Safety evaluation of rapid build-up schedules with IR-standardized allergen extracts for subcutaneous immunotherapy of allergic respiratory diseases.

Introduction: The conventional schedule used in specific subcutaneous immunotherapy (SCIT) is a slow treatment that often leads to poor compliance or discontinuation of treatment. These disadvantages have led to design administration schedules that shorten the build-up phase without increasing the adverse reactions rate.

Areas Covered: This report reviews the available scientific documentation of the safety profile of build-up schedules for SCIT with Alustal Rapid® (a suspension of standardized allergen extracts adsorbed on aluminum hydroxide gel for specific immunotherapy) in the treatment of IgE-mediated rhinitis, conjunctivitis and bronchial asthma to inhaled allergens.

Systemic tolerability of specific subcutaneous immunotherapy with index-of-reactivity-standardized allergen extracts administered using clustered regimens: a retrospective, observational, multicenter study.

Background: Subcutaneous immunotherapy is an etiological therapy for certain IgE-mediated diseases. It is usually administered in 2 phases: induction and maintenance. Administration in clustered schedules during the induction phase may be a valid alternative to reach the maintenance dose early if the treatment is well tolerated.

Retrospective study of tolerance to short initiation schedules in subcutaneous immunotherapy.

With the aim of evaluating tolerance to new shorter initiation schedules in subcutaneous immunotherapy everyday clinical practice, a study was carried out using Pangramin Plus with initiation periods between 3 (Cluster) and 6 (Plus) weeks. All the information was processed retrospectively and both systemic (SR) and local (LR) adverse reactions occurring between September 2002 and February 2003 were recorded. A total of 353 patients (261 Plus and 91 Cluster) were included and 2,886 doses were administered (2,166 in initiation and 720 in maintenance).

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

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.

Immunotherapy safety: a prospective multi-centric monitoring study of biologically standardized therapeutic vaccines for allergic diseases.

Background: The fear of side-effects has led to strict regulations preventing a more widespread use of specific immunotherapy (SIT) in some countries, in spite of the low risk of systemic reactions (SRs) reported in well-controlled studies. The goal of the study was to carry out a prospective and multi-centric trial to evaluate the safety, risk factors and compliance degree of commercially available SIT.

Materials And Methods: The study was carried out in 14 allergy departments from Spain.