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Background: The objective of this study was to determine whether a cluster scheme of allergic immunotherapy (AIT), starting administration of the therapeutic extract with the highest available concentration vial (vial B) of Allergovit®, affords adequate safety and tolerance under conditions of routine clinical practice. Methods: An observational study with retrospective collection of data from protocolled patients' medical records was designed. Patients of 5-65 years old with diagnosis of rhinitis with or without bronchial allergic asthma and hypersensitivity to pollen were selected. Patients were treated with subcutaneous Allergovit®, starting with cluster high doses (500 + 500 TU/1500 + 1500 TU/3000 + 3000 TU) on days 1/8/15 of the build-up phase and 6000 TU monthly on the maintenance phase for 2 years. Results: One hundred and ten patients were included being 51.8% (57) females with a mean age of 30.9 years (95% CI 28.1-33.6). During the first year of AIT, 46 patients suffered 69 adverse reactions (5% of injections). Local reactions were observed in 3.03% of injections (60), and systemic reactions in 0.46% of injections (9). Fifteen systemic reactions were observed in 11 patients during 2 years: 3/Grade 1, 11/Grade 2 and 1/Grade 3, all of them were resolved in 1 day. Conclusions: Cluster AIT reduces the vaccination build-up period, reaching the desired maintenance dose within 2 weeks. The low number of local and systemic reactions observed, the low severity and the resolution of all of them mostly in only 1 day, and the similar safety results observed in other cluster schemes allow to conclude that the cluster scheme evaluated (500 + 500 TU/1500 + 1500 TU/3000 + 3000 TU) was safe for the patients.

Background:The objective of the study was to determine patient compliance and adherence to treatment with Allergen Immunotherapy (AIT) with Allergovit ® for pollen allergic rhinitis and/or bronchial asthma.Methods: A retrospective observational study was designed, included pollen allergic patients with rhinoconjunctivitis and/or bronchial asthma treated with subcutaneous immunotherapy with Allergovit ® . Compliance with treatment was defined as the ratio between administered and prescribed doses. Compliance was considered adequate when higher than 80%. Adherence was evaluated from the number of patients withdrawing from the treatment during 3-year follow-up. Causes for non-adherence, symptoms evolution and the physician Clinical Global Impression score were also documented.Results: A total of 176 patients from 9 Allergy Units were included, 44.4% (n=79) males; mean age 33.8 years (95%CI 31.9-35.7). AIT administration was preseasonal in 19.9% (n=32), pre-co-seasonal in 2.5% (n=4) and perennial in 77.6% (n=125). The presence and frequency of ocular, nasal and bronchial symptoms decreased significantly during follow-up (p<0.0001). Mean compliance with treatment in years 1, 2 and 3 was: 98.6%, 98.7% and 96.5%. Compliance was adequate in years 1, 2 and 3 in 95.9%, 95% and 96.2% of the cases. The three years of immunotherapy were completed by 158 patients (89.8%). Reasons for non-adherence were mainly symptoms improvement and the appearance of adverse reactions. The latter were observed in 34 patients (19.3%), with 40 adverse reactions during three years of follow-up: Thirty-three reactions were local and seven were systemic. Conclusions:Observed compliance and adherence to AIT immunotherapy was very high, throughout the three-year follow-up period, and the treatment showed an adequate safety profile.