Phase 3 Trial of Epicutaneous Immunotherapy in Toddlers with Peanut Allergy.
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Greenhawt Matthew, Sindher Sayantani B, Wang Julie, O'Sullivan Michael, du Toit George, Kim Edwin H, Albright Deborah, Anvari Sara, Arends Nicolette, Arkwright Peter D, Bégin Philippe, Blumchen Katharina, Bourrier Thierry, Brown-Whitehorn Terri, Cassell Heather, Chan Edmond S, Ciaccio Christina E, Deschildre Antoine, Divaret-Chauveau Amandine, Dorris Stacy L, Dorsey Morna J, Eiwegger Thomas, Erlewyn-Lajeunesse Michel, Fleischer David M, Ford Lara S, Garcia-Lloret Maria, Giovannini-Chami Lisa, Hourihane Jonathan O, Jay Nicola, Jones Stacie M, Kerns Leigh Ann, Kloepfer Kirsten M, Leonard Stephanie, Lezmi Guillaume, Lieberman Jay A, Lomas Jeanne, Makhija Melanie, Parrish Christopher, Peake Jane, Perrett Kirsten P, Petroni Daniel, Pfützner Wolfgang, Pongracic Jacqueline A, Quinn Patrick, Robison Rachel G, Sanders Georgiana, Schneider Lynda, Sharma Hemant P, Trujillo Juan, Turner Paul J, Tuttle Katherine, Upton Julia E, Varshney Pooja, Vickery Brian P, Vogelberg Christian, Wainstein Brynn, Wood Robert A, Bee Katharine J, Campbell Dianne E, Green Todd D, Rouissi Rihab, Peillon Aurélie, Bahnson Henry T, Bois Timothée, Sampson Hugh A, Burks A Wesley
Аннотация
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 group. Serious adverse events occurred in 8.6% of the patients in the intervention group and 2.5% of those in the placebo group; anaphylaxis occurred in 7.8% and 3.4%, respectively. Serious treatment-related adverse events occurred in 0.4% of patients in the intervention group and none in the placebo group. Treatment-related anaphylaxis occurred in 1.6% in the intervention group and none in the placebo group.
CONCLUSIONS: In this trial involving children 1 to 3 years of age with peanut allergy, epicutaneous immunotherapy for 12 months was superior to placebo in desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms. (Funded by DBV Technologies; EPITOPE ClinicalTrials.gov number, NCT03211247.).