11 research outputs found

    International severe asthma registry (ISAR): Protocol for a global registry

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    Background: Severe asthma exerts a disproportionately heavy burden on patients and health care. Due to the heterogeneity of the severe asthma population, many patients need to be evaluated to understand the clinical features and outcomes of severe asthma in order to facilitate personalised and targeted care. The International Severe Asthma Registry (ISAR) is a multi-country registry project initiated to aid in this endeavour. Methods: ISAR is a multi-disciplinary initiative benefitting from the combined experience of the ISAR Steering Committee (ISC; comprising 47 clinicians and researchers across 29 countries, who have a special interest and/or experience in severe asthma management or establishment and maintenance of severe asthma registries) in collaboration with scientists and experts in database management and communication. Patients (=18 years old) receiving treatment according to the 2018 definitions of the Global Initiative for Asthma (GINA) Step 5 or uncontrolled on GINA Step 4 treatment will be included. Data will be collected on a core set of 95 variables identified using the Delphi method. Participating registries will agree to provide access to and share standardised anonymous patient-level data with ISAR. ISAR is a registered data source on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. ISAR's collaborators include Optimum Patient Care, the Respiratory Effectiveness Group (REG) and AstraZeneca. ISAR is overseen by the ISC, REG, the Anonymised Data Ethics and Protocol Transparency Committee and the ISAR operational committee, ensuring the conduct of ethical, clinically relevant research that brings value to all key stakeholders. Conclusions: ISAR aims to offer a rich source of real-life data for scientific research to understand and improve disease burden, treatment patterns and patient outcomes in severe asthma. Furthermore, the registry will provide an international platform for research collaboration in respiratory medicine, with the overarching aim of improving primary and secondary care of adults with severe asthma globally. © 2020 The Author(s)

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

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    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. © 2022 The Author

    Comparative effectiveness of Anti-IL5 and Anti-IgE biologic classes in patients with severe asthma eligible for both

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    Background: Patients with severe asthma may present with characteristics representing overlapping phenotypes, making them eligible for more than one class of biologic. Our aim was to describe the profile of adult patients with severe asthma eligible for both anti-IgE and anti-IL5/5R and to compare the effectiveness of both classes of treatment in real life. Methods: This was a prospective cohort study that included adult patients with severe asthma from 22 countries enrolled into the International Severe Asthma registry (ISAR) who were eligible for both anti-IgE and anti-IL5/5R. The effectiveness of anti-IgE and anti-IL5/5R was compared in a 1:1 matched cohort. Exacerbation rate was the primary effectiveness endpoint. Secondary endpoints included long-term-oral corticosteroid (LTOCS) use, asthma-related emergency room (ER) attendance, and hospital admissions. Results: In the matched analysis (n = 350/group), the mean annualized exacerbation rate decreased by 47.1% in the anti-IL5/5R group and 38.7% in the anti-IgE group. Patients treated with anti-IL5/5R were less likely to experience a future exacerbation (adjusted IRR 0.76; 95% CI 0.64, 0.89; p < 0.001) and experienced a greater reduction in mean LTOCS dose than those treated with anti-IgE (37.44% vs. 20.55% reduction; p = 0.023). There was some evidence to suggest that patients treated with anti-IL5/5R experienced fewer asthma-related hospitalizations (IRR 0.64; 95% CI 0.38, 1.08), but not ER visits (IRR 0.94, 95% CI 0.61, 1.43). Conclusions: In real life, both anti-IgE and anti-IL5/5R improve asthma outcomes in patients eligible for both biologic classes; however, anti-IL5/5R was superior in terms of reducing asthma exacerbations and LTOCS use. © 2023 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd

    Analysis of comorbidities and multimorbidity in adult patients in the International Severe Asthma Registry

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    9 páginasBackground: Investigation for the presence of asthma comorbidities is recommended by the Global Initiative for Asthma because their presence can complicate asthma management. Objective: To understand the prevalence and pattern of comorbidities and multimorbidity in adults with severe asthma and their association with asthma-related outcomes. Methods: This was a cross-sectional study using data from the International Severe Asthma Registry from 22 countries. A total of 30 comorbidities were identified and categorized a priori as any of the following: (1) potentially type 2–related comorbidities, (2) potentially oral corticosteroid (OCS)–related comorbidities, or (3) comorbidities mimicking or aggravating asthma. The association between comorbidities and asthma-related outcomes was investigated using multivariable models adjusted for country, age at enrollment, and sex (ie male or female). Results: Of the 11,821 patients, 69%, 67%, and 55% had at least 1 potentially type 2–related, potentially OCS-related, or mimicking or aggravating comorbidities, respectively; 57% had 3 or more comorbidities, and 33% had comorbidities in all 3 categories. Patients with allergic rhinitis, nasal polyposis, and chronic rhinosinusitis experienced 1.12 (P = .003), 1.16 (P < .001), and 1.29 times (P < .001) more exacerbations per year, respectively, than those without. Patients with nasal polyposis and chronic rhinosinusitis were 40% and 46% more likely (P < .001), respectively, to have received long-term (LT) OCS. All assessed potential OCS-related comorbidities (except obesity) were associated with a greater likelihood of LTOCS use (odds ratios [ORs]: 1.23-2.77) and, except for dyslipidemia, with a greater likelihood of uncontrolled asthma (ORs: 1.29-1.68). All mimicking or aggravating comorbidities assessed were associated with more exacerbations (1.24-1.68 times more), all (except bronchiectasis) with increased likelihood of uncontrolled asthma (ORs: 1.57-1.81), and all (except chronic obstructive pulmonary disease) with increased likelihood of LTOCS use (ORs: 1.37-1.57). A greater number of comorbidities was associated with worse outcomes. Conclusion: In a global study, comorbidity or multimorbidity is reported in most adults with severe asthma and is associated with poorer asthma-related outcomes. Clinical Trial Registration: The International Severe Asthma Registry database has ethical approval from the Anonymous Data Ethics Protocols and Transparency (ADEPT) committee (ADEPT0218) and is registered with the European Union Electronic Register of Post-Authorization Studies (European Network Centres for Pharmacoepidemiology and Pharmacovigilance [ENCEPP]/DSPP/23720). The study was designed, implemented, and reported in compliance with the European Network Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) Code of Conduct (EMA 2014; EUPAS44024) and with all applicable local and international laws and regulations, and registered with ENCEPP (https://www.encepp.eu/encepp/viewResource.htm?id=48848). Governance was provided by ADEPT (registration number: ADEPT1121). © 2023 The AuthorsEl aprendizaje de la medicina utilizando recursos de las humanidades es un proceso complejo que requiere de estrategias pedagógicas que eviten la fragmentación y la paradoja de la transferencia. La aplicación del diseño pedagógico con estos propósitos en la educación en cirugía, ha sido limitada. Objetivos. Presentar los resultados de una estrategia pedagógica para integrar la enseñanza de la cirugía con las humanidades con base en el modelo teórico de aprendizaje cognitivo, y evaluar su asociación con las percepciones de los estudiantes en torno al aprendizaje. Materiales y métodos. Se desarrolló un diseño pedagógico para la enseñanza de condiciones clínicas en cirugía utilizando recursos de las humanidades médicas. Se evaluaron las percepciones estudiantiles en torno al soporte y la articulación ofrecidos por los profesores para la integración de ambas disciplinas, así como en torno a su propio aprendizaje mediante cuestionarios validados. Se utilizaron modelos de regresión lineal para evaluar la asociación propuesta. Resultados. Se incluyeron 216 estudiantes en el análisis y se obtuvieron altos promedios en cada una de las variables. Por cada unidad adicional atribuida al soporte y la articulación desplegadas por los profesores para integrar ambas disciplinas, la percepción del aprendizaje (b) aumentó en 0,45 (IC95% 30-0,60) y en 0,40 (IC95% 25-55) (coeficiente de determinación múltiple -R2=0,64, p &lt; 0,001), respectivamente. Conclusiones. Las estrategias educativas centradas en las técnicas de soporte y articulación orientadas a integrar las humanidades médicas y la cirugía en el proceso de enseñanza, se asociaron positivamente con las percepciones de los estudiantes sobre el aprendizaje. Se requieren nuevos estudios que evalúen los efectos de estas intervenciones en el aprendizaje y la memoria a largo plazo. © 2019, Instituto Nacional de Salud

    Management of anaphylaxis due to COVID-19 vaccines in the elderly

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    Older adults, especially men and/or those with diabetes, hypertension, and/or obesity, are prone to severe COVID-19. In some countries, older adults, particularly those residing in nursing homes, have been prioritized to receive COVID-19 vaccines due to high risk of death. In very rare instances, the COVID-19 vaccines can induce anaphylaxis, and the management of anaphylaxis in older people should be considered carefully. An ARIA-EAACI-EuGMS (Allergic Rhinitis and its Impact on Asthma, European Academy of Allergy and Clinical Immunology, and European Geriatric Medicine Society) Working Group has proposed some recommendations for older adults receiving the COVID-19 vaccines. Anaphylaxis to COVID-19 vaccines is extremely rare (from 1 per 100,000 to 5 per million injections). Symptoms are similar in younger and older adults but they tend to be more severe in the older patients. Adrenaline is the mainstay treatment and should be readily available. A flowchart is proposed to manage anaphylaxis in the older patients. © 2021 EAACI and John Wiley and Sons A/S. Published by John Wiley and Sons Ltd

    Management of anaphylaxis due to COVID-19 vaccines in the elderly

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    none149siOlder adults, especially men and/or those with diabetes, hypertension, and/or obesity, are prone to severe COVID-19. In some countries, older adults, particularly those residing in nursing homes, have been prioritized to receive COVID-19 vaccines due to high risk of death. In very rare instances, the COVID-19 vaccines can induce anaphylaxis, and the management of anaphylaxis in older people should be considered carefully. An ARIA-EAACI-EuGMS (Allergic Rhinitis and its Impact on Asthma, European Academy of Allergy and Clinical Immunology, and European Geriatric Medicine Society) Working Group has proposed some recommendations for older adults receiving the COVID-19 vaccines. Anaphylaxis to COVID-19 vaccines is extremely rare (from 1 per 100,000 to 5 per million injections). Symptoms are similar in younger and older adults but they tend to be more severe in the older patients. Adrenaline is the mainstay treatment and should be readily available. A flowchart is proposed to manage anaphylaxis in the older patients.noneBousquet J.; Agache I.; Blain H.; Jutel M.; Ventura M.T.; Worm M.; Del Giacco S.; Benetos A.; Bilo B.M.; Czarlewski W.; Abdul Latiff A.H.; Al-Ahmad M.; Angier E.; Annesi-Maesano I.; Atanaskovic-Markovic M.; Bachert C.; Barbaud A.; Bedbrook A.; Bennoor K.S.; Berghea E.C.; Bindslev-Jensen C.; Bonini S.; Bosnic-Anticevich S.; Brockow K.; Brussino L.; Camargos P.; Canonica G.W.; Cardona V.; Carreiro-Martins P.; Carriazo A.; Casale T.; Caubet J.-C.; Cecchi L.; Cherubini A.; Christoff G.; Chu D.K.; Cruz A.A.; Dokic D.; El-Gamal Y.; Ebisawa M.; Eberlein B.; Farrell J.; Fernandez-Rivas M.; Fokkens W.J.; Fonseca J.A.; Gao Y.; Gavazzi G.; Gawlik R.; Gelincik A.; Gemicioglu B.; Gotua M.; Guerin O.; Haahtela T.; Hoffmann-Sommergruber K.; Hoffmann H.J.; Hofmann M.; Hrubisko M.; Illario M.; Irani C.; Ispayeva Z.; Ivancevich J.C.; Julge K.; Kaidashev I.; Khaitov M.; Knol E.; Kraxner H.; Kuna P.; Kvedariene V.; Lauerma A.; Le L.T.T.; Le Moing V.; Levin M.; Louis R.; Lourenco O.; Mahler V.; Martin F.C.; Matucci A.; Milenkovic B.; Miot S.; Montella E.; Morais-Almeida M.; Mortz C.G.; Mullol J.; Namazova-Baranova L.; Neffen H.; Nekam K.; Niedoszytko M.; Odemyr M.; O'Hehir R.E.; Okamoto Y.; Ollert M.; Palomares O.; Papadopoulos N.G.; Panzner P.; Passalacqua G.; Patella V.; Petrovic M.; Pfaar O.; Pham-Thi N.; Plavec D.; Popov T.A.; Recto M.T.; Regateiro F.S.; Reynes J.; Roller-Winsberger R.E.; Rolland Y.; Romano A.; Rondon C.; Rottem M.; Rouadi P.W.; Salles N.; Samolinski B.; Santos A.F.; S Sarquis F.; Sastre J.; M. G. A. Schols J.; Scichilone N.; Sediva A.; Shamji M.H.; Sheikh A.; Skypala I.; Smolinska S.; Sokolowska M.; Sousa-Pinto B.; Sova M.; Stelmach R.; Sturm G.; Suppli Ulrik C.; Todo-Bom A.M.; Toppila-Salmi S.; Tsiligianni I.; Torres M.; Untersmayr E.; Urrutia Pereira M.; Valiulis A.; Vitte J.; Vultaggio A.; Wallace D.; Walusiak-Skorupa J.; Wang D.-Y.; Waserman S.; Yorgancioglu A.; Yusuf O.M.; Zernotti M.; Zidarn M.; Chivato T.; Akdis C.A.; Zuberbier T.; Klimek L.Bousquet, J.; Agache, I.; Blain, H.; Jutel, M.; Ventura, M. T.; Worm, M.; Del Giacco, S.; Benetos, A.; Bilo, B. M.; Czarlewski, W.; Abdul Latiff, A. H.; Al-Ahmad, M.; Angier, E.; Annesi-Maesano, I.; Atanaskovic-Markovic, M.; Bachert, C.; Barbaud, A.; Bedbrook, A.; Bennoor, K. S.; Berghea, E. C.; Bindslev-Jensen, C.; Bonini, S.; Bosnic-Anticevich, S.; Brockow, K.; Brussino, L.; Camargos, P.; Canonica, G. W.; Cardona, V.; Carreiro-Martins, P.; Carriazo, A.; Casale, T.; Caubet, J. -C.; Cecchi, L.; Cherubini, A.; Christoff, G.; Chu, D. K.; Cruz, A. A.; Dokic, D.; El-Gamal, Y.; Ebisawa, M.; Eberlein, B.; Farrell, J.; Fernandez-Rivas, M.; Fokkens, W. J.; Fonseca, J. A.; Gao, Y.; Gavazzi, G.; Gawlik, R.; Gelincik, A.; Gemicioglu, B.; Gotua, M.; Guerin, O.; Haahtela, T.; Hoffmann-Sommergruber, K.; Hoffmann, H. J.; Hofmann, M.; Hrubisko, M.; Illario, M.; Irani, C.; Ispayeva, Z.; Ivancevich, J. C.; Julge, K.; Kaidashev, I.; Khaitov, M.; Knol, E.; Kraxner, H.; Kuna, P.; Kvedariene, V.; Lauerma, A.; L. T. T., Le; Le Moing, V.; Levin, M.; Louis, R.; Lourenco, O.; Mahler, V.; Martin, F. C.; Matucci, A.; Milenkovic, B.; Miot, S.; Montella, E.; Morais-Almeida, M.; Mortz, C. G.; Mullol, J.; Namazova-Baranova, L.; Neffen, H.; Nekam, K.; Niedoszytko, M.; Odemyr, M.; O'Hehir, R. E.; Okamoto, Y.; Ollert, M.; Palomares, O.; Papadopoulos, N. G.; Panzner, P.; Passalacqua, G.; Patella, V.; Petrovic, M.; Pfaar, O.; Pham-Thi, N.; Plavec, D.; Popov, T. A.; Recto, M. T.; Regateiro, F. S.; Reynes, J.; Roller-Winsberger, R. E.; Rolland, Y.; Romano, A.; Rondon, C.; Rottem, M.; Rouadi, P. W.; Salles, N.; Samolinski, B.; Santos, A. F.; S Sarquis, F.; Sastre, J.; M. G. A. Schols J., ; Scichilone, N.; Sediva, A.; Shamji, M. H.; Sheikh, A.; Skypala, I.; Smolinska, S.; Sokolowska, M.; Sousa-Pinto, B.; Sova, M.; Stelmach, R.; Sturm, G.; Suppli Ulrik, C.; Todo-Bom, A. M.; Toppila-Salmi, S.; Tsiligianni, I.; Torres, M.; Untersmayr, E.; Urrutia Pereira, M.; Valiulis, A.; Vitte, J.; Vultaggio, A.; Wallace, D.; Walusiak-Skorupa, J.; Wang, D. -Y.; Waserman, S.; Yorgancioglu, A.; Yusuf, O. M.; Zernotti, M.; Zidarn, M.; Chivato, T.; Akdis, C. A.; Zuberbier, T.; Klimek, L

    Adherence to treatment in allergic rhinitis using mobile technology. The MASK Study

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    Background: Mobile technology may help to better understand the adherence to treatment. MASK-rhinitis (Mobile Airways Sentinel NetworK for allergic rhinitis) is a patient-centred ICT system. A mobile phone app (the Allergy Diary) central to MASK is available in 22 countries.Objectives: To assess the adherence to treatment in allergic rhinitis patients using the Allergy Diary App.Methods: An observational cross-sectional study was carried out on all users who filled in the Allergy Diary from 1 January 2016 to 1 August 2017. Secondary adherence was assessed by using the modified Medication Possession Ratio (MPR) and the Proportion of days covered (PDC) approach.Results: A total of 12143 users were registered. A total of 6949 users reported at least one VAS data recording. Among them, 1887 users reported >= 7 VAS data. About 1195 subjects were included in the analysis of adherence. One hundred and thirty-six (11.28%) users were adherent (MPR >= 70% and PDC = 70% and PDC = 1.50) and 176 (14.60%) were switchers. On the other hand, 832 (69.05%) users were non-adherent to medications (MPR <70%). Of those, the largest group was non-adherent to medications and the time interval was increased in 442 (36.68%) users.Conclusion and clinical relevance: Adherence to treatment is low. The relative efficacy of continuous vs on-demand treatment for allergic rhinitis symptoms is still a matter of debate. This study shows an approach for measuring retrospective adherence based on a mobile app. This also represents a novel approach for analysing medication-taking behaviour in a real-world setting.Public Health and primary carePrevention, Population and Disease management (PrePoD

    Allergic Rhinitis and its Impact on Asthma (ARIA) Phase 4 (2018): Change management in allergic rhinitis and asthma multimorbidity using mobile technology

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    Allergic Rhinitis and its Impact on Asthma (ARIA) has evolved from a guideline by using the best approach to integrated care pathways using mobile technology in patients with allergic rhinitis (AR) and asthma multimorbidity. The proposed next phase of ARIA is change management, with the aim of providing an active and healthy life to patients with rhinitis and to those with asthma multimorbidity across the lifecycle irrespective of their sex or socioeconomic status to reduce health and social inequities incurred by the disease. ARIA has followed the 8-step model of Kotter to assess and implement the effect of rhinitis on asthma multimorbidity and to propose multimorbid guidelines. A second change management strategy is proposed by ARIA Phase 4 to increase self-medication and shared decision making in rhinitis and asthma multimorbidity. An innovation of ARIA has been the development and validation of information technology evidence-based tools (Mobile Airways Sentinel Network [MASK]) that can inform patient decisions on the basis of a self-care plan proposed by the health care professional.Public Health and primary carePrevention, Population and Disease management (PrePoD

    Rhinitis associated with asthma is distinct from rhinitis alone : The ARIA-MeDALL hypothesis

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    Asthma, rhinitis, and atopic dermatitis (AD) are interrelated clinical phenotypes that partly overlap in the human interactome. The concept of "one-airway-one-disease," coined over 20 years ago, is a simplistic approach of the links between upper- and lower-airway allergic diseases. With new data, it is time to reassess the concept. This article reviews (i) the clinical observations that led to Allergic Rhinitis and its Impact on Asthma (ARIA), (ii) new insights into polysensitization and multimorbidity, (iii) advances in mHealth for novel phenotype definitions, (iv) confirmation in canonical epidemiologic studies, (v) genomic findings, (vi) treatment approaches, and (vii) novel concepts on the onset of rhinitis and multimorbidity. One recent concept, bringing together upper- and lower-airway allergic diseases with skin, gut, and neuropsychiatric multimorbidities, is the "Epithelial Barrier Hypothesis." This review determined that the "one-airway-one-disease" concept does not always hold true and that several phenotypes of disease can be defined. These phenotypes include an extreme "allergic" (asthma) phenotype combining asthma, rhinitis, and conjunctivitis. Rhinitis alone and rhinitis and asthma multimorbidity represent two distinct diseases with the following differences: (i) genomic and transcriptomic background (Toll-Like Receptors and IL-17 for rhinitis alone as a local disease; IL-33 and IL-5 for allergic and non-allergic multimorbidity as a systemic disease), (ii) allergen sensitization patterns (mono- or pauci-sensitization versus polysensitization), (iii) severity of symptoms, and (iv) treatment response. In conclusion, rhinitis alone (local disease) and rhinitis with asthma multimorbidity (systemic disease) should be considered as two distinct diseases, possibly modulated by the microbiome, and may be a model for understanding the epidemics of chronic and autoimmune diseases.Peer reviewe
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