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.
RCT Entities:
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 peanutallergy. METHODS: We enrolled 40 children aged 9 to 36 months with suspected or known peanutallergy. 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.
Authors: A Thyagarajan; S M Jones; A Calatroni; L Pons; M Kulis; C S Woo; M Kamalakannan; B P Vickery; A M Scurlock; A Wesley Burks; W G Shreffler Journal: Clin Exp Allergy Date: 2012-08 Impact factor: 5.018
Authors: Janet Rothers; Marilyn Halonen; Debra A Stern; I Carla Lohman; Sara Mobley; Amber Spangenberg; Dayna Anderson; Anne L Wright Journal: J Allergy Clin Immunol Date: 2011-06-16 Impact factor: 10.793
Authors: Satya D Narisety; Pamela A Frischmeyer-Guerrerio; Corinne A Keet; Mark Gorelik; John Schroeder; Robert G Hamilton; Robert A Wood Journal: J Allergy Clin Immunol Date: 2014-12-18 Impact factor: 10.793
Authors: David M Fleischer; Mary Kay Conover-Walker; Lynn Christie; A Wesley Burks; Robert A Wood Journal: J Allergy Clin Immunol Date: 2003-07 Impact factor: 10.793
Authors: Stacie M Jones; Laurent Pons; Joseph L Roberts; Amy M Scurlock; Tamara T Perry; Mike Kulis; Wayne G Shreffler; Pamela Steele; Karen A Henry; Margaret Adair; James M Francis; Stephen Durham; Brian P Vickery; Xiaoping Zhong; A Wesley Burks Journal: J Allergy Clin Immunol Date: 2009-07-03 Impact factor: 10.793
Authors: Marco H K Ho; Wilfred H S Wong; Ralf G Heine; Clifford S Hosking; David J Hill; Katrina J Allen Journal: J Allergy Clin Immunol Date: 2008-01-30 Impact factor: 10.793
Authors: Elissa M Abrams; Stephanie C Erdle; Scott B Cameron; Lianne Soller; Edmond S Chan Journal: Curr Allergy Asthma Rep Date: 2021-04-30 Impact factor: 4.806
Authors: Scott H Sicherer; Robert A Wood; Tamara T Perry; Stacie M Jones; Donald Y M Leung; Alice K Henning; Peter Dawson; A Wesley Burks; Robert Lindblad; Hugh A Sampson Journal: Allergy Date: 2019-07-15 Impact factor: 13.146
Authors: Amedee Renand; Mohamed H Shamji; Kristina M Harris; Tielin Qin; Erik Wambre; Guy W Scadding; Peter A Wurtzen; Stephen J Till; Alkis Togias; Gerald T Nepom; William W Kwok; Stephen R Durham Journal: J Allergy Clin Immunol Date: 2017-11-09 Impact factor: 10.793