Criteria used by health professionals on the selection of allergen immunotherapy in real clinical practice: Methodology.

Background: Allergen immunotherapy (AIT) is today the only etiological therapy for respiratory allergic diseases, including allergic rhinitis, allergic conjunctivitis, and allergic asthma. Even though interest in real-world data has recently increased, publications mainly focus on short-term and long-term efficacy and safety of AIT. Indeed, information is still lacking regarding the "key parameters" or "drivers of prescription" used by doctors to prescribe AIT or by the patients to accept AIT as treatment for their respiratory allergic disease. Examining these factors is therefore the main goal of the CHOICE-Global Survey: "Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice: An international academic electronic survey". Methods: We present the methodology of the CHOICE-Global Survey, an academic, prospective, multicenter, observational, transversal, web-based e-survey, conducted in real-life clinical settings designed to collect data from 31 countries representing 9 global different socio-economic and demographic regions. In the present document, we describe the survey, how it was conceived and developed, how data are stored and analyzed, and the different steps that will provide this information to the allergy community. Conclusions: The CHOICE-Global Survey will be able to provide, from an academic point of view, information on the drivers of prescription of AIT in real-life practice and improve understanding regarding the key parameters considered by doctors and patients for such therapy.

GRAZAX®: a sublingual immunotherapy vaccine for Hay fever treatment: from concept to commercialization.

Allergen immunotherapy has been used for more than 100 y, but only recently underlying immunological mechanisms have started to be understood. New Allergy vaccines are now considered to be full pharmaceutical products, that should comply with general as well as specific pharmaceutical legal framework. GRAZAX® is the first global allergy vaccine developed in compliance with the new legal environment and is thus a reference for developing new allergy vaccines. Here, we provide a rationale description of GRAZAX®, providing a sequential description of its pharmaceutical and clinical development. With more than 25 clinical trials, involving more than 8000 patients, including as well three 5-y prospective clinical trials, GRAZAX® is a key product to understand the unique position of allergen-specific immunotherapy as a disease-modifying intervention.

Clinical experience with specific immunotherapy to horse dander.

OBJECTIVE: This open clinical study was designed to investigate the occurrence of adverse reactions of specific immunotherapy (SIT) with horse dander and to recognize signs of efficacy regarding horse-induced cutaneous and respiratory symptoms. METHODS: Twenty-four patients attending our Outpatient Clinic in Huelva (Spain) with horse-induced allergy were selected for receiving a standardized extract of horse dander (Alutard SQ). RESULTS: Local and systemic reactions (five adverse reactions in four patients) were observed during the induction phase of treatment when administering the doses with the highest allergen concentration. Systemic side effects were mild, one immediate case consisting of wheezing and prompt response to treatment and one mild conjunctival hyperemia. Doses were reduced in all cases, and good tolerance to SIT was maintained. The sensitivity of patients to horse dander as assessed by deliberate natural exposure to horse decreased significantly when patients reached maintenance dose: Conjunctivitis symptoms were reduced in all patients, rhinitic symptoms in 93%, asthmatic symptoms in 90%, and cutaneous symptoms in 87% of the patients. Subjective assessment of a patient's allergic disease on a visual analog scale (VAS) showed an improvement. Ninety-five percent of the patients were highly satisfied with the treatment (efficacy, suitability, and troubles). CONCLUSION: Specific immunotherapy with standardized horse-allergen extract is a safe treatment with the doses of allergen extract administered in the present study. In addition, it seems to have beneficial effects in patients with moderate-severe rhinoconjunctivitis and/or asthma.

Specific immunotherapy with a standardized latex extract in allergic workers: a double-blind, placebo-controlled study.

BACKGROUND: Preventive measures have been proposed to reduce the risk of sensitization to natural rubber latex (NRL), but this is not always feasible. OBJECTIVE: The aim of this study was to determine the efficacy and safety of specific immunotherapy with a standardized latex extract in sensitized workers. METHODS: Twenty-four patients allergic to NRL with contact urticaria (n = 8) and rhinitis or asthma (n = 16) were included (16 in the active group and 8 in the placebo group). Treatment started in a cluster immunotherapy protocol, with injections every week for 3 months and then every other week for another 3 months. RESULTS: Patients in the active group had significantly lower values than patients in the placebo group in skin terms of reactivity to NRL (P <.01), rubbing test results (P =.047), and latex glove use test results (P =.046) after 6 months of treatment. There were no significant differences between the active and placebo groups in symptom scores, use of medication, self-assessment, or methacholine test results either before or after treatment. Differences in nasal and bronchial symptoms during specific inhalation challenges (P = not significant and P =.05, respectively) were observed in favor of the active group. In the active group 32 systemic reactions were observed (8% of doses), mostly during the build-up period, being more frequent in patients with respiratory symptoms (P =.004). All reactions responded promptly to treatment. CONCLUSION: Clinical efficacy was shown mainly on cutaneous symptoms, although an improvement in rhinitis and asthma symptoms was also observed during specific inhalation challenges. Latex-specific immunotherapy might be a useful approach for the treatment of latex allergy in sensitized workers.

Allergen vaccination with a liposome-encapsulated extract of Dermatophagoides pteronyssinus: a randomized, double-blind, placebo-controlled trial in asthmatic patients.

BACKGROUND: Liposomes are potent immunologic adjuvants and have been proposed as allergen carriers in allergy vaccination. OBJECTIVE: We sought to investigate the efficacy and safety of vaccination with Dermatophagoides pteronyssinus encapsulated in liposomes. METHODS: We conducted a double-blind, placebo-controlled study. Fifty-five asthmatic patients sensitized to mites were randomly assigned vaccination with D pteronyssinus extract encapsulated in liposomes or empty liposomes for a period of 12 months. The principal parameters were symptom and medication-consumption scores. The percentage of healthy days (ie, days without medication and with absent or mild symptoms) was calculated. Immediate and late skin test results, allergen bronchial challenge test results, and allergen-specific serum immunoglobulin levels were evaluated before and after treatment. RESULTS: All clinical scores were markedly lower in the active group than in the placebo group after vaccination. Nearly half (45.8%) of the patients actively treated reduced their symptom and medication scores by at least 60% versus only 12% of patients receiving placebo treatment (P =.0388). The percentage of healthy days in the active group rose from 10.5% before treatment to 64.5% afterward (P =.0008). Reduction in organ sensitivity was demonstrated by skin prick test responses (P <.01), late-phase response after intradermal testing (P =.009), and bronchial challenge test results (P =.026) in the active group. Serum levels of specific IgG increased throughout the treatment, whereas specific IgE levels showed only an initial transient increase. No change in these parameters was observed in the placebo group. Vaccination was well tolerated, and no subcutaneous nodules appeared. CONCLUSION: Vaccination with D pteronyssinus encapsulated in liposomes is an effective and safe treatment for allergy-induced asthma.