Long-Term Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: An Open-Label Active Treatment (REALISE Study)

被引：1

作者：

Pongracic, Jacqueline A. ^{[1
]}

Gagnon, Remi ^{[2
]}

Sussman, Gordon ^{[3
]}

Siri, Dareen ^{[4
,5
]}

Oriel, Roxanne C. ^{[6
]}

Brown-Whitehorn, Terri F. ^{[7
]}

Anvari, Sara ^{[8
]}

Berger, William E. ^{[9
]}

Bird, J. Andrew ^{[10
]}

Chan, Edmond S. ^{[11
]}

Chinthrajah, R. Sharon ^{[12
]}

Chong, Hey J. ^{[13
]}

Fineman, Stanley M. ^{[14
]}

Fleischer, David M. ^{[15
]}

Gonzalez-Reyes, Erika ^{[16
]}

Kim, Edwin H. ^{[17
]}

Lanser, Bruce J. ^{[18
,19
]}

MacGinnitie, Andrew

Mehta, Hemalini ^{[20
]}

Petroni, Daniel ^{[21
,22
]}

Rupp, Ned ^{[23
]}

Schneider, Lynda C. ^{[24
,25
]}

Scurlock, Amy M. ^{[26
,27
]}

Sher, Lawrence D. ^{[28
]}

Shreffler, Wayne G. ^{[29
,30
]}

Sindher, Sayantani B. ^{[9
]}

Wood, Robert ^{[31
]}

Yang, William H. ^{[32
,34
]}

Sampson, Hugh A. ^{[6
]}

Bois, Timothee ^{[33
]}

Green, Todd D. ^{[13
,33
]}

Campbell, Dianne E. ^{[33
,34
]}

Bee, Katharine J. ^{[33
]}

Begin, Philippe ^{[35
]}

机构：

[1] Northwestern Univ, Feinberg Sch Med, Ann & Robert H Lurie Childrens Hosp Chicago, Dept Allergy & Immunol, Chicago, IL USA

[2] Clin Specialisee Allergie Capitale, Quebec City, PQ, Canada

[3] Gordon Sussman Clin Res, Toronto, ON, Canada

[4] Midwest Allergy Sinus Asthma Sneeze Wheeze & Itch, Clin Res Ctr, Normal, IL USA

[5] Southern Illinois Univ, Sch Med, Dept Otolaryngol Head & Neck Surg, Springfield, IL USA

[6] Kravis Childrens Hosp, Elliot & Roslyn Jaffe Food Allergy Inst, Div Pediat Allergy & Immunol, Dept Pediat,Icahn Sch Med Mt Sinai, New York, NY USA

[7] Univ Penn, Childrens Hosp Philadelphia, Perelman Sch Med, Dept Pediat, Philadelphia, PA USA

[8] Texas Childrens Hosp, Baylor Coll Med, Div Immunol Allergy & Retrovirol, Houston, TX USA

[9] Allergy & Asthma Solut, Trabuco Canyon, CA USA

[10] Univ Texas Southwestern Med Ctr, Dept Pediat, Div Allergy & Immunol, Dallas, TX USA

[11] Univ British Columbia, British Columbia Childrens Hosp, Dept Pediat, Vancouver, BC, Canada

[12] Stanford Univ, Sean N Parker Ctr Allergy & Asthma Res, Palo Alto, CA USA

[13] Univ Pittsburgh, UPMC Childrens Hosp Pittsburgh, Sch Med, Div Allergy & Immunol, Pittsburgh, PA USA

[14] Emory Univ, Sch Med, Dept Pediat, Atlanta Allergy & Asthma, Atlanta, GA USA

[15] Univ Colorado Denver, Sch Med, Childrens Hosp Colorado, Dept Pediat, Aurora, CO USA

[16] South Texas Allergy & Asthma Med Profess, San Antonio, TX USA

[17] Univ North Carolina, Sch Med, Dept Pediat, Div Pediat Allergy & Immunol, Chapel Hill, NC USA

[18] Natl Jewish Hlth, Dept Pediat, Denver, CO USA

[19] Univ Colorado, Sch Med, Aurora, CO USA

[20] Allergy & Asthma Specialists PA, Minneapolis, MN USA

[21] Seattle Allergy & Asthma Res Inst, Seattle, WA USA

[22] BioCryst Pharmaceut Inc, Clin Dev, Durham, NC USA

[23] Natl Allergy & Asthma Res, N Charleston, SC USA

[24] Harvard Med Sch, Boston Childrens Hosp, Div Immunol, Boston, MA USA

[25] Harvard Med Sch, Dept Pediat, Boston, MA USA

[26] Univ Arkansas Med Sci, Dept Pediat, Little Rock, AR USA

[27] Arkansas Childrens Hosp, Little Rock, AR USA

[28] Peninsula Res Associates, Rolling Hills Estates, CA USA

[29] Massachusetts Gen Hosp, Food Allergy Ctr, Boston, MA USA

[30] Massachusetts Gen Hosp, Ctr Immunol & Inflammatory Dis, Boston, MA USA

[31] Johns Hopkins Univ, Sch Med, Dept Pediat, Baltimore, MD USA

[32] Ottawa Allergy Res Corp, Ottawa, ON, Canada

[33] DBV Technol SA, Montrouge, France

[34] Westmead Childrens Hosp, Dept Clin Immunol & Allergy, Westmead, NSW, Australia

[35] Ctr Hosp Univ St Justine, Dept Pediat, Sect Allergy Immunol & Rheumatol, Montreal, PQ, Canada

来源：

JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE | 2025年 / 13卷 / 05期

关键词：

Epicutaneous immunotherapy; VIASKIN; Peanut al-lergy; Long-term safety; Immunotherapy; Real-world setting; Children; Desensitization; Food allergy; ORAL IMMUNOTHERAPY; PREVALENCE; IGE;

D O I：

10.1016/j.jaip.2025.02.024

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

BACKGROUND: Owing to limited treatment options for peanut allergy, patients remain at risk for allergic reactions due to accidental exposure. Epicutaneous immunotherapy (EPIT) is a novel treatment being investigated for peanut allergy. OBJECTIVE: This study assessed long-term safety of EPIT with VIASKIN peanut patch 250 mg (VP250) via an open-label extension of the REAL Life Use and Safety of EPIT (REALISE) trial. METHODS: REALISE was a phase 3 trial in peanut-allergic children aged 4 through 11 years that included a 6-month, randomized, double-blind, placebo-controlled treatment phase, followed by an open-label, single-arm, active treatment period for up to 36 months. RESULTS: Of the 392 participants (male 54.8%; median age 7.2 y) who received at least 1 dose of treatment, 77.8% completed the 36-month active treatment. Mean adherence to treatment was high at 96.4%. Most participants (98.7%) experienced at least 1 treatment-emergent adverse event (TEAE); the majority were mild or moderate and decreased in frequency and severity over time. Most participants (94.6%) experienced at least 1 treatment-related TEAE. Local skin reactions were the most common treatment-related TEAE with the incidence decreasing from year 1 (87.8%) to year 3 (19.2%). Serious treatment-related TEAEs were reported in 2 participants. No specific safety signals were identified in the 14 participants enrolled with a history of severe anaphylaxis (Anaphylaxis Staging System grade 3). CONCLUSION: Consistent with previous phase 3 studies, longterm EPIT with VIASKIN peanut patch 250 mg was well tolerated with high adherence in peanut-allergic children aged 4 through 11 years (clinicaltrials.gov; NCT: NCT02916446). (c) 2025 The Authors. Published by Elsevier Inc. on behalf of the American Academy of Allergy, Asthma & Immunology. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/). (J Allergy Clin Immunol Pract 2025;13:1190-200)

引用

页码：1190 / 1200.e3

页数：14

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