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Kari C. Nadeau - One of the best experts on this subject based on the ideXlab platform.
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Trends in egg specific immunoglobulin levels during natural tolerance and Oral Immunotherapy
Allergy, 2019Co-Authors: Sandra Andorf, Bryan J. Bunning, Dana Tupa, Shu Cao, Andrew J. Long, Magnus P. Borres, Stephen J. Galli, Rebecca S. Chinthrajah, Kari C. NadeauAbstract:Trends in egg specific immunoglobulin levels during natural tolerance and Oral Immunotherapy
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Anti-IgE treatment with Oral Immunotherapy in multifood allergic participants: a double-blind, randomised, controlled trial
The lancet. Gastroenterology & hepatology, 2017Co-Authors: Sandra Andorf, Dana Tupa, Andrew J. Long, Stephen J. Galli, Natasha Purington, Whitney Block, Erica Brittain, Amanda Rudman Spergel, Manisha Desai, Kari C. NadeauAbstract:Summary Background Despite progress in single food Oral Immunotherapy, there is little evidence concerning the safety and efficacy of treating individuals with multiple food (multifood) allergies. We did a pilot study testing whether anti-IgE (omalizumab) combined with multifood Oral Immunotherapy benefited multifood allergic patients. Methods We did a blinded, phase 2 clinical trial at Stanford University. We enrolled participants, aged 4–15 years, with multifood allergies validated by double-blind, placebo-controlled food challenges to their offending foods. Inclusion criteria included a positive skin prick test of 6 mm or more (wheal diameter, above the negative control), a food-specific serum IgE concentration of more than 4 kU/L for each food, or both, and a positive double-blind, placebo-controlled food challenge at 500 mg or less of food protein. Exclusion criteria included eosinophilic oesophagitis and severe asthma. Participants were randomised (3:1) with a block size of four, to receive multifood Oral Immunotherapy to two to five foods, together with omalizumab (n=36) or placebo (n=12). 12 individuals who fulfilled the same inclusion and exclusion criteria were included as controls. These individuals were not randomised and received neither omalizumab nor Oral Immunotherapy. Omalizumab or placebo was administered subcutaneously for 16 weeks, with Oral Immunotherapy starting at week 8, and was stopped 20 weeks before the exit double-blind, placebo-controlled food challenge at week 36. The primary endpoint was the proportion of participants who passed double-blind, placebo-controlled food challenges to at least two of their offending foods. This completed trial is registered with ClinicalTrials.gov, number NCT02643862. Findings Between March 25, 2015, and Aug 18, 2016, 165 participants were assessed for eligibility, of whom 84 did not meet the inclusion criteria and 21 declined to participate. We enrolled and randomised 48 eligible participants and the remaining 12 patients were included as nonrandomised, untreated controls. At week 36, a significantly greater proportion of the omalizumab-treated (30 [83%] of 36) versus placebo (four [33%] of 12) participants passed double-blind, placebo-controlled food challenges to 2 g protein for two or more of their offending foods (odds ratio 10·0, 95% CI 1·8–58·3, p=0·0044). All participants completed the study. There were no serious or severe (grade 3 or worse) adverse events. Participants in the omalizumab group had a significantly lower median per-participant percentage of Oral Immunotherapy doses associated with any adverse events (27% vs 68%; p=0·0082). The most common adverse events in both groups were gastrointestinal events. Interpretation In multifood allergic patients, omalizumab improves the efficacy of multifood Oral Immunotherapy and enables safe and rapid desensitisation. Funding US National Institutes of Health (NIH).
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combining anti ige with Oral Immunotherapy
Applied Immunohistochemistry & Molecular Morphology, 2017Co-Authors: Chunrong Lin, Ivan T. Lee, Vanitha Sampath, Chitra Dinakar, Rosemarie H. Dekruyff, Lynda C. Schneider, Kari C. NadeauAbstract:Food allergy is a significant medical problem that affects up to 8% of children in developed countries. At present, there are no curative therapies available in routine practice and management of food allergy involves strict allergen avoidance, education, and prompt treatment upon accidental exposure. Oral Immunotherapy (OIT) is an efficacious experimental approach to food allergy and has been shown to provide a substantial benefit in terms of allergen desensitization. However, OIT is associated with high rates of allergic reactions, and the period of protection offered by OIT appears to be limited and highly variable. Recurrence of allergen sensitivity after a period of treatment discontinuation is commonly observed. With the aim of overcoming these limitations of OIT, several trials have studied omalizumab (anti-IgE monoclonal antibody) as an adjuvant treatment for patients undergoing OIT. Results from these trials have shown that the addition of omalizumab to OIT leads to a significant decrease in the frequency and severity of reactions, which allows for an increase in the threshold of tolerance to food allergens. This review provides a summary of the current literature and addresses some of the key questions that remain regarding the use of omalizumab in conjunction with OIT.
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Combining anti‐IgE with Oral Immunotherapy
Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2017Co-Authors: Chunrong Lin, Ivan T. Lee, Vanitha Sampath, Chitra Dinakar, Rosemarie H. Dekruyff, Lynda C. Schneider, Kari C. NadeauAbstract:Food allergy is a significant medical problem that affects up to 8% of children in developed countries. At present, there are no curative therapies available in routine practice and management of food allergy involves strict allergen avoidance, education, and prompt treatment upon accidental exposure. Oral Immunotherapy (OIT) is an efficacious experimental approach to food allergy and has been shown to provide a substantial benefit in terms of allergen desensitization. However, OIT is associated with high rates of allergic reactions, and the period of protection offered by OIT appears to be limited and highly variable. Recurrence of allergen sensitivity after a period of treatment discontinuation is commonly observed. With the aim of overcoming these limitations of OIT, several trials have studied omalizumab (anti-IgE monoclonal antibody) as an adjuvant treatment for patients undergoing OIT. Results from these trials have shown that the addition of omalizumab to OIT leads to a significant decrease in the frequency and severity of reactions, which allows for an increase in the threshold of tolerance to food allergens. This review provides a summary of the current literature and addresses some of the key questions that remain regarding the use of omalizumab in conjunction with OIT.
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Oral Immunotherapy for food allergy
Seminars in immunology, 2017Co-Authors: Deborah M. Hussey Freeland, Monali Manohar, Sandra Andorf, Benjamin D. Hobson, Wenming Zhang, Kari C. NadeauAbstract:Food allergy is a pathological, potentially deadly cascade of immune responses to molecules or molecular fragments that are normally innocuous when encountered in foods, such as milk, egg, or peanut. As the incidence and prevalence of food allergy rise, the standard of care is poised to advance beyond food allergen avoidance coupled with injectable epinephrine treatment of allergen-induced systemic reactions. Recent studies provide evidence that Oral Immunotherapy may effectively redirect the atopic immune responses of food allergy patients as they ingest small but gradually increasing allergen doses over many months, eliciting safer immune responses to these antigens. Research into the molecular and cellular bases of pathological and therapeutic immune responses, and into the possibilities for their safe and effective modulation, is generating tremendous interest in basic and clinical immunology. We synthesize developments, innovations, and key challenges in our understanding of the immune mechanisms associated with atopy and Oral Immunotherapy for food allergy.
Mimi L.k. Tang - One of the best experts on this subject based on the ideXlab platform.
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Peanut Oral Immunotherapy: State of the Art.
Immunology and allergy clinics of North America, 2019Co-Authors: Mimi L.k. Tang, Adriana Chebar Lozinsky, Paxton LokeAbstract:Cumulative evidence shows that peanut Oral Immunotherapy (OIT) is effective at inducing desensitization through downregulation of effector pathways in the allergic reaction cascade; however, only a subset of patients achieve sustained unresponsiveness (remission), which requires redirection of the underlying allergic response toward tolerance. A recent meta-analysis of peanut OIT randomized trials found that OIT is associated with a threefold greater risk of anaphylaxis and twofold greater risk of epinephrine use than allergen avoidance. Strategies to reduce adverse events associated with OIT and improve the ability for OIT to induce sustained unresponsiveness are required to improve the benefit-risk of peanut OIT.
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The longitudinal impact of probiotic and peanut Oral Immunotherapy on health-related quality of life.
Allergy, 2017Co-Authors: A. Dunn Galvin, Annelouise Ponsonby, S. Mcmahon, K.‐c. Hsiao, Mimi L.k. TangAbstract:Background We previously reported that probiotic and peanut Oral Immunotherapy (PPOIT) was effective at inducing sustained unresponsiveness compared with placebo in a double-blind, placebo-controlled randomized trial. This study evaluated the impact of PPOIT on health-related quality of life (HRQL). Method Fifty-one participants (PPOIT 24; placebo 27) from the PPOIT trial completed Food Allergy Quality of Life Questionnaire (FAQLQ-PF) and Food Allergy Independent Measure (FAIM) at pre-treatment, end-of-treatment and 3 months after end-of-treatment. A total of 42 participants (20 PPOIT; 22 placebo) completed measures at 12 months post-treatment. Changes over time in PPOIT and placebo groups were examined by repeated-measures analysis of variance and paired t tests. Results Probiotic and peanut Oral Immunotherapy was associated with significant improvement in FAQLQ-PF (F = 3.63, P = .02), with mean difference 0.8 at 3 months post-treatment (P = .05) and 1.3 at 12 months post-treatment (P = .005), exceeding the 0.5 minimal clinically important difference for FAQLQ-PF. For FAIM, mean difference was 0.5 (P = .03) at 3 months and 0.4 (P = .04) at 12 months post-treatment. In placebo group, post-treatment FAQLQ and FAIM remained unchanged from pretreatment. Improvement in FAQLQ-PF and FAIM scores related specifically to acquisition of sustained unresponsiveness rather than to receiving PPOIT treatment or participation in the trial. Conclusions Probiotic and peanut Oral Immunotherapy has a sustained beneficial effect on psychosocial impact of food allergy at 3 and 12 months after end-of-treatment. Treatment was not associated with reduced HRQL relative to baseline in either PPOIT or placebo groups, indicating that PPOIT was well tolerated and psychological well-being was not negatively impacted. Improved HRQL was specifically associated with acquisition of sustained unresponsiveness.
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An update on Oral Immunotherapy for the treatment of food allergy
Paediatrics and Child Health, 2016Co-Authors: Mimi L.k. Tang, Kuang-chih HsiaoAbstract:Abstract Food allergy is an important public health concern, affecting 10% of infants, 5–6% of children and 2% of adults in westernized countries. Current management involves food avoidance, education of patients and carers in the emergency management of allergic reactions and in some cases provision of an adrenaline autoinjector. Oral Immunotherapy (OIT) has recently been explored as a potential treatment for food allergy. This review will discuss mechanisms of Oral tolerance and summarize clinical and immunologic effects of OIT.
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administration of a probiotic with peanut Oral Immunotherapy a randomized trial
The Journal of Allergy and Clinical Immunology, 2015Co-Authors: Mimi L.k. Tang, Wesley Burks, Annelouise Ponsonby, Francesca Orsini, Dean Tey, Marnie Robinson, Paul V Licciardi, Susan DonathAbstract:Background Coadministration of a bacterial adjuvant with Oral Immunotherapy (OIT) has been suggested as a potential treatment for food allergy. Objective To evaluate a combined therapy comprising a probiotic together with peanut OIT. Methods We performed a double-blind, placebo-controlled randomized trial of the probiotic Lactobacillus rhamnosus CGMCC 1.3724 and peanut OIT (probiotic and peanut Oral Immunotherapy [PPOIT]) in children (1-10 years) with peanut allergy. The primary outcome was induction of sustained unresponsiveness 2 to 5 weeks after discontinuation of treatment (referred to as possible sustained unresponsiveness). Secondary outcomes were desensitization, peanut skin prick test, and specific IgE and specific IgG 4 measurements. Results Sixty-two children were randomized and stratified by age (≤5 and >5 years) and peanut skin test wheal size (≤10 and >10 mm); 56 reached the trial's end. Baseline demographics were similar across groups. Possible sustained unresponsiveness was achieved in 82.1% receiving PPOIT and 3.6% receiving placebo ( P P 4 levels (all P Conclusion This is the first randomized placebo-controlled trial evaluating the novel coadministration of a probiotic and peanut OIT and assessing sustained unresponsiveness in children with peanut allergy. PPOIT was effective in inducing possible sustained unresponsiveness and immune changes that suggest modulation of the peanut-specific immune response. Further work is required to confirm sustained unresponsiveness after a longer period of secondary peanut elimination and to clarify the relative contributions of probiotics versus OIT.
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Oral Immunotherapy and tolerance induction in childhood.
Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology, 2013Co-Authors: Mimi L.k. Tang, David MartinoAbstract:Prevalence rates of food allergy have increased rapidly in recent decades. Of concern, rates of increase are greatest among children under 5 yrs of age and for those food allergies that persist into adulthood such as peanut or tree nut allergy and shellfish allergy. Given these trends, the overall prevalence of food allergy will compound over time as the number of children affected by food allergy soars and a greater proportion of food-allergic children are left with persistent disease into adulthood. It is therefore vital to identify novel curative treatment approaches for food allergy. Acquisition of Oral tolerance to the diverse array of ingested food antigens and intestinal microbiota is an active immunologic process that is successfully established in the majority of individuals. In subjects who develop food allergy, there is a failure or loss of Oral tolerance acquisition to a limited number of food allergens. Oral Immunotherapy (OIT) offers a promising approach to induce specific Oral tolerance to selected food allergens and represents a potential strategy for long-term curative treatment of food allergy. This review will summarize the current understanding of Oral tolerance and clinical trials of OIT for the treatment of food allergy.
Brian P. Vickery - One of the best experts on this subject based on the ideXlab platform.
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Peanut Oral Immunotherapy: a Current Perspective.
Current allergy and asthma reports, 2020Co-Authors: Meera Patrawala, Jennifer Shih, Gerald B. Lee, Brian P. VickeryAbstract:Peanut Oral Immunotherapy (OIT) is one of the most studied experimental therapies for food allergy. With the recently FDA-approved peanut product, Palforzia, the goal of this article is to review the most recent data from clinical trials, discuss recent trends, and anticipate future developments. The latest research suggests that peanut OIT could be a promising option for peanut-allergic patients, with the majority of participants in research studies achieving the primary efficacy endpoint of desensitization, as well as sustained unresponsiveness in select populations. Some studies also showed improvements in food allergy-related quality of life. However, peanut OIT is not without risk or side effects, including potentially serious allergic reactions. Future research will need to evaluate the short- and long-term effectiveness of the therapy in the real-world setting, predictors of important treatment outcomes, and the use of adjunctive therapies that may mitigate some of these allergic reactions.
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ar101 Oral Immunotherapy for peanut allergy
The New England Journal of Medicine, 2018Co-Authors: Brian P. Vickery, Stacie M. Jones, Kirsten Beyer, Wayne G Shreffler, Andrea Vereda, Thomas B Casale, George Du Toit, Jonathan Ob Hourihane, Annette MarcantonioAbstract:BACKGROUND Peanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions. METHODS In a phase 3 trial, we screened participants 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge. Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic Oral Immunotherapy drug) or placebo in an escalating-dose program. Participants who completed the regimen (i.e., received 300 mg per day of the maintenance regimen for approximately 24 weeks) underwent a double-blind, placebo-controlled food challenge at trial exit. The primary efficacy end point was the proportion of participants 4 to 17 years of age who could ingest a challenge dose of 600 mg or more, without dose-limiting symptoms. RESULTS Of the 551 participants who received AR101 or placebo, 496 were 4 to 17 years of age; of these, 250 of 372 participants (67.2%) who received active treatment, as compared with 5 of 124 participants (4.0%) who received placebo, were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge (difference, 63.2 percentage points; 95% confidence interval, 53.0 to 73.3; P<0.001). During the exit food challenge, the maximum severity of symptoms was moderate in 25% of the participants in the active-drug group and 59% of those in the placebo group and severe in 5% and 11%, respectively. Adverse events during the intervention period affected more than 95% of the participants 4 to 17 years of age. A total of 34.7% of the participants in the active-drug group had mild events, as compared with 50.0% of those in the placebo group; 59.7% and 44.4% of the participants, respectively, had events that were graded as moderate, and 4.3% and 0.8%, respectively, had events that were graded as severe. Efficacy was not shown in the participants 18 years of age or older. CONCLUSIONS In this phase 3 trial of Oral Immunotherapy in children and adolescents who were highly allergic to peanut, treatment with AR101 resulted in higher doses of peanut protein that could be ingested without dose-limiting symptoms and in lower symptom severity during peanut exposure at the exit food challenge than placebo. (Funded by Aimmune Therapeutics; PALISADE ClinicalTrials.gov number, NCT02635776 .).
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AR101 Oral Immunotherapy for Peanut Allergy
The New England journal of medicine, 2018Co-Authors: Brian P. Vickery, Stacie M. Jones, Kirsten Beyer, Wayne G Shreffler, Andrea Vereda, Thomas B Casale, George Du Toit, Jonathan Ob Hourihane, Annette Marcantonio, Rezi ZawadzkiAbstract:BACKGROUND Peanut allergy, for which there are no approved treatment options, affects patients who are at risk for unpredictable and occasionally life-threatening allergic reactions. METHODS In a phase 3 trial, we screened participants 4 to 55 years of age with peanut allergy for allergic dose-limiting symptoms at a challenge dose of 100 mg or less of peanut protein (approximately one third of a peanut kernel) in a double-blind, placebo-controlled food challenge. Participants with an allergic response were randomly assigned, in a 3:1 ratio, to receive AR101 (a peanut-derived investigational biologic Oral Immunotherapy drug) or placebo in an escalating-dose program. Participants who completed the regimen (i.e., received 300 mg per day of the maintenance regimen for approximately 24 weeks) underwent a double-blind, placebo-controlled food challenge at trial exit. The primary efficacy end point was the proportion of participants 4 to 17 years of age who could ingest a challenge dose of 600 mg or more, without dose-limiting symptoms. RESULTS Of the 551 participants who received AR101 or placebo, 496 were 4 to 17 years of age; of these, 250 of 372 participants (67.2%) who received active treatment, as compared with 5 of 124 participants (4.0%) who received placebo, were able to ingest a dose of 600 mg or more of peanut protein, without dose-limiting symptoms, at the exit food challenge (difference, 63.2 percentage points; 95% confidence interval, 53.0 to 73.3; P
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Immune mechanisms of Oral Immunotherapy
The Journal of allergy and clinical immunology, 2017Co-Authors: Michael D. Kulis, Sarita U. Patil, Erik Wambre, Brian P. VickeryAbstract:Oral Immunotherapy (OIT) has demonstrated reproducibly successful desensitization in patients with food allergy completing clinical trials and, in some studies, sustained unresponsiveness. These clinical outcomes have been associated with characteristic modifications in the allergen-specific immune response, but a detailed synthesis of OIT's mechanisms of action is lacking. In this rostrum we review the current evidence regarding the human immune response to OIT, explore possible mechanisms, and identify knowledge gaps for future research.
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Oral Immunotherapy for Food Allergy.
Immunology and allergy clinics of North America, 2016Co-Authors: Allison J. Burbank, Brian P. Vickery, Puja Sood, Robert A. WoodAbstract:Food allergy is a potentially life-threatening condition with no approved therapies, apart from avoidance and injectable epinephrine for acute allergic reactions. Oral Immunotherapy (OIT) is an experimental treatment in which food-allergic patients consume gradually increasing quantities of the food to increase their threshold for allergic reaction. This therapy carries significant risk of allergic reactions. The ability of OIT to desensitize patients to particular foods is well-documented, although the ability to induce tolerance has not been established. This review focuses on recent studies for the treatment of food allergies such as cow's milk, hen's egg, and peanut.
Fumio Takaiwa - One of the best experts on this subject based on the ideXlab platform.
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Update on the use of transgenic rice seeds in Oral Immunotherapy.
Immunotherapy, 2013Co-Authors: Fumio TakaiwaAbstract:Rice seed provides an ideal production platform for pharmaceuticals in terms of high productivity and stability, as well as the scalability, safety and economy that are expected in plant production systems. Furthermore, these therapeutic products are bioencapsulated in protein bodies, which are seed-specific storage organelles that provide protection from digestion by gastrointestinal enzymes during delivery to the gut-associated lymphoid tissue. Thus, rice seed provides an ideal delivery system for the mucosal immune system. Oral Immunotherapy using unprocessed transgenic rice seed containing therapeutic products has been demonstrated to induce effective mucosal immune tolerance and immune reactions against allergies and pathogens.
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Inhibition of allergen-induced airway inflammation by low-dose Oral Immunotherapy with transgenic rice seeds independently of immunoglobulin e synthesis
International Archives of Allergy and Immunology, 2012Co-Authors: Mayumi Saeki, Toshiro Takai, Tomoe Nishimura, Kazuko Takada, Akio Mori, Osamu Kaminuma, Fumio Takaiwa, Kazuya Suzuki, Takachika HiroiAbstract:BACKGROUND: Oral Immunotherapy is potentially useful for the treatment of allergic diseases. We previously demonstrated that allergen-induced airway inflammation and immunoglobulin E (IgE) production in mice were suppressed by Oral administration of high-dose transgenic (Tg) rice seeds (approximately 50 g/kg/day) expressing a T cell epitope of Dermatophagoides pteronyssinus group 1 allergen (Der p 1). However, this amount of Tg rice seeds was not realistic in our daily life. In this study, allergen-induced airway inflammation and IgE production following Oral Immunotherapy with a realistic (lowest) dose of Tg rice seeds were investigated.\n\nMETHODS: Mice Orally administered with Tg or non-Tg rice seeds at approximately 5 g/kg/day for 1 week were immunized with recombinant Der p 1, and then challenged with the corresponding allergen. The infiltration of inflammatory cells into the airways and the levels of allergen-specific serum IgE were examined.\n\nRESULTS: Low-dose Oral administration of Tg rice seeds significantly inhibited the allergen-induced infiltration of eosinophils and lymphocytes into the airways, but allergen-specific IgE synthesis was not changed.\n\nCONCLUSIONS: Low-dose Oral Immunotherapy with Tg rice seeds could suppress allergen-induced airway inflammation through mechanisms other than the downregulation of IgE synthesis.
Philippe Begin - One of the best experts on this subject based on the ideXlab platform.
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Update on Oral Immunotherapy for egg allergy
Human vaccines & immunotherapeutics, 2017Co-Authors: François Graham, Natacha Tardio, Louis Paradis, Anne Des Roches, Philippe BeginAbstract:Oral Immunotherapy (OIT) is an emerging treatment of IgE-mediated egg allergy. In the past decade, a multitude of studies have assessed the potential for egg OIT to induce clinical desensitization. The following review will evaluate the efficacy and safety of this therapy as determined by randomized controlled, non-randomized controlled and uncontrolled trials. Recent studies using reduced allergenic egg products and anti-IgE assisted therapy to improve egg OIT safety will also be discussed. Recent advances in the mechanisms underlying food OIT suggest that certain immune parameters may be helpful in monitoring response to therapy, including egg OIT. Although, egg OIT is consistently shown to be effective with regards to clinical desensitization, fewer studies have looked at persistent tolerance or sustained unresponsiveness. Limited results of long-term follow-up trials suggest that this therapy may have disease-modifying effects. In general, the comparison of studies is complicated by major differences in study designs, OIT protocols and endpoints.
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Oral Immunotherapy for the treatment of food allergy.
Human vaccines & immunotherapeutics, 2014Co-Authors: Philippe Begin, R. Sharon Chinthrajah, Kari C. NadeauAbstract:Oral Immunotherapy (OIT) is an emerging new therapy for food allergy. With multiple small exploratory trials and some large randomized-controlled phase 2 trials recently published and under way, there is a clear progress and interest toward making this a treatment option for patients suffering from food allergies. However, there are still many questions to be answered and parameters to fine-tune before OIT becomes an accepted option outside of the research setting. This review covers the main milestones in the development of OIT for food allergy and further discusses important specific issues that will have direct impact on its clinical application. More specifically, previous publications showing evidence for the induction of tolerance are specifically reviewed and varying safety, tolerability and efficacy parameters from previous reports are also discussed.
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safety and feasibility of Oral Immunotherapy to multiple allergens for food allergy
Allergy Asthma & Clinical Immunology, 2014Co-Authors: Philippe Begin, Lisa C Winterroth, Tina Dominguez, Shruti P Wilson, Liane Bacal, Anjuli Mehrotra, Bethany Kausch, Anthony Trela, Elisabeth G Hoyte, Gerri OriordanAbstract:Background: Thirty percent of children with food allergy are allergic to more than one food. Previous studies on Oral Immunotherapy (OIT) for food allergy have focused on the administration of a single allergen at the time. This study aimed at evaluating the safety of a modified OIT protocol using multiple foods at one time. Methods: Participants underwent double-blind placebo-controlled food challenges (DBPCFC) up to a cumulative dose of 182 mg of food protein to peanut followed by other nuts, sesame, dairy or egg. Those meeting inclusion criteria for peanut only were started on single-allergen OIT while those with additional allergies had up to 5 foods included in their OIT mix. Reactions during dose escalations and home dosing were recorded in a symptom diary. Results: Forty participants met inclusion criteria on peanut DBPCFC. Of these, 15 were mono-allergic to peanut and 25 had additional food allergies. Rates of reaction per dose did not differ significantly between the two groups (median of 3.3% and 3.7% in multi and single OIT group, respectively; p = .31). In both groups, most reactions were mild but two severe reactions requiring epinephrine occurred in each group. Dose escalations progressed similarly in both groups although, per protocol design, those on multiple food took longer to reach equivalent doses per food (median +4 mo.; p < .0001). Conclusions: Preliminary data show Oral Immunotherapy using multiple food allergens simultaneously to be feasible and relatively safe when performed in a hospital setting with trained perso nnel. Additional, larger, randomized studies are required to continue to test safety and efficacy of multi-OIT. Trial registration: Clinicaltrial.gov NCT01490177 Keyword: Food allergy, Oral Immunotherapy (OIT), Specific Oral tolerance induction (SOTI), Multiple, Safety, Efficacy
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Safety and feasibility of Oral Immunotherapy to multiple allergens for food allergy.
Allergy asthma and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology, 2014Co-Authors: Philippe Begin, Lisa C Winterroth, Tina Dominguez, Shruti P Wilson, Liane Bacal, Anjuli Mehrotra, Bethany Kausch, Anthony Trela, Elisabeth G Hoyte, Gerri O'riordanAbstract:Background Thirty percent of children with food allergy are allergic to more than one food. Previous studies on Oral Immunotherapy (OIT) for food allergy have focused on the administration of a single allergen at the time. This study aimed at evaluating the safety of a modified OIT protocol using multiple foods at one time.