Evaluation of a pre-co-seasonal and a perennial schedule of a single multiallergen depigmented-polymerized subcutaneous immunotherapy in paediatric patients.

Abstract

Compare a pre-co-seasonal with a perennial schedule using an undiluted mixture of a depigmented-polymerized grass/Olea europaea immunotherapy (2,000 DPP/mL) in pediatric patients with rhinitis/rhinoconjunctivitis with or without controlled asthma. Primary objective was to determine the non-superiority of a perennial compared to a pre-co-seasonal schedule by means of Paediatric/Adolescent Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ/AdolRQLQ). Secondary objectives were Paediatric Asthma/Caregiver´s Quality of Life Questionnaire (PAQLQ/PACQLQ) Asthma Control Test (ACT), Visual Analogue Scale global assessment of allergic disease (VAS), use of resources and immunological response. All variables were compared during the pollen season (April-June) without (2015) and with (2016) immunotherapy. Forty patients were included in the study of which 29 patients were assigned to the perennial and 11 to the pre-co-seasonal schedule. During 2016 pollen season a significant improvement in the PRQLQ/AdolRQLQ, PAQLQ/AdolAQLQ, ACT and VAS score were observed both in perennial and pre-co-seasonal schedule group. No significant differences were seen between treatment schedules for PRQLQ/AdolRQLQ, PAQLQ/AdolAQLQ and ACT scores comparing both pollen seasons. A significant increase in sIgG4 and reduction in the number of rescue medications used and number of patients who needed visit to any specialist was observed in both treatment schedules during 2016 pollen season. No relevant differences were found in the safety profile of any treatment schedule. Treatment with undiluted mixture of a depigmented-polymerized Grass/Olea europaea allergen immunotherapy has proven to be effective both using a perennial and a pre-co-seasonal schedule and therefore suitable for polyallergic patients.