PMID- 37779517
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231030
IS  - 2772-8293 (Electronic)
IS  - 2772-8293 (Linking)
VI  - 2
IP  - 3
DP  - 2023 Aug
TI  - Long-term safety and immunologic outcomes of daily oral immunotherapy for peanut 
      allergy.
PG  - 100120
LID - 10.1016/j.jacig.2023.100120 [doi]
LID - 100120
AB  - BACKGROUND: Oral immunotherapy containing peanut (Arachis hypogaea) allergen 
      powder-dnfp (PTAH) (Palforzia [Aimmune Therapeutics, Brisbane, Calif]) for 9 to 
      12 months resulted in higher tolerated amounts of peanut protein in PTAH-treated 
      individuals aged 4 to 17 years with peanut allergy than in placebo-treated 
      participants. OBJECTIVE: We aimed to describe additional long-term pooled safety 
      data and changes in peanut sensitization markers from baseline through 
      approximately 5 years of treatment. METHODS: The results from 6 clinical trials 
      of PTAH (3 controlled and 3 open-label extension studies [N = 1227]) were pooled, 
      and analysis of safety outcomes and immunologic data was performed. The PTAH 
      doses were administered sequentially as follows: initial dose escalation (dose 
      increased to 6 mg over 2 days), updosing (dose increased every 2 weeks to 300 mg 
      for a minimum of 6 months), and maintenance dosing (300 mg per day). RESULTS: 
      There was a trend toward decreased adverse events (AEs) at years 1 and 2 that was 
      maintained up to 5 years, with 94% of patients experiencing mild or moderate AEs 
      and only 13% discontinuing PTAH use because of AEs overall. Gastrointestinal 
      symptoms were the most commonly reported treatment-related AEs. A downward trend 
      in systemic allergic reactions was also reported. PTAH treatment resulted in 
      reduced levels of peanut-specific IgE after the first year and increased levels 
      of peanut-specific IgG4, with a lowered peanut-specific IgE:IgG4 ratio. 
      A reduction in median peanut skin prick test wheal diameter was observed (11.50 
      mm at baseline vs 5.75 mm at year 5). CONCLUSION: Long-term immunomodulation 
      without any new safety signals was reported with PTAH immunotherapy in the 
      largest safety data set and longest treatment duration for oral immunotherapy 
      published to date.
CI  - (c) 2023 The Author(s).
FAU - Bird, J Andrew
AU  - Bird JA
AD  - Department of Pediatrics, University of Texas Southwestern, Dallas, Tex.
FAU - Nilsson, Caroline
AU  - Nilsson C
AD  - Clinical Research and Education, Karolinska Institutet, Sachs' Children and Youth 
      Hospital, Stockholm, Sweden.
FAU - Brown, Kari
AU  - Brown K
AD  - Aimmune Therapeutics, Brisbane, Calif.
FAU - Pham, Trinh
AU  - Pham T
AD  - Aimmune Therapeutics, Brisbane, Calif.
FAU - Tilles, Stephen
AU  - Tilles S
AD  - Aimmune Therapeutics, Brisbane, Calif.
FAU - du Toit, George
AU  - du Toit G
AD  - Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.
FAU - Assa'ad, Amal
AU  - Assa'ad A
AD  - Division of Allergy and Immunology, Cincinnati Children's Hospital Medical 
      Center, Cincinnati, Ohio.
LA  - eng
PT  - Journal Article
DEP - 20230527
PL  - United States
TA  - J Allergy Clin Immunol Glob
JT  - The journal of allergy and clinical immunology. Global
JID - 9918453488706676
PMC - PMC10509957
OTO - NOTNLM
OT  - PTAH
OT  - immunologic outcomes
OT  - oral immunotherapy
OT  - peanut (Arachis hypogaea) allergen powder
OT  - peanut allergy
OT  - pooled safety
EDAT- 2023/10/02 06:42
MHDA- 2023/10/02 06:43
PMCR- 2023/05/27
CRDT- 2023/10/02 04:14
PHST- 2022/12/05 00:00 [received]
PHST- 2023/03/13 00:00 [revised]
PHST- 2023/03/21 00:00 [accepted]
PHST- 2023/10/02 06:43 [medline]
PHST- 2023/10/02 06:42 [pubmed]
PHST- 2023/10/02 04:14 [entrez]
PHST- 2023/05/27 00:00 [pmc-release]
AID - S2772-8293(23)00045-0 [pii]
AID - 100120 [pii]
AID - 10.1016/j.jacig.2023.100120 [doi]
PST - epublish
SO  - J Allergy Clin Immunol Glob. 2023 May 27;2(3):100120. doi: 
      10.1016/j.jacig.2023.100120. eCollection 2023 Aug.