Impact of COVID-19 in allergen immunotherapy: An Italian survey

Allergen immunotherapy (AIT) is a common treatment for patients with allergic asthma and allergic rhinoconjunctivitis. There is evidence that the COVID-19 pandemic could have altered the administration of AIT in patients in some countries, as the pandemic caused major limitations to healthcare access and delivery. The objective of this study was to evaluate the impact of the disruption imposed by the pandemic on the perceptions and administration of AIT therapies in Italy. An online survey was carried out among Italian allergists between 22 February 2021 and 12 April 2021. The results show that Italian physicians (N=66) did not consider that the COVID-19 pandemic presented an added risk to patients with allergic asthma or rhinitis receiving AIT. Although most treatments continued, there were reduced rates of AIT therapy initiations and sublingual AIT was favored over subcutaneous AIT (AU)

Predictors of Completion of Sublingual Immunotherapy.

OBJECTIVES: Sublingual immunotherapy (SLIT) has emerged as an effective treatment alternative to subcutaneous immunotherapy (SCIT) given its improved safety profile and more convenient dosing. However, SLIT still relies on daily dosing for many years to optimize effectiveness. This study sought to investigate factors that influence patient completion of SLIT. METHODS: We performed an institutional retrospective review of patients who received SLIT (2008-2020). Completion was defined as completing at least 36 months of SLIT. Patient demographics and characteristics, including the number of allergens treated, history of asthma and sinus surgery, number of clinic visits, and total time undergoing SLIT, were documented. Multivariate models were used to analyze predictors of SLIT completion. Subgroup analysis was performed among pediatric patients and patients who discontinued SLIT. RESULTS: Of the 404 total patients, 249 (61.6%) discontinued, 47 (11.6%) completed, and 108 (26.7%) were currently undergoing SLIT. The mean duration of therapy was 11.2 months for those who discontinued and 49.4 months for patients who completed SLIT. The odds of SLIT completion were twice as high with each additional clinic visit (P < .001), and twice as high when the dosage was increased during therapy (P = .06). Pediatric patients younger than age 12 with a history of asthma were over five times more likely to complete therapy (P = .045). Patients with more clinic visits (P < .001) and higher associated costs (P = .003) were less likely to be lost to follow-up. CONCLUSION: Increasing the frequency of clinic visits, improving therapy availability, and mitigating concerns about clinical efficacy may increase patient completion of SLIT. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E2111-E2115, 2021.

The safety of carbamylated monomeric allergoids for sublingual immunotherapy. Data from a pharmacovigilance study.

Aim: Sublingual immunotherapy (SLIT) is significantly less concerned by systemic reactions than subcutaneous immunotherapy. Allergoids were introduced to reduce systemic reaction to subcutaneous immunotherapy, but may also be used for SLIT. Methods: This pharmacovigilance study evaluated the post-marketing reports collected in a safety database, including the number and the type (serious or not serious) of adverse drug reactions (ADRs) in Italy by SLIT with the carbamylated monomeric allergoid (CMA). Results: More than 15,000,000 CMA tablets were administered, with 25 spontaneous reports of ADRs, only two being serious. Conclusion: The rate of ADRs to CMA we found in this pharmacovigilance survey, corresponding to 0.0004% of all administered doses, is far lower than the rates commonly reported for allergen SLIT products.

Role of sublingual immunotherapy in the treatment of asthma: An updated systematic review.

BACKGROUND: The purpose of the systematic review is to evaluate the efficacy and safety of sublingual immunotherapy (SLIT) for the treatment of allergic asthma. METHODS: PubMed, Embase, and CENTRAL databases were searched, updating an earlier review (January 1, 2005 through May 8, 2017). Randomized, controlled studies (RCTs) were included, which reported one of the prespecified outcomes: asthma symptoms measured by control composite scores; quality of life; medication use; pulmonary physiology; and health-care utilization. For safety outcomes, RCTs and observational studies were included. Two independent reviewers extracted data, assessed risk of bias, and graded strength of evidence (SOE) for each outcome. RESULTS: Fourteen RCTs (n = 2585) assessed the efficacy of SLIT for asthma. The RCTs utilized house dust mite (HDM), birch, or grass allergen. SLIT improved asthma symptoms (high SOE), decreased use of long-term control medication, and improved forced expiratory volume in 1 second (FEV1 ) (moderate SOE). SLIT may decrease quick-relief medication use, and improve disease-specific quality of life (low SOE). For safety, 20 RCTs and 10 observational studies (n = 3621) were identified. Local (risk differences ranged from -0.03 to +0.765) and systemic allergic reactions (risk differences ranged from -0.03 to +0.06) were a common occurrence in SLIT and control groups. Life-threatening reactions were uncommon, with 3 cases of anaphylaxis and no deaths reported. CONCLUSION: There is moderate-to-high strength evidence that SLIT improves allergic asthma symptoms, reduces long-term control medication use, and improves FEV1 based on studies of HDM, birch, and grass. SLIT rarely is associated with life-threatening adverse events.

Compliance with allergen immunotherapy and factors affecting compliance among patients with respiratory allergies.

BACKGROUND: Allergen-specific immunotherapy (AIT) is safe and effective for the treatment of allergic rhinitis and allergic asthma. However, patient non-compliance is a major barrier to achieving optimal outcomes Objective: To determine the level of compliance among patients using AIT and to identify factors associated with non-compliance Methods: A retrospective analysis using questionnaires was conducted to study compliance among 236 patients with allergic rhinitis with or without asthma who began AIT in 2009 or 2010 Results: The compliance rates at 3 y were 58.7% among patients on subcutaneous immunotherapy (SCIT) and 11.6% among those on sublingual immunotherapy (SLIT). The mean durations of treatment with SCIT and SLIT were 31 (+/-18.3) and 15.9 (+/-14.7) months, respectively. The most common causes of non-compliance among patients on SCIT were the frequency of injections (82.2%), the duration of treatment (70.9%), and commuting to the Allergy Center (67.7%). Reasons for non-compliance among patients on SLIT were related to inconvenience (43.4%), improvement without treatment (30.2%) and perception of poor efficacy (25.0%) Conclusion: Compliance with AIT is low, but at 3 years, it was higher among patients on SCIT than among patients on SLIT. Reasons for non-compliance include difficulty adjusting to treatment protocols and a perception that the efficacy is low. Patient education regarding the treatment course and the slow effect, as well as the need for close follow up to effectively prevent and treat adverse reactions, are important factors for improving compliance and treatment outcomes.

Comprehensive Study of Patients' Compliance with Sublingual Immunotherapy in House Dust Mite Perennial Allergic Rhinitis.

INTRODUCTION: Allergen immunotherapy is a long-term treatment that has been associated with patient adherence issues. The aim of the study was to increase the knowledge on compliance of patients allergic to house dust mites, receiving sublingual immunotherapy (SLIT). METHODS: A retrospective observational study was performed in 53 Spanish allergy units. We enrolled patients undergoing the SLIT treatment for house dust mites including a scheduled control visit 12 months after initiating the therapy. We conducted a comprehensive assessment of compliance using three methods. In the first step, an allergist evaluated the patients according to the results of an interview and the existing medical records. The subjects taking more than 80% of the overall prescription were defined as compliant. The remaining noncompliant patients were divided into groups taking less than 25%, 25-50%, and 50-80% of the prescribed SLIT. In the second stage, we conducted the Morisky-Green test. Finally, the noncompliant patients were asked to fill a self-report assessment form. Data were stratified into age groups. The potential factors affecting compliance were also investigated. RESULTS: Overall, 380 subjects participated in the study. The compliance rate was 79.7%, and the treatment discontinuation rate was 22.5%, while 66.8% of patients were adherent (both compliant and continuing with the treatment). The results showed that children were the most compliant and adolescents the least compliant (86.6% and 60.9%, respectively). The main reason for noncompliance was "forgetting some doses" in 31.0% of the children, 48.0% of the adolescents, and 53.2% of the adults. Compliance was associated with the following factors: age, number of annual control visits, and reduction in symptomatic medication. CONCLUSION: Our results showed that two out of three patients with house dust mite-induced allergic rhinitis adhered to the SLIT treatment. Multidisciplinary and integral solutions are needed to improve the compliance, with special attention paid to adolescents. FUNDING: Stallergenes Greer Spain.

Ranking in importance of allergen extract characteristics for sublingual immunotherapy by Italian specialists.

The efficacy of allergen immunotherapy (AIT) is well supported by evidence from trials and meta-analyses. However, its actual performance in daily practice may be diminished by several pitfalls, including inappropriate patient selection, and, especially, the use of allergen extracts of insufficient quality. We performed a survey, the Allergen Immunotherapy Decision Analysis, to evaluate which criteria specialists use to choose products for sublingual immunotherapy (SLIT) in adult patients suffering from allergic respiratory disease. We surveyed a total of 169 Italian allergists randomly chosen from a database belonging to a market research company (Lexis Ricerche, Milan, Italy). The survey was performed between October and November 2012 under the aegis of the European Center for Allergy Research Foundation and consisted of a questionnaire-based electronic survey prepared by a scientific board of 12 AIT experts. The questionnaire comprised two parts, the first of which contained 14 items to be ranked by each participant according to the importance assigned to each when choosing SLIT products. The physicians' rankings assigned major importance to the level of evidence-based validation of efficacy and safety, standardization of the product, efficacy based on personal experience, and defined content(s) of the major allergen(s) in micrograms. The results of this survey show that Italian allergists rank the quality-related characteristics of allergen extracts as highly important when choosing products for AIT. The allergists' preference for high-quality products should be addressed by regulatory agencies and by producers.