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

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• 作者：Brian P. Vickery ; MD^a ; Jelena P. Berglund ; PhD^b ; Caitlin M. Burk ; BA^a ; Jason P. Fine ; PhD^a ; Edwin H. Kim ; MD ; MHS^a ; Jung In Kim ; MS^a ; Corinne A. Keet ; MD ; PhD^c ; Michael Kulis ; PhD^a ; Kelly G. Orgel ; BS^a ; Rishu Guo ; MD ; PhD^a ; Pamela H. Steele ; CPNP^a ; Yamini V. Virkud ; MD ; MPH^d ; Ping Ye ; PhD^a ; Benjamin L. Wright ; MD^e ; Robert A. Wood ; MD^c ; A. Wesley Burks ; MD^a ; ^{wesley.burks@unc.edu}
• 关键词：Oral immunotherapy ; desensitization ; sustained unresponsiveness ; early intervention ; peanut allergy ; randomized clinical trial
• 刊名：Journal of Allergy and Clinical Immunology
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：139
• 期：1
• 页码：173-181.e8
• 全文大小：1650 K
• 卷排序：139

文摘

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.ObjectiveWe sought to test the safety, effectiveness, and feasibility of early OIT (E-OIT) in the treatment of peanut allergy.MethodsWe 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.ResultsOf 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.ConclusionsAt 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.