1. 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
- Author
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Jones, Stacie M, Kim, Edwin H, Nadeau, Kari C, Nowak-Wegrzyn, Anna, Wood, Robert A, Sampson, Hugh A, Scurlock, Amy M, Chinthrajah, Sharon, Wang, Julie, Pesek, Robert D, Sindher, Sayantani B, Kulis, Mike, Johnson, Jacqueline, Spain, Katharine, 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, and Network, Immune Tolerance
- Subjects
Biomedical and Clinical Sciences ,Nutrition ,Vaccine Related ,Clinical Trials and Supportive Activities ,Clinical Research ,Pediatric ,Food Allergies ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Administration ,Oral ,Allergens ,Arachis ,Child ,Child ,Preschool ,Desensitization ,Immunologic ,Double-Blind Method ,Female ,Humans ,Immune Tolerance ,Male ,Peanut Hypersensitivity ,Treatment Outcome ,Immune Tolerance Network ,Medical and Health Sciences ,General & Internal Medicine ,Biomedical and clinical sciences ,Health sciences - Abstract
BackgroundFor young children with peanut allergy, dietary avoidance is the current standard of care. We aimed to assess whether peanut oral immunotherapy can induce desensitisation (an increased allergic reaction threshold while on therapy) or remission (a state of non-responsiveness after discontinuation of immunotherapy) in this population.MethodsWe did a randomised, double-blind, placebo-controlled study in five US academic medical centres. Eligible participants were children aged 12 to younger than 48 months who were reactive to 500 mg or less of peanut protein during a double-blind, placebo-controlled food challenge (DBPCFC). Participants were randomly assigned by use of a computer, in a 2:1 allocation ratio, to receive peanut oral immunotherapy or placebo for 134 weeks (2000 mg peanut protein per day) followed by 26 weeks of avoidance, with participants and study staff and investigators masked to group treatment assignment. The primary outcome was desensitisation at the end of treatment (week 134), and remission after avoidance (week 160), as the key secondary outcome, were assessed by DBPCFC to 5000 mg in the intention-to-treat population. Safety and immunological parameters were assessed in the same population. This trial is registered on ClinicalTrials.gov, NCT03345160.FindingsBetween Aug 13, 2013, and Oct 1, 2015, 146 children, with a median age of 39·3 months (IQR 30·8-44·7), were randomly assigned to receive peanut oral immunotherapy (96 participants) or placebo (50 participants). At week 134, 68 (71%, 95% CI 61-80) of 96 participants who received peanut oral immunotherapy compared with one (2%, 0·05-11) of 50 who received placebo met the primary outcome of desensitisation (risk difference [RD] 69%, 95% CI 59-79; p
- Published
- 2022