PMID- 19183164 OWN - NLM STAT- MEDLINE DCOM- 20090623 LR - 20121115 IS - 1398-9995 (Electronic) IS - 0105-4538 (Linking) VI - 64 IP - 6 DP - 2009 Jun TI - Randomized double-blind, placebo-controlled trial of sublingual immunotherapy with a Pru p 3 quantified peach extract. PG - 876-83 LID - 10.1111/j.1398-9995.2008.01921.x [doi] AB - 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. 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. FAU - Fernandez-Rivas, M AU - Fernandez-Rivas M AD - Unidad de Alergia, Fundacion Hospital Alcorcon, Alcorcon, Spain. FAU - Garrido Fernandez, S AU - Garrido Fernandez S FAU - Nadal, J A AU - Nadal JA FAU - Diaz de Durana, M D Alonso AU - Diaz de Durana MD FAU - Garcia, B E AU - Garcia BE FAU - Gonzalez-Mancebo, E AU - Gonzalez-Mancebo E FAU - Martin, S AU - Martin S FAU - Barber, D AU - Barber D FAU - Rico, P AU - Rico P FAU - Tabar, A I AU - Tabar AI LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20090121 PL - Denmark TA - Allergy JT - Allergy JID - 7804028 RN - 0 (Allergens) RN - 0 (Antigens, Plant) RN - 0 (Immunoglobulin G) RN - 0 (Plant Proteins) RN - 0 (Pru p 3 allergen) RN - 37341-29-0 (Immunoglobulin E) SB - IM MH - Administration, Sublingual MH - Adult MH - Allergens/*administration & dosage/immunology MH - Antigens, Plant MH - Desensitization, Immunologic/adverse effects/*methods MH - Double-Blind Method MH - Female MH - Food Hypersensitivity/*therapy MH - Humans MH - Immunoglobulin E/blood MH - Immunoglobulin G/blood MH - Male MH - Plant Proteins MH - Prunus/*immunology MH - Skin Tests EDAT- 2009/02/03 09:00 MHDA- 2009/06/24 09:00 CRDT- 2009/02/03 09:00 PHST- 2009/02/03 09:00 [entrez] PHST- 2009/02/03 09:00 [pubmed] PHST- 2009/06/24 09:00 [medline] AID - ALL1921 [pii] AID - 10.1111/j.1398-9995.2008.01921.x [doi] PST - ppublish SO - Allergy. 2009 Jun;64(6):876-83. doi: 10.1111/j.1398-9995.2008.01921.x. Epub 2009 Jan 21.