title: Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective.
abstract: 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.
  
  
  
  We sought to test the safety, effectiveness, and feasibility of early OIT (E-OIT) in the treatment of peanut allergy.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Brian P
authors: BP
authors: Vickery
authors: Duke University School of Medicine, Durham, NC.
authors: Jelena P
authors: JP
authors: Berglund
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Caitlin M
authors: CM
authors: Burk
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Jason P
authors: JP
authors: Fine
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Edwin H
authors: EH
authors: Kim
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Jung In
authors: JI
authors: Kim
authors: Johns Hopkins School of Medicine, Baltimore, Md.
authors: Corinne A
authors: CA
authors: Keet
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Michael
authors: M
authors: Kulis
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Kelly G
authors: KG
authors: Orgel
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Rishu
authors: R
authors: Guo
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Pamela H
authors: PH
authors: Steele
authors: Massachusetts General Hospital, Boston, Mass.
authors: Yamini V
authors: YV
authors: Virkud
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC.
authors: Ping
authors: P
authors: Ye
authors: Mayo Clinic, Scottsdale, Ariz.
authors: Benjamin L
authors: BL
authors: Wright
authors: Johns Hopkins School of Medicine, Baltimore, Md.
authors: Robert A
authors: RA
authors: Wood
authors: University of North Carolina-Chapel Hill, Chapel Hill, NC. Electronic address: wesley.burks@unc.edu.
authors: A Wesley
authors: AW
authors: Burks
mesh_terms: D000485:Allergens / Q000276:immunology; D052179:Antigens, Plant / Q000276:immunology; D010367:Arachis / Q000276:immunology; D002675:Child, Preschool; D003888:Desensitization, Immunologic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D007223:Infant; D008297:Male; D021183:Peanut Hypersensitivity / Q000097:blood / Q000628:therapy*; D010940:Plant Proteins / Q000276:immunology
chemical_list: D000485:Allergens; D052179:Antigens, Plant; D010940:Plant Proteins; D007073:Immunoglobulin E
keywords: Oral immunotherapy; desensitization; early intervention; peanut allergy; randomized clinical trial; sustained unresponsiveness