Efficacy and safety of oral immunotherapy in children aged 1–3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study

Jones, Stacie M.; Kim, Edwin; Nadeau, Kari; Nowak‐Węgrzyn, Anna; Wood, Robert A.; Sampson, Hugh A.; Scurlock, Amy M.; Chinthrajah, Sharon; Wang, Julie; Pesek, Robert D.; Sindher, Sayantani; Kulis, Mike; Johnson, Jacqueline L.; Spain, K.; Babineau, Denise C.; Chin, Hyunsook; Laurienzo-Panza, Joy; Yan, Rachel; Larson, David; Qin, Tielin; Whitehouse, Don; Sever, Michelle L.; Sanda, Srinath; Plaut, Marshall; Wheatley, Lisa M.; Burks, A. Wesley

doi:10.1016/s0140-6736(21)02390-4

Cited by 203 publications

(171 citation statements)

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“…In our study, each food challenge consisted of several escalating doses of the food protein in flour or powder form concealed in an appropriate vehicle, such as applesauce or pudding, ingested by the participant every 15 min as tolerated. Typically, challenges started with 2 mg and escalated upto a max of 8 g of total food protein as per our validated methods [26][27][28]. Results from these food challenges as well as biomarker data from our study suggest that a daily dose of multiple allergens may be efficacious for the prevention of FA, even at low amounts (total 300 mg or 30 mg of each protein).…”

Section: Discussionmentioning

confidence: 79%

“…Each food challenge consisted of several escalating doses of the food protein in flour or powder form concealed in an appropriate vehicle, such as applesauce or pudding, ingested by the participant every 15 min as tolerated. Typically challenges started with 2 mg and escalated upto a max of 8 g of total food protein as per our validated methods [26][27][28]. Specific IgG4, sIgE and IgG4/IgE ratios for all 10 allergens are shown in Figure 3a-j.…”

Section: R Peer Review 9 Of 24mentioning

confidence: 99%

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Early Introduction of Multi-Allergen Mixture for Prevention of Food Allergy: Pilot Study

et al. 2022

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The incidence and prevalence of food allergy (FA) is increasing. While several studies have established the safety and efficacy of early introduction of single allergens in infants for the prevention of FA, the exact dose, frequency, and number of allergens that can be safely introduced to infants, particularly in those at high or low risk of atopy, are still unclear. This 1-year pilot study evaluated the safety of the early introduction of single foods (milk, egg, or peanut) vs. two foods (milk/egg, egg/peanut, milk/peanut) vs. multiple foods (milk/egg/peanut/cashew/almond/shrimp/walnut/wheat/salmon/hazelnut at low, medium, or high doses) vs. no early introduction in 180 infants between 4–6 months of age. At the end of the study, they were evaluated for plasma biomarkers associated with food reactivity via standardized blood tests. Two to four years after the start of the study, participants were evaluated by standardized food challenges. The serving sizes for the single, double, and low dose mixtures were 300 mg total protein per day. The serving sizes for the medium and high dose mixtures were 900 mg and 3000 mg total protein, respectively. Equal parts of each protein were used for double or mixture foods. All infants were breastfed until at least six months of age. The results demonstrate that infants at either high or low risk for atopy were able to tolerate the early introduction of multiple allergenic foods with no increases in any safety issues, including eczema, FA, or food protein induced enterocolitis. The mixtures of foods at either low, medium, or high doses demonstrated trends for improvement in food challenge reactivity and plasma biomarkers compared to single and double food introductions. The results of this study suggest that the early introduction of foods, particularly simultaneous mixtures of many allergenic foods, may be safe and efficacious for preventing FA and can occur safely. These results need to be confirmed by larger randomized controlled studies.

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Section: Discussionmentioning

confidence: 79%

Section: R Peer Review 9 Of 24mentioning

confidence: 99%

Early Introduction of Multi-Allergen Mixture for Prevention of Food Allergy: Pilot Study

et al. 2022

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“…Data suggest the efficacy of peanut oral immunotherapy (OIT) increases as the age at treatment onset decreases. This finding was confirmed in a prespecified subset of children <4 years of age who were part of a trial of children with peanut allergy randomly assigned to peanut OIT (minimum daily maintenance dose target 250 mg, maximum 2000 mg) or placebo 1. In these younger patients, desensitization after two years of maintenance therapy and sustained unresponsiveness (SU) after six months of avoidance was reported in 71 and 21 percent versus 2 and 2 percent in the treatment and placebo groups, respectively.…”

Section: Allergy and Immunology — Food Allergy And Intolerancementioning

confidence: 69%

UpToDate®

2022

The Nurse Practitioner

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UpToDate ® and The Nurse Practitioner are collaborating to present select "What's New" content. UpToDate is an evidence-based, clinical support resource used worldwide by healthcare practitioners to make decisions at the point of care. For complete, current "What's New" content, or to become a subscriber for full content access, visit go.uptodate.com/np. "What's New" is free for all medical professionals. Disclaimer: This content is provided for reference purposes only and represents a portion of the UpToDate topic. Readers should not rely on the content or any information cited here as being applicable to specifi c patient circumstances. All topics are updated as new evidence becomes available and our peer review process is complete.

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“…The study, published in the Lancet ,1 reported that the median tolerated dose after 2.5 years was 5005 mg in children given peanut oral immunotherapy and was 5 mg in the placebo group (P<0.001). However, 26 weeks later the median tolerated dose was 755 mg with peanut oral immunotherapy and 0 mg with placebo, showing that the benefits of treatment had waned.…”

Section: Quality Of Lifementioning

confidence: 99%

“…Seven in 10 young children with peanut allergy achieved desensitisation after two and a half years of treatment with immunotherapy, a US trial has reported,1 although the effect waned over time, with just one in five still in remission 26 weeks after treatment ended.…”

mentioning

confidence: 99%

Peanut allergy: one in five children achieved lasting remission after oral immunotherapy, study reports

Mahase¹

2022

BMJ

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Efficacy and safety of oral immunotherapy in children aged 1–3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study

Cited by 203 publications

References 30 publications

Early Introduction of Multi-Allergen Mixture for Prevention of Food Allergy: Pilot Study

Early Introduction of Multi-Allergen Mixture for Prevention of Food Allergy: Pilot Study

UpToDate®

Peanut allergy: one in five children achieved lasting remission after oral immunotherapy, study reports

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