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Biomedical subjects

C Incorvaia

Publications and source records attributed to C Incorvaia.

At least 19 recordsLinked to original sources
PubMed2006

Cationic liposomes as potential carriers for ocular administration of peptides with anti-herpetic activity.

In the present study the preparation, characterization and activity of cationic liposomes containing the secretory form of herpes simplex virus type 1 (HSV-1) glycoprotein B (gB1s) or two related polylysine rich peptides, namely DTK1 and DTK2, were described. The immunotherapeutic potential of these HSV antigens containing liposomes was examined with a rabbit ocular model of HSV-1 infection. Our study indicates that the liposomes (i) are able to encapsulate quantitatively gB1s and around 30% the DTK peptides, (ii) are characterized by dimensions compatible with ocular applications and (iii) can release the peptide comparably to the free solution. In addition, neutralization studies demonstrated that an anti-DTK specific polyclonal antiserum can inhibit HSV-1 infection, indicating that such peptides could be a good immunogen/antigen in an anti-HSV vaccine formulation. Although the vaccination protocol did not induce protection against the eye disease, a significative protection against a lethal ocular challenge was detectable together with the absence of reactivation episodes from latency on the survived animals. In this respect, the use of cationic liposomes coupled to gB1s and DTK peptides, as a local ocular vaccine, could represent an interesting approach in order to obtain a possible efficacy in protecting animals against a subsequent HSV-1 ocular challenge.

Animals↗
PubMed2006

Dose dependence of efficacy but not of safety in sublingual immunotherapy.

Sublingual immunotherapy (SLIT) currently represents, as indicated by meta-analysis of its efficacy and safety, a valid option to the generally used traditional subcutaneous immunotherapy (SCIT) for treating respiratory allergy. Regarding efficacy, recent studies demonstrated that, similar to what has already been observed in SCIT as well as in experimental and clinical studies about the magnitudo of allergen exposure, the effectiveness on both clinical symptoms and immunologic changes depends on the amount of allergen administered during treatment. In addition, in vitro studies addressed with the role of dendritic cells, currently considered to be of pivotal importance in orienting toward tolerance the immune response to allergens, showed that the internalisation of allergen molecules, which is followed by tolerogenic presentation to T cells, depends on the amount of allergen. However, such dose dependence is not apparent concerning the safety. In fact, the comparison of studies respectively conducted with high and low allergen doses did not show differences in the rate of systemic reactions, which in any case never had the presentation of anaphylaxis, and instead a significant difference in the rate of local reactions, following the oral and gastrointestinal contact with the allergen extract, in favour of high dose studies.

Administration, Sublingual↗
PubMed2006

Dose dependence of efficacy and safety of subcutaneous immunotherapy.

A number of experimental and clinical evidence has shown that exposure to high amounts of allergen molecules favours the development of tolerance. This is true also for subcutaneous immunotherapy (SCIT), for which a dose dependence of clinical efficacy was clearly demonstrated. The effective doses, measured as microg of major allergens, to be administered during maintenance treatment were established for the main allergens. Regarding pollens, the range of effectiveness corresponds to 25-41 and 13-20 microg of major allergens Phl p 5 and Phl p 6 for grasses, to 10-47 microg of Amb a 1 for ragweed, to 12 microg of Bet v 1 for birch, and to 6.2 microg of Par j 1 for Parietaria. With house dust mites, a maintenance dose of 5-11.5 microg of the major allergen from Dermatophagoides pteronyssinus Der p 1 is associated to clinically relevant effects, and with cat epithelium the clinical success is observed using a dose of 13-15 microg of Fel d 1. Nevertheless, there are adverse reactions facing SCIT, which are related to the amount of injected allergen. In fact, the safety decreases when the administered doses increase. This has led to "optimal doses" being defined which show a good balance between efficacy and safety (corresponding for example to a dose of 7 microg for Der p 1 and of 13 microg for Fel d 1). The dose dependency with respect to both efficacy and safety makes essential to accurately consider the risk/benefit ratio in each patient eligible for SCIT.

Allergens↗
PubMed2006

Practice parameters for sublingual immunotherapy.

The efficacy and safety of sublingual immunotherapy (SLIT) are currently supported by clinical trials, meta-analysis and post-marketing surveys. Practice parameters for clinical use of SLIT are proposed here by a panel of Italian specialists, with reference to evidence based criteria. Indications to SLIT include allergic rhinoconjunctivitis, asthma, and isolated conjunctivitis (strength of recommendation: grade A). As to severity of the disease, SLIT is indicated in moderate/severe intermittent rhinitis, persistent rhinitis and mild to moderate asthma (grade D). SLIT may be safely prescribed also in children aged three to five years (grade B), and its use in subjects aged more than 60 years is not prevented when the indications and contraindication are ascertained (grade D). The choice of the allergen to be employed for SLIT should be made in accordance with the combination of clinical history and results of skin prick tests (grade D). Polysensitisation, i.e. the occurrence of multiple positive response does not exclude SLIT, which may be done with the clinically most important allergens (grade D). As to practical administration, co-seasonal, pre co-seasonal, and continuous schedules are available, being the latter recommended for perennial allergens or for pollens with particularly prolonged pollination, such as Parietaria (grade D). For pollens with relatively short pollination, such as grasses and trees (cypress, birch, alder, hazelnut, olive) the pre co-seasonal and perennial schedules are preferred (grade C). The build-up phases suggested by manufacturers can be safely used (grade A), but they can be modified according to the patient's tolerance (grade C). A duration of SLIT of 3-5 years is recommended to ensure a long-lasting clinical effect after the treatment has been terminated (grade C).

Administration, Sublingual↗
PubMed2005

The safety of sublingual-swallow immunotherapy: an analysis of published studies.

BACKGROUND: As the main target of sublingual immunotherapy (SLIT) is to reduce at most the occurrence of adverse events (AE), safety represents a critical issue. This aspect deserves particular mention when a higher dose of allergen extract than traditional subcutaneous immunotherapy (SCIT) is required to be effective: that may be up to 500 times that employed for SCIT. OBJECTIVE: All published controlled studies concerning SLIT-swallow were analysed to evaluate AE rates. METHODS: Studies were subdivided in two groups: (i) studies using low allergen dose (LAD), i.e. ranging from 1 to 50 times the dose commonly administered with SCIT, and (ii) studies with high allergen dose (HAD), i.e. ranging from 50 to 500 times the dose administered with SCIT. RESULTS: Twenty-five studies were altogether analysed: 13 studies belonged to the low-dose group, 12 belonged to the high-dose group. We considered all patients with at least one AE. Local reactions were significantly more frequent in the LAD group than in the HAD group (P<0.0001), while there was no difference in the rate of systemic reactions. Severe systemic reactions were never reported. CONCLUSION: This study represents the first analysis of the safety of SLIT concerning the allergen dose employed in the treatment. There is evidence that AE occurrence is substantially not dose-dependent. This fact highlights two main clinical aspects: the elevated tolerability of SLIT in general and the safety of HAD regimen.

Administration, Sublingual↗
PubMed2005

Dose dependence of immunological response to sublingual immunotherapy.

BACKGROUND: Sublingual-swallow immunotherapy (SLIT) is an accepted treatment for allergic rhinitis but its optimal dosage is scantly investigated. We studied the dose dependence of clinical efficacy and immunological response to SLIT by administering two different dosages of the same allergen in rhinitic children monosensitized to grass pollen. METHODS: Seventy-one patients with comparable age and symptoms were randomized to receive SLIT by the same grass pollen extract from Stallergenes (Antony, France), 40 of them with the 100 IR and 31 with the 300 IR extract. All patients recorded diary cards for symptoms, medications and side-effects of the treatment, and had measurements of specific IgE and IgG4 in serum by the CAP System FEIA (Pharmacia, Uppsala, Sweden) and in nasal secretion by an in situ incubation method with the same reagents of CAP System FEIA. RESULTS: Symptom/medication scores during the pollen season were significantly higher in patients treated with the lower dosage compared with those treated with the 300 IR dosage. Side-effects occurred with a comparable rate (25.8%vs 27.5%) in the two groups. Serum-specific IgE and IgG4 had no significant changes after 3 months of SLIT in both groups, while a significant seasonal increase of nasal IgE (P = 0.015) and IgG4 (P = 0.019) was found only in patients treated with the lower dosage. CONCLUSIONS: A rise of specific IgG4 and a blunting of seasonal increase of specific IgE in serum was repeatedly reported during subcutaneous immunotherapy (SCIT) with pollen extracts. Our findings show such blunting of specific nasal IgE along with a low symptom/medication score in patients treated with SLIT with the higher dosage, but not a concomitant rise of specific nasal IgG4. This suggests a local immunological effect of SLIT, different from systemic mechanisms of SCIT.

Administration, Sublingual↗
PubMed2005

Different outcomes of pulmonary rehabilitation in patients with COPD with or without exacerbations.

BACKGROUND: Pulmonary rehabilitation is recognised as an effective treatment in reducing disability and improving the quality of life in patients with COPD. We evaluated the effects of a course of pulmonary rehabilitation in improving the physical performance and lung function in patients with or without COPD exacerbations. METHODS: 74 patients with COPD were enrolled, 37 (24 males and 13 females, mean age 74.6 years) without exacerbations (group A), and 37 (23 males, 14 females, mean age 73.9 years) with exacerbations (group B). The latter must have had the latest exacerbation at least one month before the inclusion. All patients underwent to a rehabilitation programme of 8 visits in 4 weeks in a day-hospital setting, with exercise training, respiratory muscle training and education on COPD. The changes in physical performance and lung function in respect to baseline were measured by a 6-minute walking test, using phethysmography, and by an analogic manometer measuring maximal inspiratory and expiratory pressures (MIP, MEP). RESULTS: Patients of group A showed a mean increase in timed walk distance of 58.38 +/- 57.46 m, compared to a mean increase of 31.38 +/- 44.78 m in group B patients (p = 0.028). As to lung function, a mean increase of 178.92 +/- 132.28 ml in FEV1 in group A versus 67.84 +/- 102.04 ml in group B (p < 0.0001) and a mean increase of 22.36 +/- 25.06 cm H2O in MEP in group A versus 7.70 +/- 12.28 cm H2O in group B (p = 0.002) was found. CONCLUSIONS: These findings indicate that patients with COPD with exacerbations achieve a less favourable outcome of pulmonary rehabilitation, with a significantly lower improvement of physical performance, respiratory muscle strength and lung function in respect to subjects without exacerbations.

Aged↗
PubMed2005

Physical exercise does not favour adverse reactions to allergen immunotherapy by the sublingual route.

It is generally recommended in consensus documents on allergen immunotherapy to avoid any kind of physical exercise in the 24 hours following the administration of the allergen extract but such recommendation is not supported by scientific evidence. We evaluated the risk of developing adverse reactions in a group of patients submitted to sublingual immunotherapy by performing a controlled exercise test. Eleven patients were included in the study, 8 treated with grass pollen and 3 with Parietaria pollen extract by Staloral300 (Stallergénes, Antony, France), with the build-up phase in 11 days suggested by the manufacturer and a top dose of 300 IR. At the first maintenance dose, in all patients were measured heart rate, blood pressure, FEV1, and tryptase in blood. Then the maintenance dose was assumed and the physical exercise performed by cycloergometer maintaining a heart rate around 100 b/min and measuring again tryptase, blood pressure and FEV1. The results showed that no patient had adverse reaction following physical exercise, neither showed significant changes in FEV1, blood pressure, or tryptase level, which was 5.57 +/- 4.54 mcg/l before and 5.81 +/- 4.34 mcg/l after exercise. This suggests that there is no reason to advise against physical exercise, and particularly sporting activity, in patients treated with sublingual immunotherapy thus avoiding to interfere with the subject's lifestyle and consequently with his quality of life.

Abdominal Pain↗
PubMed2005

Comparison of allergen immunotherapy and drug treatment in seasonal rhinoconjunctivitis: a 3-years study.

Drug treatment and specific immunotherapy (SIT) are both effective in seasonal rhinoconjunctivitis, but the former acts only on allergic symptoms while the latter modifies the natural history of the disease. Only a few studies compared the clinical efficacy of the two treatments with contrasting results. We planned a study to compare the efficacy of SIT (15 patients) and drug treatment (15 patients) in moderate to severe seasonal rhinoconjunctivitis caused by sensitization to grass pollen. SIT was performed by a 5-grass extract standardized in IR and absorbed onto calcium phosphate (Phostal, Stallergénes, Antony, France) using the conventional build-up phase in 12 weeks and a maintenance treatment with monthly injection for three years. Drug treatment was done with cetirizine as antihistamine, mometasone furoate as nasal topical steroid, and levocabastine eyedrops. All patients registered during the pollen season their symptoms and drug consumption. After one year 12 of 15 patients treated with SIT had less symptoms and drug consumption in respect to baseline compared to none in drug treated group (p = 0.021) and after three years 15 of 15 were improved in group A compared to one of 15 in group B (p = 0.008). These findings indicate an higher efficacy of SIT in patients with seasonal rhinitis not only in the long term but also in the first year of treatment.

Administration, Intranasal↗
PubMed2005

Cost effectiveness of sublingual immunotherapy in children with allergic rhinitis and asthma.

BACKGROUND: Economic evaluations are increasingly relevant in order to provide support for decision makers when judging about alternative ways to allocate public funds. Aim of this study was to evaluate the economic effect of treatment with high dose sublingual immunotherapy (SLIT) in children. METHODS: The study involved one allergy center, located in the north of Milan, Italy. From the existing records of patients seen for allergic disease, we extracted all children and adolescents with allergic disease, who had 1-year data prior to receiving SLIT and 3-year data on SLIT. Outcome measures (number of exacerbations, visits, absence from nursery or school), direct costs (euros spent on drugs, specialist visits, SLIT) and indirect costs (costs resulting from children school and parental work loss) were analysed. A second analysis compared a sub-group of allergic asthmatic children with a control group for costs, based on records of patients not SLIT-treated, extracted from a network-database of paediatricians. RESULTS: 135 patients were extracted, of which 46 had perennial, and 89 had seasonal allergy with comparable gender and age distribution. A substantial reduction was found in all outcome measures during SLIT compared with the before period. The average annual cost/patient was 2672 before SLIT initiation and _629/year during SLIT. Similar results were found for allergen subgroups. The asthma sub-analysis involved 41 children with SLIT and 35 controls. Again, SLIT patients showed a substantial reduction in outcome measures; the direct cost/patient over the whole follow-up (4 years) was _1182 for SLIT patients and _1100 for controls. CONCLUSION: High dose SLIT may be effective in reducing the cost of allergic rhinitis and asthma and comparably expensive to conventional treatment in children with allergic asthma over a 4 years follow-up.

Administration, Sublingual↗
PubMed2004

[Value of skin prick test and atopy patch test in mite-induced respiratory allergy and/or atopic eczema/dermatitis syndrome].

AIM: The atopy patch test (APT) was introduced to assess sensitization to inhalant allergens in patients with atopic/eczema dermatitis syndrome (AEDS), but its diagnostic role in subjects with respiratory allergy is scantly investigated. We sought to evaluate the response to APT and to skin prick tests (SPT) with mite extracts in subjects with persistent respiratory symptoms (rhinoconjunctivitis, rhinosinusitis, asthma), with AEDS, and with both the diseases. METHODS: Eighty-nine patients were included in the study, 75 (84.3%) children and 14 (15.7%) adults, 54 (60.7%) males and 35 (39.3%) females (median age 5.4 years). They were divided in 3 groups, respectively formed by 47 (mean age 12.3+/-11.6 years), 15 (mean age 2.2+/-2.5 years), and 27 (mean age 6.2+/-6.3 years) subjects, according to the presence of only respiratory symptoms, only AEDS, or both, and underwent to usual SPT with mite extracts and to APTs done by mite extract in Finn chambers and removed after 48 hours, with readings after 20 minutes and 24 hours. RESULTS: Of the 89 patients, 24 showed a positive SPT and 69 a positive APT; in 17 both SPT and APT were positive, while 13 were negative to the 2 tests. The APT was more frequently positive than SPT not only in the 2 groups with AEDS -- 32/42 (86.5%) vs 8/42 (21.6%) -- but also in the group with only respiratory symptoms -- 37/47 (78.7%) vs 16/47 (34%). CONCLUSION: These results confirm the high value of APT in patients with mite-induced AEDS and suggest that its routine use might improve also the diagnosis of respiratory allergy to house dust mites.

Adult↗
PubMed2004

Prevalence of allergic reactions to Hymenoptera stings in northern Italy.

The epidemiology of Hymenoptera venom allergy in Europe showed prevalence of systemic reactions of about 3%, but is scantly investigated in Italy. We studied two samples of the general and an at risk population, i.e. the foresters, in northern Italy. A standardized questionnaire dealing with allergic reactions to Hymenoptera stings was submitted to the subjects included in the study, who were factory workers in Milan and Verona and foresters in Lombardy. An overall number of 574 subjects participated to the study, 462 (299 males and 163 females, mean age 40.1 yrs, range 20-63 yrs) were factory workers and 112 (all males, mean age 38.8 yrs, range 24-59 yrs) were foresters. Among factory workers, 302 (65.4%) were stung by Hymenoptera, 49 (10.6%) had had large local reactions, and 13 (2.8%) systemic reactions. Among foresters, 76 (67.8%) were stung, 11 (9.8%) had had large local reactions, and 5 (4.5%) systemic reactions. The systemic reactions were life-threatening in 3 (0.6%) industrial workers and 2 (1.8%) foresters. The prevalence of systemic reaction of 2.8% in the general population agrees with the data reported from a number of countries with temperate climate. The prevalence of 4.5% in foresters attributed to this population a risk only slightly increased.

Adult↗