Tolerability and surrogate efficacy parameters of a polymerized depot mixture pollen extracts without dilutional effect

Author:

Quiralte Joaquín1,Lara María Angeles2,Sánchez Gemma Vanesa3,Monteserín Javier4,Fernández Luís5,Gómez-Fernández María Cruz6ORCID,Madariaga Begoña6,Arilla Carmen6,Asturias Juan Andrés6,Begoña Leire6,Martínez Alberto6

Affiliation:

1. Hospital Universitario Virgen del Rocío, Allergology Department, Sevilla, Spain

2. Hospital Clínico de Granada, Allergology Department, Granada, Spain

3. Hospital Universitario del Henares, Allergology Department, Madrid, Spain

4. Hospital Virgen Macarena, Allergology Department, Sevilla, Spain

5. Hospital de Zafra, Allergology Department, Badajoz, Spain

6. ROXALL España, R&D Department, Zamudio, Spain

Abstract

Aim: To evaluate tolerability of subcutaneous immunotherapy, in a polymerized mixture ( Olea europaea/ Phleum pratense) depot presentation. Patients & methods: A total of 47 poly-allergic patients received: an abbreviated schedule with three injections at weekly intervals or a cluster schedule with two administrations in 1 day. Both treatments continued with 3 monthly maintenance administrations. Results: Two systemic reactions, (4.3%). One grade 0 and one grade I. No local reactions. Immunoglobulin levels, increased significantly at final visit versus baseline in sIgG and sIgG4; in both schedules and allergens, no significant changes in specific immunoglobulin E levels were detected. Cutaneous reactivity at final visit decreased significantly. Conclusion: Both administration schedules with polymerized mixture of O. europaea/ P. pratense, presented an excellent tolerability profile and induced preliminary efficacy changes.

Publisher

Future Medicine Ltd

Subject

Oncology,Immunology,Immunology and Allergy

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