Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective

Brian P. Vickery, Jelena P. Berglund, Caitlin M. Burk, Jason P. Fine, Edwin H. Kim, Jung In Kim, Corinne A. Keet, Michael Kulis, Kelly G. Orgel, Rishu Guo, Pamela H. Steele, Yamini V. Virkud, Ping Ye, Benjamin L. Wright, Robert A. Wood, A. Wesley Burks

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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.

LanguageEnglish (US)
Pages173-181.e8
JournalJournal of Allergy and Clinical Immunology
Volume139
Issue number1
DOIs
StatePublished - Jan 1 2017

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Preschool Children
Immunotherapy
Peanut Hypersensitivity
Immunoglobulin E
Safety
Food
Food Hypersensitivity
Therapeutics
Placebos
Maintenance
Arachis

Keywords

  • desensitization
  • early intervention
  • Oral immunotherapy
  • peanut allergy
  • randomized clinical trial
  • sustained unresponsiveness

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. / Vickery, Brian P.; Berglund, Jelena P.; Burk, Caitlin M.; Fine, Jason P.; Kim, Edwin H.; Kim, Jung In; Keet, Corinne A.; Kulis, Michael; Orgel, Kelly G.; Guo, Rishu; Steele, Pamela H.; Virkud, Yamini V.; Ye, Ping; Wright, Benjamin L.; Wood, Robert A.; Burks, A. Wesley.

In: Journal of Allergy and Clinical Immunology, Vol. 139, No. 1, 01.01.2017, p. 173-181.e8.

Research output: Contribution to journalArticle

Vickery, BP, Berglund, JP, Burk, CM, Fine, JP, Kim, EH, Kim, JI, Keet, CA, Kulis, M, Orgel, KG, Guo, R, Steele, PH, Virkud, YV, Ye, P, Wright, BL, Wood, RA & Burks, AW 2017, 'Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective' Journal of Allergy and Clinical Immunology, vol 139, no. 1, pp. 173-181.e8. DOI: 10.1016/j.jaci.2016.05.027
Vickery, Brian P. ; Berglund, Jelena P. ; Burk, Caitlin M. ; Fine, Jason P. ; Kim, Edwin H. ; Kim, Jung In ; Keet, Corinne A. ; Kulis, Michael ; Orgel, Kelly G. ; Guo, Rishu ; Steele, Pamela H. ; Virkud, Yamini V. ; Ye, Ping ; Wright, Benjamin L. ; Wood, Robert A. ; Burks, A. Wesley. / Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. In: Journal of Allergy and Clinical Immunology. 2017 ; Vol. 139, No. 1. pp. 173-181.e8
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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.",
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AU - Berglund,Jelena P.

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AU - Fine,Jason P.

AU - Kim,Edwin H.

AU - Kim,Jung In

AU - Keet,Corinne A.

AU - Kulis,Michael

AU - Orgel,Kelly G.

AU - Guo,Rishu

AU - Steele,Pamela H.

AU - Virkud,Yamini V.

AU - Ye,Ping

AU - Wright,Benjamin L.

AU - Wood,Robert A.

AU - Burks,A. Wesley

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N2 - 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.

AB - 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.

KW - desensitization

KW - early intervention

KW - Oral immunotherapy

KW - peanut allergy

KW - randomized clinical trial

KW - sustained unresponsiveness

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