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Article ; Online: The need for change: Lessons learned from Food and Drug Administration-approved peanut oral immunotherapy.

Mustafa, S Shahzad / Mack, Douglas P

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

2023 Volume 130, Issue 5, Page(s) 542–543

MeSH term(s)	United States ; Humans ; Arachis ; Peanut Hypersensitivity/therapy ; United States Food and Drug Administration ; Fabaceae ; Allergens ; Administration, Oral ; Desensitization, Immunologic ; Immunotherapy
Chemical Substances	Allergens
Language	English
Publishing date	2023-05-03
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	1228189-x
ISSN	1534-4436 ; 0003-4738 ; 1081-1206
ISSN (online)	1534-4436
ISSN	0003-4738 ; 1081-1206
DOI	10.1016/j.anai.2023.01.031
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Article ; Online: Flex-IT! Applying "Platform Trials" Methodology to Immunotherapy for Food Allergy in Research and Clinical Practice.

Mack, Douglas P / Upton, Julia / Patel, Nandinee / Turner, Paul J

The journal of allergy and clinical immunology. In practice

2024 Volume 12, Issue 3, Page(s) 554–561

Abstract: There is an increasing trend in the management of food allergy toward active treatment using allergen immunotherapy (AIT). Although AIT is efficacious, treatment-related adverse events are common, particularly with oral immunotherapy in those with high ... ...

Abstract	There is an increasing trend in the management of food allergy toward active treatment using allergen immunotherapy (AIT). Although AIT is efficacious, treatment-related adverse events are common, particularly with oral immunotherapy in those with high levels of allergen-specific IgE sensitization. In clinical practice, these adverse events inevitably create challenges: clinicians and patients routinely face decisions whether to alter the dose itself, the frequency of dosing, and the pace of escalation, or indeed discontinue AIT altogether. Flexibility is therefore needed to adapt treatment, particularly in clinical practice, so that participants are "treated-to-target." For example, this may entail a significant change in the dosing protocol or even switching from one route of administration to another in response to frequent adverse events. We refer to this approach as flexible immunotherapy. However, there is little evidence to inform clinicians as to what changes to treatment are most likely to result in treatment success. Classical clinical trials rely, by necessity, on relatively rigid updosing protocols. To provide an evidence base to optimize AIT, the food allergy community should adopt adaptive platform trials, where a "master protocol" facilitates more efficient evaluation, including longer-term outcomes of multiple interventions. Within a single clinical trial, participants are able to switch between different treatment arms; interventions can be added or dropped without compromising the integrity of the trial. Developing platform trials for food AIT may initially be costly, but they represent a significant opportunity to grow the evidence base (with respect to both treatment outcomes and biomarker discovery) at scale. In addition, they could help understand longitudinal disease trajectories that are difficult to study in clinical trials for food allergy due to the time needed to demonstrate changes in efficacy. Finally, their adoption would achieve greater collaboration and consistency in approaches to proactive management of food allergy in routine clinical practice. As a community, we need to actively pursue this with funders and established research collaborations to deliver the very best outcomes for our patients and their families.
MeSH term(s)	Humans ; Food Hypersensitivity/therapy ; Food Hypersensitivity/etiology ; Desensitization, Immunologic/methods ; Food ; Allergens/therapeutic use ; Administration, Oral
Chemical Substances	Allergens
Language	English
Publishing date	2024-01-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2024.01.009
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Article ; Online: SQ sublingual immunotherapy tablets for children with allergic rhinitis: A review of phase three trials.

Csonka, Péter / Hamelmann, Eckard / Turkalj, Mirjana / Roberts, Graham / Mack, Douglas P

Acta paediatrica (Oslo, Norway : 1992)

2024

Abstract: Aim: To provide paediatricians with a summary of efficacy and safety of SQ sublingual immunotherapy (SLIT) tablets from phase three, randomised, double-blind, placebo-controlled trials in children and adolescents with allergic rhinitis or ... ...

Abstract	Aim: To provide paediatricians with a summary of efficacy and safety of SQ sublingual immunotherapy (SLIT) tablets from phase three, randomised, double-blind, placebo-controlled trials in children and adolescents with allergic rhinitis or rhinoconjunctivitis, with and without asthma. Methods: PubMed searches were conducted and unpublished data were included if necessary. Results: Of the 93 publications, 12 were identified reporting 10 trials. One trial was excluded as paediatric-specific efficacy data were unavailable. The nine eligible trials evaluated grass, house dust mite, ragweed and tree SLIT tablets. Consistent reductions in allergic rhinitis or rhinoconjunctivitis symptoms and medication use were observed with SQ SLIT tablets versus placebo. In a five-year trial, sustained reduction of allergic rhinoconjunctivitis symptoms, asthma symptoms and medication use were observed with SQ grass SLIT tablet versus placebo. The number-needed-to-treat to prevent asthma symptoms and medication use in one additional child during follow-up was lowest in younger children. SQ SLIT tablets were generally well tolerated across trials. Conclusion: Evidence supports use of SQ SLIT tablets in children and adolescents with allergic rhinitis or rhinoconjunctivitis, with and without asthma. Long-term data demonstrate disease-modifying effects of SQ grass SLIT tablet and suggest the clinical relevance of initiating allergy immunotherapy earlier in the disease course.
Language	English
Publishing date	2024-03-26
Publishing country	Norway
Document type	Journal Article ; Review
ZDB-ID	203487-6
ISSN	1651-2227 ; 0365-1436 ; 0803-5253
ISSN (online)	1651-2227
ISSN	0365-1436 ; 0803-5253
DOI	10.1111/apa.17221
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Article ; Online: An allergist's approach to food poisoning.

Patel, Pinkal / Komorowski, Adam S / Mack, Douglas P

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

2022 Volume 130, Issue 4, Page(s) 444–451

Abstract: Foodborne illnesses represent a significant global health concern. These preventable diseases lead to substantial mortality and morbidity worldwide. Substantial overlap with food allergy exists with similar clinical presentations and symptom onset. ... ...

Abstract	Foodborne illnesses represent a significant global health concern. These preventable diseases lead to substantial mortality and morbidity worldwide. Substantial overlap with food allergy exists with similar clinical presentations and symptom onset. Knowledge of the typically implicated microorganisms and toxins can help properly identify these diseases. A thorough history is essential to differentiate between these 2 disorders. The types of food implicated may be similar including milk, egg, fish, and shellfish. The timing of symptom onset may overlap and lead to misdiagnosis of disorders such as food protein-induced enterocolitis syndrome. Classically, histamine-related food poisoning is also typically confused with true food allergy and may be seen as related to fish and cheese. Knowledge of epidemiology, patterns, and etiology of allergic conditions and foodborne illness may help the allergist differentiate among these common diseases.
MeSH term(s)	Animals ; Humans ; Allergists ; Foodborne Diseases/diagnosis ; Foodborne Diseases/epidemiology ; Foodborne Diseases/etiology ; Food Hypersensitivity/diagnosis ; Food Hypersensitivity/epidemiology ; Food Hypersensitivity/etiology ; Seafood ; Allergens
Chemical Substances	Allergens
Language	English
Publishing date	2022-11-02
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1228189-x
ISSN	1534-4436 ; 0003-4738 ; 1081-1206
ISSN (online)	1534-4436
ISSN	0003-4738 ; 1081-1206
DOI	10.1016/j.anai.2022.10.021
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Article: Practical challenges in oral immunotherapy resolved through patient-centered care.

Graham, François / Mack, Douglas P / Bégin, Philippe

Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology

2021 Volume 17, Issue 1, Page(s) 31

Abstract: Oral immunotherapy (OIT) is now widely recognized as a valid option for the management of IgE-mediated food allergies. However, in real-life practice, OIT can lead to a variety of unique situations where the best course of action is undetermined. In ... ...

Abstract	Oral immunotherapy (OIT) is now widely recognized as a valid option for the management of IgE-mediated food allergies. However, in real-life practice, OIT can lead to a variety of unique situations where the best course of action is undetermined. In patient-centered care, individual patient preferences, needs and values, should guide all clinical decisions. This can be achieved by using shared-decision making and treatment customization to navigate areas of uncertainty in a way that is responsive to patient's needs and preferences. However, in the context of OIT, lack of awareness of potential protocol adaptability or alternatives can become a barrier to treatment personalization. The purpose of this article is to review the theoretical bases of patient-centered care and shared decision-making and their practical implication for the patient-centered delivery of OIT. Clinical cases highlighting common challenges in real-life OIT practice are presented along with a discussion of potential personalized management options to be considered. While the practice of OIT is bound to evolve as additional scientific and experiential knowledge is gained, it should always remain rooted in the general principles of patient-centered care.
Language	English
Publishing date	2021-03-18
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2434973-2
ISSN	1710-1492 ; 1710-1484
ISSN (online)	1710-1492
ISSN	1710-1484
DOI	10.1186/s13223-021-00533-6
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Article ; Online: Age-Related Food Aversion and Anxiety Represent Primary Patient Barriers to Food Oral Immunotherapy.

Trevisonno, Jordan / Venter, Carina / Pickett-Nairne, Kaci / Bégin, Philippe / Cameron, Scott B / Chan, Edmond S / Cook, Victoria E / Factor, Jeffrey M / Groetch, Marion / Hanna, Mariam A / Jones, Douglas H / Wasserman, Richard L / Mack, Douglas P

The journal of allergy and clinical immunology. In practice

2024

Abstract: ... represented the prominent obstacle to continuation. Taste aversion was associated with a slower buildup (P ... 02) and a reduction in dose (P = .002). Taste aversion was a strongly age-dependent barrier ... for initiation (P < .001) and continuation (P < .002), with older children over 6 years of age reporting ...

Abstract	Background: Although oral immunotherapy (OIT) for food allergy is a reasonable treatment option, barriers to this procedure's implementation have not been extensively evaluated from a patient perspective. Objective: We evaluated the barriers patients face during OIT administration, including anxiety and taste aversion, and the role of health care professionals, especially dietitians. Methods: A survey in Canada and the United States involved families currently enrolled in food OIT programs. Results: Of responses from 379 participants, fear of reaction was the most common barrier to OIT initiation, with 45.6% reporting it being a "very significant" barrier with other fears reported. However, taste aversion represented the prominent obstacle to continuation. Taste aversion was associated with a slower buildup (P = .02) and a reduction in dose (P = .002). Taste aversion was a strongly age-dependent barrier for initiation (P < .001) and continuation (P < .002), with older children over 6 years of age reporting it as a very significant barrier (P < .001). Boredom was reported as a concern for specific allergens such as peanut, egg, sesame, and hazelnuts (P < .05), emphasizing the need for diverse food options. Notably, 59.9% of respondents mixed OIT foods with sweet items. Despite these dietary concerns, dietitians were underutilized, with only 9.5% of respondents having seen a dietitian and the majority finding dietitian support helpful with greater certainty about the exact dose (P < .001). Conclusions: Taste aversion and anxiety represent primary patient-related barriers to OIT. Taste aversion was highly age dependent, with older patients being more affected. Dietitians and psychology support were underutilized, representing a critical target to improve adherence and OIT success.
Language	English
Publishing date	2024-03-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2024.03.014
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Article ; Online: Updates in Food Allergy Prevention in Children.

Abrams, Elissa M / Shaker, Marcus / Stukus, David / Mack, Douglas P / Greenhawt, Matthew

Pediatrics

2023 Volume 152, Issue 5

Abstract: Although significant evidence exists that feeding early has a role in the prevention of food allergy, this intervention in isolation may not be sufficient. Recent evidence highlights that early introduction of peanut specifically has had no significant ... ...

Abstract	Although significant evidence exists that feeding early has a role in the prevention of food allergy, this intervention in isolation may not be sufficient. Recent evidence highlights that early introduction of peanut specifically has had no significant impact on the populational prevalence of peanut allergy. Other factors that may contribute to food allergy prevention include regularity of ingestion once an allergen is introduced and consideration to the form in which the allergen is introduced (such as baked versus cooked egg). There are also many practicalities to early feeding and some discrepant viewpoints on these practicalities, which has led to poor implementation of early feeding strategies. In general, preemptive screening before food introduction is not recommended by most international allergy societies. Although there is little guidance to inform early introduction of allergens other than milk, egg, and peanut, the mechanism of sensitization is thought to be similar and there is no harm to early introduction. In terms of frequency and duration of feeding, there is little evidence to inform any concrete recommendations.
MeSH term(s)	Humans ; Child ; Infant ; Animals ; Food Hypersensitivity/epidemiology ; Food Hypersensitivity/prevention & control ; Peanut Hypersensitivity/epidemiology ; Peanut Hypersensitivity/prevention & control ; Peanut Hypersensitivity/diagnosis ; Milk ; Allergens ; Arachis ; Egg Hypersensitivity/diagnosis
Chemical Substances	Allergens
Language	English
Publishing date	2023-10-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	207677-9
ISSN	1098-4275 ; 0031-4005
ISSN (online)	1098-4275
ISSN	0031-4005
DOI	10.1542/peds.2023-062836
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Article: Minimization of ragweed allergy immunotherapy costs through use of the sublingual immunotherapy tablet in Canadian children with allergic rhinoconjunctivitis.

Ellis, Anne K / Mack, Douglas P / Gagnon, Rémi / Hammerby, Eva / Gosain, Sheena

Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology

2023 Volume 19, Issue 1, Page(s) 7

Abstract: Background: Allergy immunotherapy (AIT), in the form of subcutaneous immunotherapy (SCIT) with alum-precipitated aqueous extracts, SCIT with a modified ragweed pollen allergen tyrosine adsorbate (MRPATA; Pollinex: Methods: A cost minimization ... ...

Abstract	Background: Allergy immunotherapy (AIT), in the form of subcutaneous immunotherapy (SCIT) with alum-precipitated aqueous extracts, SCIT with a modified ragweed pollen allergen tyrosine adsorbate (MRPATA; Pollinex Methods: A cost minimization analysis was conducted comparing the short ragweed SLIT-tablet, 12 Amb a 1-U, preseasonally with preseasonal ragweed SCIT, annual ragweed SCIT, or MRPATA. The analysis was conducted over a time horizon of 3 years from a public payer perspective in Ontario and Quebec. Resources and costs associated with medication and services of healthcare professionals were considered for each treatment. The resource and cost input values for the model were obtained from published literature and validated by Canadian clinical experts in active allergy practice. A discount rate of 1.5% was applied. Several scenario analyses were conducted to determine the impact of many of the key base case assumptions on the outcomes. Results: Over the total 3-year time horizon, the ragweed SLIT-tablet had a potential cost savings of $900.14 in Ontario and $1023.14 in Quebec when compared with preseasonal ragweed SCIT, of $6613.22 in Ontario and $8750.64 in Quebec when compared with annual ragweed SCIT, and $79.62 in Ontario and $429.49 in Quebec when compared with MRPATA. The ragweed SLIT-tablet had higher drug costs compared with the other AIT options, but lower costs for healthcare professional services. The lower costs for healthcare professional services with the ragweed SLIT-tablet were driven by the need for fewer office visits than SCIT. Scenario analysis indicated that costs were most impacted by including societal costs (e.g., costs associated with patient/caregiver travel and time lost). The potential cost savings of the ragweed SLIT-tablet versus SCIT and MRPATA was maintained in most scenarios. Conclusions: In this cost minimization analysis, the ragweed SLIT-tablet provided estimated cost savings from a public payer perspective for the treatment of ragweed ARC in Canadian children compared with SCIT or MRPATA.
Language	English
Publishing date	2023-01-18
Publishing country	England
Document type	Journal Article
ZDB-ID	2434973-2
ISSN	1710-1492 ; 1710-1484
ISSN (online)	1710-1492
ISSN	1710-1484
DOI	10.1186/s13223-023-00758-7
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Article ; Online: Protective role of tissue-resident Tregs in a murine model of beryllium-induced disease.

Atif, Shaikh M / Mack, Douglas G / Martin, Allison K / Fontenot, Andrew P

JCI insight

2022 Volume 7, Issue 16

Abstract: CD4+ T cells drive the immunopathogenesis of chronic beryllium disease (CBD), and their recruitment to the lung heralds the onset of granulomatous inflammation. We have shown that CD4+ Tregs control granuloma formation in an HLA-DP2 Tg model of CBD. In ... ...

Abstract	CD4+ T cells drive the immunopathogenesis of chronic beryllium disease (CBD), and their recruitment to the lung heralds the onset of granulomatous inflammation. We have shown that CD4+ Tregs control granuloma formation in an HLA-DP2 Tg model of CBD. In these mice, beryllium oxide (BeO) exposure resulted in the accumulation of 3 distinct CD4+ T cell subsets in the lung, with the majority of tissue-resident memory cells expressing FoxP3. The amount of Be regulated the number of total and antigen-specific CD4+ T cells and Tregs in the lungs of HLA-DP2 Tg mice. Depletion of Tregs increased the number of IFN-γ-producing CD4+ T cells and enhanced lung injury, while mice treated with IL-2/αIL-2 complexes had increased Tregs and reduced inflammation and Be-responsive T cells in the lung. BeO-experienced resident Tregs suppressed anti-CD3-induced proliferation of CD4+ T cells in a contact-dependent manner. CTLA-4 and ICOS blockade, as well as the addition of LPS to BeO-exposed mice, increased the effector T cell (Teff)/Treg ratio and enhanced lung injury. Collectively, these data show that the protective role of tissue-resident Tregs is dependent on quantity of Be exposure and is overcome by blocking immune regulatory molecules or additional environmental insults.
MeSH term(s)	Animals ; Berylliosis ; Beryllium ; Disease Models, Animal ; Inflammation ; Lung Injury ; Mice
Chemical Substances	Beryllium (OW5102UV6N)
Language	English
Publishing date	2022-08-22
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ISSN	2379-3708
ISSN (online)	2379-3708
DOI	10.1172/jci.insight.156098
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Article ; Online: Weighing peanut candies used for oral immunotherapy mitigates variable peanut protein dose.

Mack, Douglas P / Foster, Gary A / Mack, Jacob D / Mack, Lauren C / Hanna, Mariam A

The journal of allergy and clinical immunology. In practice

2020 Volume 9, Issue 1, Page(s) 521–523.e1

MeSH term(s)	Administration, Oral ; Allergens ; Arachis ; Candy ; Desensitization, Immunologic ; Humans ; Immunotherapy ; Peanut Hypersensitivity/therapy
Chemical Substances	Allergens
Keywords	covid19
Language	English
Publishing date	2020-08-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2020.07.054
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