Barrier repair therapy for facial atopic eczema with a non-steroidal emollient cream containing rhamnosoft, ceramides and iso-leucine. A six-case report series.

Atopic eczema (AE) is a skin disease very common in paediatric population and face region is commonly involved. AE of the face represents a therapeutic challenge limiting the use, especially for long periods, of corticosteroid topical products due to the high risk of atrophic skin changes. Skin barrier alterations and reduction of innate immune mechanisms (reduced levels of anti-microbial peptides) are now considered the hallmarks of AE. Therefore emollient and barrier repair therapies with topical steroid-free substances could be an alternative or an adjuvant strategy in managing AE especially for the face. A non-steroidal, anti-inflammatory moisturizing cream with barrier repair actions, containing rhamnosoft, ceramides and L-isoleucine (ILE) (Nutratopic pro-AMP) has been recently developed for the specific treatment of AE of the face. We report a series of 6 pediatric cases (2 female and 4 male, age from 6 months to 4 years) with facial eczema in children treated with pro-AMP cream for two/four weeks as single treatment, applied twice daily in the affected area with photograph documentation (baseline and after treatment). Pictures of the skin lesions at baseline and after treatment were taken in all cases using a high-definition digital camera. Pro-AMP cream use was associated with a clinical relevant improvement of all signs of eczema. The product was well tolerated. This case series document the clinical efficacy of a barrier repair therapy cream containing rhamnosoft, ceramides and iso-leucine in the treatment of atopic eczema of the face.

Efficacy, safety and tolerability of sublingual monomeric allergoid in tablets given without up-dosing to pediatric patients with allergic rhinitis and/or asthma due to grass pollen.

The efficacy and safety of monomeric allergoid (Lofarma, Milan) have been demonstrated in adults but very few studies have examined it in children. This study therefore investigated the efficacy and safety of this sublingual immunotherapy (SLIT) at the dosage of 1000 AU five times a week without any up-dosing. Forty allergic children (17 M and 23 F, mean age 7 years, range 4-16 years), 16 with rhinitis and 24 with rhinitis and asthma, were randomized to SLIT or drug therapy. All the patients were sensitized to grass; some were also sensitized, though to a lesser extent, to Parietaria, Olea and Betulaceae. The patients were treated pre-/co-seasonally for two years. A visual analogue scale (VAS) was used at baseline and at the end of the first and second pollen seasons to rate the patients' well-being. The VAS score was significantly higher after both the first and the second year of treatment in the SLIT group than in the controls (p<0.05). It improved in comparison to baseline only in the active group. All 40 children tolerated the therapy very well. The monomeric allergoid at the dosage of 5000 AU/week thus appears to have a good efficacy and safety profile in children.

The safety of sublingual immunotherapy with one or multiple pollen allergens in children.

BACKGROUND: Since the majority of allergic patients are polysensitized, it is often necessary to prescribe immunotherapy with multiple allergens. It is crucial to know if the administration of multiple allergens with sublingual immunotherapy (SLIT) increases the risk of side-effects in children. METHODS: Consecutive children with respiratory allergy because of pollens, receiving SLIT for multiple or single allergens were followed-up in a postmarketing survey. Inclusion criteria were those for prescribing SLIT according to guidelines. Parents recorded in a diary card the side-effects (eye symptoms, rhinitis/ear itching, asthma, oral itching/swelling, nausea, vomiting, abdominal pain, diarrhoea, urticaria, angioedema and anaphylaxis). The side-effects were graded as mild, moderate and severe. RESULTS: Four hundred and thirty-three children (285 male, age range 3-18 years) receiving SLIT were surveyed. Of them, 179 received a single extract, and 254 multiple allergens. The total number of doses given was 40 169 (17 143 with single allergen). Overall, 178 episodes were reported. Of them, 76 occurred with the single allergen (42.46% patients, 4.43/1000 doses) and 102 (40.3% patients, 4.42/1000 doses) with multiple allergens (P = NS). 165 episodes (92.5%) were mild and self-resolving and were equally distributed in the two groups. In 13 cases, the events were judged of moderate severity and medical advice was required. Three patients discontinued SLIT, despite the local side-effects being mild. No emergency treatment was required at all. CONCLUSION: The use of multiple allergens for SLIT does not increase the rate of side-effects in children.

Applicability of extracellular electrical impedance tomography in monitoring respiratory tract inflammation.

BACKGROUND: The presence of persistent mild inflammation is widely considered to provide the immunopathogenic basis for bronchial, nasal, or sinusal inflammation between critical phases and in asymptomatic periods. Exhaled nitric oxide (NO) is currently the most reliable marker of rhinobronchial inflammation, but its routine assessment is difficult as the test is available only in highly specialized centers. OBJECTIVE: The aim of this study was to evaluate the agreement between a new diagnostic method (extracellular electrical impedance tomography) and immunological and clinical symptom scores, anterior rhinomanometry, peak expiratory flow rate (PEFR), serum eosinophil cationic protein (ECP) level, and blood eosinophil count in the clinical monitoring of respiratory tract inflammation before and after treatment of asthma or rhinitis. PATIENTS AND METHODS: Eighty-seven patients were studied; 73 had mild persistent asthma (PEFR > or = 20% below predicted) and 14 had rhinitis. At baseline (TO), the patients underwent a medical examination to record symptom scores, PEFR, anterior rhinomanometry, an extracellular electrolytic conductivity test (bioimpedance tomography), serum ECP level and blood eosinophil count. Appropriate treatment was prescribed, following the guidelines of the Global Initiative for Asthma and the Allergic Rhinitis and Its Impact on Asthma. After 21 days of therapy (T1), the patients were re-evaluated for the same parameters. RESULTS AND CONCLUSIONS: This study demonstrates the good agreement (Cohen's kappa = 0.689) between the symptom scores of patients with rhinitis and the findings of extracellular tomography and very good agreement (kappa = 0.846) between symptom scores of asthma patients and extracellular tomography. These findings validate the use of this new technique for the real-time monitoring and adjustment of treatment in these clinical settings.

Pharmacoeconomics of subcutaneous allergen immunotherapy.

The current burden of allergic diseases, estimated by both direct and indirect costs, is very relevant. In fact the cost estimation for rhinitis amount globally to 4-10 billion dollars/year in the U.S. and to an average annual cost of 1089 euros per child/adolescent and 1543 euros per adult in Europe. The estimated annual costs in Northern America for asthma amounted to 14 billion dollars. Consequently, preventive strategies aimed at reducing the clinical severity of allergy are potentially able to reduce its costs. Among them, specific immunotherapy (SIT) joins to the preventive capacity the carryover effect once treatment is discontinued. A number of studies, mainly conducted in the US and Germany demonstrated a favourable cost-benefit balance. In the nineties, most surveys on patients with allergic rhinitis and asthma reported significant reductions of the direct and indirect costs in subjects treated with SIT compared to those treated with symptomatic drugs. This is fully confirmed in recent studies conducted in European countries: in Denmark the direct cost per patient/year of the standard care was more than halved following SIT; in Italy a study on Parietaria allergic patients demonstrated a significant difference in favor of SIT plus drug treatment for three years versus drug treatment alone, with a cost reduction starting from the 2nd year and increasing to 48% at the 3rd year, with a highly statistical significance which was maintained up to the 6th year, i.e. 3 years after stopping immunotherapy, corresponding to a net saving for each patient at the final evaluation of 623 euros per year; in France a cost/efficacy analysis comparing SIT and current symptomatic treatment in adults and children with dust mite and pollen allergy showed remarkable savings with SIT for both allergies in adults and children.

Economic evaluation of sublingual immunotherapy: an analysis of literature.

Allergic rhinitis and asthma constitute a global health problem because of their very high prevalence and the consequent burden of disease, concerning medical and economical issues. Among the treatments of allergy, specific immunotherapy has the capacity to favourably alter the natural history of the disease both during and after its performance and thus to reduce the direct and indirect costs of allergic rhinitis and asthma. A number of studies reported such cost reduction for traditional, subcutaneous immunotherapy and recent data demonstrate that also sublingual immunotherapy (SLIT) is associated to economic advantages and/or monetary savings, specifically in terms of reduction of disease economic burden. Only few formal economic assessments of SLIT have been carried out so far, this article will present and discuss the published studies addressed to this issue. The data obtained, although the number of studies is still limited, provide preliminary evidence supporting a SLIT effect on sparing costs for respiratory allergy.

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).

Long-term and preventive effects of sublingual allergen-specific immunotherapy: a retrospective, multicentric study.

There is now an increasing body of evidence to support the practice of allergen-specific sublingual-swallow immunotherapy (SLIT) in the treatment of IgE-mediated respiratory allergies. Recent studies on traditional injection therapy have pointed out that this form of treatment is not only capable to decrease actual allergic symptoms, but may also have long-term clinical and preventive effects and may influence atopy natural history. In the year 2000, our group published a retrospective, multicenter study showing the efficacy and safety of SLIT in a survey of 302 patients. We now carried out a second study on the same patients, with the aim of investigating long-term and preventive effects of SLIT. Beside the well-known safety and efficacy of this treatment (80.8% of patients reported clinical benefits), SLIT proved also to elicit long term clinical effects: over a mean follow-up of 11.6 months after the end of treatment, 80.8% of patients still maintained the previously achieved benefits. During the follow-up period, only 1% of non-asthma patients reported an onset of respiratory symptoms, and only 9.6% of patients undergoing new skin tests showed new sensitizations. All the clinical benefits were strongly linked to the length of treatment: patients with long-lasting benefits were treated for a mean length of 29.1 months, while patients showing a return to pre-SLIT condition were treated for a mean 13.3 months. SLIT can obtain long-term and preventive effects so far attributed to injection immunotherapy.