Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: Open-Label Extension to EPITOPE.
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Greenhawt Matthew, Albright Deborah, Anvari Sara, Arends Nicolette, Arkwright Peter D, Bégin Philippe, Blümchen Katharina, Brown-Whitehorn Terri, Cassell Heather, Chan Edmond S, Ciaccio Christina E, Deschildre Antoine, Divaret-Chauveau Amandine, Dorris Stacy, Dorsey Morna, Du Toit George, Eiwegger Thomas, Erlewyn-Lajeunesse Michel, Fleischer David M, Ford Lara S, Garcia-Lloret Maria, O'B Hourihane Jonathan, Jay Nicola, Jones Stacie M, Kim Edwin H, Kloepfer Kirsten, Leonard Stephanie, Lezmi Guillaume, Lieberman Jay, Lomas Jeanne, Makhija Melanie, O'Sullivan Michael, Parrish Christopher, Peake Jane, Perrett Kirsten P, Petroni Daniel, Pongracic Jacqueline A, Quinn Patrick, Robison Rachel G, Sanders Georgiana, Schneider Lynda, Sharma Hemant, Sindher Sayantani B, Trujillo Juan, Turner Paul J, Tuttle Katherine, Upton Julia, Varshney Pooja, Vickery Brian P, Vogelberg Christian, Wainstein Brynn, Wang Julie, Wood Robert, Bee Katharine J, Campbell Dianne E, Green Todd D, Rouissi Rihab, Bahnson Henry T, Bois Timothée, Sampson Hugh A, Burks A Wesley
Аннотация
OBJECTIVE: To assess the interim efficacy and safety of VP250 from the first year of the EPITOPE open-label extension (OLE) study.
METHODS: Eligible participants enrolled in the OLE study for up to 3 years of total treatment with annual double-blind, placebo-controlled food challenges (DBPCFCs) and safety assessments; here we report the first-year OLE (year 2) results.
RESULTS: A total of 266 EPITOPE participants enrolled in the OLE study; 244 underwent month 24 DBPCFC (n = 166 VP250; n = 78 placebo). After 24 months of VP250, 81.3% reached an eliciting dose (ED) ≥1000 mg, 63.8% reached an ED ≥2000 mg, and 55.9% completed the DBPCFC (cumulative dose: 3444 mg) without meeting stopping criteria. No treatment-related anaphylaxis or serious treatment-related adverse events occurred during year 2 in this treatment arm. Local application-site reactions occurred less frequently in year 2 versus year 1. In placebo-treated EPITOPE participants, outcomes after 1 year of open-label VP250 were consistent with EPITOPE treatment results: 62.7% reached an ED ≥1000 mg, 36.5% reached an ED ≥2000 mg, and 28.4% completed the DBPCFC without meeting stopping criteria; and there was 1 treatment-related anaphylaxis event.
CONCLUSIONS: Two years of VP250 in young peanut-allergic children demonstrated continued increases in treatment effect without new safety signals. This supports the potential of VP250 as a safe and effective treatment for peanut allergy in young children.
CLINICALTRIALS: GOV: NCT03859700.