Global Variability in Administrative Approval Prescription Criteria for Biologic Therapy in Severe Asthma.

BACKGROUND: Regulatory bodies have approved five biologics for severe asthma. However, regional differences in accessibility may limit the global potential for personalized medicine. OBJECTIVE: To compare global differences in ease of access to biologics. METHODS: In April 2021, national prescription criteria for omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab were reviewed by severe asthma experts collaborating in the International Severe Asthma Registry. Outcomes (per country, per biologic) were (1) country-specific prescription criteria and (2) development of the Biologic Accessibility Score (BACS). The BACS composite score incorporates 10 prescription criteria, each with a maximum score of 10 points. Referenced to European Medicines Agency marketing authorization specifications, a higher score reflects easier access. RESULTS: Biologic prescription criteria differed substantially across 28 countries from five continents. Blood eosinophil count thresholds (usually ≥300 cells/µL) and exacerbations were key requirements for anti-IgE/anti-IL-5/5R prescriptions in around 80% of licensed countries. Most countries (40% for dupilumab to 54% for mepolizumab) require two or more moderate or severe exacerbations, whereas numbers ranged from none to four. Moreover, 0% (for reslizumab) to 21% (for omalizumab) of countries required long-term oral corticosteroid use. The BACS highlighted marked between-country differences in ease of access. For omalizumab, mepolizumab, benralizumab, and dupilumab, only two, one, four, and seven countries, respectively, scored equal or higher than the European Medicines Agency reference BACS. For reslizumab, all countries scored lower. CONCLUSIONS: Although some differences were expected in country-specific biologic prescription criteria and ease of access, the substantial differences found in the current study present a challenge to implementing precision medicine across the world.

Responders and nonresponders to pharmacotherapy and allergen immunotherapy.

Allergen immunotherapy (AIT) is a very useful therapy for allergic rhinitis. However, some patients do not achieve the expected results. The aim of the study was to investigate the potential factors that could affect the result, either good or poor, from AIT.Methods: A retrospective analysis of 1624 patients with allergic rhinitis who underwent AIT and 1519 matched patients who underwent only symptomatic therapy (without AIT) was performed. Symptoms, medications scores and quality of life related to allergic diseases before and after therapy were recorded. Cluster analysis on all of the patients was performed to find any associations between responsiveness to therapy and the analyzed parameters. Responsiveness to therapy was assessed by the Mailing criteria.Results: A total of 1266 (77.8%) patients from the AIT group met the criterion of 30% or greater improvement, and 1061 (65.2%) of these patients met the threshold of 60% or greater improvement according to the Mailing criteria. Patients who had a frequently better response to AIT were highly represented in the two clusters. There were subjects with a short history of allergic rhinitis and concomitant allergy to grass pollen or house dust mites. Patients with a prolonged duration of allergic rhinitis before therapy and with polysensitization were more frequently worse responders to AIT.Conclusion: Responsiveness to therapy, including that to AIT, is difficult to assess. However, there were associations suggesting that short-term allergic rhinitis and monovalent allergies to grass pollen or mites could correspond to a better response to AIT.

International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis.

BACKGROUND: Critical examination of the quality and validity of available allergic rhinitis (AR) literature is necessary to improve understanding and to appropriately translate this knowledge to clinical care of the AR patient. To evaluate the existing AR literature, international multidisciplinary experts with an interest in AR have produced the International Consensus statement on Allergy and Rhinology: Allergic Rhinitis (ICAR:AR). METHODS: Using previously described methodology, specific topics were developed relating to AR. Each topic was assigned a literature review, evidence-based review (EBR), or evidence-based review with recommendations (EBRR) format as dictated by available evidence and purpose within the ICAR:AR document. Following iterative reviews of each topic, the ICAR:AR document was synthesized and reviewed by all authors for consensus. RESULTS: The ICAR:AR document addresses over 100 individual topics related to AR, including diagnosis, pathophysiology, epidemiology, disease burden, risk factors for the development of AR, allergy testing modalities, treatment, and other conditions/comorbidities associated with AR. CONCLUSION: This critical review of the AR literature has identified several strengths; providers can be confident that treatment decisions are supported by rigorous studies. However, there are also substantial gaps in the AR literature. These knowledge gaps should be viewed as opportunities for improvement, as often the things that we teach and the medicine that we practice are not based on the best quality evidence. This document aims to highlight the strengths and weaknesses of the AR literature to identify areas for future AR research and improved understanding.

SQ grass sublingual allergy immunotherapy tablet for disease-modifying treatment of grass pollen allergic rhinoconjunctivitis.

BACKGROUND: Allergy immunotherapy is a treatment option for allergic rhinoconjunctivitis (ARC). It is unique compared with pharmacotherapy in that it modifies the immunologic pathways that elicit an allergic response. The SQ Timothy grass sublingual immunotherapy (SLIT) tablet is approved in North America and throughout Europe for the treatment of adults and children (≥5 years old) with grass pollen-induced ARC. OBJECTIVE: The clinical evidence for the use of SQ grass SLIT-tablet as a disease-modifying treatment for grass pollen ARC is discussed in this review. METHODS: The review included the suitability of SQ grass SLIT-tablet for patients with clinically relevant symptoms to multiple Pooideae grass species, single-season efficacy, safety, adherence, coseasonal initiation, and cost-effectiveness. The data from the long-term SQ grass SLIT-tablet clinical trial that evaluated a clinical effect 2 years after a continuous 3-year treatment period were presented in the context of regulatory criteria that define a clinically meaningful effect. RESULTS: This trial demonstrated that the clinical effect of the SQ grass SLIT-tablet is maintained, which is also supported by the immunologic findings. CONCLUSION: Therefore, the SQ grass SLIT-tablet has an indication as a disease-modifying therapy in Europe, and a sustained effect is recognized in the United States.

360 degree perspective on allergic rhinitis management in Italy: a survey of GPs, pharmacists and patients.

BACKGROUND: General practitioners (GPs), community pharmacists and allergic rhinitis (AR) patients in Italy were surveyed in order to gain insight from all three perspectives into the diagnosis, management and burden of AR in Italy. METHODS: General practitioners and pharmacists (n = 100 for each) were surveyed by telephone; questions related to overall practice and to last AR patient seen. Patients (n = 552) completed a questionnaire after visiting specialist allergy centres. Questions related to diagnosis and treatment, degree of everyday limitation from AR, and satisfaction with treatment. The data were analysed descriptively. RESULTS: Allergic rhinitis was managed mainly by GPs, who reported making the diagnosis themselves in 68 % of cases; rhinorrhea (64 %), sneezing (57 %) and congestion (49 %) were the symptoms most frequently taken into account. Limitation from AR on everyday life was rated 6.2 out of 10 by GPs. Pharmacists most often considered eye tearing (54 %) in their diagnosis. Almost half of GPs (49 %) and 87 % of pharmacists were unaware of the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines. The most commonly reported prescribed treatments by GPs were branded mometasone furoate, desloratadine, ebastine and generic mometasone; 21 % prescribed homeopathic products occasionally. On average, GPs remembered that their last patient case had moderate/severe disease, was prescribed anti-histamine monotherapy (37 % of cases), and did not change prescription (78 %). Pharmacists recommended an antihistamine for 56 % of clients who asked for advice, and a nasal decongestant for 21 %. Patients rated limitation from AR on everyday life as 5.7/10. 55 % reported using multiple therapies, and 43 % were not satisfied or weakly satisfied with their current treatment. Patients' main expectation for the future was to succeed in managing their AR symptoms (45 %), while 22 % hoped for a definitive cure. Many patients (61 %) were concerned their health would deteriorate. CONCLUSIONS: Allergic rhinitis is largely managed by GPs in Italy, with pharmacists also playing a role, yet awareness of the ARIA guidelines among these groups is low. Patient satisfaction with treatment is moderate or low. New more effective treatments are needed to improve AR management in Italy. Allergy education programs need to be better targeted to GPs and pharmacists, and communication with patients regarding symptom control must be improved.

Aerobiological diagnosis of respiratory allergy by a personal sampler: two case reports.

We describe two cases of respiratory allergy (asthma), which were difficult to diagnosis from an etiological viewpoint. The routine diagnostic tests were not able to determine the causal allergens, although the clinical history suggested that allergens were confined to restricted environments. Therefore, an aerobiological sampling by means of a battery-powered portable device was carried out. This approach allowed identification of the responsible allergens, which were Alternaria spores in one case and thuja pollen in the other. Once a targeted environmental care had been performed, the patients' symptoms rapidly improved and antiasthma therapy could be stepped down or discontinued. We suggest that, in selected cases of difficult diagnosis the presence of proximity allergens is suspected, aerobiological sampling with a portable device should be considered.