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Biomedical subjects

S Parmiani

Publications and source records attributed to S Parmiani.

At least 19 recordsLinked to original sources

Efficacy and safety of subcutaneous immunotherapy with a biologically standardized extract of Ambrosia artemisiifolia pollen: a double-blind, placebo-controlled study.

BACKGROUND: The allergological relevance of Ambrosia in Europe is growing but the efficacy of the injective immunotherapy for this allergen has been documented only in Northern America. OBJECTIVE: We sought to study the safety and efficacy of injective immunotherapy in European patients sensitized to Ambrosia artemisiifolia. METHODS: Thirty-two patients (18 M/14 F, mean age 36.78, range 23-60 years) suffering from rhinoconjunctivitis and/or asthma and sensitized to Ambrosia were enrolled and randomized in a double-blind, placebo-controlled (DBPC) study lasting 1 year. A maintenance dose corresponding to 7.2 microg of Amb a 1 was administered at 4-week intervals after the build-up. During the second and the third year, all patients were under active therapy in an open fashion. Symptom and medication scores, skin reactivity to Ambrosia (parallel line biological assay), and pollen counts were assessed throughout the trial. RESULTS: Twenty-three patients completed the trial. No severe adverse event was observed. During the DBPC phase, actively treated patients showed an improvement in asthmatic symptoms (P=0.02) and drug (P=0.0068) scores days with asthmatic symptoms (P=0.003), days with rhinitis symptoms (P=0.05), and days with intake of drugs (P=0.0058), as compared to before therapy. No improvement for any of these parameters was detected in the placebo group. Moreover, the number of days with rhinitis and asthma was significantly higher in the placebo as compared to the active group (P=0.048 and P<0.0001, respectively). Patients who switched from placebo to active therapy improved in rhinoconjunctivitis, asthma, and drug intake. The skin reactivity decreased significantly (12.2-fold, P=0.0001) in the active group whereas a slight increase (1.07-fold, P=0.87) was observed in the placebo group after the DBPC phase. After switching to active therapy, patients previously under placebo showed a significant decrease of this parameter (4.78-fold, P=0.002). CONCLUSION: Injective immunotherapy is safe and clinically effective in European patients sensitized to Ambrosia.

Adult↗

Sublingual immunotherapy abrogates seasonal bronchial hyperresponsiveness in children with Parietaria-induced respiratory allergy: a randomized controlled trial.

BACKGROUND: The use of immunotherapy in asthmatic children is still controversial. Sublingual immunotherapy (SLIT) may represent an advance, due to the good safety profile, but little is known about its effects on lung function and nonspecific bronchial responsiveness. OBJECTIVE: The aim of this study was to assess the effects of SLIT on these parameters, in children with Parietaria pollen-induced asthma. METHODS: Thirty children with asthma solely due to Parietaria who participated in a previous randomized, placebo-controlled trial with SLIT were studied: pulmonary function test and methacholine challenge were carried out at baseline in winter 1999 (out season), during the 1999 season (before randomization), and during the 2001 season. RESULTS: Before randomization, there was a significant fall in methacholine provocation concentration during the pollen season vs baseline in both groups (SLIT group 9.78 +/- 5.95 mg/ml vs 3.37 +/- 2.99 mg/ml; placebo 8.70 +/- 6.25 mg/ml vs 2.44 +/- 2.25 mg/ml; P =.005). In the second pollen season, the response to methacholine returned to baseline values in the active group (9.10 +/- 7.7 mg/ml; P = NS vs baseline), whereas in the placebo group a significant increase in reactivity was still present (2.46 +/- 2.26; P = 0.008 vs baseline). No significant difference in FEV(1) and FEF(25-75) between the two groups was observed at all times. CONCLUSIONS: Our data show that SLIT abrogates the seasonal bronchial hyperreactivity in children with asthma due to Parietaria. This may be regarded as an indirect evidence of the effect on bronchial inflammation.

Adolescent↗

Tolerance and effects on skin reactivity to latex of sublingual rush immunotherapy with a latex extract.

BACKGROUND: Specific immunotherapy could be a therapeutic tool for the increasing problem of sensitisation to Natural Rubber Latex (NRL). OBJECTIVE: To investigate the tolerability of SLIT for Latex and its effects on skin reactivity. METHODS: Twenty-six patients (mean age 35.5 years) with an average history of 7.5 years of cutaneous symptoms plus respiratory symptoms (23/26) due to NRL were studied. All underwent rush sublingual therapy (4 days) with a standardized NRL extract followed by a 9-week maintenance treatment. Local and systemic adverse reactions were monitored throughout the treatment. Skin reactivity to NRL extract was evaluated before, during and at the end of the treatment by latex glove-use test, rubbing test and skin prick test. RESULTS: All patients reached the maintenance dose. Out of 1044 administered doses, 257 (24.6%) produced adverse reactions from which 21.4% were local. Only 10.1% of cases required treatment, mainly with antihistamines alone (5.8%), with 2-agonists alone (0.8%) or associated to antihistamines and/or corticosteroids (2.7%). One patient was precautionary treated twice with adrenaline but completed the treatment without further problems. The glove-use test improved significantly after 5 days and 10 weeks of treatment (p = 0.003, p = 0.0004 respectively), whereas the rubbing test improved significantly only after 10 weeks of treatment. Doctor's assessments confirmed the results obtained with the glove-use test (p = 0.003 after 5 days, and p = 0.004 after 10 weeks) but not those obtained with the rubbing test. No change was detected for SPTs. CONCLUSION: SLIT for NRL allergy is able to modify skin reactivity to NRL in days as assessed with methods reproducing HCWs normal exposure to the allergen. Tolerance of SLIT is better than tolerance reported for injective therapy with NRL, but the build up phase should be administered under medical surveillance until sufficient experience has been accumulated. The long-term effect of the treatment deserves further investigation.

Administration, Sublingual↗

Long-lasting effect of sublingual immunotherapy in children with asthma due to house dust mite: a 10-year prospective study.

BACKGROUND: Subcutaneous immunotherapy for respiratory allergy has shown a long-lasting efficacy after its discontinuation, whereas this evidence is still lacking for sublingual immunotherapy, despite the fact that it is widely used. OBJECTIVE: We aimed to evaluate whether a long-lasting effect of SLIT occurs, in a prospective parallel group controlled study. METHODS: Sixty children (mean age 8.5 years) suffering from allergic asthma/rhinitis due to mites were subdivided into two matched groups: 35 underwent a 4- to 5-year course of SLIT with standardized extract and 25 received only drug therapy. The patients were evaluated at three time points (baseline, end of SLIT and 4 to 5 years after SLIT discontinuation) regarding presence of asthma, use of anti-asthma drugs, skin prick tests and specific IgE. RESULTS: We found that in the SLIT group there was a significant difference vs. baseline for the presence of asthma (P </= 0.001) and the use of asthma medications (P </= 0.01), whereas no difference was observed in the control group. The mean peak expiratory flow result was significantly higher in the active group than in the control group after 10 years. No change was seen as far as new sensitizations were concerned. Specific IgE showed a near-significant increase (baseline vs. 10 years, P = 0.06) only in the control group. CONCLUSION: Our study demonstrates that sublingual immunotherapy is effective in children and that it maintains the clinical efficacy for 4 to 5 years after discontinuation.

Administration, Sublingual↗

Impact of sublingual immunotherapy on seasonal asthma and skin reactivity in children allergic to Parietaria pollen treated with inhaled fluticasone propionate.

BACKGROUND: Immunotherapy is a recognized treatment for allergic respiratory diseases. OBJECTIVE: To study the usefulness of immunotherapy in combination with optimal pharmacological therapy. METHODS: Thirty-eight children (8-14 years) suffering from seasonal asthma+/-rhinoconjunctivitis due to Parietaria poorly controlled by anti-allergic drugs treatment were selected. After randomization according to a double-blind placebo-controlled design they received active sublingual immunotherapy (15 children) or placebo (15 children) for 13 months combined with inhaled fluticasone twice a day during the pollen season. Eight children were taken as control, whereas all patients were instructed to take symptomatic drugs on need. Early and late skin response to the allergen were assessed in all patients before and after treatment. Drug and symptom scores, as well as visual analogue scores (VASs) and Parietaria pollen counts were assessed during the pollen season. RESULTS: Groups were well balanced for age, gender, early and late skin response before treatment. Four children dropped out, in one case in relationship with active sublingual immunotherapy (SLIT) administration. Chest and nose symptoms, as well as drug scores and VASs were significantly better in both the active or placebo SLIT+fluticasone (S+F) as compared to the control group (P between <0.001 and 0.043). Eye symptoms were significantly better in the active S+F group as compared to control (P=0.025). The VASs were significantly better in the active S+F group as compared to the placebo S+F group (P=0.037). The early skin response decreased significantly in the active S+F group (P<0.001), whereas the late skin response changed significantly in all groups, with an increase in the placebo+fluticasone group (P=0.019) and in the control group (P=0.037) and a decrease (P<0.0001) in the active S+F group. CONCLUSION: The clinical efficacy of S+F is equal to that of fluticasone alone, but the addition of SLIT has effects also on non-bronchial symptoms.

Administration, Inhalation↗

Variation of the skin end-point in patients treated with sublingual specific immunotherapy.

The reduction in skin reactivity in sensitized subjects is a common finding after injective specific immunotherapy. Few data are, on the contrary, available for sublingual immunotherapy. We assessed the skin reactivity by the end-point titration method in 90 monosensitized subjects (age range 3-50; mean age 19.63) at the baseline and for four consecutive years during the SLIT treatment with two different maintenance regimens. The yearly duration of drug intake was monitored throughout the observation period. Age and skin reactivity to histamine (p < 0.0001; r = 0.871), and age and skin prick end-point (p < 0.0001; r = 0.523) turned out to be statistically positively correlated at baseline. No correlation was on the contrary found between age and the ratio allergen wheal/histamine wheal (p = 0.857; r = -0.019). After 4 years all patients showed at least a significant 4-fold decrease of the skin end-point, whereas 46/90 (51.1%) showed a 16-fold decrease and 29/90 (32.2%) a 64-fold decrease (p < 0.001 in all cases). At the end of the SLIT treatment, 21/90 patients (23.3%) were not using any drug, whereas 16/16 (100%) had given up the use of eye drops, and 34/35 (97%) had given up the use of bronchodilators and bronchial steroids (p < 0.001). After SLIT, 52/90 patients showed a reduction by at least 50% of the yearly duration of drug intake (p < 0.0001). An apparent relationship between the progressively decreasing rate of use of drugs and the decrease in skin reactivity was found, but it did not reach the point of statistical significance (p = 0.081). Patients treated with the daily allergen administration schedule, in spite of a lower cumulative dosage, showed a significantly greater decrease in skin reactivity (p < 0.001) and a higher rate of both no use of any drug (p = 0.013) and of at least a 50% reduction of the yearly duration of drug intake (p = 0.001) as compared to patients treated with three allergen administrations per week.

Administration, Sublingual↗

Differential diagnosis by the endpoint method in patients skin-reactive to more than one inhalant allergen.

In recent years there has been an increasing number of patients suffering from respiratory symptoms and skin test positive to more than one allergen, and in many cases neither the clinical history nor the specific IgE determination has proved useful in establishing a ranking among two or more positive allergens. This study was designed to test the usefulness of the skin-prick test endpoint technique for the identification of the most important allergen(s) among those skin test positive. To this end, 118 consecutive patients (age range 4-60 years) skin test positive to between 2 and 6 different allergens were selected and submitted to the skin-prick test endpoint technique with serial 1:4 dilutions of standardized commercial allergens. The skin-prick test endpoint technique was unable to establish a ranking in only 7 patients sensitized to two allergens, whereas a difference in the range 2-10 between the highest and the lowest endpoint dilution in the same patient could be established in all other cases. Some allergens known to be widely crossreactive (D. farinae and D. pteronyssinus; cultivated and common grasses; birch and hazel) showed a similar skin reactivity only in few cases when tested according to the skin-prick test endpoint technique. This finding suggests a specific sensitization only for one allergen (or mixture) of each crossreacting couple. Moreover, in 60/118 patients the allergen able to evoke the largest skin reaction with the standard diagnostic did not have the highest skin-prick endpoint, suggesting that the ranking of allergens on the basis of the dimension of the wheal obtained with the standard diagnostic is a concept that should be revised and updated.

Administration, Inhalation↗

Sublingual tryptase and ECP in children treated with grass pollen sublingual immunotherapy (SLIT): safety and immunologic implications.

BACKGROUND: The clinical safety of sublingual immunotherapy (SLIT) has been repeatedly confirmed; nevertheless, the possible onset of local oral symptoms is still a concern, and nothing is known about the pathogenesis of this effect. We aimed to determine whether the administration of SLIT in allergic children can evoke an IgE-mediated reaction, by measuring the levels of sublingual tryptase and ECP. METHODS: Thirty children (7-12 years old) with allergic rhinitis/asthma due to grass pollen were prescribed SLIT. In these children, an allergen-specific nasal challenge was performed, and nasal tryptase and ECP were measured before and after. Sublingual ECP and tryptase were also assessed before the SLIT, after 1 month, and after 6 months of treatment. Ten matched allergic children and 10 healthy ones served as controls for the baseline levels of sublingual ECP and tryptase. RESULTS: The levels of nasal tryptase and ECP significantly increased after nasal challenge (P<0.001), whereas no change during the SLIT course (at the beginning, after 1 month, and after 6 months) could be detected in sublingual tryptase either before or after SLIT administration. The sublingual ECP significantly decreased after 6 months of SLIT. The baseline levels of nasal tryptase and ECP were significantly higher in allergic subjects than in healthy controls, as was the level of sublingual ECP. CONCLUSIONS: In the presence of an IgE-mediated reaction (ASNC), a significant increase of tryptase and ECP can be seen. When SLIT is administered, such a phenomenon does not occur; therefore, SLIT does not elicit any IgE reaction in the mouth. It is noteworthy that allergic subjects display higher levels of nasal ECP and tryptase than healthy subjects, even when symptom-free, and these observations may indicate the presence of subclinical inflammation.

Administration, Sublingual↗

Prevention of new sensitizations in monosensitized subjects submitted to specific immunotherapy or not. A retrospective study.

BACKGROUND: Specific immunotherapy is the only currently available allergen-orientated treatment able to modify the natural history of respiratory allergic diseases. Safety and clinical efficacy of this treatment are well documented, but evidence about the ability to reduce new sensitizations is still poor. OBJECTIVE: We report a retrospective study conducted in order to assess the prevention of new sensitizations in monosensitized subjects treated with specific immunotherapy vs. monosensitized patients treated with anti-allergic drugs. METHODS: 8396 monosensitized patients with respiratory symptoms were selected according to an open, retrospective design. Group A included 7182 patients submitted to specific immunotherapy (and anti-allergic drugs when needed) for 4 years and then treated with drugs for at least 3 years. Group B included 1214 patients treated only with drugs for at least 7 years. All patients underwent prick test with a standard panel of allergens and total and specific IgE determination before and after 4 years of treatment and again 3 years later. RESULTS: Groups were well balanced. Polysensitized subjects were 23.75% in Group A and 68.03% in Group B after 4 years (P < 0.0001) and 26.95% and 76.77%, respectively, after 7 years (P < 0.0001). Asthmatic subjects were more prone to develop polysensitization in comparison to subjects suffering only from rhinitis (32.14% instead of 27.29% after 4 years, 36.5% instead of 31.33% after 7 years; P < 0.0001). Specific IgE decreased by 24.11% in Group A and increased by 23.87% in Group B (P < 0.0001). Total IgE decreased by 17.53% in Group A and increased by 13.71% in Group B (P < 0.0001). CONCLUSIONS: Specific immunotherapy was observed retrospectively to reduce new sensitizations in monosensitized subjects suffering from respiratory allergic diseases.

Administration, Inhalation↗

Prevention of new sensitizations in asthmatic children monosensitized to house dust mite by specific immunotherapy. A six-year follow-up study.

BACKGROUND: Specific immunotherapy (SIT) is a recognized way of treating IgE-mediated respiratory diseases. The clinical outcome is usually better in allergic children than in adults. OBJECTIVE: To increase our knowledge of the ability of SIT to prevent the onset of new sensitizations in monosensitized subjects, so far poorly documented. METHODS: 134 children (age range 5-8 years), who had intermittent asthma with or without rhinitis, with single sensitization to mite allergen (skin prick test and serum-specific IgE), were enrolled. SIT was proposed to all the children's parents, but was accepted by only 75 of them (SIT Group). The remaining 63 children were treated with medication only, and were considered the Control Group. Injective SIT with mite mix was administered to the SIT Group during the first three years and all patients were followed for a total of 6 years. All patients were checked for allergic sensitization(s) by skin prick test and serum-specific IgE every year until the end of the follow-up period. RESULTS: Both groups were comparable in terms of age, sex and disease characteristics. 123 children completed the follow-up study. At the end of the study, 52 out of 69 children (75.4%) in the SIT Group showed no new sensitization, compared to 18 out of 54 children (33.3%) in the Control Group (P < 0.0002). Parietaria, Gramineae and Olea were the most common allergens responsible for the new sensitization(s). CONCLUSIONS: According to our data, SIT may prevent the onset of new sensitizations in children with respiratory symptoms monosensitized to house dust mite (HDM).

Air Pollution, Indoor↗

Variation in skin reactivity inhalant allergens estimated by the end-point technique.

Skin prick testing is commonly used to diagnose IgE-mediated sensitization to allergens, whereas the longitudinal variability in positive/negative results can be used for clinical and epidemiological purposes. Few publications have investigated the longitudinal variability in skin reactivity, and most studies have concluded that seasonal changes in exposure to environmental allergens are paralleled by a change in skin reactivity. Our trial investigated the relationship between variations in skin reactivity and seasonal exposure to allergens in sensitized subjects, by use of a sensitive method-the end-point technique. Forty-three patients monosensitized to inhalant allergens were selected, and the skin prick end-point technique with serial 1:4 dilutions of standardized commercial allergens was used to assess skin reactivity. Twenty-two patients sensitized to pollens with a short pollination period were tested before and after the pollen season, whereas the other 21 patients sensitized to house dust mites or to a species with a long pollination period such as Parietaria were tested in the same month 12 months later. Patients tested with the end-point technique showed a large interindividual variability in skin reactivity. None of the patients in either group showed a decrease in skin sensitivity with time whereas 9 out of 43 showed no change and 34 out of 43 showed an increase (p < .0001). According to our data, skin reactivity increases in sensitized subjects over time, and this increase seems not to have a circannual rhythm related to the seasonal exposure to environmental allergens, since it can be detected both in pollen- and mite-sensitized patients after a 12-month interval.

Administration, Inhalation↗

Clinical and immunologic effects of long-term sublingual immunotherapy in asthmatic children sensitized to mites: a double-blind, placebo-controlled study.

BACKGROUND: Immunotherapy through local routes is thought to be a valuable therapeutic option for respiratory allergy. We investigated the clinical efficacy and immunologic effects of sublingual immunotherapy (SLIT) in asthmatic children with mite-induced respiratory allergy. METHODS: Twenty-four patients (age range 8-15 years), suffering from mild to moderate asthma, with single sensitization to mite allergen, were enrolled. After a 1-year observation phase, patients were randomly allocated to one of two groups, and were given SLIT (sublingual-spit) as drops for 2 years according to a double-blind, placebo-controlled (DBPC) design. Symptoms/medication scores (diary card), visual analog scale, and immunologic parameters (house-dust-mite [HDM]-specific IgE, and total HDM-specific IgG and IgG4) were determined during the observation phase and during the DBPC treatment period. RESULTS: Twenty-one patients completed the study. At the beginning of the treatment, no difference in environmental allergenic pressure could be shown between the groups. After 2 years of therapy, there was a significant decrease in asthmatic symptoms (P=0.0001) and medication use (P=0.0001) in the active group compared to the placebo group. The visual analog score on overall asthma symptoms improved in the SLIT group (P=0.0001), but not in the placebo group. Nevertheless, the immunologic results did not show significant differences in HDM-specific IgE and total HDM-specific IgG or IgG4 between the active and placebo groups (P = NS). No relevant side-effects were recorded throughout the study. CONCLUSIONS: Our results suggest that treatment for 2 years with SLIT is clinically safe and effective in significantly decreasing respiratory symptoms in children with mild to moderate asthma sensitized to HDM. On the other hand, the lack of changes of the immunologic parameters calls for further investigations with special reference to kinetics and mechanism(s) of action of this mode of treatment.

Administration, Sublingual↗

Clinical and immunologic effects of a rush sublingual immunotherapy to Parietaria species: A double-blind, placebo-controlled trial.

BACKGROUND: The local (noninjection) routes of immunotherapy are presently regarded as viable therapeutic options for respiratory allergy, and their mechanisms of action are currently undergoing investigation. OBJECTIVE: We evaluated the clinical efficacy of a preseasonal rush sublingual-swallow immunotherapy and its effects on allergic inflammation in patients with seasonal rhinoconjunctivitis caused by Parietaria species. METHODS: Thirty patients with Parietaria species-induced rhinoconjunctivitis (13 with mild intermittent asthma) were randomly assigned sublingual-swallow immunotherapy or placebo in a rush preseasonal course. We assessed the seasonal symptom-drug intake score by diary card and the inflammatory infiltration and the intercellular adhesion molecule 1 expression on nasal epithelium after specific allergenic challenge before and after treatment. RESULTS: The investigated immunotherapy was well tolerated, and no side effects were recorded. A significant reduction of the symptom score (P =.016) and drug intake score (P =. 008) after immunotherapy was observed only in the active group. A decrease of the cumulative score was observed also in the placebo group (P =.046), but the significance was clearly higher (P =.006) in the active group. In the active group a reduction of neutrophils (P =.001), eosinophils (P =.01), and intercellular adhesion molecule 1 expression (P =.04) after specific nasal challenge was also detected. CONCLUSION: The present results suggest that this sublingual-swallow immunotherapy administered through a rush schedule is clinically effective and safe and that it decreases the immune-mediated inflammatory responses to the allergen.

Administration, Sublingual↗

Sublingual immunotherapy: a double-blind, placebo-controlled trial with Parietaria judaica extract standardized in mass units in patients with rhinoconjunctivitis, asthma, or both.

BACKGROUND: New routes of administering immunotherapy in respiratory allergy are being studied as an alternative to conventional injective immunotherapy. We carried out a study to evaluate the clinical efficacy and effects of sublingual immunotherapy in patients with Parietaria judaica-induced respiratory allergy. METHODS: A double-blind, placebo-controlled design was followed. Thirty patients with P. judaica rhinoconjunctivitis, mild asthma, or both were randomly chosen for sublingual immunotherapy (14 patients) or placebo treatment (16 patients). The patients underwent preseasonal rush induction treatment followed by coseasonal maintenance treatment during the Parietaria pollen season. Symptom and drug scores, as well as specific IgE and specific IgG4, were recorded. RESULTS: Significantly lower symptom and drug scores were found (P=0.04), especially during the Parietaria pollination period, in the immunotherapy group. No significant difference in specific IgE and specific IgG4 was detected between the active and placebo groups; a statistically significant increase of specific IgE was detected in both groups (P=0.05). No patient undergoing active sublingual immunotherapy reported local or systemic side-effects. CONCLUSIONS: Our data suggest that sublingual immunotherapy is both clinically effective and safe in treating patients with Parietaria-induced rhinoconjunctivitis and mild asthma.

Administration, Sublingual↗

Post-marketing surveillance study on the safety of sublingual immunotherapy in pediatric patients.

BACKGROUND: Immunotherapy (IT) is the only causal treatment for allergic subjects recognized to be effective and to offer long-lasting efficacy. The noninjective routes, aimed at improving the safety of the treatment, have been validated as effective in adults, but documentation of their safety in children is still poor. The aim of the present survey study was to assess the safety of sublingual immunotherapy in pediatric patients, by evaluating a large population. METHODS: A total of 268 children (aged 2-15 years), receiving sublingual IT for respiratory allergy, were followed-up over a period ranging from 3 months to 7 years (mean 34 months). The side-effects possibly due to the treatment were recorded on a proper diary card; self-assessment of the clinical outcome was also evaluated. RESULTS: About 96000 doses of extract were globally administered. Local side-effects were of no clinical relevance. Eight side-effects were reported (3% of patients; 0.083 per 1000 doses). Seven systemic side-effects (abdominal pain, conjunctival itching, and rhinitis) were mild and required no treatment. One case of urticaria was well controlled with oral antihistamines. No life-threatening event occurred. The clinical outcome was judged excellent or good by 80% of the patients. CONCLUSIONS: The sublingual IT herein investigated appeared to be well tolerated and safe in pediatric patients. The risk/benefit ratio was therefore favorable.

Administration, Sublingual↗