Paola Puccinelli

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.

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.

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

BACKGROUNDnThe local (noninjection) routes of immunotherapy are presently regarded as viable therapeutic options for respiratory allergy, and their mechanisms of action are currently undergoing investigation.nnnOBJECTIVEnWe 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.nnnMETHODSnThirty 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.nnnRESULTSnThe 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.nnnCONCLUSIONnThe 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.

Sublingual immunotherapy in children with allergic polysensitization.

Polysensitization is quite frequent in allergic children and may cause difficulties for the allergist in prescribing allergen-specific immunotherapy. This study aimed at evaluating the clinical effectiveness of 1 year of sublingual immunotherapy (SLIT) in a cohort of Italian allergic children with polysensitization. This open study was performed on 51 polysensitized children (34 boys; mean age, 11.8 years; range, 5.2-17.7 years) with allergic rhinitis and/or mild to moderate asthma. All of them were treated with SLIT for 1 year. The kind and the number of prescribed allergen extracts, the type of diagnosis, the severity of symptoms, and the use of drugs were evaluated at baseline and after 1 year. The adverse events to SLIT were also evaluated. Forty-two children were treated with a single extract, four with two different extracts and three with a mix of allergens. SLIT treatment induced a significant reduction in the number of sensitizations (p = 0.018); significant improvement of allergic rhinitis classification and severity; significant reduction of ocular, nasal, and bronchial symptoms (p < 0.01 for all); and drugs use (p < 0.01 for all drugs). No systemic reactions to SLIT were observed. This open study provides evidence that polysensitization is not an obstacle for prescribing SLIT in polysensitized children. Indeed, SLIT efficacy on clinical parameters is significant after 1 year and the therapy is safe.

Polysensitization as a challenge for the allergist: the suggestions provided by the Polysensitization Impact on Allergen Immunotherapy studies

Introduction: Polysensitization, that is, sensitization to more than one allergen family, is a common feature of patients with allergic rhinitis (AR) and significantly impairs their quality of life (QoL). Allergen-specific immunotherapy is the only causal treatment for AR. However, the polysensitization phenomenon may represent a crucial obstacle as far as it concerns the choice of the allergen extract to be used for immunotherapy. Areas covered: A series of real-life based multi-center studies, named POLISMAIL (Polysensitization Impact on Allergen Immunotherapy), have been designed with the aim of evaluating the behavior of allergists in managing polysensitized AR patients. The effect of immunotherapy treatment in these patients was also evaluated. A single allergen extract was used in two-thirds of patients, whereas a mix of two allergens was chosen in the remaining. The severity grade of AR and the QoL were significantly improved by immunotherapy. Both outcomes confirmed that immunotherapy with one or two allergen extracts achieves a significant improvement in polysensitized patients. Expert opinion: In conclusion, POLISMAIL studies demonstrate that polysensitization should not represent a counter-indication for prescribing immunotherapy. The choice of limiting sublingual immunotherapy to one to two allergen extracts, preferably separated and at high dosages, is sufficient and effective in improving symptoms and QoL.

Patient-related factors in rhinitis and asthma: the satisfaction with allergy treatment survey

Abstract Background: Patient satisfaction with the prescribed treatments represents a crucial issue that may have clinical relevance as it may significantly affect treatment compliance. We designed an observational study to evaluate the satisfaction level concerning different pharmacological treatments for allergic rhinitis (AR) and asthma in a real-life setting. Methods: The study was conducted in 21 allergy centres homogeneously distributed in Italy. Three hundred and one patients (46.8% males; 53.2% females; mean [SD] age, 33.1 [13.8] years) with AR and/or asthma were consecutively evaluated. Diagnosis, classification, symptom severity, and satisfaction degree (assessed by a questionnaire) were the parameters considered. Results: Only 33.5% of the AR patients were satisfied with the rhinitis treatments. Only 40.7% of the asthmatic patients were satisfied with the asthma treatments. Some factors associated with treatment dissatisfaction are as follows: female gender (odds ratio [OR] 2.36; pu2009<u20090.01), co-morbidity (OR 2.39; pu2009<u20090.05), rhinitis severity (OR 1.39; pu2009<u20090.05), asthma severity (OR 2.04; pu2009<u20090.05), and antihistamine use (OR 2.53); however, the use of bronchodilators had a favourable impact (OR 0.28; pu2009<u20090.05). The relatively low number of subjects prevented performing stratification of patients by treatment classes. Conclusion: The findings of this real-life study strengthen the concept that AR is particularly troublesome and that most allergic patients suffering from both rhinitis and asthma are dissatisfied with prescribed drugs.

Adherence issues related to sublingual immunotherapy as perceived by allergists

Objectives: 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.

The efficacy of sublingual immunotherapy for respiratory allergy is not affected by different dosage regimens in the induction phase.

BACKGROUNDnSublingual administration of allergens is a safe and effective alternative to subcutaneous immunotherapy in patients with respiratory allergies. A drawback to this therapeutic approach is the relatively long and complex management of the induction phase.nnnAIM OF THE STUDYnTo determine whether different induction regimens affect the outcome of sublingual immunotherapy.nnnMETHODS AND RESULTSnAdult and pediatric patients with allergic rhinoconjunctivitis and/or asthma were included in the study. Ten subjects served as controls and received symptomatic treatments. Forty-three subjects were allocated to sublingual immunotherapy, with three different induction protocols (8-, 15- and 20-day, respectively). Symptom and medication scores, skin test results and (in asthmatic patients) FEV1 values were monitored for two years. Adverse effects were recorded. All induction regimens produced a significant improvement in symptom and medication usage (p < 0.0001); skin test scores decreased (p < 0.0001) and FEV1 improved (p < 0.05). In contrast, symptom and skin test scores did not significantly change in controls. No relevant adverse effects were observed with any of the induction regimens.nnnCONCLUSIONSnFor patients with respiratory allergies, sublingual immunotherapy with an 8-day induction protocol is safe and effective. Our results encourage the usage of shorter induction regimens, which produce better compliance with this therapy.

The Clinical Stage of Allergic Rhinitis is Correlated to Inflammation as Detected by Nasal Cytology

Allergic rhinitis (AR) is the most common allergic disease. The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines classify AR according to its duration and severity and suggest recommended treatments, but there is evidence that these guidelines are insufficiently followed. Considering the validity of histopathological data, physicians are more likely to be persuaded by such information on AR. Thus, we attempted to define the severity of AR by nasal cytology on the basis of the ARIA classification. We examined 64 patients with AR caused by sensitization to grass pollen. We clinically defined AR according to the ARIA classification and performed nasal cytology by Rhino-probe sampling, staining and reading by optical microscopic observation. Clinically, 22 (34.4%), 21 (32.8%), 10 (15.6%), and 11 (17.2%) patients had mild intermittent, moderate-to-severe intermittent, mild persistent, and moderate-to-severe persistent AR, respectively. Nasal cytology detected neutrophils in 49 patients, eosinophils in 41 patients, mast cells in 21 patients, and lymphocytes or plasma cells in 28 patients. The patients with moderate-to-severe AR had significantly more mast cells and lymphocytes/ plasma cells than those with mild AR. Our findings demonstrate that the ARIA classification of AR severity is associated with different cell counts in nasal cytology; especially, moderate-to-severe AR shows significantly increased counts of mast cells and lymphocyte or plasma cells. The ease of performing nasal cytology ensures is feasibility as an office AR diagnostic procedure for primary care physicians, able to indicate when anti-inflammatory treatments, such as intranasal corticosteroids and subcutaneous or sublingual allergen immunotherapy, are needed.

Development of a sublingual allergy vaccine for grass pollinosis.

Grass pollen is a very common cause of allergic rhinitis and asthma. The only treatment targeting the underlying causes of allergy is immunotherapy (IT). Sublingual immunotherapy (SLIT) has been introduced to solve the problem of systemic reactions to subcutaneous IT (SCIT). This article evaluates the characteristics of the allergen extract, Staloral, in terms of practical administration, effectiveness, safety, and mechanism of action. Efficacy data were obtained from double-blind, placebo-controlled studies using Staloral in patients sensitized to grass pollen, while practical administration, cost-effectiveness, and mechanism of action data were provided by well designed studies. The efficacy and safety of Staloral, as demonstrated by review of published studies which used doses up to 1125 times those administered with SCIT, shows that this allergen extract has optimal characteristics for treating patients with seasonal allergies due to grass pollens. The main mechanism of action is the interaction between dendritic cells of the oral mucosa and the subsequent tolerance induced in T-cells.