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Biomedical subjects

S Parmiani

Publications and source records attributed to S Parmiani.

At least 19 recordsLinked to original sources

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↗

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↗

Sublingual versus injective immunotherapy in grass pollen allergic patients: a double blind (double dummy) study.

BACKGROUND: Injective immunotherapy is a well-known and recognized treatment for allergic diseases, but its safety has been questioned during recent years. Alternative administration routes have been proposed and there is a growing interest and experience in sublingual therapy. The safety of alternative routes is nonetheless a real advantage, so long as it is not counterbalanced by a loss of clinical benefit. OBJECTIVE: We have compared the efficacy of the same biologically standardized grass pollen extract administered through the injective or the sublingual route, in a group of 20 patients followed for two pollen seasons. METHODS: Both therapies were administered for 12 months according to a double-blind (double-dummy) plan; at the end of the trial the cumulative dosage of the sublingual therapy was 2.4 times higher than that of the injective therapy. Data about skin reactivity, symptoms and drugs scores during the pollen season, as well as total specific IgG and specific IgG4, during and after the trial, were obtained. RESULTS: Our data show that sublingual and injective therapy are equally effective according to subjective clinical parameters, with a statistically highly significant reduction of symptoms and drugs (P = 0.002 for symptoms and drugs in SLIT-treated patients; P = 0.002 for symptoms and P = 0.0039 for drugs in patients given injections). On the other hand, objective parameters (total specific IgG, specific IgG4, skin reactivity) changed only in patients treated with active injective therapy, with P < 0.001, P < 0.001 and P = 0.021, respectively. CONCLUSIONS: The discrepancies observed could be interpreted as a consequence of different mechanisms of actin of the two therapies or to the lack of close relationships between the clinical and the objective parameters which were considered here.

Administration, Sublingual↗

Minimal persistent inflammation is present at mucosal level in patients with asymptomatic rhinitis and mite allergy.

The natural exposure to house dust mites causes sensitization in genetically susceptible patients. Persistent exposure of sensitized patients causes chronic inflammation, and consequently, hyperreactivity, thus promoting the development of clinical features. Recently, intercellular adhesion molecule-1 (ICAM-1)/CD54 expression on epithelial cells triggered by allergen has been demonstrated and related to the inflammation caused by the allergic reaction. Therefore we evaluated the possible presence of inflammation (i.e., inflammatory cell infiltrate and ICAM-1/CD54 expression on epithelium) at conjunctival and nasal levels in patients with asymptomatic allergic rhinitis caused by mites, in their relatives living in the same environment, and in healthy volunteers. In addition, the possible relationship between inflammation and house dust mite allergen exposure was evaluated. Conjunctival and nasal scrapings of allergic subjects enrolled in the study showed many inflammatory cells. A mild ICAM-1/CD54 expression on conjunctival and nasal epithelium was detectable in allergic subjects, whereas relatives and healthy volunteers showed few inflammatory cells and no ICAM-1/CD54 expression on epithelial cells. A detectable level of house dust mite, sufficient to cause sensitization, was found in all houses. This study demonstrates a minimal persistent inflammation at conjunctival and nasal levels constantly detectable in patients without symptoms who are sensitized to mites and continuously exposed to the natural allergens.

Adolescent↗

Sublingual immunotherapy in tree pollen allergy. Double-blind, placebo-controlled study with a biologically standardised extract of three pollens (alder, birch and hazel) administered by a rush schedule.

BACKGROUND: sublingual immunotherapy has been recognised as safe and effective but it is still poorly documented in tree pollen allergy. Allergy to alder, birch and hazel is important in Northern European countries but its clinical relevance is increasing in Southern Europe. METHODS: thirty patients, selected and observed for one pollen season, were randomised to receive placebo (15 patients) or active treatment (15 patients). Twenty-seven patients completed the first year and 24 of them were treated with active therapy during the second year of the study in comparison to a parallel group of ten patients treated only with drugs. Symptom and drug scores during each pollen season, birch-specific IgE, changes in skin test reactivity, changes in specific Nasal Provocation Test and the daily average pollen count for the relevant trees were considered for the assessment of the efficacy of the treatment. RESULTS: both active and placebo group showed a statistically significant improvement in scores in comparison to the previous year, under a lower allergenic pressure. The improvement was higher in the active group (76.04 % reduction of drugs) but not significantly different from that registered in the placebo group (37.05 % reduction). In the open phase of the study, treated patients showed significantly better scores in comparison to the control group. No significant changes in skin reactivity, specific IgE and Nasal Provocation Test were registered. SLIT tolerance was very good. CONCLUSIONS: our data show a better but not statistically significant clinical outcome for patients actively treated with SLIT, but the placebo effect and the year-by-year variability of the environmental allergenic load in our small-size pilot study do not allow for a conclusive statement about the efficacy of this form of therapy.

Administration, Sublingual↗

The safety and efficacy of immunotherapy with aluminum hydroxide-adsorbed venom extract of Vespula spp. An open, retrospective study.

BACKGROUND: specific immunotherapy for Hymenoptera Venom (VIT) is considered a life-saving treatment in insect sting allergy. A few studies with depot VIT have been published, but they are mainly focussed on patients sensitized to Apis. METHODS: this retrospective study was designed to evaluate both efficacy and safety of depot VIT for Vespula. Thirty-six patients (age range 6-73 years) with a history of systemic reactions (grade III to IV according to Mueller) after a Vespula sting, and specific sera IgE RAST to Vespula at least class 2, were administered a depot preparation of venom reaching 50 microgram as monthly maintenance dose. After the first year the maintenance dose was administered every other month. Thirty-three patients were treated for a minimum of 5 years. Reactions to any new field sting of the relevant insect were recorded during the treatment and for 6 to 24 months after its interruption. RESULTS: the treatment showed an excellent tolerance, with only a few local side effects. Thirteen patients (11 Grade IV according to Mueller before VIT) under treatment showed only local reactions after each field sting (18 field stings in total) by the relevant insect. Four patients (3 Grade IV according to Mueller before VIT) had a total of 6 field stings after the interruption of the 5-year treatment, with only local reactions. CONCLUSIONS: according to our results, and in agreement with previous published studies, VIT for Vespula spp. with depot extracts has an excellent tolerance and is clinically effective.

Adolescent↗

An extensively hydrolysed cow's milk formula improves clinical symptoms of gastroesophageal reflux and reduces the gastric emptying time in infants.

BACKGROUND: About 20 % of infants fed with breast-milk substitutes suffer from Gastro Esophageal Reflux (GER) and 1/3 of them also show Cow's Milk Allergy (CMA) symptoms. METHODS: We planned this study to assess by dynamic echography the usefulness of an Extensively Hydrolysed Cow's Milk Formula (eHF) in infants suffering from GER. Ten infants showing GER symptoms and 10 normal babies, all fed with breast-milk substitutes, were enrolled. Clinical symptom scores related to GER were assessed for one week. The Gastric Emptying Time (GET) was determined by means of dynamic echography after feeding with cow's milk-derived formulae and again after a week feeding with eHF in subjects previously showing GER symptoms. RESULTS: All infants with a clinical diagnosis for GER showed an abnormally high average GET in comparison to normal subjects (205 vs 124 min, p = 0.000). Switching to the eHF led to a significant clinical improvement (p = 0.0039) especially in babies skin-test and RAST positive to cow's milk, and to a significant decrease toward the normal value of the GET (167 min, p < 0.001). CONCLUSIONS: The eHF tested improves GER symptoms in infants suffering from this disease. Our experience confirms and supports the use of dynamic echography as a reliable, simple, and non-invasive diagnostic method for infants with an increased GET associated with clinical symptoms of GER.

Animals↗