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

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.

• Authors: Satya D Narisety, Pamela A Frischmeyer-Guerrerio, Corinne A Keet, Mark Gorelik, John Schroeder, Robert G Hamilton, Robert A Wood
• Journal: The Journal of allergy and clinical immunology (J Allergy Clin Immunol) Vol. 135 Issue 5 Pg. 1275-82.e1-6 (May 2015) ISSN: 1097-6825 [Electronic] United States
• PMID: 25528358 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, N.I.H., Intramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 American Academy of Allergy, Asthma & Immunology. All rights reserved.

Chemical References

• Allergens
• Immunoglobulin G
• Immunoglobulin E

Topics

• Administration, Oral
• Administration, Sublingual
• Adolescent
• Allergens (administration & dosage, immunology)
• Arachis (adverse effects)
• Child
• Desensitization, Immunologic (adverse effects, methods)
• Female
• Humans
• Immunoglobulin E (blood, immunology)
• Immunoglobulin G (blood, immunology)
• Male
• Peanut Hypersensitivity (diagnosis, immunology, therapy)
• Pilot Projects
• Skin Tests
• Treatment Outcome