title: Sublingual immunotherapy for peanut allergy: Long-term follow-up of a randomized multicenter trial.
abstract: BACKGROUND
  We previously reported the initial results of the first multicenter, randomized, double-blind, placebo-controlled clinical trial of peanut sublingual immunotherapy (SLIT), observing a favorable safety profile associated with modest clinical and immunologic effects in the first year.
  
  
  OBJECTIVE
  We sought to provide long-term (3-year) clinical and immunologic outcomes for our peanut SLIT trial. Key end points were (1) percentage of responders at 2 years (ie, could consume 5 g of peanut powder or a 10-fold increase from baseline), (2) percentage reaching desensitization at 3 years, (3) percentage attaining sustained unresponsiveness after 3 years, (4) immunologic end points, and (5) assessment of safety parameters.
  
  
  METHODS
  Response to treatment was evaluated in 40 subjects aged 12 to 40 years by performing a 10-g peanut powder oral food challenge after 2 and 3 years of daily peanut SLIT therapy. At 3 years, SLIT was discontinued for 8 weeks, followed by another 10-g oral food challenge and an open feeding of peanut butter to assess sustained unresponsiveness.
  
  
  RESULTS
  Approximately 98% of the 18,165 doses were tolerated without adverse reactions beyond the oropharynx, with no severe symptoms or uses of epinephrine. A high rate (>50%) discontinued therapy. By study's end, 4 (10.8%) of 37 SLIT-treated participants were fully desensitized to 10 g of peanut powder, and all 4 achieved sustained unresponsiveness. Responders at 2 years showed a significant decrease in peanut-specific basophil activation and skin prick test titration compared with nonresponders.
  
  
  CONCLUSIONS
  Peanut SLIT induced a modest level of desensitization, decreased immunologic activity over 3 years in responders, and had an excellent long-term safety profile. However, most patients discontinued therapy by the end of year 3, and only 10.8% of subjects achieved sustained unresponsiveness.
authors: Department of Pediatrics, University of North Carolina, Chapel Hill, NC. Electronic address: wburks@email.unc.edu.
authors: A Wesley
authors: AW
authors: Burks
authors: Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Md.
authors: Robert A
authors: RA
authors: Wood
authors: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors: Stacie M
authors: SM
authors: Jones
authors: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
authors: Scott H
authors: SH
authors: Sicherer
authors: Department of Pediatrics, University of Colorado Denver School of Medicine and Children's Hospital Colorado, Denver, Colo.
authors: David M
authors: DM
authors: Fleischer
authors: Department of Pediatrics, University of Arkansas for Medical Sciences and Arkansas Children's Hospital, Little Rock, Ark.
authors: Amy M
authors: AM
authors: Scurlock
authors: Department of Pediatrics, University of North Carolina, Chapel Hill, NC.
authors: Brian P
authors: BP
authors: Vickery
authors: Department of Pediatrics, National Jewish Health, Denver, Colo.
authors: Andrew H
authors: AH
authors: Liu
authors: EMMES Corporation, Rockville, Md.
authors: Alice K
authors: AK
authors: Henning
authors: EMMES Corporation, Rockville, Md.
authors: Robert
authors: R
authors: Lindblad
authors: EMMES Corporation, Rockville, Md.
authors: Peter
authors: P
authors: Dawson
authors: National Institutes of Health (National Institutes of Allergy and Infectious Diseases), Bethesda, Md.
authors: Marshall
authors: M
authors: Plaut
authors: Department of Pediatrics, Icahn School of Medicine at Mount Sinai, New York, NY.
authors: Hugh A
authors: HA
authors: Sampson
mesh_terms: D000293:Adolescent; D000485:Allergens / Q000008:administration & dosage / Q000276:immunology; D010367:Arachis / Q000009:adverse effects; D001491:Basophils / Q000276:immunology / Q000378:metabolism; D015897:Comorbidity; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood / Q000276:immunology; D008297:Male; D021183:Peanut Hypersensitivity / Q000276:immunology / Q000628:therapy*; D014674:Plant Proteins, Dietary / Q000008:administration & dosage / Q000276:immunology; D063729:Sublingual Immunotherapy; D016896:Treatment Outcome
chemical_list: D000485:Allergens; D014674:Plant Proteins, Dietary; D007073:Immunoglobulin E
keywords: Peanut allergy; desensitization; follow-up; food allergy; sublingual immunotherapy
references: J Allergy Clin Immunol. 2014 Feb;133(2):318-23
references: 24636471
references: J Allergy Clin Immunol. 1997 Jun;99(6 Pt 1):744-51
references: 9215240
references: Lancet. 2014 Apr 12;383(9925):1297-304
references: 24485709
references: J Clin Invest. 2014 May;124(5):1880-6
references: 24789880
references: Curr Opin Allergy Clin Immunol. 2014 Dec;14(6):582-90
references: 25188717
references: J Allergy Clin Immunol. 2001 Jan;107(1):191-3
references: 11150011
references: J Allergy Clin Immunol. 2003 Jun;111(6):1406-9
references: 12789247
references: J Allergy Clin Immunol. 2003 Jul;112(1):183-9
references: 12847497
references: J Allergy Clin Immunol. 2005 Nov;116(5):1073-9
references: 16275379
references: J Allergy Clin Immunol. 2007 Feb;119(2):507-8
references: 17125821
references: J Allergy Clin Immunol. 2007 Apr;119(4):1016-8
references: 17306354
references: J Allergy Clin Immunol. 2009 Aug;124(2):292-300, 300.e1-97
references: 19577283
references: J Allergy Clin Immunol. 2010 Jun;125(6):1322-6
references: 20462634
references: J Allergy Clin Immunol. 2010 Jul;126(1):83-91.e1
references: 20542324
references: Nutrition. 2011 Feb;27(2):253-67
references: 21215925
references: J Allergy Clin Immunol. 2011 Mar;127(3):640-6.e1
references: 21281959
references: J Allergy Clin Immunol. 2011 Mar;127(3):654-60
references: 21377034
references: J Allergy Clin Immunol. 2012 Feb;129(2):448-55, 455.e1-5
references: 22130425
references: J Allergy Clin Immunol. 2013 Jan;131(1):119-27.e1-7
references: 23265698
references: Allergy Asthma Proc. 2013 May-Jun;34(3):197-204
references: 23676568
references: J Allergy Clin Immunol. 2013 Aug;132(2):476-8.e2
references: 23534975
references: J Allergy Clin Immunol. 2013 Aug;132(2):353-60.e2
references: 23651609
references: J Allergy Clin Immunol Pract. 2013 Jan;1(1):15-21
references: 24229817
references: J Allergy Clin Immunol. 2014 Feb;133(2):468-75
references: 24361082
references: J Allergy Clin Immunol. 1992 Aug;90(2):256-62
references: 1500630
references: Allergy Asthma Proc. 2014 Mar-Apr;35(2):171-7
references: 24717795