Format

Send to

Choose Destination
J Allergy Clin Immunol. 2015 May;135(5):1275-82.e1-6. doi: 10.1016/j.jaci.2014.11.005. Epub 2014 Dec 18.

A randomized, double-blind, placebo-controlled pilot study of sublingual versus oral immunotherapy for the treatment of peanut allergy.

Author information

1
Department of Pediatrics, Division of Allergy, Immunology and Infectious Diseases, New Jersey Medical School, Rutgers University, Newark, NJ.
2
Department of Pediatrics, Division of Allergy and Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.
3
Department of Medicine, Division of Allergy and Immunology, Johns Hopkins University School of Medicine, Baltimore, Md.
4
Department of Pediatrics, Division of Allergy and Immunology, Johns Hopkins University School of Medicine, Baltimore, Md. Electronic address: rwood@jhmi.edu.

Abstract

BACKGROUND:

Although promising results have emerged regarding oral immunotherapy (OIT) and sublingual immunotherapy (SLIT) for the treatment of peanut allergy (PA), direct comparisons of these approaches are limited.

OBJECTIVE:

This study was conducted to compare the safety, efficacy, and mechanistic correlates of peanut OIT and SLIT.

METHODS:

In this double-blind study children with PA were randomized to receive active SLIT/placebo OIT or active OIT/placebo SLIT. Doses were escalated to 3.7 mg/d (SLIT) or 2000 mg/d (OIT), and subjects were rechallenged after 6 and 12 months of maintenance. After unblinding, therapy was modified per protocol to offer an additional 6 months of therapy. Subjects who passed challenges at 12 or 18 months were taken off treatment for 4 weeks and rechallenged.

RESULTS:

Twenty-one subjects aged 7 to 13 years were randomized. Five discontinued therapy during the blinded phase. Of the remaining 16, all had a greater than 10-fold increase in challenge threshold after 12 months. The increased threshold was significantly greater in the active OIT group (141- vs 22-fold, P = .01). Significant within-group changes in skin test results and peanut-specific IgE and IgG4 levels were found, with overall greater effects with OIT. Adverse reactions were generally mild but more common with OIT (P < .001), including moderate reactions and doses requiring medication. Four subjects had sustained unresponsiveness at study completion.

CONCLUSION:

OIT appeared far more effective than SLIT for the treatment of PA but was also associated with significantly more adverse reactions and early study withdrawal. Sustained unresponsiveness after 4 weeks of avoidance was seen in only a small minority of subjects.

KEYWORDS:

Peanut allergy; food allergy; immunotherapy; oral immunotherapy; sublingual immunotherapy

PMID:
25528358
PMCID:
PMC4430665
DOI:
10.1016/j.jaci.2014.11.005
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Elsevier Science Icon for PubMed Central
Loading ...
Support Center