TOPLINE:
Low-dose peanut oral immunotherapy with peanut allergen powder-dnfp (PTAH) is effective and safe in children aged 1 to <4 years with a peanut allergy.
METHODOLOGY:
- This phase 3 Peanut Oral Immunotherapy Study of Early Intervention for Desensitization (POSEIDON) trial was conducted across 23 sites in North America and Europe.
- The study included 146 children aged 1 to <4 years with a peanut allergy who were randomly assigned to receive PTAH (n=98) or placebo (n=48) for approximately 12 months.
- Primary endpoint: proportion of children tolerating a ≥600-mg single peanut protein dose with allergy symptom severity being not more than mild at exit double-blind, placebo-controlled food challenge (DBPCFC).
- Secondary endpoints: tolerance rates at 300- or 1000-mg single peanut protein dose with only mild allergy symptom severity at exit DBPCFC.
- A significantly higher proportion of children in the PTAH vs placebo group tolerated the ≥600-mg peanut protein dose at exit DBPCFC (73.5% vs 6.3%; P <.001).
- Compared with the placebo group, significantly more PTAH-treated children tolerated the 300 mg and 1000 mg doses (both P < .001).
- Treatment-related adverse events (TRAEs) were experienced by 75.5% and 58.3% of children in the PTAH and placebo groups, respectively, mostly during up-dosing.
- No serious or severe TRAEs were reported in either group.
"POSEIDON adds to the body of evidence supporting early intervention in peanut allergy with oral immunotherapy, with potential efficacy and tolerability advantages associated with younger age at the start of intervention," the authors concluded.
SOURCE: The study was published online on October 23 in NEJM Evidence. The lead author of the study is George Du Toit, MB BCh, Guy’s and St. Thomas’ National Health Service Foundation Trust and Kings College, London.
LIMITATIONS:
- The trial involved highly peanut-reactive children, starting with a median tolerated dose of only 30 mg, despite being at the highest risk for allergic reactions following accidental exposure.
- The trial did not include an assessment of the long-term safety or efficacy endpoints, such as remission, limiting insights into sustained effects post-treatment.
- Although 61% of the PTAH group tolerated the 2000-mg single-dose at exit DBPCFC, the study did not explore higher doses.
DISCLOSURES:
The trial was funded by Aimmune Therapeutics, a Nestle Health Science company. Several authors declared being current or former employees of Aimmune, whereas other authors reported receiving grants or travel support from or having consulting relationships with Aimmune or other sources.
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