Olerance of a cluster schedule with a house dust mite extract quantified in mass units: multicentre study.

ABSTRACT

The standardisation of allergenic extracts in micrograms of the major allergen has encouraged the search for new treatment schedules, with the purpose of shortening the number of visits and doses required to reach the maintenance dose without eliciting a greater risk of adverse reactions for the patients. With this objective, a prospective multicentre pharmacovigilance study was designed that included 200 patient with allergic rhinoconjunctivitis and/or allergic asthma sensitised to mites (Dermatophagoides pteronyssinu and/or farinae). The dose increment period was carried out using a cluster schedule, where the optimal dose wa reached after 4 visits, administering two doses in each visit. The duration of the study was 5 months and a total o 1902 doses were administered. At the end of the trial, 31 adverse reactions in 23 patients were recorded. Six of these were systemic (0.3% of t administered doses) recorded in 6 patients (3% of the sample). One was an immediate reaction (grade 1) and delayed (4 mild and 1 moderate). Two were asthmatic exacerbations, 2 cutaneous reactions, 1 rhinitis and 1 an unspecific symptom (not IgE-mediated). Two appeared upon administration of the first vial and the remaining 4 after administration of the third cluster. Therefore, the schedule tested presents an adequate tolerance profile, suggesting savings (compared to th conventional schedule of 13 doses per patient) of 1800 visits and 1000 treatment doses in the whole study.