PMID- 34848381
OWN - NLM
STAT- MEDLINE
DCOM- 20220712
LR  - 20220727
IS  - 2213-2201 (Electronic)
VI  - 10
IP  - 7
DP  - 2022 Jul
TI  - Safety of Epicutaneous Immunotherapy in Peanut-Allergic Children: REALISE 
      Randomized Clinical Trial Results.
PG  - 1864-1873.e10
LID - S2213-2198(21)01295-2 [pii]
LID - 10.1016/j.jaip.2021.11.017 [doi]
AB  - BACKGROUND: Treatment options for peanut allergy are limited. In previous 
      clinical trials, epicutaneous immunotherapy with a patch containing 250-mug peanut 
      protein (Viaskin Peanut 250 mug [VP250]) was well tolerated and statistically 
      superior to placebo in desensitizing peanut-allergic children. OBJECTIVE: To 
      examine the safety of VP250 in children, using a study design approximating 
      potential real-world use. METHODS: REAL LIfe Use and Safety of EPIT (REALISE) is 
      a phase 3 multicenter study consisting of a 6-month, randomized, double-blind, 
      placebo-controlled period followed by open-label active treatment. Children aged 
      4 to 11 years with physician diagnosis of peanut allergy received daily treatment 
      with placebo (6 months) or VP250 (up to 36 months). Data from the 6-month, 
      randomized, controlled phase of REALISE are reported. RESULTS: Three hundred 
      ninety-three children were randomized 3:1 to receive VP250 (n = 294) or placebo 
      (n = 99) for 6 months; 284 (72.3%) children had a history of peanut anaphylaxis. 
      According to parent diary, all participants receiving VP250 and 83.8% receiving 
      placebo reported at least 1 episode of local skin reaction, with frequency 
      decreasing over time. Only 4 participants (1.4%) receiving VP250 discontinued 
      because of adverse events (AEs). Epinephrine was administered for allergic 
      reactions attributed to VP250 in 7 children (2.4%), of whom 5 remained in the 
      study; none involved severe anaphylaxis. Overall, AE rates were similar among 
      participants with and without a history of peanut anaphylaxis. CONCLUSIONS: In a 
      study designed to mirror real-world use, VP250 was observed to be well tolerated 
      in peanut-allergic children, consistent with previous phase 2b and 3 studies.
CI  - Copyright (c) 2021 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Pongracic, Jacqueline A
AU  - Pongracic JA
AD  - Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill. Electronic 
      address: JPongracic@luriechildrens.org.
FAU - Gagnon, Remi
AU  - Gagnon R
AD  - Clinique Specialisee en Allergie de la Capitale, Quebec, QC, Canada.
FAU - Sussman, Gordon
AU  - Sussman G
AD  - Gordon Sussman Clinical Research, Toronto, ON, Canada.
FAU - Siri, Dareen
AU  - Siri D
AD  - Midwest Allergy Sinus Asthma SC/SWIA Clinical Research Center, Normal, Ill.
FAU - Oriel, Roxanne C
AU  - Oriel RC
AD  - Division of Allergy and Immunology, Department of Pediatrics, the Elliot and 
      Roslyn Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, 
      Kravis Children's Hospital, New York, NY.
FAU - Brown-Whitehorn, Terri F
AU  - Brown-Whitehorn TF
AD  - Children's Hospital of Philadelphia, Perelman School of Medicine, University of 
      Pennsylvania, Philadelphia, Pa.
FAU - Green, Todd D
AU  - Green TD
AD  - DBV Technologies SA, Montrouge, France; UPMC Children's Hospital of Pittsburgh 
      and University of Pittsburgh School of Medicine, Pittsburgh, Pa.
FAU - Campbell, Dianne E
AU  - Campbell DE
AD  - DBV Technologies SA, Montrouge, France.
FAU - Anvari, Sara
AU  - Anvari S
AD  - Texas Children's Hospital, Houston, Tex; Baylor College of Medicine, Houston, 
      Tex.
FAU - Berger, William E
AU  - Berger WE
AD  - Allergy and Asthma Associates of Southern California, Mission Viejo, Calif.
FAU - Bird, J Andrew
AU  - Bird JA
AD  - University of Texas Southwestern Medical Center, Dallas, Tex.
FAU - Chan, Edmond S
AU  - Chan ES
AD  - Division of Allergy & Immunology, Department of Pediatrics, British Columbia 
      Children's Hospital, University of British Columbia, Vancouver, BC, Canada.
FAU - Cheema, Amarjit
AU  - Cheema A
AD  - Cheema Research Inc, Mississauga, ON, Canada.
FAU - Chinthrajah, R Sharon
AU  - Chinthrajah RS
AD  - Sean N. Parker Center for Allergy and Asthma Research, Stanford University, 
      Stanford, Calif.
FAU - Chong, Hey Jin
AU  - Chong HJ
AD  - UPMC Children's Hospital of Pittsburgh and University of Pittsburgh School of 
      Medicine, Pittsburgh, Pa.
FAU - Dowling, Paul J
AU  - Dowling PJ
AD  - Division of Allergy and Immunology, Children's Mercy Hospital Kansas City, Kansas 
      City, Mo.
FAU - Fineman, Stanley M
AU  - Fineman SM
AD  - Department of Pediatrics, Emory University School of Medicine, Atlanta Allergy & 
      Asthma, Atlanta, Ga.
FAU - Fleischer, David M
AU  - Fleischer DM
AD  - Children's Hospital Colorado, University of Colorado Denver School of Medicine, 
      Aurora, Colo.
FAU - Gonzalez-Reyes, Erika
AU  - Gonzalez-Reyes E
AD  - South Texas Allergy & Asthma Medical Professionals, San Antonio, Tex.
FAU - Kim, Edwin H
AU  - Kim EH
AD  - University of North Carolina School of Medicine, Chapel Hill, NC.
FAU - Lanser, Bruce J
AU  - Lanser BJ
AD  - National Jewish Health, Denver, Colo.
FAU - MacGinnitie, Andrew
AU  - MacGinnitie A
AD  - Division of Immunology, Boston Children's Hospital and Department of Pediatrics, 
      Harvard Medical School, Boston, Mass.
FAU - Mehta, Hemalini
AU  - Mehta H
AD  - Allergy and Asthma Specialists, PA, Minneapolis, Minn.
FAU - Petroni, Daniel
AU  - Petroni D
AD  - Seattle Allergy & Asthma Research Institute, Seattle, Wash.
FAU - Rupp, Ned
AU  - Rupp N
AD  - National Allergy and Asthma Research, North Charleston, SC.
FAU - Schneider, Lynda C
AU  - Schneider LC
AD  - Division of Immunology, Boston Children's Hospital and Department of Pediatrics, 
      Harvard Medical School, Boston, Mass.
FAU - Scurlock, Amy M
AU  - Scurlock AM
AD  - Department of Pediatrics, University of Arkansas for Medical Sciences and 
      Arkansas Children's Hospital, Little Rock, Ark.
FAU - Sher, Lawrence D
AU  - Sher LD
AD  - Peninsula Research Associates, Rolling Hills Estates, Calif.
FAU - Shreffler, Wayne G
AU  - Shreffler WG
AD  - Massachusetts General Hospital, Boston, Mass.
FAU - Sindher, Sayantani B
AU  - Sindher SB
AD  - Sean N. Parker Center for Allergy and Asthma Research, Stanford University, 
      Stanford, Calif.
FAU - Stillerman, Allan
AU  - Stillerman A
AD  - Allergy and Asthma Specialists, PA, Minneapolis, Minn.
FAU - Wood, Robert
AU  - Wood R
AD  - Johns Hopkins Hospital, Baltimore, Md.
FAU - Yang, William H
AU  - Yang WH
AD  - Ottawa Allergy Research Corporation and Department of Medicine, University of 
      Ottawa Medical School, Ottawa, ON, Canada.
FAU - Bois, Timothee
AU  - Bois T
AD  - DBV Technologies SA, Montrouge, France.
FAU - Sampson, Hugh A
AU  - Sampson HA
AD  - Division of Pediatric Allergy and Immunology, Icahn School of Medicine at Mount 
      Sinai, New York, NY.
FAU - Begin, Philippe
AU  - Begin P
AD  - Section of Allergy, Immunology and Rheumatology, Department of Pediatrics, CHU 
      Sainte-Justine, Montreal, QC, Canada.
LA  - eng
GR  - UL1 TR001422/TR/NCATS NIH HHS/United States
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20211127
PL  - United States
TA  - J Allergy Clin Immunol Pract
JT  - The journal of allergy and clinical immunology. In practice
JID - 101597220
RN  - 0 (Allergens)
RN  - 0 (Immunologic Factors)
SB  - IM
CIN - J Allergy Clin Immunol Pract. 2022 Jul;10(7):1874-1875. PMID: 35809991
MH  - Administration, Oral
MH  - Allergens/therapeutic use
MH  - *Anaphylaxis/etiology
MH  - Arachis
MH  - Child
MH  - Desensitization, Immunologic/methods
MH  - Humans
MH  - Immunologic Factors/therapeutic use
MH  - *Peanut Hypersensitivity/drug therapy
OTO - NOTNLM
OT  - Children
OT  - Desensitization
OT  - Epicutaneous immunotherapy (EPIT)
OT  - Food allergy
OT  - Immunotherapy
OT  - Peanut allergy
OT  - Real-world setting
EDAT- 2021/12/02 06:00
MHDA- 2022/07/14 06:00
CRDT- 2021/12/01 06:04
PHST- 2021/07/09 00:00 [received]
PHST- 2021/10/19 00:00 [revised]
PHST- 2021/11/03 00:00 [accepted]
PHST- 2021/12/02 06:00 [pubmed]
PHST- 2022/07/14 06:00 [medline]
PHST- 2021/12/01 06:04 [entrez]
AID - S2213-2198(21)01295-2 [pii]
AID - 10.1016/j.jaip.2021.11.017 [doi]
PST - ppublish
SO  - J Allergy Clin Immunol Pract. 2022 Jul;10(7):1864-1873.e10. doi: 
      10.1016/j.jaip.2021.11.017. Epub 2021 Nov 27.