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The prevalence of asthma in Italy is estimated to be around 4%; it affects approximately 2,000,000 citizens, and up to 80-90% of patients have mild-to-moderate asthma. Despite the clinical relevance of mild-to-moderate asthma, longitudinal observational data are very limited, including data on disease progression (worsening vs. improvement), the response to treatment, and prognosis. Studies are needed to develop long-term, observational, real-life research in large cohorts. The primary outcomes of this study will be based on prospective observation and the epidemiological evolution of mild and moderate asthma. Secondary outcomes will include patient-reported outcomes, treatments over time, disease-related functional and inflammatory patterns, and environmental and life-style influences.This study, called the Mild/Moderate Asthma Network of Italy (MANI), is a research initiative launched by the Italian Respiratory Society and the Italian Society of Allergology, Asthma and Clinical Immunology. MANI is a cluster-based, real world, cross-sectional, prospective, observational cohort study that includes 20,000 patients with mild-to-moderate asthma. (ClinicalTrials.gov Identifier: NCT04796844).Despite advances in asthma care, several research gaps remain to be addressed through clinical research. This study will add important new knowledge about long-term disease history, the transferability of clinical research results to daily practice, the efficacy of currently recommended strategies, and their impact on the burden and evolution of the disease.MANI:Mild/Moderate Asthma Network of ItalySANI:Severe Asthma Network ItalyGINA:Global Initiative for AsthmaSABA:short acting β2-agonistsICS:inhaled corticosteroidsCRF:Case Report Form.

Background: In this project the authors use a narrative medicine (NM) approach to assess the promotion of trust in the relationship between physicians and their asthma patients. Methods: Following a NM educational course for physicians, a research was carried out in which at least 5 written narratives (parallel charts) for each participating physician were collected and qualitatively analysed according to Bury’s classification and the Grounded Theory. Results: The results of this study were of speculative and clinical interest. In particular, 66 participants wrote 314 narratives (246 on adult and 68 on paediatric patients). As a result of applying the NM approach, when the relationships remained problematic, many physicians wrote with a moral style about their adult (67%), and paediatric patients (33%) - especially in cases of asthmatic children’s or adolescents’ overprotective or absent families (40%) -. On the contrary, physicians who were able to listen to their patients with empathy (35%) made more shared decisions with patients, even with those they initially had a bad relationship. The used words of welcome, interest and acceptance were promoting patients’ trust that lead to restoring their activities in 45% of cases, according to physicians self-reporting. Conclusions: These approaches of NM are useful in daily clinical practice, with the goal of improving the quality of life (QOL) of patients with severe asthma, even in cases in which the doctor-patient relationship isn’t initially good.

Background Omalizumab therapy is effective and safe in patients with chronic spontaneous urticaria (CSU) resistant to nonsedating histamine 1 (H 1 ) antihistamines (nsAHs). Objective To evaluate the efficacy and safety of omalizumab in elderly (aged ≥65 years) patients with nonsedating H 1 -antihistamine–refractory CSU in a real-life setting. Methods Patients with nonsedating H 1 -antihistamine–refractory CSU (n = 322) treated with omalizumab administered every 4 weeks in doses of 300 mg for 24 weeks were divided into 2 groups according to age at omalizumab treatment onset: 15 to 64 years and 65 years or older. Treatment response was assessed using a 7-day urticaria activity score (UAS7). Adverse effects of omalizumab therapy were recorded. Results Among patients, 32 (9.9%) were 65 years or older. At baseline, CSU characteristics were generally similar among the groups, although the presence of angioedema was statistically significantly lower in patients younger than 65 years. Any differences in weekly itch severity score, hive score, and UAS7 between the 2 age groups were not significant at weeks 4, 12, and 24, with the exception of the hive score at 24 weeks and the UAS7 at week 24. No significant between-group differences were seen in the proportion of patients with a UAS7 of 6 or lower and with a UAS7 score of 0 at weeks 4, 12, 24, and 40. The proportion of patients with at least one adverse event reported as suspected to be caused by study drug was 10% in the younger group vs 6.3% in the older group ( P = .53). Conclusion Our study found that omalizumab is a well-tolerated and effective therapy for elderly patients with nonsedating H 1 -antihistamine–refractory CSU.

Uvula oedema is a condition characterized by a sensation of a foreign body in the oropharynx and difficulty to speak; sometimes, if associated with glottis oedema, difficulty to breathe and dysphonia are also present. Urticaria is a disease characterized by itching wheals on the skin, and sometimes angioedema. Chronic urticaria is spontaneous when the etiology is unknown. Chronic urticaria may be disabling and difficult to treat, with a negative impact on the patient's quality of life. Omalizumab administration is suggested for refractory patients as add-on therapy to the antihistamines, in a third line. In Italy, omalizumab may be used for the treatment of spontaneous chronic urticaria in patients older than 12 years, refractory to antihistamines, with UAS >3 and UAS7 > 16. We describe a case of a 62-year-old woman had had recurring uvula oedema and chronic urticaria, not responder to antihistamines and oral corticosteroids. After 6 months of treatment with omalizumab and antihistamines, no urticaria recurrence was reported and no new episodes of angioedema had occurred. Our experience showed that omalizumab might be effective in patients with recurrent uvula oedema associated with urticaria.

SummaryBackground Urticaria is a common disorder that affects as many as 20% of all people at some time during their lifetime. Objectives To analyse the prevalence of various forms of urticaria according to an aetiological and clinical classification, we carried out a 4-year study in an outpatient clinic. Methods The study was carried out on 562 consecutive patients (178 males and 384 females; mean age 35·4 ± 16), who had been referred to our unit for the study of urticaria and angio-oedema. Baseline investigations included: the patient's family and personal history of allergy; duration of symptoms, presence of associated symptoms and objective signs of the current episode; clinical, laboratory and instrumental investigations; assessment of response to antihistamine treatment. Results A family history of atopy was present in 35% of patients and a personal history of allergy in 24%. We subdivided urticaria and angio-oedema into several groups on the basis of their clinical and aetiological aspects. Of the 562 patients, 424 (76%) presented with ordinary urticaria (43 acute urticaria, 311 chronic urticaria, 70 episodic urticaria), 80 (14%) physical urticaria, 49 (9%) angio-oedema without weals, six (1%) IgE-mediated contact urticaria and three (0·5%) urticarial vasculitis. In 64 cases (11%) urticaria/angio-oedema was associated with one or more symptoms. We identified 394 cases (82%) of idiopathic urticaria, 42 (9%) of immunological urticaria, 29 (6%) of non-immunological urticaria and 17 (3%) of urticaria secondary to infections. Of the treated subjects, 54% showed a good response to treatment with antihistamines. Conclusions Our data provide an overview of urticaria/angio-oedema in a large series of patients, based on clinical–aetiological aspects, and related to recent diagnostic guidelines.

The involvement of the synovium is common in phlogistic processes of various joint diseases. Apart from synoviocytes and the other cells in the synovial tissue, circulating cells recruited from peripheral blood also participate in the phlogistic process. The increased expression of adhesion molecules on both circulating and endothelial cell surface may further this recruitment. We studied 15 patients affected by serious gonarthrosis requiring a prosthetic implant (GPI) and 7 with knee prosthesis aseptic loosening (KPL) to evaluate adhesion molecule expression and phlogistic infiltration in the synovium using immunohistochemistry and microscopic analysis. As control we studied 10 subjects affected by degenerative meniscopathies undergoing a selective arthroscopic surgical meniscectomy. Analysis with Kruskal-Wallis test showed no statistical significant differences in the expression of CD54, CD11a, CD11b and CD18 in three groups examined. The model of variance analysis (Friedman test), showed that CD54 expression is greater in patients with GPI and KPL in comparison with the other molecules. Adhesion molecules and their functions are important in arthropathies not only because their evaluation can allow us to identify the degree of inflammation and to predict its evolution, but also because pharmacological control of their expression could have important therapeutic implications.

Silvia Scurati1, Franco Frati1, Gianni Passalacqua2, Paola Puccinelli1, Cecile Hilaire1, Cristoforo Incorvaia3, Italian Study Group on SLIT Compliance 1Scientific and Medical Department, Stallergenes, Milan, Italy; 2Allergy and Respiratory Diseases, Department of Internal Medicine, Genoa; 3Allergy/Pulmonary Rehabilitation, ICP Hospital, Milan, ItalyObjectives: 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.Methods: 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.Results: 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.Conclusion: 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.Keywords: adherence, sublingual immunotherapy, efficacy, cost, side effects

Summary Background Allergen-specific immunotherapy (SIT) is an effective treatment for patients with respiratory allergies. However, subcutaneous injection of allergens can provoke systemic side-effects. Objective This study was carried out to determine the incidence and risk factors of systemic reactions caused by SIT treatment, using extracts of different inhalant allergens, adsorbed in aluminium hydroxide and biologically standardized with the major allergens quantified in mass units. Methods Five hundred and fifty-five subjects with allergic rhinitis and/or asthma were evaluated on clinical history and skin prick test (SPT) reactions to common inhalant allergens. Subcutaneous SIT was administered to all patients, according to the suggested precautionary guidelines and administration schedule. Patients were treated with house dust mite, grass pollen, Parietaria judaica pollen and olive pollen extracts, each receiving one or two extracts. Results A total of 36 359 injections were administered in the 555 patients. We observed 34 episodes of serious systemic side-effects (0.093% of all injections), in 29 patients (5.2% of all patients), and no fatalities. About 55% of patients reported mild rhinitis and asthma. The majority (59%) of the serious systemic reactions (SSR), and all the anaphylactic reactions, were immediate (i.e. occurred within 30 min after the injection). Asthmatic subjects were at higher risk of SSR than patients with rhinitis (P = 0.01). Most of the side-effects observed occurred during the dose-increase phase (P

Chronic Idiopathic Urticaria (CIU) is a cutaneous disorder for which there is no identifiable specific etiologic agent. Some recent evidences suggest that CIU might be an autoimmune disease. We analyzed immunological features occurring in CIU and evaluated effectiveness and tolerance of Cyclosporin A (CsA) treatment in patients unresponsive to antihistaminic treatment. Twenty patients with CIU were recruited after a selective diagnostic protocol and were divided into two groups. CsA was prescribed for group 1 and Prednisone for group 2 as control, for 8 weeks. Before and after the therapy we performed on all patients immunological studies. For all patients symptoms disappeared after a few days of therapy. Before therapy all patients showed activated B cells (CD19+CD23+ cells) and among B CD19+ cells, about 20% were CD5+ (cells that synthesize natural autoantibodies). After treatment with Prednisone in group 2, a significant reduction of CD4+ lymphocytes (p = 0,01) was observed. Our findings might support the CIU autoimmune pathogenetic hypothesis. The clinical remission in the CsA-treated group confirmed the therapeutic effectiveness of this therapy in antihistaminic unresponsive CIU and, at dosage used, side effects were rare, mild and reversible. Thus, CsA might be a good therapeutic alternative in CIU patients unresponsive to conventional treatments.

Sir, (20% reduction) compared to the placebo group measThe pathogenesis of atopic dermatitis (AD) is only ured by SCORAD index, as shown in Fig. 1. The partly understood. Evidence supports the potential role combined score of daytime pruritus and sleep loss of soluble mediators as leukotrienes (LTs) (1). Drugs remained similar throughout the study and was not that selectively inhibit the formation or action of LTs statistically signiŽ cant between the two treatments (F = have been introduced as a new form of anti0.08 p =0.92) and the diVerent times of observation in ammatory therapy in asthma. Montelukast is an (F =1.95 p =0.18). The blood-chemistry tests conducted antileukotriene agent known as CysLT1 receptor antagat the end of treatment revealed no changes in any of onist. Cysteinyl LTs (LTC4, LTD4, LTE4) are potent the studied patients and no adverse eVects were observed smooth muscle constrictors, and contribute to the onset by the investigator or reported by the patient, thereby of in ammation by their ability to cause plasma extraconŽ rming the tolerability of montelukast. vasation and eosinophil recruitment (2). The objective of our study was to evaluate the eYcacy and tolerability DISCUSSION of montelukast as a therapeutic agent for severe AD in adults. Montelukast is generally a safe drug during long-term treatment; side eVects are minimal (4). Indeed, in our MATERIAL AND METHODS study montelukast was well tolerated, conŽ rming observations by other authors of the safety of this drug (4–6). We enrolled 20 adult male patients with severe AD according This could be particularly relevant for patients aVected to the SCORAD index (severe AD: mean objective score > 40) with AD who may need treatment for long periods of (3). Their ages ranged from 18 to 28 years (mean age 22 ± 3.7). One month before treatment, the patients were asked to time. The anti-in ammatory potential of anti-LTs in discontinue all medication except emollients. The study was asthma has been conŽ rmed in a number of studies (7, approved by the ethics committee and subjects signed an 8). The role of the LTs in AD remains unclear. A informed consent form to participate in the study. Exclusion prolonged elevation of the urinary levels of LTE4 has criteria were: pregnancy, pregnancy potential and current lactation; a history of liver disease; allergy to montelukast or cross-reacting medication; use of phenobarbital, phenytoin or rifampicin. Subjects were randomized into two groups of 10 to receive montelukast 10mg or placebo for 6 weeks in a double-blind study. Furthermore, during the study, all subjects were not allowed other treatment for AD. EYcacy was assessed by SCORAD index and subjective symptoms were evaluated separately at baseline, and after 3 and 6 weeks. The SCORAD index combines objective signs (extent and intensity of lesions) and subjective (daytime pruritus and sleep loss) criteria. Evaluations were made at each visit by the same investigator for each patient. Blood tests were performed for total blood cell count and blood chemistry (aspartate transaminase, total bilirubin, creatinine and urea). Baseline mean values were compared using Student’s t-test for unpaired samples. The eYcacy of the two treatments at diVerent times was evaluated using a split-plot analysis of variance (ANOVA). Comparison between t0 and t2 (time of treatment at baseline and end of the study) was evaluated with Student’s t-test for unpaired samples.