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

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.