Severe Asthma Standard-of-Care Background Medication Reduction With Benralizumab: ANDHI in Practice Substudy

peer reviewedBackground: The phase IIIb, randomized, parallel-group, placebo-controlled ANDHI double-blind (DB) study extended understanding of the efficacy of benralizumab for patients with severe eosinophilic asthma. Patients from ANDHI DB could join the 56-week ANDHI in Practice (IP) single-arm, open-label extension substudy. Objective: Assess potential for standard-of-care background medication reductions while maintaining asthma control with benralizumab. Methods: Following ANDHI DB completion, eligible adults were enrolled in ANDHI IP. After an 8-week run-in with benralizumab, there were 5 visits to potentially reduce background asthma medications for patients achieving and maintaining protocol-defined asthma control with benralizumab. Main outcome measures for non–oral corticosteroid (OCS)-dependent patients were the proportions with at least 1 background medication reduction (ie, lower inhaled corticosteroid dose, background medication discontinuation) and the number of adapted Global Initiative for Asthma (GINA) step reductions at end of treatment (EOT). Main outcomes for OCS-dependent patients were reductions in daily OCS dosage and proportion achieving OCS dosage of 5 mg or lower at EOT. Results: For non–OCS-dependent patients, 53.3% (n = 208 of 390) achieved at least 1 background medication reduction, increasing to 72.6% (n = 130 of 179) for patients who maintained protocol-defined asthma control at EOT. A total of 41.9% (n = 163 of 389) achieved at least 1 adapted GINA step reduction, increasing to 61.8% (n = 110 of 178) for patients with protocol-defined EOT asthma control. At ANDHI IP baseline, OCS dosages were 5 mg or lower for 40.4% (n = 40 of 99) of OCS-dependent patients. Of OCS-dependent patients, 50.5% (n = 50 of 99) eliminated OCS and 74.7% (n = 74 of 99) achieved dosages of 5 mg or lower at EOT. Conclusions: These findings demonstrate benralizumab's ability to improve asthma control, thereby allowing background medication reduction. © 202

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

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