data from consultations involving 85 individuals. Thirty-eight (38) recommendations were made for the practice of oral immunotherapy for the treatment of IgE mediated food allergy, based on evidence and a diversity of ethical imperatives. All recommendations were aimed at fostering a context conducive to achieving objectives identified by patients and caregivers with food allergy. Notably, specific recommendations were developed to promote a culture of shared responsibility between patients and healthcare system, equity in access, patient empowerment, shared decision making and personalization of OIT protocols to reflect patients' needs. It also provides recommendations to optimize organization of care to generate capacity to meet demand according to patient choice, e.g. OIT or avoidance. These recommendations were made acknowledging the necessity of ensuring sustainability of the clinical offer in light of various economic considerations. © The Author(s) 2020. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article' s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article'A multidisciplinary team comprised of experts from a diversity of fields was assembled, including allergists and other healthcare professional...

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Section: Box 6: Recommendations For the Safe Provision Of Oit Ethicalmentioning

confidence: 81%

Section: Ethical Imperative Data or Other Considerations In Support mentioning

confidence: 99%

Section: Ethical Imperative Data or Other Considerations In Support mentioning

confidence: 99%

“…Whether or not the outcomes (i.e. desensitization, continued consumption or sustained unresponsiveness) are worth pursuing remains patients' prerogative, in line with the principle of patient autonomy It is supported by a moderate amount of consistent clinical evidence, from three long-term, 2-arm follow-up studies of RCTs (high risk of bias due to open-label; mean follow-up 2.5 to 5 years; completeness of follow-up: 77 to 90%) [50][51][52], three large case series in clinical practice (N ≥ 145) (moderate risk of bias using the IHE tool due to single-center, retrospective design; median follow-up: 1.5 to 6.5 years; completeness of follow-up: 83 to 99%) [33,53,54], and four smaller single-arm, follow-up studies (N = 43 to 100) at low to high risk of bias (completeness of follow-up: 82 to 100%) [35][36][37]55]. This is coherent with data from consultations.…”

Section: Ethical Imperative Data or Other Considerations In Support mentioning

confidence: 99%

mentioning

confidence: 99%

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CSACI guidelines for the ethical, evidence-based and patient-oriented clinical practice of oral immunotherapy in IgE-mediated food allergy

Bégin

Chan

Kim

et al. 2020

Allergy Asthma Clin Immunol

136

118

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Nanoparticles in Allergen‐Delivery Systems for Allergen‐Specific Immunotherapy

Lee,

Chandrawati,

Lee

2024

Advanced Therapeutics

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Allergen‐specific immunotherapy (AIT) has demonstrated its ability to induce desensitization, resulting in reduced allergen‐specific immunoglobulin E (sIgE) accompanied by increased clinical thresholds. However, ensuring safety during therapy, especially with oral immunotherapy, and achieving long‐term tolerance continue to be significant challenges. To address these issues, a concept of nanoencapsulation of allergens has emerged. This paper reviews biodegradable and non‐biodegradable nanoparticles as an allergen‐delivery system, as well as adjuvants for the improvement of the efficacy of AIT. Of all the nanoparticles reviewed, polymethyl methacrylate (PMMA) and chitosan are the most popular nanoparticles for encapsulating macromolecular allergens for oral immunotherapy. Although poly(lactic‐co‐glycolic acid) (PLGA) demonstrates higher stability in the gastrointestinal environment and allergen‐loaded PLGA attenuates the sIgE antibody binding in a murine model, it has inconsistent loading capacity and is difficult to reproduce. Studies on biodistribution, pharmacokinetics, and pharmacodynamics of nanoparticles, however, should be highlighted to ensure the long‐term safety profile of utilizing nanoparticles in immunotherapy. In this regard, encapsulation efficiency and release behavior of allergens from nanoparticles are important components in predicting the safety and efficacy of treatments. The stability, reproducibility, and scalability of encapsulated allergens should also be considered for the translation to clinical applications.

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A Review of Shared Decision-Making, Published Protocols, and Post-desensitization Strategies in Oral Immunotherapy (OIT)

Laubach,

Kim,

Greenhawt

et al. 2024

Curr Allergy Asthma Rep

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Purpose of Review The aim of this review is to highlight key published oral immunotherapy (OIT) protocols and post-desensitization strategies for the major food allergens and to cover important concepts to consider when evaluating OIT for food-allergic patients. Shared decision-making should help identify patient and family values which will help influence the type of evidence-based protocol and maintenance strategy to use. Recent Findings With food OIT emerging as a treatment option, there is a pressing need for patients, physicians, and other providers to have a nuanced understanding of the management choices available to them. There are now randomized controlled trials (RCT) of OIT for peanut, egg, milk, and wheat, and reports of cohorts of patients who have undergone OIT for tree nuts and sesame clinically. The current published protocols contain significant diversity in terms of starting dose, build-up schedule, maintenance dose, and even the product used for desensitization. Emerging data can help direct the long-term maintenance strategy for patients on OIT. Summary Based on patient and family values elicited through the shared decision-making process, an OIT protocol may be selected that balances the level of desensitization, potential side effects, frequency of clinic visits, and potential to induce sustained unresponsiveness, among other factors. Once maintenance dosing is reached, most patients will need to maintain regular exposure to the food allergen to remain desensitized. The option to transition to commercial food products with equivalent amounts of food protein as the OIT maintenance dose would simplify the dosing process and perhaps improve palatability as well. Less frequent or decreased OIT dosing can provide practical benefits but may affect the level of desensitization and safety for some patients.

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Walnut oral immunotherapy for desensitisation of walnut and additional tree nut allergies (Nut CRACKER): a single-centre, prospective cohort study

Cited by 81 publications

References 35 publications

CSACI guidelines for the ethical, evidence-based and patient-oriented clinical practice of oral immunotherapy in IgE-mediated food allergy

CSACI guidelines for the ethical, evidence-based and patient-oriented clinical practice of oral immunotherapy in IgE-mediated food allergy

Nanoparticles in Allergen‐Delivery Systems for Allergen‐Specific Immunotherapy

A Review of Shared Decision-Making, Published Protocols, and Post-desensitization Strategies in Oral Immunotherapy (OIT)

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