Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy

作者：Matthew Greenhawt, Sayantani Sindher, Julie Wang, Michael David O'Sullivan, George Du Toit, Edwin Kim, Deborah Albright, Sara Anvari, Nicolette Arends, Peter D. Arkwright, Philippe Bégin, Katharina Blümchen, T. Bourrier, Terri A. Brown‐Whitehorn, Heather Cassell, Edmond S. Chan, Christina E. Ciaccio, A. Deschildre, Amandine Divaret‐Chauveau, Stacy L. Dorris, Morna J. Dorsey, Thomas Eiwegger, Michel Erlewyn‐Lajeunesse, David Mark Fleischer, Lara S. Ford, Maria Garcia-Lloret, Lisa Giovannini‐Chami, Jonathan O’B Hourihane, Nicola Jay, Stacie M. Jones, Leigh Ann Kerns, Kirsten M. Kloepfer, Stephanie Ann Leonard, Guillaume Lezmi, Phil Lieberman, Jeanne M. Lomas, Melanie Makhija, Christopher P. Parrish, Jane Peake, Kirsten P. Perrett, Daniel Petroni, Wolfgang Pfützner, Jacqueline A. Pongracic, Patrick Quinn, Rachel Glick Robison, Georgiana Sanders, Lynda C. Schneider, Hemant Sharma, Juan Trujillo, Paul Turner, Katherine R. Tuttle, Julia Elizabeth Mainwaring Upton, Pooja Varshney, Brian P. Vickery, Christian Vogelberg, Brynn Kevin Wainstein, R.J.K. Wood, Katharine J. Bee, Dianne Elizabeth Campbell, Todd D. Green, Rihab Rouissi, Aurélie Peillon, Henry T. Bahnson, Timothée Bois, Hugh A. Sampson, A. Wesley Burks · 发表于：New England Journal of Medicine · 年份：2023 · DOI：10.1056/nejmoa2212895 · 被引用次数：139 · 研究领域：Food Allergy and Anaphylaxis Research、Respiratory and Cough-Related Research、Transgenic Plants and Applications

BACKGROUND: No approved treatment for peanut allergy exists for children younger than 4 years of age, and the efficacy and safety of epicutaneous immunotherapy with a peanut patch in toddlers with peanut allergy are unknown. METHODS: We conducted this phase 3, multicenter, double-blind, randomized, placebo-controlled trial involving children 1 to 3 years of age with peanut allergy confirmed by a double-blind, placebo-controlled food challenge. Patients who had an eliciting dose (the dose necessary to elicit an allergic reaction) of 300 mg or less of peanut protein were assigned in a 2:1 ratio to receive epicutaneous immunotherapy delivered by means of a peanut patch (intervention group) or to receive placebo administered daily for 12 months. The primary end point was a treatment response as measured by the eliciting dose of peanut protein at 12 months. Safety was assessed according to the occurrence of adverse events during the use of the peanut patch or placebo. RESULTS: Of the 362 patients who underwent randomization, 84.8% completed the trial. The primary efficacy end point result was observed in 67.0% of children in the intervention group as compared with 33.5% of those in the placebo group (risk difference, 33.4 percentage points; 95% confidence interval, 22.4 to 44.5; P<0.001). Adverse events that occurred during the use of the intervention or placebo, irrespective of relatedness, were observed in 100% of the patients in the intervention group and 99.2% in the placebo g...