Search

The diagnosis of allergic reactions to penicillins (AR-PEN) is very complex as there is a loss of sensitization over time, which leads to negative skin tests (STs) and specific IgE in serum, and even to tolerance to the drug involved. However, STs may become positive after subsequent exposure to the culprit drug (resensitization), with the risk of inducing potentially severe reactions. The exact rate of resensitization to penicillins is unknown, ranging from 0% to 27.9% in published studies.To analyze the rate of resensitization in patients with suggestive AR-PEN by repeating STs (retest) after an initial evaluation (IE).Patients with suspected AR-PEN were prospectively evaluated between 2017 and 2020. They underwent STs, and a randomized group also underwent a drug provocation test (DPT) with the culprit. Only patients with negative STs and/or DPT were included. All included cases were retested by STs at 2-8 weeks.A total of 545 patients were included: 296 reporting immediate reactions (IRs) and 249 non-immediate reactions (NIRs). Eighty (14.7%) cases had positive results in retest (RT+): 63 (21.3%) IRs and 17 (6.8%) NIRs (p 0.0001). The rate of RT+ was higher in anaphylaxis compared with all other reactions (45.8% vs 9.1%, p 0.0001). The risk of RT+ was higher from the fifth week after IE (OR: 4.64, CI: 2.1-11.6; p 0.001) and increased with the patient's age (OR: 1.02; CI: 1.01-1.04; p = 0.009).Due to the high rate of resensitization, retest should be included in the diagnostic algorithm of IRs to penicillins after an initial negative study, especially in anaphylaxis, to avoid potentially severe reactions after subsequent prescriptions of these drugs.

Asthma, with several phenotypes and endotypes, is considered particularly suited for precision medicine. The identification of different non-invasive biomarkers may facilitate diagnosis and treatment. Recently, Staphylococcus aureus and its enterotoxins (SE) have been found to have a role in inducing persistent type 2 airway inflammation in severe asthma, but also in such comorbidities as chronic rhinosinusitis with nasal polyposis (CRSwNP).The aim of this retrospective study was to evaluate the prevalence of SE-IgE sensitization in a multicentric Italian cohort of severe asthmatic patients and correlate it with demographic and clinical characteristics.A total of 249 patients were included in the analysis, out of which 25.3% were staphylococcal enterotoxin B (SEB)-IgE positive. We found a meaningful association between SEB-IgE and female gender, a positive association was also measured between CRS and CRSwNP. No significant association was found between SEB-IgE sensitization and atopy, the occurrence of exacerbations and corticosteroid dosages. In the SEB-IgE-positive patient, blood eosinophil count does not appear to be correlated with the severity of the disease. Patients with SEB-IgE sensitization are, on average, younger and with an earlier disease onset, thus confirming the possibility to consider SEB-IgE sensitization as an independent risk factor for developing asthma.Our data confirm that the search for SE in the initial screening phase of these patients is helpful to better phenotype them, may predict the evolution of comorbidities and lead to a targeted therapeutic choice; in this point of view this represents a goal of precision medicine.

Participant dropouts can reduce the power of allergen immunotherapy clinical trials. Evaluation of the dropout rate and reasons for dropout are important not only in the planning of clinical studies but are also relevant for adherence to immunotherapy in daily clinical practice. A systematic review was carried out in order to establish the overall dropout rate among published double-blind, placebo-controlled randomized clinical trials of sublingual immunotherapy for respiratory allergic diseases. Dropouts were analysed in regards to allergen, formulation, treatment schedule, participant age, study size, number of centres and type of allergic disease. Relative dropout rates in placebo and active groups as well as reasons for dropout were also assessed. A total of 81 studies, comprising 9998 patients, were included. Dropout rates in sublingual immunotherapy controlled studies do not appear to be a major problem with a composite dropout percentage of 14% (95% CI:11.9-16). Furthermore, they are not different for active compared to placebo-treated participants. This lends support to the positive clinical outcomes seen in meta-analyses of these trials.

To cite this article: Baiardini I, Braido F, Bindslev-Jensen C, Bousquet PJ, Brzoza Z, Canonica GW, Compalati E, Fiocchi A, Fokkens W, Gerth van Wijk R, Gimenez-Arnau A, Godse K, Grattan C, Grob JJ, La Grutta S, Kalogeromitros D, Kocaturk E, Lombardi C, Mota-Pinto A, Ridolo E, Saini SS, Sanchez-Borges M, Senna GE, Terreehorst I, Todo Bom A, Toubi E, Bousquet J, Zuberbier T, Maurer M. Recommendations for assessing patient-reported outcomes and health-related quality of life in patients with urticaria: a GA2LEN taskforce position paper. Allergy 2011; 66: 840–844. Abstract The aim of this Global Allergy and Asthma European Network (GA2LEN) consensus report is to provide recommendations and suggestions for assessing patient-reported outcomes (PROs) including health-related quality of life in patients with urticaria. We recommend that PROs should be used both in clinical trials and routine practice for the evaluation of urticaria patients. We suggest that PROs should be considered as the primary outcome of future clinical trials. Two validated and disease-specific instruments for assessing PROs are available, the urticaria activity score (for symptoms) and the chronic urticaria questionnaire on quality of life CU-Q2oL. This latter tool, CU-Q2oL, is available in many languages and should be preferred, where available, over more generic instruments for assessing urticaria-specific effects on quality of life. CU-Q2oL is only suited for the investigation of patients with chronic spontaneous urticaria. Similar instruments for other forms of urticaria have yet to be developed and validated. Also, tools for assessing other chronic spontaneous urticaria PROs besides quality of life and symptoms are needed.

The GA 2 LEN taskforce on Patient-Reported Outcomes (PROs) and Health-Related Quality of Life (HRQoL) published in 2009 a position paper concerning PROS and HRQoL assessment in clinical trials on allergy. Because of the specificity of this topic in asthma and rhinitis, specific recommendations are needed. The aim of this position paper is to define PROs and their meaning in asthma and rhinitis research, explore the available tools to provide criteria for a proper choice, identify patientrelated factor which could influence PROs assessment, define specific recommendations for assessment, analysis and results spreading, underline the unexplored areas and unmet needs. PROs assessment is gaining increasing importance, and it must be performed with a rigorous methodological procedure and using validated tools. This approach enables to better understand patient-related factors influencing clinical trials and real-life management outcomes, identify patients subgroups that can benefit from specific treatment and management plan and tailor treatment to address PROs (not only physician-defined targets) to improve asthma and rhinitis management.

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

Fluticasone propionate aqueous nasal spray (FPANS) is a topically active glucocorticoid which has been successfully used for the treatment of seasonal allergic rhinitis (SAR). Topical levocabastine is a highly selective H1 antagonist which has been proposed as an alternative treatment of SAR. The purpose of this study was to compare the clinical efficacy of two topical nasal treatments, FPANS and levocabastine, in the treatment of SAR. Additionally, the effect of treatments on nasal inflammation was examined during natural pollen exposure. A group of 288 adolescent and adult patients with at least a 2-year history of SAR to seasonal pollens participated in a multicenter, doubleblind, double-dummy, and placebo-controlled study. Patients were treated with either FPANS 200 microg, once daily (n = 97), or topical levocabastine, 200 microg, given twice daily (n = 96), or matched placebo (n = 95) for a period of 6 weeks, starting from the expected beginning of the pollen season. Clinically relevant pollens included Parietaria, olive, and grass. Assessment of efficacy was based on scores of daily nasal symptoms and on nasal cytology of nasal lavage. Nasal lavage was performed immediately before, during, and at the end of treatment in 39 patients. FPANS significantly increased the percentage of symptom-free days for nasal obstruction on waking and during the day, rhinorrhea, sneezing, and itching. FPANS provided a better control for night and day nasal obstruction (P

Local nasal immunotherapy represents an alternative route of allergen administration. It was proposed to overcome the risk of systemic reactions rarely reported during the traditional subcutaneous immunotherapy. Some studies carried out in the past generally showed good efficacy but poor tolerability. The aqueous extracts mostly used in these studies carry some drawbacks such as the volume effect, self-digestion and the difficulty of administering reproducible dosages. The recent availability of allergen extracts in powder form has led to better stability and standardization. The studies carried out with these freeze-dried allergens showed clinical efficacy and good tolerability in perennial (mite, cat) and seasonal (grass, birch, Parietaria) allergic rhinitis. According to these findings this new local nasal immunotherapy with extract in powder form represents a suitable alternative to the traditional immunotherapy in the treatment of allergic rhinitis.

Background The present study aimed to develop a short validated patient-completed questionnaire, the RhinAsthma Patient Perspective (RAPP), to assess the health-related quality of life (HRQoL) in patients with asthma and comorbid allergic rhinitis in clinical practice. Methods A provisional RAPP questionnaire was formed from candidate items identified through retrospective analysis of 333 RHINASTHMA questionnaires. This was then tested on 150 asthma patients with allergic rhinitis. Results Psychometric analyses identified eight items fitting a unidimensional model to form RAPP. Internal consistency (Cronbach's alpha coefficient > 0.8) and agreement with RHINASTHMA (r = −0.31, P = 0.0001) were excellent. Criterion, discriminant, and convergent validity were good. Reliability in 47 stable patients was very good (intra-class and concordance correlation coefficients were 0.90 and 0.89, respectively). Responsiveness in 103 patients with health improvement or deterioration was significantly associated with changes in Global Rating Scale (r = −0.4965, P

In a 20-d, double-blind, randomized, parallel study, the efficacy of cetirizine and terfenadine was compared in 30 patients with chronic idiopathic urticaria. Subjects were randomly divided into two 15-patient groups. The first group was given cetirizine (10 mg once daily); the second terfenadine (60 mg twice daily). Cetirizine proved to be more effective than terfenadine in controlling urticaria symptoms. In fact, the score of the investigators' overall assessment was significantly lower in the cetirizine-treated group than in the terfenadine-treated group. Moreover, patient evaluation by a visual analog scale and symptoms assessed on a 4-point scale showed a better improvement in the cetirizine group. The number and severity of side-effects were similar in both treatment groups.

The modalities of administration of sublingual immunotherapy (SLIT), including dosing, build-up phase, duration of the treatment, and frequency of the maintenance dose are largely variable. In the case of pollen (SLIT), the complexity increases, since preseasonal, coseasonal and pre-coseasonal regimens can be used. The administration regimens are of relevance from a practical point of view, but can also have economic implications. We review herein the available literature (randomized double blind controlled studies) on pollen SLIT, in order to derive experimentally-supported suggestions about the regimens of administration that should be preferred.

Introduction: The Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines provide a stepwise treatment to rhinitis, which classifies the disease according to its duration and severity. Objectives: The aim of the study was to verify whether these variables influence drug prescriptions for rhinitis and asthma. Methods: A multi-centre cross-sectional pharmaco-epidemiological survey was carried out on 1610 allergic rhinitis patients and the relationship between the clinical features of rhinitis and drug therapy for rhinitis and asthma was evaluated. Results: A total of 1321 adult patients were enrolled. Mild intermittent rhinitis was diagnosed in 7.7%of the patients, moderate/severe intermittent in 17.1%, mild persistent in 11.6%, and moderate/severe persistent in 63.6%. A high level of rhinitis-asthma comorbidity (616/1321 = 46.6%) was found. The majority of patients [1060 (80.24%)] were treated. Significant associations between the severity of rhinitis and the presence of therapy (P = 0.008), the use of oral antihistamines (P

Asthma is a multifaceted disease and therefore numerous markers or measurements of its severity and activity are available. Among them, functional parameters (spirometry), clinical assessment (symptoms and quality of life) and biomarkers of inflammation are the most widely used. Nonetheless, it is difficult to establish a clear correlation among the mentioned parameters, as each of them seems to measure a particular aspect of the disease and to be partially independent of the others. This fact has been demonstrated, for instance, for methacholine reactivity that weakly correlates with inflammation (1) or for quality of life that poorly correlates with symptoms (2). During the last years new evaluation parameters for asthma have been introduced. One of them is the measurement of exhaled nitric oxide (eNO) as an indirect marker of inflammation (3) that can be assessed through a proper apparatus with a simple expiratory manoeuvre. Another new instrument for asthma evaluation is the asthma control test (ACT), that allows a quick self-assessment of the degree of control of the disease (4). The ACT consists of five questions enquiring about the frequency of symptoms in the last 4 weeks. Each question has five possible answers scored from 1 (worst) to 5 (best). The higher the ACT score (25 points is the maximum achievable), the better controlled is asthma. We attempted to assess whether there is some correlation among asthma ACT score, eNO and forced expiratory volume at 1 s (FEV1) in outpatients receiving the first diagnosis of asthma, which was graded in severity according to GINA criteria (http://www.ginasthma.com). Patients, referred for the first time for respiratory complaints and without a previous diagnosis of asthma, underwent a detailed clinical history, clinical visit and spirometry (with methacholine test or reversibility test). Asthma was diagnosed on the basis of: (i) history of attacks of chest tightness, cough, wheezing, nocturnal awakenings, and (ii) impaired spirometry with a reversibility of at least 12% in the FEV1 after salbutamol or, in alternative a normal spirometry with a positive methacholine test. The severity of asthma was graded according to GINA guidelines. Before prescribing an adequate therapy, ACT was administered and eNO was assessed. Exhaled nitric oxide was measured by a CLD 88 sp (ECO-Medics, Duernten, Switzerland), the threshold value of eNO was 20 p.p.b. From April to May 2006, 27 patients (17 male, mean age 31.9, age range 16– 57 years) were diagnosed with asthma for the first time. The severity of the disease according to GINA was: intermittent in one, mild in six, moderate in 16 and severe in four. Their FEV1 ranged from 69% to 110% and eNO varied between 18 and 208 p.p.b. Looking at the four parameters (Fig. 1) there was no correlation between FEV1 and ACT (r 1⁄4 0.26, P 1⁄4 0.2) and between FEV1 and eNO AL LERGY 2 0 0 7 : 6 2 : 2 0 7 – 2 1 2 • a 2007 THE AUTHORS • JOURNAL COMPILAT ION a 2007 BLACKWELL MUNKSGAARD • CONTRIBUT IONS TO THIS SECT ION WILL NOT UNDERGO PEER REVIEW, BUT WILL BE REV IEWED BY THE ASSOCIATE EDITORS •

Background: In health-related quality of life (HRQL) studies on allergic rhinitis, both disease-specific and generic questionnaires have been extensively used. Seasonal allergic rhinitis (SAR) has been studied mainly by focusing on symptomatology. The present study aimed to evaluate the SAR-HRQL by means of two questionnaires, the Medical Outcome Study Short Form Health Survey (SF-36) and a new instrument examining satisfaction in 32 aspects of daily life: the Satisfaction Profile (SAT-P). Methods: Thirty-three patients with SAR (aged 33.5±8.5 years; 12 men, 21 women) were evaluated during and 2 months after the pollen season. Data were compared with reference samples by t-test, and baseline and follow-up HRQL scores were compared by a matched-pair test. Results: Patients' HRQL scores collected during the pollen season were significantly lower than reference sample data in many SF-36 scores and in one SAT-P item. No differences emerged between SF-36 and SAT-P scores collected outside the pollen season and reference sample scores. Compared to baseline, outside the pollen season, patients reported significantly higher scores in the following SF-36 scales: physical functioning (P=0.002), physical role (P=0.00001), bodily pain (P=0.01), and vitality (P=0.008); and significantly higher scores in only two SAT-P items (physical well-being [P=0.009] and resistance to stress [P=0.01]). Conclusions: Our data confirm the utility of using symptomatologic and health-status questionnaires in evaluating the HRQL of SAR patients. More general quality of life questionnaires may prevent the symptomatologic and functional problems from being adequately recognized and managed. SAT-P can be a fruitful additional tool in HRQL evaluation.

Preseasonal local nasal immunotherapy (LNIT) by means of an extract in macronized powder form has been studied in allergic rhinitis to parietaria. Twenty-four Parietaria-sensitive patients have been studied for 18 weeks in a double-blind controlled trial. Subjects were selected on the basis of a positive skin test, RAST and intranasal challenge to Parietaria antigen. Three eight-patient groups were randomly planned: the first group was given native Parietaria product, the second modified Parietaria product, and the third placebo. During the pollen season no difference was observed in mean weekly symptom score between the three groups, while the mean weekly medication score was significantly lower in the treated groups than the control group. Only the treated groups showed a significant increase in specific nasal threshold to Parietaria after treatment. Adverse reactions to LNIT, limited to the upper respiratory tract, occurred rarely and did not interfere with the dose schedule. This study indicates that LNIT in powder form may be a suitable alternative to the traditional subcutaneous immunotherapy in terms of clinical efficacy and safety.