Present address: Servicio de Alergia, Hospital Clínico San Carlos, Madrid, Spain.
Randomized double-blind, placebo-controlled trial of sublingual immunotherapy with a Pru p 3 quantified peach extract
Version of Record online: 21 JAN 2009
© 2009 The Authors. Journal compilation © 2009 Blackwell Munksgaard
Volume 64, Issue 6, pages 876–883, June 2009
How to Cite
Fernández-Rivas, M., Garrido Fernández, S., Nadal, J. A., Alonso Díaz de Durana, M. D., García, B. E., González-Mancebo, E., Martín, S., Barber, D., Rico, P. and Tabar, A. I. (2009), Randomized double-blind, placebo-controlled trial of sublingual immunotherapy with a Pru p 3 quantified peach extract. Allergy, 64: 876–883. doi: 10.1111/j.1398-9995.2008.01921.x
- Issue online: 11 MAY 2009
- Version of Record online: 21 JAN 2009
- Accepted for publication 6 September 2008
- food allergy;
- food immunotherapy;
- lipid transfer protein;
- sublingual immunotherapy
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 IgG4 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 IgG4 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 IgG4 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.
Conclusion: 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.