Randomized double-blind, placebo-controlled trial of sublingual immunotherapy with a Pru p 3 quantified peach extract.
BACKGROUND
Peach allergy is highly prevalent in the Mediterranean area; it is persistent and potentially severe, and therefore a prime target for immunotherapy. We aimed to study the efficacy and safety of sublingual immunotherapy (SLIT) with a peach extract quantified in mass units for Pru p 3, the peach lipid transfer protein.


METHODS
Randomized, double-blind, placebo-controlled (DBPC) clinical trial. The main efficacy outcome was the change in the response to a DBPC food challenge (DBPCFC) with peach. Secondary efficacy outcomes were the changes in skin prick test (SPT), and in specific immunoglobulin E (IgE) and IgG(4) to Pru p 3. Tolerance was assessed with a careful recording of adverse events.


RESULTS
After 6 months of SLIT, the active group tolerated a significantly higher amount of peach (three- to ninefold), presented a significant decrease (5.3 times) in SPT, and a significant increase in IgE and IgG(4) to Pru p 3. No significant changes were observed within the placebo group. Statistically significant inter-group differences were only observed in the SPT and IgG(4) responses. No serious adverse events were reported. Systemic reactions were mild, and observed with a similar frequency in both groups. Local reactions were significantly more frequent in the active group (three times) and 95% of them restricted to the oral cavity.


CONCLUSIONS
In this first exploratory clinical trial, SLIT for peach allergy seems to be a promising therapeutic option that could modify the clinical reactivity of the patients to peach intake and the underlying immunological response with a good tolerance.
Fernández-Rivas
M
M
Unidad de Alergia, Fundación Hospital Alcorcón, Alcorcón, Spain.
Garrido Fernández
S
S
Nadal
J A
JA
Díaz de Durana
M D Alonso
MD
García
B E
BE
González-Mancebo
E
E
Martín
S
S
Barber
D
D
Rico
P
P
Tabar
A I
AI
D000286:Administration, Sublingual; D000328:Adult; D000485:Allergens / Q000008:administration & dosage* / Q000276:immunology; D052179:Antigens, Plant; D003888:Desensitization, Immunologic / Q000009:adverse effects / Q000379:methods*; D004311:Double-Blind Method; D005260:Female; D005512:Food Hypersensitivity / Q000628:therapy*; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D010940:Plant Proteins; D027861:Prunus / Q000276:immunology*; D012882:Skin Tests
D000485:Allergens; D052179:Antigens, Plant; D007074:Immunoglobulin G; D010940:Plant Proteins; C463181:Pru p 3 allergen; D007073:Immunoglobulin E