A multicenter, randomized, parallel-group trial assessing compliance, tolerability, safety, and efficacy to treatment with grass allergy tablets in 261 patients with grass pollen rhinoconjunctivitis.

Background. Allergen-specific sublingual immunotherapy (SLIT) is considered a causal treatment of respiratory allergies. Compliance to the SLIT is an important aspect for a positive clinical outcome. Study Aim. To evaluate if compliance with grass Allergy Immunotherapy Tablet (AIT) can be increased by providing an electronic compliance device (CED) (Memozax; a tablet-container with a programmable daily acoustic alarm). Patients and Methods. 261 patients with grass allergy were enrolled and randomized (1 : 1) to 1-year treatment with AIT (Grazax) using a CED (group A; n = 122) or without (Group B, n = 139). Compliance was measured through tablet count at each visit. Results. The 12-month compliance, mean (SD), in group A was 83% (21) and 83% (24) in group B. A total of 81% of patients reported a significant clinical improvement of symptoms after treatment in comparison with the previous year. No severe adverse reactions were observed in the study. Conclusion. Compliance to the treatment with AIT administered for 12 consecutive months is in general good. The use of CED is not associated with a greater compliance. AIT treatment was associated with a significant clinical improvement in >80% of patients with a good tolerability and safety profile.

A method for the analysis of milk and egg allergens for the atopy patch test.

The patch test with food antigens (atopy patch test, APT) has been reported as a more specific method than prick or RAST for the early detection of cow's milk and/or egg sensitizations in children. Standardization of APT extracts is a major issue on the road towards full clinical exploitation of this assay. Here, we used sodium dodecyl sulphate polyacrylamide gel electrophoresis (SDS-PAGE) to characterize sensitivity and specificity of commercial preparations of APT for milk and egg allergies, which are expected to improve the reliability of this test, when compared with fresh food allergen sources. We found that: (i) SDS-PAGE is an appropriate technique for quality control of APT and (ii) commercial milk and egg APT are equivalent to fresh food preparations in terms of allergen content. Clinical trials aimed at characterizing sensitivity and specificity of APT in the diagnosis of food allergy in children will benefit from this technique.

Observational study of sublingual specific immunotherapy in persistent and intermittent allergic rhinitis: the EFESO trial.

BACKGROUND: Sublingual specific immunotherapy (SLIT) is a valid treatment for allergies. However, there are few data on a large sample size regarding its clinical role in 'real life'. STUDY AIM: We performed a multicentre, case-control study to evaluate the effectiveness of SLIT in patients with allergic rhinitis (AR). METHODS: A total of 305 patients with AR were enrolled. Cases (n=154) were defined as patients with intermittent (64%) or persistent (36%) AR who were treated daily for at least two consecutive years with specific SLIT. Controls (n=151) were defined as age-, sex- and type of allergen-matched AR subjects who were never treated with specific immunotherapy. The main outcomes of the study were the rhinoconjunctivitis symptom score (SS) and the symptomatic medication score (MS). SS and MS were evaluated at the end of the observational period in relation to the peak of relevant pollen season or during the period of maximum allergen exposure in case of non-seasonal allergens. RESULTS: SS mean (SD) value was 5.1 (3.0) in cases and 9.3 (3.3) in controls (-43%) (p=0.0001). MS mean (SD) value was 2.6 (1.8) and 4.4 (2.6) in the case and control groups, respectively (-41%) (p=0.0001). At the end of the observation period, asthma-related symptoms were present in 8.5% of cases and in 20% in the control group (p=0.01). CONCLUSION: The EFficacia nella rinitE allergica di SlitOne (EFESO) trial shows that SLIT treatment in AR is associated with lower SS and MS in comparison with controls. SLIT is also associated with a lower incidence of asthma and new sensitizations. As this was an observational study, our results need to be confirmed in randomized, double-blind, controlled trials.

Sublingual immunotherapy efficacy in patients with atopic dermatitis and house dust mites sensitivity: a prospective pilot study.

BACKGROUND: Specific subcutaneous immunotherapy (SCIT) with house dust mite (HDM) preparation has recently been shown to improve eczema in patients with atopic dermatitis (AD). So far, there is less data regarding efficacy and safety of specific sublingual immunotherapy (SLIT) in patients with AD. STUDY AIM: To evaluate in an open non-controlled, non-randomized pilot trial the effect of SLIT with HDM allergen extracts preparation (SLITone, ALK Abellò Italy) on SCORAD in adult patients with mild-moderate AD. PATIENTS AND METHODS: 86 Subjects (53 females and 33 males) between 3 and 60 years of age with AD and IgE-proved (Class > 2) HDM sensitization were enrolled after their informed consent in the trial. Exclusion criteria were severe asthma and treatment with systemic or high potent topical corticosteroids or immunosuppressant agents. Patients were treated with SLIT (Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts: SLITone, ALK-Abellò) for at least 12 months. SCORAD was evaluated at baseline and after 12 months of treatment. RESULTS: Baseline SCORAD value, mean +/- SD, was 43.3 +/- 13.7 (range 15-84). After 1 year of SLIT, mean +/- SD, SCORAD value was reduced to 23.7 +/- 13.3 (range: 0-65) (p = 0.0001; unpaired t-test vs. baseline). This was a 46% reduction in SCORAD in comparison with baseline value. A significant improvement, defined as a SCORAD reduction of > 30%, was observed in 51 out of 86 patients (59%). In 5 patients (5.8%) SCORAD values did not change at the end of the observation period. In 30 patients (35%) the SCORAD reduction after SIT was

Quantitative assessment of the compliance with once-daily sublingual immunotherapy in children (EASY project: evaluation of a novel SLIT formulation during a year).

Compliance is a major determinant for allergy treatment, especially in children. Sublingual immunotherapy (SLIT) is self-managed at home, and no quantitative data on pediatric adherence are available. We studied the compliance in a large real-life setting. A simplified schedule of SLIT was used, consisting of a 10-day updosing phase followed by maintenance treatment in monodose containers to be taken daily (SLITOne). Italian specialists throughout Italy assessed the compliance in children who were newly prescribed SLIT according to guidelines. Parents were contacted with unscheduled telephone interviews at the third and sixth month of therapy and asked to count at that moment the remaining vials. Data from 71 children (38 boys, age range 2-13 yr) were enclosed in the database. Thirty had rhinoconjunctivitis, four asthma and 37 rhinoconjunctivitis + asthma. SLIT was prescribed for: mites in 57 (81%) subjects, grasses in 11 (15%) and 3 (4%) grass + olive mixture. Compliance data were available for all children at 3 months, and for 56 at 6 months. At 3 months, 85% of subjects had a compliance rate >75% (69% of them adhered >90%). At 6 months, 84% had a compliance rate >75% (66% of them adhered >90%). In four cases SLIT was discontinued for economical reasons, and in one case (1.4%) for side effects probably related to therapy. These data obtained in a quite large sample of children and in real-life confirm that the compliance with SLITOne is good, despite the therapy managed at home.

Randomized open comparison of the safety of SLIT in a no-updosing and traditional updosing schedule in patients with Parietaria allergy.

BACKGROUND: Due to optimal safety of sublingual immunotherapy (SLIT), it was suggested that a slow up-dosing phase maybe not necessary, and therefore the treatment will be more patient-friendly, avoiding dosing mistakes. PATIENTS: Twenty adult patients suffering allergic rhinitis due to Parietaria, were enrolled. Half of them received the traditional schedule and the other half immediately started with 200 STU. RESULTS: No difference was observed between the traditional up-dosing treatment schedule and no-up-dosing treatment schedule in terms of side effects, even mild local side effects, even mild local side effects was greater with traditional regimen.

Efficacy, safety, and modulation of immunologic markers by immunotherapy with honeybee venom: comparison of standardized quality depot versus aqueous extract.

Venom immunotherapy (IT) is a very effective method for the treatment of Hymenoptera venom allergy. We compared safety, efficacy, and modulation of specific immunologic parameters in 70 patients sensitized to Apis mellifera, treated for > or = 5 years with standardized quality (SQ) aqueous IT, either with a rush (n = 20) or with a cluster (n = 20) induction protocol, or with an SQ depot extract and a cluster induction protocol (n = 30). We made an open, noncontrolled study. Side effects were monitored and the effects of field stings during the maintenance phase of the treatment and after its interruption were recorded. Skin reactivity to Apis was measured by end point dilution and specific serum immunoglobulin E (IgE) were measured by a solid-phase-based assay. The depot IT was better tolerated than aqueous IT with rush induction. This was caused by mainly the lower frequency in the induction phase of systemic side effects (3.4% versus 36.8% [p < 0.0041] on a "per patient" and 0.1% versus 0.9% [p = 0.0092] on a "per dose "basis, respectively). The cluster protocol with the aqueous extract tended to be better tolerated that the rush protocol. About one-half of patients from each group were re-stung during the study and all suffered only minor discomfort. Reduction of skin reactivity and of serum-specific IgE was significant in the three groups (p < 0.02 in all cases). SQ Depot IT to Apis venom allergy administered with a cluster protocol induces less side effects and is equally effective then IT with SQ aqueous extract administered with a rush protocol.

Randomized open comparison of the safety of SLIT in a no-updosing and traditional updosing schedule in patients with Parietaria allergy / Estudio comparativo abierto y aleatorio de la seguridad de la inmunoterapia sublingual con una pauta no progresiva y otra progresiva tradicional en pacientes alérgicos a parietaria

Background: Due to optimal safety of sublingual immunotherapy (SLIT), it was suggested that a slow up-dosing phase maybe not necessary, and therefore the treatment will be more patient-friendly, avoiding dosing mistakes. Patients: Twenty adult patients suffering allergic rhinitis due to Parietaria, were enrolled. Half of them received the traditional schedule and the other half immediately started with 200 STU. Results: No difference was observed between the traditional up-dosing treatment schedule and no-updosing treatment schedule in terms of side effects, even mild local side effects was grater with traditional regimen

Antecedentes: Debido a la óptima seguridad de la inmunoterapia sublingual, se sugirió que la fase de aumento progresivo de la dosis podría no ser necesaria, y por lo tanto el tratamiento sería más fácil para los pacientes, evitándose los errores de dosificación. Pacientes: Se seleccionaron 20 pacientes adultos con rinitis alérgica por sensibilización a Parietaria. La mitad de ellos recibió la pauta tradicional y la otra mitad empezó con la dosis de 200 STU. Resultados: No ser observó diferencia entre la pauta tradicional y la que se inició con la dosis de mantenimiento, en relación con efectos colaterales, incluso hubo efectos locales más frecuentes con el régimen tradicional

Changes in inflammatory and clinical parameters and in bronchial hyperreactivity asthmatic children sensitized to house dust mites following sublingual immunotherapy.

UNLABELLED: In allergic patients with rhinoconjunctivitis (RNC), sublingual immunotherapy (SLIT) is effective in reducing both clinical symptoms and immuno-mediated local inflammatory responses. The study evaluates whether SLIT could reduce upper airway inflammation and improve clinical parameters also in children with rhinoconjunctivitis and asthma from house dust mite sensitization. Ten children with mild to intermittent asthma, monosensitized to house dust mites, received SLIT (Der p 1 monthly dose = 48 microg) for 2 years, in addition to "as needed" pharmacologic treatment. Before (T0) and after treatment (T2), changes were evaluated in (1) nasal eosinophilia, (2) intercellular adhesion molecule (ICAM)-1 expression by nasal epithelial cells, (3) RNC, asthma, and drug-intake scores, assessed by diary card, (4) pulmonary function parameters, and (5) bronchial reactivity to methacholine (MCh). RESULTS: All children completed the study without side or adverse effects. After the treatment period, we found no modification in nasal eosinophil values in mean fluorescence channel percentages, but a significant downregulation in ICAM-1 expression by nasal epithelial cells [mean (mfc): T0: 13.5 +/- 3.8 mfc; T2:4.6 +/- 0.5 mfc; p = 0.04]. These changes were associated with a reduction in RNC score [median values: T0: 3.4 (1.4-6.2); T2: 1.1 (0.6-2.4) p = 0.012], asthma score [median values: T0: 0.5 (0.4-1.0); T2: 0.3 (0.1-0.5); p = 0.005] and drug-intake score [median values: T0: 4.2 (3.1-5.3); T2: 1.1 (0-3.0); p = 0.005]. These clinical effects were not associated with changes in pulmonary function parameters (p > 0.05), but with improvement in bronchial reactivity to MCh [mean values: T0: 338.8 (91.5-1255.5); T2: 1698.2 (1,110.5-2,597.1); p = 0.02]. To what extent these observations may be related to the natural improvement of respiratory allergy symptoms with age remains to be determined.