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Food AIT and Desensitization

Top 10 Scientific Articles in the field of food AIT and desensitization published in 2017.

Long-term clinical and immunological effects of probiotic and peanut oral immunotherapy after treatment cessation: 4-year follow-up of a randomized, double-blind, placebo-controlled trial.  
Hsiao KC, Ponsonby AL , Axelrad A, Pitkin S, Tang MLK, on behalf of the PPOIT Study Team.
The Lancet Child &Adolescent Health. 2017;1:2. doi: 10.1016/S2352-4642(17)30041-X.
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Reasons for recommending the article:

  • The Probiotic and Peanut OIT (PPOIT) randomised trial has generated intense interest due to the high rates of sustained unresponsiveness reported in the parent study. This study presents long -term follow up of participants.
  • Few studies have evaluated long term sustained unresponsiveness outcomes post OIT. This is the first and only OIT study to evaluate for challenge-proven sustained unresponsiveness years after treatment cessation.  
  • The study reported high rates of continuing peanut ingestion and challenge proven sustained unresponsiveness. This suggests that sustained unresponsiveness is a realistic goal for food allergy treatment.
  • The accompanying Editorial titled “Probiotic and peanut oral immunotherapy: a breakthrough for allergy treatment” highlighted the significance of this manuscript.

Reviewer’s comments: There is significant interest in oral immunotherapy (OIT) as a treatment for food allergies. Studies suggest that OIT is effective at inducing desensitisation (ability to ingest an increased amount of food without reaction that is maintained by regular exposure to the food), however its ability to induce tolerance or sustained unresponsiveness appears limited. As desensitisation requires continued regular ingestion several approaches to increase the induction of tolerance or sustained unresponsiveness with OIT have been explored, including combined administration of OIT with immune modifying adjuvants. One such approach is the administration of probiotic and OIT. Tang et al previously reported results from a double blind placebo controlled randomised trial which showed high rates of sustained unresponsiveness following Probiotic and Peanut OIT (PPOIT) compared with placebo (82% vs 3.6%) (J Allergy Clin Immunol 2015). In this study, the authors investigated long-term (4 years after treatment cessation) outcomes in participants who completed the parent double-blind, placebo-controlled randomized trial.  They found that participants from the PPOIT group were significantly more likely to have continued eating peanut compared to those from the placebo group (67% vs 4%) and 58% of participants from the PPOIT group who consented to a DBPCFC had persistent 8-week sustained unresponsiveness compared with only one (7%) participant from the placebo group, 4 years of after treatment cessation. This is the first study to evaluate for long term challenge proven sustained unresponsiveness years after treatment cessation. Findings suggest that sustained unresponsiveness is a realistic target for food allergy treatment.

Abstract:
Background: Oral immunotherapy has attracted much interest as a potential treatment for food allergy, yet little is known about its long-term effects. We aimed to assess long-term outcomes in participants who completed a randomized, double-blind, placebo-controlled trial of combined probiotic and peanut oral immunotherapy (PPOIT), which was previously shown to induce desensitization and 2-week sustained unresponsiveness.
Methods: All participants who completed the PPOIT randomized trial were eligible to participate in this follow-up study 4 years after treatment cessation. Peanut intake and adverse reactions to peanut in the 4 years after treatment cessation were systematically documented with a structured questionnaire administered by allergy nurses. Additionally, participants were invited to undergo peanut skin prick tests, measurement of peanut sIgE and sIgG4 concentrations, and double-blind placebo-controlled peanut challenge to assess 8-week sustained unresponsiveness.
Findings: 48 (86%) of 56 eligible participants were enrolled in the follow-up study. Mean time since stopping treatment was 4·2 years in both PPOIT (SD 0·6) and placebo (SD 0·7) participants. Participants from the PPOIT group were significantly more likely than those from the placebo group to have continued eating peanut (16 [67%] of 24 vs one [4%] of 24; absolute difference 63% [95% CI 42–83], p=0·001; number needed to treat 1·6 [95% CI 1·2–2·4]). Four PPOIT-treated participants and six placebo participants reported allergic reactions to peanut after intentional or accidental intake since stopping treatment, but none had anaphylaxis. PPOIT-treated participants had smaller wheals in peanut skin prick test (mean 8·1 mm [SD 7·7] vs 13·3 mm [7·6]; absolute difference –5·2 mm [95% CI –10·3 to 0·0]; age-adjusted and sex-adjusted p=0·035) and significantly higher peanut sIgG4:sIgE ratios than placebo participants (geometric mean 67·3 [95% CI 10·3–440·0] vs 5·2 [1·2–21·8]; p=0·031). Seven (58%) of 12 participants from the PPOIT group attained 8-week sustained unresponsiveness, compared with one (7%) of 15 participants from the placebo group (absolute difference 52% [95% CI 21–82), p=0·012; number needed to treat 1·9 [95% CI 1·2–4·8]).
Interpretation: PPOIT provides long-lasting clinical benefit and persistent suppression of the allergic immune response to peanut.

 

Effect of Varying Doses of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Exposure Among Patients With Peanut Sensitivity. A Randomized Clinical Trial.
Sampson HA, Shreffler WG, Yang WH, Sussman GL, Brown-Whitehorn TF, Nadeau KC, Cheema AS, Leonard SA, Pongracic JA, Sauvage-Delebarre C, Assa'ad AH, de Blay F, Bird JA, Tilles SA, Boralevi F, Bourrier T, Hébert J, Green TD, Gerth van Wijk R, Knulst AC, Kanny G, Schneider LC, Kowalski ML, Dupont C.
JAMA. 2017. 318:18.  doi: 10.1001/jama.2017.16591.
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Reasons for recommending the article:

  • Epicutaneous immunotherapy has shown promise as a treatment for food allergy in preclinical studies and limited trials in humans. In this phase 2b double-blind, placebo-controlled dose-ranging trial, a 250 ug peanut patch was found to result in a 2 fold higher response rate (50% vs. 25%) compared to placebo after 12 months of treatment. Treatment-emergent adverse events (TEAEs) were experienced by nearly all subjects on active treatment, although serious TEAES were infrequent and rarely led to study discontinuation. The patch had the greatest benefit in children 6-11 years of age.

Abstract:
Importance: Epicutaneous immunotherapy may have potential for treating peanut allergy but has been assessed only in preclinical and early human trials.
Objective: To determine the optimal dose, adverse events (AEs), and efficacy of a peanut patch for peanut allergy treatment.
Design, Setting, and Participants: Phase 2b double-blind, placebo-controlled, dose-ranging trial of a peanut patch in peanut-allergic patients (6-55 years) from 22 centers, with a 2-year, open-label extension (July 31, 2012-July 31, 2014; extension completed September 29, 2016). Patients (n = 221) had peanut sensitivity and positive double-blind, placebo-controlled food challenges to an eliciting dose of 300 mg or less of peanut protein.
Interventions: Randomly assigned patients (1:1:1:1) received an epicutaneous peanut patch containing 50 μg (n = 53), 100 μg (n = 56), or 250 μg (n = 56) of peanut protein or a placebo patch (n = 56). Following daily patch application for 12 months, patients underwent a double-blind, placebo-controlled food challenge to establish changes in eliciting dose.
Main Outcomes and Measures: The primary efficacy end point was percentage of treatment responders (eliciting dose: ≥10-times increase and/or reaching ≥1000 mg of peanut protein) in each group vs placebo patch after 12 months. Secondary end points included percentage of responders by age strata and treatment-emergent adverse events (TEAEs).
Results: Of 221 patients randomized (median age, 11 years [quartile 1, quartile 3: 8, 16]; 37.6% female), 93.7% completed the trial. A significant absolute difference in response rates was observed at month 12 between the 250-μg (n = 28; 50.0%) and placebo (n = 14; 25.0%) patches (difference, 25.0%; 95% CI, 7.7%-42.3%; P = .01). No significant difference was seen between the placebo patch vs the 100-μg patch. Because of statistical testing hierarchical rules, the 50-μg patch was not compared with placebo. Interaction by age group was only significant for the 250-μg patch (P = .04). In the 6- to 11-year stratum, the response rate difference between the 250-μg (n = 15; 53.6%) and placebo (n = 6; 19.4%) patches was 34.2% (95% CI, 11.1%-57.3%; P = .008); adolescents/adults showed no difference between the 250-μg (n = 13; 46.4%) and placebo (n = 8; 32.0%) patches: 14.4% (95% CI, -11.6% to 40.4%; P = .40). No dose-related serious AEs were observed. The percentage of patients with 1 or more TEAEs (largely local skin reactions) was similar across all groups in year 1: 50-μg patch = 100%, 100-μg patch = 98.2%, 250-μg patch = 100%, and placebo patch = 92.9%. The overall median adherence was 97.6% after 1 year; the dropout rate for treatment-related AEs was 0.9%.
Conclusions and Relevance: In this dose-ranging trial of peanut-allergic patients, the 250-μg peanut patch resulted in significant treatment response vs placebo patch following 12 months of therapy. These findings warrant a phase 3 trial.

 

Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective.
Vickery BP, Berglund JP, Burk CM, Fine JP, Kim EH1, Kim JI, Keet CA, Kulis M, Orgel KG, Guo R, Steele PH, Virkud YV, Ye P, Wright BL, Wood RA, Burks AW.
J Allergy Clin Immunol. 2017;139:1. doi: 10.1016/j.jaci.2016.05.027. Epub 2016 Aug 10.
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Reasons for recommending the article:

  • Youngest study of OIT
  • Evidence of equivalence of 300mg and 3000mg in this young age group
  • Strongest SU reported to date

Abstract:
Background: Oral immunotherapy (OIT) is an effective experimental food allergy treatment that is limited by treatment withdrawal and the frequent reversibility of desensitization if interrupted. Newly diagnosed preschool children may have clinical and immunological characteristics more amenable to treatment.
Objective: We sought to test the safety, effectiveness, and feasibility of early OIT (E-OIT) in the treatment of peanut allergy.
Methods: We enrolled 40 children aged 9 to 36 months with suspected or known peanut allergy. Qualifying subjects reacted to peanut during an entry food challenge and were block-randomized 1:1 to receive E-OIT at goal maintenance doses of 300 or 3000 mg/d in a double-blinded fashion. The primary end point, sustained unresponsiveness at 4 weeks after stopping early intervention oral immunotherapy (4-SU), was assessed by double-blinded, placebo-controlled food challenge either upon achieving 4 prespecified criteria, or after 3 maintenance years. Peanut-specific immune responses were serially analyzed. Outcomes were compared with 154 matched standard-care controls.
Results: Of 40 consented subjects, 3 (7.5%) did not qualify. Overall, 29 of 37 (78%) in the intent-to-treat analysis achieved 4-SU (300-mg arm, 17 of 20 [85%]; 3000 mg, 12 of 17 [71%], P = .43) over a median of 29 months. Per-protocol, the overall proportion achieving 4-SU was 29 of 32 (91%). Peanut-specific IgE levels significantly declined in E-OIT-treated children, who were 19 times more likely to successfully consume dietary peanut than matched standard-care controls, in whom peanut-specific IgE levels significantly increased (relative risk, 19.42; 95% CI, 8.7-43.7; P < .001). Allergic side effects during E-OIT were common but all were mild to moderate.
Conclusions: At both doses tested, E-OIT had an acceptable safety profile and was highly successful in rapidly suppressing allergic immune responses and achieving safe dietary reintroduction.

 

Omalizumab facilitates rapid oral desensitization for peanut allergy.
MacGinnitie AJ, Rachid R, Gragg H, Little SV, Lakin P, Cianferoni A, Heimall J, Makhija M, Robison R, Chinthrajah RS, Lee J, Lebovidge J, Dominguez T, Rooney C, Lewis MO, Koss J4, Burke-Roberts E, Chin K, Logvinenko T, Pongracic JA, Umetsu DT, Spergel J, Nadeau KC, Schneider LC.
J Allergy Clin Immunol. 2017; 139:3. doi:  10.1016/j.jaci.2016.08.010. Published online 2016 Sep 5.
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Reasons for recommending the article:

  • Significantly higher dose escalation on initial dose escalation day. Possibly clinically relevant protection even on day 1.
  • Ability for more rapid updosing
  • Improved safety vs OIT along

Abstract:
Background: Oral immunotherapy (OIT) is an effective experimental food allergy treatment that is limited by treatment withdrawal and the frequent reversibility of desensitization if interrupted. Newly-diagnosed preschool children may have clinical and immunological characteristics more amenable to treatment.
Objective: To test the safety, effectiveness, and feasibility of early OIT (E-OIT) in the treatment of peanut allergy.
Methods: We enrolled 40 children aged 9–36 months with suspected or known peanut allergy. Qualifying subjects reacted to peanut during an entry food challenge and were block-randomized 1:1 to receive E-OIT at goal maintenance doses of 300 or 3000 mg/day in a double-blinded fashion. The primary endpoint, sustained unresponsiveness at four weeks after stopping E-OIT (4-SU), was assessed by DBPCFC either upon achieving four pre-specified criteria, or after three maintenance years. Peanut-specific immune responses were serially analyzed. Outcomes were compared to 154 matched standard-care controls.
Results: Of 40 consented subjects, three (7.5%) did not qualify. Overall, 29/37 (78%) in the intent-to-treat analysis achieved 4-SU (300 mg arm, 17/20 [85%]; 3000 mg, 12/17 [71%], p=0.43) over a median of 29 months. Per-protocol, the overall proportion achieving 4-SU was 29/32 (91%). Peanut-specific IgE levels significantly declined in E-OIT-treated children, who were 19 times more likely to successfully consume dietary peanut than matched standard-care controls, in whom peanut-specific IgEs significantly increased (RR 19.42 [95%CI 8.7 – 43.7], p<0.001). Allergic side effects during E-OIT were common but all were mild-moderate.
Conclusion: At both doses tested, E-OIT had an acceptable safety profile and was highly successful in rapidly suppressing allergic immune responses and achieving safe dietary reintroduction.

 

Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults.
Jones SM, Sicherer SH, Burks AW, Leung DY, Lindblad RW, Dawson P, Henning AK, Berin MC2, Chiang D, Vickery BP, Pesek RD, Cho CB, Davidson WF, Plaut M, Sampson HA, Wood RA; Consortium of Food Allergy Research.
J Allergy Clin Immunol. 2017;139:4. doi: 10.1016/j.jaci.2016.08.017. Epub 2016 Oct 26.
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Reasons for recommending the article:

  • Evidence of efficacy of EPIT in NIH-sponsored phase 2 study

Abstract:
Background: Peanut allergy is common, life-threatening, and without therapeutic options. We evaluated peanut epicutaneous immunotherapy (EPIT) by using Viaskin Peanut for peanut allergy treatment.
Objective: We sought to evaluate the clinical, safety, and immunologic effects of EPIT for the treatment of peanut allergy.
Methods: In this multicenter, double-blind, randomized, placebo-controlled study, 74 participants with peanut allergy (ages 4-25 years) were treated with placebo (n = 25), Viaskin Peanut 100 μg (VP100; n = 24) or Viaskin Peanut 250 μg (VP250; n = 25; DBV Technologies, Montrouge, France). The primary outcome was treatment success after 52 weeks, which was defined as passing a 5044-mg protein oral food challenge or achieving a 10-fold or greater increase in successfully consumed dose from baseline to week 52. Adverse reactions and mechanistic changes were assessed.
Results: At week 52, treatment success was achieved in 3 (12%) placebo-treated participants, 11 (46%) VP100 participants, and 12 (48%) VP250 participants (P = .005 and P = .003, respectively, compared with placebo; VP100 vs VP250, P = .48). Median change in successfully consumed doses were 0, 43, and 130 mg of protein in the placebo, VP100, and VP250 groups, respectively (placebo vs VP100, P = .014; placebo vs VP250, P = .003). Treatment success was higher among younger children (P = .03; age, 4-11 vs >11 years). Overall, 14.4% of placebo doses and 79.8% of VP100 and VP250 doses resulted in reactions, predominantly local patch-site and mild reactions (P = .003). Increases in peanut-specific IgG4 levels and IgG4/IgE ratios were observed in peanut EPIT-treated participants, along with trends toward reduced basophil activation and peanut-specific TH2 cytokines.
Conclusions: Peanut EPIT administration was safe and associated with a modest treatment response after 52 weeks, with the highest responses among younger children. This, when coupled with a high adherence and retention rate and significant changes in immune pathways, supports further investigation of this novel therapy.

 

Efficacy and safety of AR101 in oral immunotherapy for peanut allergy: results of ARC001, a randomized, double-blind, placebo controlled Phase-2 clinical trial.
Bird JA, Spergel JM, Jones SM, Rachid R, Assa'ad AH, Wang J, Leonard SA, Laubach SS, Kim EH, Vickery BP, Davis BP, Heimall J, Cianferoni A, MacGinnitie AJ, Crestani E, Burks AW; ARC001 Study Group.
J Allergy Clin Immunol Pract. 2018; 6:2. doi: 10.1016/j.jaip.2017.09.016. Epub 2017 Oct 31.
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Reasons for recommending the article:

  • Positive phase 2 data of the AR101 PN OIT product paving the way for phase 3 study

Abstract:
Background: Peanut oral immunotherapy, using a variety of approaches, has been previously shown to induce desensitization in peanut-allergic subjects, but no products have been approved for clinical use by regulatory agencies.
Objective: We performed the first phase 2 multicentered study to assess the safety and efficacy of AR101, a novel oral biologic drug product.
Methods: A randomized, double-blind, placebo-controlled trial was conducted at 8 US centers. Eligible subjects were 4 to 26 years old, sensitized to peanut, and had dose-limiting symptoms to ≤143 mg of peanut protein in a screening double-blind, placebo-controlled food challenge (DBPCFC). Subjects were randomized 1:1 to daily AR101 or placebo and gradually up-dosed from 0.5 to 300 mg/day. The primary endpoint was the proportion of subjects in each arm able to tolerate ≥443 mg (cumulative peanut protein) at exit DBPCFC with no or mild symptoms.
Results: Fifty-five subjects (29 AR101, 26 placebo) were enrolled. In the intention-to-treat analysis, 23 of 29 (79%) and 18 of 29 (62%) AR101 subjects tolerated ≥443 mg and 1043 mg at exit DBPCFC, respectively, versus 5 of 26 (19%) and 0 of 26 (0%) placebo subjects (both P < .0001). Compared with placebo, AR101 significantly reduced symptom severity during exit DBPCFCs and modulated peanut-specific cellular and humoral immune responses. Gastrointestinal (GI) symptoms were the most common treatment-related adverse events (AEs) in both groups, with 6 AR101 subjects (21%) withdrawing, 4 of those due primarily to recurrent GI AEs.
Conclusions: In this study, AR101 demonstrated an acceptable safety profile and demonstrated clinical activity as a potential immunomodulatory treatment option in peanut-allergic children over the age of 4, adolescents, and young adults.

 

Conducting an Oral Food Challenge to Peanut in an Infant.
Bird JA, Groetch M, Allen KJ, Bock SA, Leonard S, Nowak-Wegrzyn AH, Sicherer S, Clark A, Fleischer DM, Venter C, Vickery B, Young MC.
J Allergy Clin Immunol Pract. 2017; 5:2. doi: 10.1016/j.jaip.2016.07.019
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Reasons for recommending the article:

  • Practical advice to address feasibility of LEAP guidelines

Abstract: Results from the Learning Early About Peanut trial and its follow-up study suggest that early peanut introduction in the diets of high-risk infants may prevent the development of peanut allergy. Allergy organizations around the world released a unified statement, the Consensus Communication on Early Peanut Introduction and the Prevention of Peanut Allergy in High Risk Infants, in response to results from the Learning Early About Peanut trial, which recommends early introduction of peanut into the diet of those children at greatest risk of development of peanut allergy. As a result, it is expected that practicing allergists will experience an increased demand to perform an oral food challenge (OFC) in infants. Allergists often perform OFCs; however, conducting an OFC in an infant creates unique circumstances that have not been considered in previously published OFC guideline documents. The purpose of this workgroup report is to provide guidance to practitioners regarding the proper approach for conducting a peanut challenge in an infant.

 

The prevalence of food allergy and other allergic diseases in early childhood in a population-based study: HealthNuts age 4-year follow-up.
Peters RL, Koplin JJ, Gurrin LC, Dharmage SC, Wake M, Ponsonby AL, Tang MLK, Lowe AJ, Matheson M, Dwyer T, Allen KJ; HealthNuts Study.
J Allergy Clin Immunol. 2017;140:1. doi: 10.1016/j.jaci.2017.02.019.
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Reasons for recommending the article:

  • Further food allergy prevalence data in largest birth cohort study around food allergy to date

Abstract:
Background: The HealthNuts study previously reported interim prevalence data showing the highest prevalence of challenge-confirmed food allergy in infants internationally. However, population-derived prevalence data on challenge-confirmed food allergy and other allergic diseases in preschool-aged children remain sparse.
Objective: This study aimed to report the updated prevalence of food allergy at age 1 year from the whole cohort, and to report the prevalence of food allergy, asthma, eczema, and allergic rhinitis at age 4 years.
Methods: HealthNuts is a population-based cohort study with baseline recruitment of 5276 one-year-old children who underwent skin prick test (SPT) to 4 food allergens and those with detectable SPT results had formal food challenges. At age 4 years, parents completed a questionnaire (81.3% completed) and those who previously attended the HealthNuts clinic at age 1 year or reported symptoms of a new food allergy were invited for an assessment that included SPT and oral food challenges. Data on asthma, eczema, and allergic rhinitis were captured by validated International Study of Asthma and Allergies in Childhood questionnaires.
Results: The prevalence of challenge-confirmed food allergy at age 1 and 4 years was 11.0% and 3.8%, respectively. At age 4 years, peanut allergy prevalence was 1.9% (95% CI, 1.6% to 2.3%), egg allergy was 1.2% (95% CI, 0.9% to 1.6%), and sesame allergy was 0.4% (95% CI, 0.3% to 0.6%). Late-onset peanut allergy at age 4 years was rare (0.2%). The prevalence of current asthma was 10.8% (95% CI, 9.7% to 12.1%), current eczema was 16.0% (95% CI, 14.7% to 17.4%), and current allergic rhinitis was 8.3% (95% CI, 7.2% to 9.4%). Forty percent to 50% of this population-based cohort experienced symptoms of an allergic disease in the first 4 years of their life.
Conclusions: Although the prevalence of food allergy decreased between age 1 year and age 4 years in this population-based cohort, the prevalence of any allergic disease among 4-year-old children in Melbourne, Australia, is remarkably high.

 

Prevalence of clinic-defined food allergy in early adolescence: The SchoolNuts study.
Sasaki M, Koplin JJ, Dharmage SC, Field MJ, Sawyer SM, McWilliam V, Peters RL, Gurrin LC, Vuillermin PJ, Douglass J, Pezic A, Brewerton M, Tang MLK, Patton GC, Allen KJ.
J Allergy Clin Immunol. 2018; 141:1. doi: 10.1016/j.jaci.2017.05.041.
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Reasons for recommending the article:

  • Evidence of increasing allergic sensitization in adolescent age group

Abstract:
Background: Rising rates of food-induced anaphylaxis have recently been shown in the adolescent age group, following earlier descriptions of a rise in children younger than 5 years. However, few population-based studies have examined the prevalence of food allergy in adolescence using objective measures such as oral food challenge (OFC).
Objective: We sought to determine the prevalence of food allergy among a population-based sample of 10- to 14-year-old adolescents using clinical evaluation including OFC to confirm the diagnosis.
Methods: Schools were randomly selected from greater metropolitan Melbourne, Australia. Students aged 10 to 14 years, and their parents, were asked to complete a questionnaire regarding the adolescent's food allergy or food-related reactions. Clinic evaluation, which consisted of skin prick tests and OFC where eligible, was undertaken if students were suspected to have current food allergy from parent response. Among 9816 students assessed, 5016 had complete parent response and clinic evaluation when eligible. An additional 4800 students had student questionnaires only.
Results: The prevalence of clinic-defined current food allergy based on history, sensitization data, and OFC results was 4.5% (95% CI, 3.9-5.1), with the most common food triggers being peanut, 2.7% (95% CI, 2.3-3.2), and tree nut, 2.3% (95% CI, 1.9-2.8). Among the additional group of 4800 adolescents who had only self-reported food allergy status available, the prevalence of self-reported current food allergy was 5.5% (95% CI, 4.9-6.2), with peanut, 2.8% (95% CI, 2.3-3.3), and tree nut, 2.3% (95% CI, 1.9-2.8), the most common.
Conclusions: Approximately 1 in 20 10- to 14-year-old school students in Melbourne has current food allergy. This high prevalence suggests that the previously reported rise in food-induced anaphylaxis in this age group may reflect an increasing prevalence of food allergy rather than simply increased reporting of anaphylaxis.

 

Quantitative Assessment of the Safety Benefits Associated with Increasing Clinical Peanut Thresholds Through Immunotherapy.
J Allergy Clin Immunol Pract. 2018; 6:2. doi: 10.1016/j.jaip.2017.05.006.
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Reasons for recommending the article:

  • Model of real world exposures to understand actual protection from immunotherapy shows increases in reaction threshold to 300 and 1000mg provides over 95% risk reduction

Abstract:
Background: Peanut immunotherapy studies are conducted with the aim to decrease the sensitivity of patients to peanut exposure with the outcome evaluated by testing the threshold for allergic response in a double-blind placebo-controlled food challenge. The clinical relevance of increasing this threshold is not well characterized.
Objective: We aimed to quantify the clinical benefit of an increased threshold for peanut-allergic patients.
Methods: Quantitative risk assessment was performed by matching modeled exposure to peanut protein with individual threshold levels. Exposure was modeled by pairing US consumption data for various food product categories with potential contamination levels of peanut that have been demonstrated to be present on occasion in such food products. Cookies, ice cream, doughnuts/snack cakes, and snack chip mixes were considered in the risk assessment.
Results: Increasing the baseline threshold before immunotherapy from 100 mg or less peanut protein to 300 mg peanut protein postimmunotherapy reduces the risk of experiencing an allergic reaction by more than 95% for all 4 food product categories that may contain trace levels of peanut residue. Further increase in the threshold to 1000 mg of peanut protein had an additional quantitative benefit in risk reduction for all patients reacting to 300 mg or less at baseline.
Conclusions: We conclude that achieving thresholds of 300 mg and 1000 mg of peanut protein by peanut immunotherapy is clinically relevant, and that the risk for peanut-allergic patients who have achieved this increased threshold to experience an allergic reaction is reduced in a clinically meaningful way.