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Adverse Events and Labeling Issues Related to Suspected Sesame Allergy Reported in an Online Survey
Background: Allergen avoidance is critical for those with IgE-mediated food allergy (FA) but can only be successful with accurate product information. While the Food and Drug Administration (FDA) maintains the Center for Food Safety and Nutrition (CFSAN) Adverse Event Reporting System (CAERS) to collect adverse event (AE) reports related to foods, there is significant under-reporting and information regarding product labeling issues is limited.Objective: The purpose of this study was to describe allergic reactions associated with accidental oral exposure to sesame and the role of product labeling.
Source: Annals of Allergy, Asthma and Immunology - December 6, 2021 Category: Allergy & Immunology Authors: Kim Nguyen, Eva Greenthal, Sarah Sorscher, Peter Lurie, Jonathan M. Spergel, Katie Kennedy Source Type: research
Allergy evaluation of messenger RNA vaccine reactions is crucial, with a specific role for polyethylene glycol testing
The US Food and Drug Administration granted emergency authorization to both Pfizer-BioNTech's BNT162B2 messenger RNA (mRNA) and Moderna's mRNA-1273 coronavirus disease 2019 (COVID-19) vaccines in December 2020. Uncommon (2.5-4.7 events per million) anaphylactic reactions were observed that had not been reported in phase III studies which excluded individuals with a history of an allergy to a vaccine or components of the mRNA vaccines. From that moment on, allergists have played a crucial role in the vaccine rollout and have clarified a very specific role for polyethylene glycol (PEG) testing.
Source: Annals of Allergy, Asthma and Immunology - June 16, 2022 Category: Allergy & Immunology Authors: Pragya Shrestha, Cosby Allen Stone Tags: Perspective Source Type: research
Transitioning individuals with peanut allergy from US Food and Drug Administration-approved peanut oral immunotherapy to a dietary peanut product
Management of peanut allergy (PA) has expanded from strict avoidance with prompt treatment of accidental exposures to include the option of peanut oral immunotherapy (POIT).1,2 Although off-label POIT has been used for years, in 2020, the US Food and Drug Administration (FDA) approved Arachis hypogaea allergen powder (Palforzia, Aimmune, Brisbane, California) for POIT in the management of PA.3 An increasing number of allergists are offering POIT in clinical practice,4 but barriers remain. Despite similar risks to off-label POIT, uptake of FDA-approved POIT remains low, with the 2 most typically cited reasons to forego this...
Source: Annals of Allergy, Asthma and Immunology - October 6, 2022 Category: Allergy & Immunology Authors: S. Shahzad Mustafa, Jodi Shroba Tags: Letters Source Type: research
The role of biologics in pediatric food allergy and eosinophilic gastrointestinal disorders
Continuing insight into the molecular mechanisms of atopic disorders has enabled the development of biologics to precisely target these diseases. Food allergy (FA) and eosinophilic gastrointestinal disorders (EGIDs) are driven by similar inflammatory molecular mechanisms and exist along the same atopic disease spectrum. Therefore, many of the same biologics are being investigated to target key drivers of mechanisms shared across the disease states. The enormous potential of biologics for the treatment of FA and EGIDs is highlighted by the significant increases in the number of ongoing clinical trials (more than 30) evaluat...
Source: Journal of Allergy and Clinical Immunology - March 1, 2023 Category: Allergy & Immunology Authors: Sayantani B. Sindher, Suzanne Barshow, Jyothi Tirumalasetty, Stefania Arasi, Dan Atkins, Maureen Bauer, Philippe B égin, Margaret H. Collins, Antoine Deschildre, Alfred D. Doyle, Alessandro Fiocchi, Glenn T. Furuta, Maria Garcia-Lloret, Maurizio Mennini, Tags: Review article Source Type: research
Jak out of the box: Targeting Bruton's tyrosine kinase, sialic acid-binding immunoglobulin-like lectin-8, and Janus kinase 1 in food allergy
There has been rapid growth in the field of immunoglobulin E-mediated food allergy therapeutics, with 1 US Food and Drug Administration –approved therapy in 2020 and several others in various stages of investigation. Oral immunotherapy is the approach with the longest track record of study and provides desensitization for most individuals undertaking the therapy. However, the therapy must be maintained for continued clinical prote ction, and adverse effects of the therapy are frequent. There is a need to improve allergen immunotherapy safety and durability and to provide a treatment that can target multiple food allergies.
Source: Annals of Allergy, Asthma and Immunology - February 1, 2023 Category: Allergy & Immunology Authors: Cecilia Berin Tags: Review Source Type: research
Benefit of SLIT and SCIT for Allergic Rhinitis and Asthma
AbstractAllergen immunotherapy (AIT) has been in use since more than one century, when Leonard Noon experimentally proved its efficacy in hayfever (Noon, in Lancet 1:1572 –3,1911). Since then, AIT was administered only as subcutaneous injections (SCIT) until the sublingual route (SLIT) was proposed in 1986. The use of SLIT was proposed following several surveys from the USA and UK that repeatedly reported fatalities due to SCIT (Lockey et al. in J Allergy Clin Immunol 75(1): 166,1985; Lockey et al. in J Allergy Clin Immunol 660 –77,1985; Committee on the safety of medicines. CSM update. Desensitizing vaccines. Br Med J...
Source: Current Allergy and Asthma Reports - December 11, 2016 Category: Allergy & Immunology Source Type: research
Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety
This study is registered with PROSPERO, number CRD42019117930.Results12 trials (n=1041; median age across trials 8·7 years [IQR 5·9–11·2]) showed that oral immunotherapy versus no oral immunotherapy increased anaphylaxis risk (risk ratio [RR] 3·12 [95% CI 1·76–5·55], I2=0%, risk difference [RD] 15·1%, high-certainty), anaphylaxis frequency (incidence rate ratio [IRR] 2·72 [1·57–4·72], I2=0%, RD 12·2%, high-certainty), and epinephrine use (RR 2·21 [1·27–3·83], I2=0%, RD 4·5%, high-certainty) similarly during build-up and maintenance (pinteraction=0·92). Oral immunotherapy increased serious adverse ev...
Source: The Lancet - April 26, 2019 Category: General Medicine Source Type: research
Recent Surveys on Food Allergy Prevalence
Substantial numbers of children and adults report having immunoglobulin E–mediated food allergies. However, generating accurate food allergy prevalence data is difficult. Self-reported data can overestimate prevalence when compared with prevalence estimates established by more rigorous methods. As of 2004, in the United States, the Food Allergen Labeling and Consumer Protection Act mandated that the label should declare the source of the food if the product contains that food or a protein-containing ingredient from that food (not all proteins in a major food allergen cause allergic reactions) in the manner described by t...
Source: Nutrition Today - January 1, 2020 Category: Nutrition Tags: Nutrition and the Lifecycle Source Type: research
Integrating oral immunotherapy into clinical practice
In 2020, the first food allergy treatment, an oral immunotherapy (OIT) product for peanut allergy, was approved by the Food and Drug Administration, and a peanut epicutaneous immunotherapy patch was under review. As food allergy therapies become available and widespread, allergy offices will need to adjust practices to be able to offer their patients these new treatments. OIT is an intensive therapy that requires commitment from patients and their families, and open communication with the practice is paramount.
Source: Journal of Allergy and Clinical Immunology - January 1, 2021 Category: Allergy & Immunology Authors: Stephanie A. Leonard, Susan Laubach, Julie Wang Tags: Reviews and feature article Source Type: research
Clinically relevant outcome measures for new pharmacotherapy, allergen avoidance and immunotherapy trials in allergic rhinoconjunctivitis
Purpose of review: The purpose of this review is to provide a current overview on both primary and secondary measures of efficacy of therapeutic interventions for clinical trials in allergic rhinoconjunctivitis (ARC) patients. In particular, this review highlights similarities and differences regarding endpoints in trials involving allergen immunotherapy (AIT), pharmacotherapy and allergen avoidance and addresses unmet needs regarding these measures in the future.
Recent findings: In 2014, the European Academy of Allergy and Clinical Immunology (EAACI) proposed a standard for the definition of the primary endpoint for AIT ...
Source: Current Opinion in Allergy and Clinical Immunology - April 29, 2015 Category: Allergy & Immunology Tags: OUTCOME MEASURES: Edited by Henry Milgrom and Pascal Demoly Source Type: research
Comparison of allergenic extracts from different origins: the value of the FDA's bioequivalent allergy unit (BAU).
Authors: Passalacqua G, Sastre J, Pfaar O, Wahn U, Demoly P
Abstract
INTRODUCTION: Allergy immunotherapy (AIT) is the only disease-modifying intervention for the treatment of allergic diseases. The clinical effectiveness of AIT is clearly dose-dependent, so it is important that clinicians can assess and compare the potency of the various products available. However, this is not possible in practice, because manufacturers use different methods to determine potency. Therefore, a clear need exists for adoption of a 'gold-standard' measure of allergenicity. The bioequivalent allergy unit (BAU) is thus far the only alle...
Source: Expert Review of Clinical Immunology - May 25, 2016 Category: Allergy & Immunology Tags: Expert Rev Clin Immunol Source Type: research
Local Side Effects of Sublingual and Oral Immunotherapy
Publication date: Available online 12 August 2016 Source:The Journal of Allergy and Clinical Immunology: In Practice Author(s): Giovanni Passalacqua, Anna Nowak-Węgrzyn, Giorgio Walter Canonica Sublingual immunotherapy (SLIT) is increasingly used worldwide, and several products have been recently registered as drugs for respiratory allergy by the European Medicine Agency and the Food and Drug Administration. Concerning inhalant allergens, the safety of SLIT is overall superior to that of subcutaneous immunotherapy in terms of systemic adverse events. No fatality has been ever reported, and episodes of anaphylaxis were de...
Source: The Journal of Allergy and Clinical Immunology: In Practice - August 12, 2016 Category: Allergy & Immunology Source Type: research
Is the better part of valor truly discretion?
Peanut allergy affects 1.4% to 4.5% of children, depending on the study and methodology. Self-reported estimates have shown an alarming 3-fold increase in US populations over 10 years, whereas UK data from a longitudinal birth cohort with challenge-based evidence have not reflected such an alarming increase.1 –4 Unfortunately, for years, the common peanut allergy management paradigm was to strictly avoid any potential exposure (including trace amounts) and carry self-injectable epinephrine. Now, we find the field on the cusp of what could be 2 therapies approved by the US Food and Drug Administration ( FDA) for the treat...
Source: Annals of Allergy, Asthma and Immunology - January 31, 2018 Category: Allergy & Immunology Authors: Matthew Greenhawt, John J. Oppenheimer Tags: Editorials Source Type: research
Qualitative evaluation of caregiver preferences for peanut immunotherapy products
In the article “Understanding caregiver goals, benefits, and acceptable risks of peanut allergy therapies,”1 the authors undertake the ambitious task of using qualitative research methods to describe the motivation and goals of caregivers of children with peanut allergy. This is a critically important area giv en the rapid increase in peanut allergy in the past 2 decades and the development of 2 different immunotherapy products, one or both of which will likely be approved by the US Food and Drug Administration and available for prescription by late 2019.
Source: Annals of Allergy, Asthma and Immunology - October 30, 2018 Category: Allergy & Immunology Authors: Stephen A. Tilles Tags: Correspondence Source Type: research
A New Peanut Allergy Drug Could Be a Promising Treatment for Children
A new drug could become the first-ever protective treatment for the more than one million children in the U.S. who suffer from peanut allergies.
In a phase-three trial, the results of which were published in the New England Journal of Medicine, the peanut-derived drug AR101 helped some children with severe peanut allergies tolerate the equivalent of two peanut kernels without serious side effects. Prior to taking the drug, none of these children could safely ingest more than the equivalent of one-tenth of a kernel.
AR101, which is manufactured by Aimmune Therapeutics (the company also designed and funded the study), delive...
Source: TIME: Health - November 19, 2018 Category: Consumer Health News Authors: Jamie Ducharme Tags: Uncategorized healthytime Research Source Type: news
