Clinical Efficacy Of Sublingual Immunotherapy Research Articles

Increase in the prevalence of follicular regulatory T cells correlates with clinical efficacy of sublingual immunotherapy with house dust mites.

Allergic rhinitis (AR) impairs quality of life and affects nearly 40% of the Japanese population. Sublingual immunotherapy (SLIT) is the disease-modifying treatment for AR, but requires the selection of a biomarker associate with clinical efficacy in patients with AR who are treated with SLIT. The present study sought to examine objective biomarkers used for assessing the clinical efficacy of SLIT. The authors examined the effects of 1 year of SLIT treatment with house dust mites (HDMs) using peripheral blood mononuclear cells (PBMCs) and serum from patients with AR. The prevalences of follicular regulatory T (Tfr), type 2 follicular helper T (Tfh2), type 2 helper T (Th2), conventional regulatory T (Treg), and type 1 regulatory T (Tr1) cells were examined by flow cytometry. Serum concentrations of HDM-specific IgA, IgE, and IgG4 antibodies, and HDM-induced production of interleukin (IL) 5 and IL-10 from cultured PBMCs were evaluated by enzyme-linked immunosorbent assay. Following 1 year of SLIT, the prevalences of Tfr, conventional Treg, and Tr1 cells were significantly increased, whereas that of Th2 cells and Tfh2 cells were significantly decreased; the serum concentration of HDM-specific IgG4 was significantly increased; and HDM-induced production of IL-5 from PBMCs was significantly decreased, while that of IL-10 was significantly increased. The increase in the prevalence of Tfr cells after SLIT correlated positively with the improvement of clinical symptom scores. An increase in Tfr cells may play an important role in SLIT, and may be a useful indicator for the clinical efficacy of SLIT.

Clinical efficacy of sublingual immunotherapy for house dust mite-allergic rhinitis with sleep disturbances

Clinical efficacy of sublingual immunotherapy for house dust mite-allergic rhinitis with sleep disturbances

Patient Needs and Benefits of Sublingual Immunotherapy for Grass Pollen-Induced Allergic Rhinitis: An Observational Study

Aim: Clinical efficacy of sublingual immunotherapy for grass pollen-induced allergic rhinitis (AR) needs to translate into patient benefit. Patients & methods: Patients received Oralair (Stallergenes, Antony, France)in real-life medical practice. Patient-relevant treatment benefits were measured with the AR-specific Patient Benefit Index. Subgroups were analyzed regarding distinct patient characteristics. Results: Data of 883 patients (children, adolescents, andadults) were analyzed. The highest-ranked patient needs referred to having less AR symptoms, being able to go outdoors, and being free in the choice of leisure activities. Most patients (89.2-94.6%) attained at least minimally relevant benefit. All subgroups reported relevant benefits, with significantly higher scores in some subgroups. Conclusion: Treatment with Oralair was associated with considerable patient-relevant benefit in all age groups.

House Dust Mite Sublingual Immunotherapy in Children Versus Adults With Allergic Rhinitis.

There are only a few studies in which the clinical efficacy of SLIT has been compared between children and adults. In addition, there is a lack of research on other factors, associated with the treatment, including immunological parameters and quality of life (QOL). To compare the effects of sublingual immunotherapy (SLIT) in adults and children on various factors: clinical efficacy, quality of life (QOL), satisfaction, immunological parameters, and adverse events. Subjects who were sensitized to house dust mites and treated with SLIT for at least 2 years were enrolled. Seventy patients who completed questionnaires measuring nasal symptoms and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores and underwent serologic tests for immunological parameters at initial, 1-year, and 2-year follow-up were selected and divided into two groups based on age: a child group (age 4-12 years, n = 44) and an adult group (age 19-59 years, n = 26). The Total Nasal Symptom Score (TNSS) was significantly decreased after 2 years of SLIT in both the child and adult groups (p < 0.001, both); however, changes in TNSS from baseline did not significantly differ between the two groups (p = 0.365). More patients in adult group were satisfied with SLIT than those in child group (p = 0.050), and changes in RQLQ score from baseline tended to be larger in adult group (p = 0.089). The levels of immunological parameters at baseline were significantly higher in the child group than in the adult group; however, changes in the levels of these parameters were not significantly different. Although more adult patients were satisfied with SLIT, the clinical effects of SLIT on nasal symptoms were comparable between child and adult groups. Despite different immunological values at baseline between the two groups, changing patterns of immunological parameters did not differ.

Enhanced Efficacy of Sublingual Immunotherapy in Childhood Allergic Asthma by Probiotics

It is expected that probiotics may act synergistically to improve the clinical efficacy of sublingual immunotherapy (SLIT). The aim of this study was to investigate the role of probiotics in enhancing efficacy of sublingual immunotherapy in childhood allergic asthma. This was a randomized single blind clinical trial conducted on 6-17 year-old asthmatic children sensitive to house dust mite allergens. Subjects were allocated to Group A receiving SLIT, Group B receiving probiotics and SLIT, Group C receiving probiotics only. Clinical parameters (FEV1 reversibility, medication score, and symptom score) and immunological parameters (total IgE, eosinophil count, IFN-γ, IL-2, IL-4, IL5, IL10, and TGF-b were evaluated in week 0 until 14. Statistical analysis revealed that the difference of clinical parameters (FEV1 reversibility, medication score, and symptom score) between groups were not significant. The difference of the immunological parameters of total IgE, IFN-γ, IL-2, IL-4, IL5, IL10, and TGF-ß were also not significant. Eosinophil count decreased in subjects who received combination SLIT with probiotics. In conclusion, probiotics enhanced the efficacy of sublingual immunotherapy in childhood allergic asthma by decreasing the eosinophil count.

Clinical efficacy of sublingual immunotherapy is associated with restoration of steady-state serum lipocalin 2 after SLIT: a pilot study

Background So far, only a few biomarkers in allergen immunotherapy exist that are associated with a clinical benefit. We thus investigated in a pilot study whether innate molecules such as the molecule lipocalin-2 (LCN2), with implications in immune tolerance demonstrated in other fields, may discriminate A) between allergic and non-allergic individuals, and B) between patients clinically responding or non-responding to sublingual allergen immunotherapy (SLIT) with house dust mite (HDM) extract. Moreover, we assessed haematological changes potentially correlating with allergic symptoms.Methods LCN2-concentrations were assessed in sera of healthy and allergic subjects (n = 126) as well as of house dust mite (HDM) allergics before and during HDM- sublingual immunotherapy (SLIT) in a randomized, double-blind, placebo-controlled trial for 24 weeks. Sera pre-SLIT (week 0), post-SLIT (week 24) and 9 months after SLIT were assessed for LCN2 levels and correlated with total nasal symptom scores (TNSS) obtained during chamber challenge at week 24 in patients receiving HDM- (n = 31) or placebo-SLIT (n = 10).Results Allergic individuals had significantly (p < 0.0001) lower LCN2-levels than healthy controls. HDM-allergic patients who received HDM-SLIT showed a significant increase in LCN2 9 months after termination of HDM-SLIT (p < 0.001), whereas in subjects receiving placebo no increase in LCN2 was observed. Among blood parameters a lower absolute rise in the lymphocyte population (p < 0.05) negatively correlated with symptom improvement (Pearson r 0.3395), and a lower relative increase in the neutrophils were associated with improvement in TNSS (p < 0.05). LCN2 levels 9 months after immunotherapy showed a low positive correlation with the relative improvement of symptoms (Pearson r 0.3293). LCN2-levels 9 months off-SLIT were significantly higher in patients whose symptoms improved during chamber challenge than in those whose symptoms aggravated (p < 0.01).Conclusion Serum LCN2 concentrations 9 months off-SLIT correlated with clinical reactivity in allergic patients. An increase in the LCN2 levels 9 months after HDM-SLIT was associated with a clinical benefit. Serum LCN2 may thus contribute to assess clinical reactivity in allergic patients.Trial registration Part of the data were generated from clinicaltrials.gov Identifier NCT01644617.

Predictivity of clinical efficacy of sublingual immunotherapy (SLIT) based on sensitisation pattern to molecular allergens in children with allergic rhinoconjunctivitis

BackgroundThe diagnostic and therapeutic approach to grass pollen allergy is now possible by detecting specific IgE (sIgE) to its allergenic components. AimTo evaluate the correlation between the sensitisation to different molecular Phleum pratense (Phl p) allergens and clinical efficacy of SLIT. MethodsThe pilot study included 36 patients affected by allergic rhinoconjunctivitis, all treated with SLIT actively. We performed serum analysis of sIgE to Phl p 1, 2, 4, 5, 6, 7, 11 and 12. The Average Rhinoconjunctivitis Total Symptom Score (ARTSS) and the Average Combined Score (ACS) were evaluated before and after one year of immunotherapy. ResultsThree different groups of sensitisation were defined based on the range of IgE reactivity to Phleum pratense allergens at baseline: group I (sIgE reactive to 1–3 allergens); group II (sIgE reactive to 4–5 allergens); and group III (sIgE reactive to 6–8 allergens). At T0 ACS was 1.79±0.18 in group I; 1.81±0.23 in group II; and 1.95±0.34 in group III. At T1 ACS was 0.85±0.55 in group I; 1.01±0.31 in group II; and 1.44±0.39 in group III. At T1 there was a significant improvement of ARTSS and ACS for group I (p=0.001). ConclusionsSublingual immunotherapy with a grass pollen is efficacious irrespective of the patients’ baseline sensitisation to either single or multiple grass pollen molecular allergens. We found that patients with few sensitisations have a greater improvement in combined symptom and medication score. SLIT improves the clinical course of allergic patients although new sensitisations may appear.

スギ花粉舌下免疫療法のヒノキ花粉飛散期の臨床効果

スギ花粉舌下免疫療法のヒノキ花粉飛散期の臨床効果

スギ花粉症舌下免疫療法の治療2年目における症状改善の増強効果

Sublingual immunotherapy (SLIT) is thought to have enhanced efficacy in the second year of treatment. We studied treatment efficacy in both the first and the second years of treatment (2015 and 2016, respectively) in patients who began SLIT in 2014. Methods: We compared 132 patients who underwent SLIT (age, 41.8 ± 17.5 years; male-to-female ratio, 75: 57) and a control group of 56 patients who underwent primary pharmacotherapy (age, 44.9 ± 13.5 years; male-to-female ratio, 25: 31). The study was performed during the peak pollen seasons of 2015 and 2016. Pollen dispersal was similar in 2015 and 2016 (2,509 grains/cm2 and 3,505 grains/cm2, respectively). The clinical efficacy of SLIT was evaluated by assessing nasal and eye symptoms and total symptoms with symptom scores and combined symptom-medication scores, visual analog scale scores, and quality of life (QOL) scores according to the Japanese rhino-conjunctivitis QOL questionnaire (JRQLQ No. 1). QOL was also evaluated with JRQLQ No. 1. The first endpoint was enhanced efficacy of SLIT in the second year compared with that in the first year. Results: With respect to nasal and eye symptoms, the assessments in the primary pharmacotherapy group were unchanged in the second year; however, most of these assessments in the SLIT group demonstrated significantly enhanced efficacy of SLIT in the second year. In QOL of SLIT, only 2 of 17 showed significantly enhanced efficacy of SLIT in the second year. Conclusion: SLIT shows enhanced efficacy in the second year.

CYTOKINE CONTENTS IN NASAL SECRETIONS OF CHILDREN WITH COMBINED FORMS OF RESPIRATORY POLLEN ALLERGY BEFORE AND AFTER THREE COURSES OF SUBLINGUAL ALLERGEN-SPECIFIC IMMUNOTHERAPY

We studied clinical efficacy of sublingual immunotherapy in children with combined respiratory forms of pollen allergy before and after three courses of treatment. The levels of G-CSF, GM-CSF, IL-10, IL-12p70, IFNγ, IL-13, IL-17A, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, TNFα, IL-8, MCP-1, MIP-1β were measured in nasal secretions. In remission state, the children with combined forms of respiratory allergy to pollen allergens showed local signs of chronic inflammatory process (in the nasal mucosa) associated with disturbed immune response, with increased synthesis of proinflammatory cytokines and decreased production anti-inflammatory cytokines, as well as enhanced reactions aimed for allergen elimination. Following clinical success of sublingual immunotherapy, we have shown a reduction in immunological imbalance, due to decreased activity of the systems modulating severity of inflammation and production of pro-inflammatory cytokines.

The influence of sublingual immunotherapy on several parameters of immunological response in children suffering from atopic asthma and allergic rhinitis depending on asthma features.

The clinical efficacy of sublingual immunotherapy (SLIT) has already been proven and is known to be high. Its influence on the immunological system of patients suffering from bronchial asthma was also examined. However, it is still unclear how the polysensitisation, coexistence of other atopic disease and asthma treatment step influence the response to treatment with specific immunotherapy. Herein we evaluate the impact of one-year SLIT on selected markers of immunological response depending on different individual and clinical factors of children suffering from atopic asthma and allergic rhinitis. Twenty-five patients aged 8.1 ± 3.1 years (range 5-15 years), 21 boys and 4 girls, suffering from asthma and allergic rhinitis with polysensitisation to seasonal and non-seasonal allergens, shortlisted for SLIT, were included in the study. Th1 cell and Th2 cell percentages, Bcl-2 expression in T cells, and basophil activation after allergen challenge (house dust mite and/or grass pollen antigen in solution used for skin prick tests) in peripheral blood were measured using flow cytometry. The association between clinical features of asthma and the influence of SLIT on immunological parameters was evaluated with exact Fisher test. No association between the influence of one-year sublingual immunotherapy on immunological system and patients' age, polysensitisation, asthma treatment step, or coexistence of any other atopic diseases was observed. However, an increase of the Th1 percentage in children sensitised against more than three allergens was found more often (at the limit of statistical significance) than in the group of children sensitised against three or less allergens. Based on our results, we cannot point to any subgroup isolated in the study, in which the response of the immunological system to sublingual immunotherapy is more satisfactory than any other. Nevertheless, the increase of Th1 cells may be more specific for polysensitised children.

Suppression of TIM-1 predicates clinical efficacy of sublingual immunotherapy for allergic rhinitis in children

ObjectiveTo evaluate the clinical efficacy of sublingual immunotherapy (SLIT) with house-dust mite (HDM) extract and to examine the change of biomarkers (TIM-1, IL-5 and IL-10) after 6-month SLIT in children with allergic rhinitis (AR). MethodsOne hundred and sixteen HDM-sensitized children with persistent AR were enrolled to assess the clinical efficacy of SLIT by determining the individual nasal symptom score (INSS) and total nasal symptom scores (TNSS) after 6-month SLIT. Moreover, the mRNA expression of TIM-1, IL-5 and IL-10 in peripheral blood mononuclear cells (PBMCs) was examined in 16 well-controlled and 12 uncontrolled AR patients using quantitative reverse transcription polymerase chain reaction (qRT-PCR). ResultsAfter 6-month SLIT, both TNSS and INSS scores were significantly decreased compared with the baseline value (p<0.01). The rates for well-controlled, partly controlled and uncontrolled children were 43.1%, 32.8% and 24.1%, respectively. Accordingly, the mRNA levels of TIM-1 and IL-5 decreased significantly and IL-10 mRNA level increased significantly compared with the baseline value in well-controlled children (p<0.05). ConclusionOur findings suggest SLIT with HDM extract is effective and safe for AR children and TIM-1 may be considered as an indicator for evaluating the clinical efficacy of SLIT.

Two year follow-up of clinical and inflammation parameters in children monosensitized to mites undergoing subcutaneous and sublingual immunotherapy

Both SCIT (subcutaneous immunotherapy) and SLIT (sublingual immunotherapy) have clinical and immunologic efficacy in children with rhinitis and asthma but comparative studies are scarce. To investigate the clinical and immunological efficacy of mite-specific SLIT and SCIT in children with rhinitis and asthma. Thirty children monosensitized to house dust mite were randomized to receive either active SCIT or SLIT or placebo for 1 yr in a double-blind double-dummy placebo controlled design (Yukselen A et al., Int Arch Allergy Immunol 2012; 157:288-298). Thereafter, the placebo group was randomized to receive SCIT or SLIT, and for 1 yr all patients received active treatment with SCIT or SLIT. Symptom scores, drug usage, titrated skin prick tests, nasal and bronchial allergen provocation doses, serum house dust mite-specific immunglobulin E, sIgG4, IL-10 and IFN- g levels were evaluated. The reduction of clinical scores with SLIT was more evident after 2 years of treatment in comparison to both the baseline and DBPC phase of the study. The change in titrated skin prick tests and nasal provocative doses was more prominent with both SCIT and SLIT at the end of the open phase. Although the increase inbronchial provocative doses was not significant at the end of the first year of treatment with SLIT, it reached a statistically significant difference after two years of treatment. The clinical efficacy of SLIT is more prominent at the end of the second year, although this improvement is observed from the first year of treatment with SCIT in mite-sensitive children.

Clinical efficacy of sublingual immunotherapy in pediatric patients with allergic rhinitis sensitized to house dust mites: Comparison to adult patients

Conclusion: Sublingual immunotherapy (SLIT) with house dust mite (HDM) extracts in school-age children and adolescents seems to be as effective as in adults. SLIT could be recommended as a therapeutic modality in pediatric allergic rhinitis (AR) patients sensitized to HDMs. Objectives: To investigate the efficacy of HDM SLIT in pediatric patients with AR. Materials and Methods: Seventy-six patients treated with HDM SLIT for at least 1 year between November 2007 and February 2010 were enrolled in this study. A young age group (n = 54) between 6 and 18 years old was compared with an adult group (n = 22). Standardized extract of HDM (Pangramin® SLIT) was used. Total symptom scores (TSS) and anti-allergic medication scores (AMS) were evaluated before and 1 year after SLIT. Results: TSS improved in both groups, and the change was comparable in the 2 groups (ΔTSS, 5.1 vs 5.3; p = 0.538). Also among the young age group, ΔTSS did not significantly differ between school-age children and adolescents (5.2 vs 4.9, p = 0.429). Thirty-five out of 54 youngsters (64.8%) and 11 out of 22 adults (50.0%) showed improvement in TSS over 30%. AMS were significantly decreased in both groups. ΔAMS tended to be higher in the young age group, but the difference did not reach statistical significance (57.2 vs 35.7, p = 0.060).

Induction of tolerance via the sublingual route: mechanisms and applications.

The clinical efficacy of sublingual immunotherapy (SLIT) with natural allergen extracts has been established in IgE-dependent respiratory allergies to grass or tree pollens, as well as house dust mites. Sublingual vaccines have an excellent safety record, documented with approximately 2 billion doses administered, as of today, in humans. The oral immune system comprises various antigen-presenting cells, including Langerhans cells, as well as myeloid and plasmacytoid dendritic cells (DCs) with a distinct localisation in the mucosa, along the lamina propria and in subepithelial tissues, respectively. In the absence of danger signals, all these DC subsets are tolerogenic in that they support the differentiation of Th1- and IL10-producing regulatory CD4+ T cells. Oral tissues contain limited numbers of mast cells and eosinophils, mostly located in submucosal areas, thereby explaining the good safety profile of SLIT. Resident oral Th1, Th2, and Th17 CD4+ T cells are located along the lamina propria, likely representing a defence mechanism against infectious pathogens. Second-generation sublingual vaccines are being developed, based upon recombinant allergens expressed in a native conformation, possibly formulated with Th1/T reg adjuvants and/or mucoadhesive particulate vector systems specifically designed to target oral dendritic cells.

Clinical efficacy and safety of sublingual immunotherapy using standardized Dermatophagoides farinae extract for children with combined allergic rhinitis and asthma syndrome

To study the clinical efficacy of sublingual immunotherapy using standardized Dermatophagoides farinae extract for children with combined allergic rhinitis and asthma syndrome. Fifty-two children, from 4 to 14 years of age, with mite-sensitive combined allergic rhinitis and asthma syndrome were treated sublingually with standardized Dermatophagoides farinae extract. The clinical efficacy was evaluated by monthly follow-up visits. After treatment for 1 or 2 years using the standardized Dermatophagoides farinae extract, the asthma and rhinitis symptom scores, medication scores and adverse reactions before and after treatment were evaluated. SPSS 17.0 software was used to analyze the data. The allergic asthma symptom scores before treatment during the day were 3.22 ± 0.66 and at night 2.05 ± 0.57. After 1 year of treatment, the day and night scores (1.68 ± 0.61, 0.94 ± 0.32) respectively, were decreased significantly (q values were 15.25 and 13.78 respectively, all P < 0.01). After 2 years of treatment, the scores (0.61 ± 0.28, 0.43 ± 0.13) were also decreased significantly (q values were 10.29 and 6.07 respectively, all P < 0.01). The allergic rhinitis symptom scores and medication scores were 2.34 ± 0.59 and 3.09 ± 1.01 respectively before treatment and 1.21 ± 0.46 and 1.89 ± 0.64 after 1 year of treatment. The differences were significant (q values were 15.48 and 18.61 respectively, all P < 0.01). The allergic rhinitis symptom scores and medication scores were 1.02 ± 0.37 and 1.49 ± 0.38 after 2 years of treatment. There was no significant difference between 2 years of treatment and 1 year of treatment (q values were 2.53 and 2.78 respectively, all P > 0.05). There were no severe adverse events during the treatment, except for mild mouth cavity discomfort. Sublingual immunotherapy using standardized Dermatophagoides farinae extract is safe and effective in the treatment of children with combined allergic rhinitis and asthma syndrome.

Sublingual immunotherapy in asthma does not influence lymphocyte sensitivity to fas stimulation

BackgroundThe resistance of T lymphocytes to Fas-mediated apoptosis is an important feature of atopic asthma. The only effective causative treatment of atopic diseases is immunotherapy. Clinical efficacy of sublingual immunotherapy (SLIT) has been already proven, but there is still limited number of studies on its influence on lymphocytes function.ObjectivesThe aim of the study was to evaluate whether SLIT could restore the sensitivity of asthmatic T cells to undergo Fas-mediated apoptosis.Materials and methodsPeripheral blood was collected from 12 patients aged 8 ± 2 years suffering from atopic asthma and undergoing sublingual specific immunotherapy. To evaluate sensitivity to Fas-mediated apoptosis, the blood was transmitted to sterile tubes and mixed with purified monoclonal antibody anti-CD95. After incubation, leukocytes were stained with Annexin V, propidium iodide, and monoclonal antibody against CD2 conjugated with phycoerythrincyanin 5.1, and then analyzed with flow cytometry. The procedure was repeated for each patient after 12 months of SLIT.ResultsStimulation with anti-CD95 of T lymphocytes from patients with atopic asthma before treatment increased the number of early apoptotic cells (from 19.5 ± 16.7% before stimulation to 26.6 ± 16.7% Annexin V positive cells after stimulation). After one year of SLIT anti-CD95 still caused an increase of the early apoptotic cells ratio in the lymphocyte population (from 12.4 ± 7.4% before stimulation to 24.7 ± 15.4% Annexin V positive T cells after CD95 stimulation). Although an increasing trend could be observed, differences between the analyzed groups were not statistically significant.ConclusionsA year of SLIT does not change the sensitivity of T lymphocytes from peripheral blood of children suffering from atopic asthma to Fas-mediated apoptosis.

Adherence issues related to sublingual immunotherapy as perceived by allergists

Sublingual immunotherapy (SLIT) is a viable alternative to subcutaneous immunotherapy to treat allergic rhinitis and asthma, and is widely used in clinical practice in many European countries. The clinical efficacy of SLIT has been established in a number of clinical trials and meta-analyses. However, because SLIT is self-administered by patients without medical supervision, the degree of patient adherence with treatment is still a concern. The objective of this study was to evaluate the perception by allergists of issues related to SLIT adherence. We performed a questionnaire-based survey of 296 Italian allergists, based on the adherence issues known from previous studies. The perception of importance of each item was assessed by a VAS scale ranging from 0 to 10. Patient perception of clinical efficacy was considered the most important factor (ranked 1 by 54% of allergists), followed by the possibility of reimbursement (ranked 1 by 34%), and by the absence of side effects (ranked 1 by 21%). Patient education, regular follow-up, and ease of use of SLIT were ranked first by less than 20% of allergists. These findings indicate that clinical efficacy, cost, and side effects are perceived as the major issues influencing patient adherence to SLIT, and that further improvement of adherence is likely to be achieved by improving the patient information provided by prescribers.

Sublingual immunotherapy with a standardized cat dander extract: evaluation of efficacy in a double blind placebo controlled study

Little information is available on the clinical efficacy of sublingual immunotherapy (SLIT) using extracts derived from mammalian epithelia. To assess clinical efficacy of cat SLIT based on natural exposure challenge test (NCT). Fifty cat allergic patients with rhinoconjunctivitis with or without asthma were included in a randomized double blind placebo controlled clinical trial of cat SLIT during 1 year. Twenty-five patients received active treatment and 25 placebo. Sublingual immunotherapy efficacy was assessed by natural exposure challenge to a cat in a cat-room and by skin tests. Airborne Fel d 1 levels, symptom scores and peak expiratory flow (PEF) values were monitored. Thirty-three (66%) out of 50 patients completed the treatment. Fel d 1 content of the maximum concentration was 0.51 microg per ml. During the build up phase, the accumulated dose was 1.7 mug of Fel d 1 and during the entire length of the study was 17.1. No adverse reports were reported. The active group showed a marked reduction (62%) in symptoms during the NCT (P < 0.001) with no changes in placebo group. Active group also showed a reduced PEF response to cat exposure (P < 0.05), and an improvement in skin test reactivity to a standardized cat extract (P < 0.05), without significant changes in placebo group. Mean Fel d 1 exposure during the NCT was 6.2 +/- 2.21 ng/m(3). The results suggest that the cat SLIT used in this study was able to improve cat allergy based on natural exposure challenge.

Randomized double‐blind controlled study with sublingual carbamylated allergoid immunotherapy in mild rhinitis due to mites

The clinical efficacy of sublingual immunotherapy (SLIT) in mite allergy and in mild disease is still a matter of debate, thus we performed a long-term clinical trial. The study was randomized, double-blind and placebo-controlled. After a 1-year assessment, 68 patients with mild rhinitis with/without asthma due to mites were randomized to drugs + placebo or drugs + SLIT for 2 years. Sublingual immunotherapy was given as soluble tablets of monomeric carbamylated allergoid. Clinical scores for asthma and rhinitis (0, absent to 3, severe) and drug consumption were assessed by diary card in the period November-February. Quality of life was assessed before and after each observation period and pharmaco-economy data were evaluated as well. Fifty-six patients completed the study. The rate of dropouts was similar in the two groups. No relevant side effect was reported. There was a significant reduction of total clinical scores (P < 0.05) in the active group vs placebo at the first year, but not at the second whereas nasal obstruction significantly improved in both years (P < 0.05). The reduction of drug intake score was significant only at the first year. No change was observed concerning most of the Short Form-36 items, because at baseline all patients displayed a normal profile. A significant change in SLIT group was seen for the item 'change in health status'. The need for extra visits was significantly lower in the active group (25%vs 43%). Sublingual immunotherapy was clinically effective and safe in mite-induced mild disease.