Adding tiotropium or long-acting ß2-agonists to inhaled corticosteroids: Asthma-related exacerbation risk and healthcare resource utilization.

Background: Based on current clinical guidelines, long-acting ß2-agonists (LABA) are frequently prescribed before long-acting muscarinic antagonists (LAMA) as an add-on to inhaled corticosteroids (ICS) in uncontrolled asthma. However, there is insufficient real-world evidence that supports this therapeutic approach. Objective: The objective was to compare asthma exacerbations and healthcare resource utilization in patients with asthma using the LAMA tiotropium bromide (Tio) or a LABA as an add-on to ICS (ICS + Tio or ICS/LABA) in a real-world setting. Methods: This retrospective, observational study included patients aged ≥12 years with asthma diagnoses identified in a U.S. longitudinal claims database (October 2015 to August 2020). The ICS + Tio and ICS/LABA cohorts were 1:2 propensity score matched for baseline variables. Outcomes were compared in the postmatched cohorts, and the risk of exacerbation was evaluated by using Kaplan-Meier curves. Results: After propensity score matching, there were 633 and 1266 patients in the ICS + Tio and ICS/LABA cohorts, respectively. The proportion of patients who experienced a severe or a moderate-or-severe exacerbation during follow-up was similar between the ICS + Tio versus ICS/LABA cohorts (4% versus 3%, p = 0.472, and 50% versus 45%, p = 0.050, respectively). The mean time to first severe (ICS + Tio 43.8 days versus ICS/LABA 49.4 days, p = 0.758) and moderate-or-severe exacerbation (ICS + Tio 65.8 days versus ICS/LABA 58.9 days, p = 0.474) was not statistically different between cohorts. The treatments had no effect on the risk of severe exacerbation, although it was 36% lower in ICS + Tio users than in ICS/LABA users (hazard ratio 0.64 [95% confidence interval, 0.22-1.84]). All-cause and asthma-related average monthly healthcare resource utilization were comparable between the treatments for hospitalizations and emergency department visits but were significantly greater in the ICS + Tio cohort than in the ICS/LABA cohort for asthma-related outpatient visits (p < 0.0001). Conclusion: This study provides real-world evidence that ICS + Tio may be a valid alternative when ICS/LABA cannot be used as first-line treatment for asthma maintenance therapy.

Proposed solutions by the American College of Allergy, Asthma, and Immunology and advocacy experts to address racial disparities in atopic dermatitis and food allergy.

Atopic dermatitis (AD) and food allergies are more prevalent and more severe in people with skin of color than White individuals. The American College of Allergy, Asthma, and Immunology (ACAAI) sought to understand the effects of racial disparities among patients with skin of color with AD and food allergies. The ACAAI surveyed its members (N = 200 completed), conducted interviews with health care providers and advocacy leaders, and hosted a roundtable to explore the challenges of diagnosis and management of AD and food allergies in people with skin of color and to discuss potential solutions. Most of the survey respondents (68%) agreed that racial disparities make it difficult for people with skin of color to receive adequate treatment for AD and food allergies. The interviews and roundtable identified access to care, burden of costs, policies and infrastructure that limit access to safe foods and patient education, and inadequate research involving people with skin of color as obstacles to care. Proposed solutions included identifying ways to recruit more people with skin of color into clinical trials and medical school, educating health care providers about diagnosis and treating AD and food allergy in people with skin of color, improving access to safe foods, creating and disseminating culturally appropriate materials for patients, and working toward longer appointment times for patients who need them. Challenges in AD and food allergy in persons with skin of color were identified by the ACAAI members. Solutions to these challenges were proposed to inspire actions to mitigate racial disparities in AD and food allergy.

Optimizing asthma management: Role of long-acting muscarinic antagonists.

Patients with asthma who are suboptimally responsive to inhaled corticosteroids (ICS) and long-acting ß2-agonists (LABAs) are frequently exposed to oral corticosteroids and high-dose ICS, which can lead to significant side effects. Long-acting muscarinic antagonists (LAMAs) have demonstrated efficacy and safety in a subset of these patients. This review summarizes the results of key studies using LAMAs in patients with asthma aged 12 years or older. LAMA as an add-on treatment improved lung function and asthma control in patients with uncontrolled asthma across studies. The efficacy of LAMAs as an add-on to ICS was superior to that of placebo and ICS dose escalation and comparable with that of LABAs. LAMA plus ICS plus LABA provided modest improvements in bronchodilation and increased the time to first severe exacerbation versus ICS plus LABA. Single-inhaler triple therapy was associated with decreased health care resource utilization and improved cost-effectiveness versus multiple inhalers. LAMAs were generally well tolerated; asthma exacerbations, bronchitis, and nasopharyngitis were common adverse events with LAMA in combination with ICS alone or ICS plus LABA. Thus, the overall evidence presented in this review supports the use of add-on LAMA treatment as a reasonable option in patients with asthma uncontrolled with ICS plus LABA or ICS alone.

The Role of Physician Advocacy in Achieving Health Equity: Where Is the Allergist-Immunologist?

As allergists and immunologists many of us have likely worked in the capacity of being an advocate for individual patients. However, how many of us are aware of our ability to be effective advocates who address root causes of health issues through policy changes? Physician advocacy is not a core competency medical specialty training (except pediatrics), yet physicians' clinical and research expertise and professional experience can be leveraged to shape policy. This rostrum describes the spectrum of activities for a physician advocate, barriers to physician advocacy, and actionable steps to encouraging the training and expansion of advocacy efforts by allergists and immunologists.

Health disparities in allergic and immunologic conditions in racial and ethnic underserved populations: A Work Group Report of the AAAAI Committee on the Underserved.

Health disparities are health differences linked with economic, social, and environmental disadvantage. They adversely affect groups that have systematically experienced greater social or economic obstacles to health. Renewed efforts are needed to reduced health disparities in the United States, highlighted by the disparate impact on racial minorities during the coronavirus pandemic. Institutional or systemic patterns of racism are promoted and legitimated through accepted societal standards, and organizational processes within the field of medicine, and contribute to health disparities. Herein, we review current evidence regarding health disparities in allergic rhinitis, asthma, atopic dermatitis, food allergy, drug allergy, and primary immune deficiency disease in racial and ethnic underserved populations. Best practices to address these disparities involve addressing social determinants of health and adopting policies to improve access to specialty care and treatment for the underserved through telemedicine and community partnerships, cross-cultural provider training to reduce implicit bias, inclusion of underserved patients in research, implementation of culturally competent patient education, and recruitment and training of health care providers from underserved communities. Addressing health disparities requires a multilevel approach involving patients, health providers, local agencies, professional societies, and national governmental agencies.

Safety of tiotropium Respimat® in black or African-American patients with symptomatic asthma.

BACKGROUND: Black patients with asthma have a higher disease burden and greater morbidity compared with other racial/ethnic groups. Tiotropium Respimat®, as add-on to at least inhaled corticosteroids (ICS), improves lung function and asthma control and reduces asthma exacerbation risk in patients, with a safety profile comparable with placebo. This study aimed to assess the safety of tiotropium Respimat®, compared with placebo, in black or African-American patients. METHODS: Data were pooled from 12 randomized, placebo-controlled, parallel-group, Phase II or III trials from the global Boehringer Ingelheim program with once-daily tiotropium Respimat® (5 µg or 2.5 µg). Trial participants had symptomatic persistent asthma with a broad range of severities and were aged 1-75 years. The safety results of black or African-American patients were compared with the overall trial population. RESULTS: Of the 5165 patients treated with tiotropium or placebo, 3.2% were black or African American. For both doses of tiotropium, the proportion of patients reporting adverse events (AEs) was approximately 10% lower compared with placebo and was generally comparable with the proportion of patients reporting AEs in all groups of the overall population. The number of investigator-assessed drug-related AEs, AEs leading to trial drug discontinuation or serious AEs reported by patients was low and comparable between treatment groups and with the overall population. CONCLUSION: Tiotropium Respimat® appears to be a generally safe add-on bronchodilator treatment option to ICS with or without other controllers in pediatric and adult black or African-American patients with asthma. CLINICAL TRIAL IDENTIFIERS: NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538, NCT00776984.

Guiding principles for use of newer biologics and bronchial thermoplasty for patients with severe asthma.

BACKGROUND: Severe asthma poses significant disease-related and economic burdens in the United States. Challenges in practice include how to define "severe asthma" for a given patient, knowing which are the right tests to perform and when, and having a better understanding of a patient's asthma phenotype. Furthermore, current guidelines do not address a clear, practical approach to treatment that is based on a patient's asthma phenotype. OBJECTIVE: To develop a consensus on the definition of severe asthma, the role of biomarkers and phenotyping severe asthma, and the use of newer biologic therapies and bronchial thermoplasty to help guide practicing clinicians. METHODS: A roundtable meeting was convened with a panel of severe asthma experts to discuss areas in practice that are not adequately addressed by current guidelines, specifically phenotype-guided treatment. RESULTS: We describe a consensus on the definition of severe asthma, asthma phenotyping with the use of available biomarkers, and guiding principles for newer biologic therapies and bronchial thermoplasty. CONCLUSION: To optimize therapy and improve outcomes such as daily symptoms, quality of life, exacerbations, and hospitalizations, a clear picture of a patient's asthma phenotype is needed to guide therapy. Determining asthma phenotypes is the foundation of precision medicine for this persistent, often difficult-to-treat disease.

Accountable care organizations and the allergist: challenges and opportunities.

For decades, health care policy experts have wrestled with ways to solve problems of access, cost, and quality in US health care. The current consensus is that the solution to all three lies in changing financial incentives for providers and delivering care through integrated systems. The currently favored vehicle for this, both in the public and private sectors, is through Accountable Care Organizations (ACOs). Medicare has several models and has fostered rapid growth in the number of operative ACOs. At least an equal number of private ACOs are in operation. Whether or not these organizations will fulfill their promise is unknown but there is reason for cautious optimism. Allergists can and should be part of the process of this transformation in our health care system. They can be integral to helping these organizations save money by reducing hospitalizations and improving the quality of allergy and asthma care in the populations served. In order to accomplish this, allergists must become more involved in their medical communities and hospitals.

Mediators of asthma outcomes.

BACKGROUND: Patient adherence, the level of asthma self-management skills, exposure to stress, and depression can have considerable influence on a wide range of asthma outcomes and thus are considered asthma outcome mediators. OBJECTIVE: National Institutes of Health institutes and other federal agencies convened an expert group to recommend standardized measures for 7 domains of asthma clinical research outcomes measures. Although the review of mediators of these outcomes was not within the scope of any specific outcome topic, a brief summary is presented so that researchers might consider potential mediators. METHODS: We prepared a summary of key mediators of asthma outcomes based on expertise and knowledge of the literature. RESULTS: The rationale for including measures of adherence, self-management skills, and exposures to stress in asthma clinical research is presented, along with a brief review of instruments for collecting this information from clinical research participants. CONCLUSIONS: Appropriate measurement of adherence, self-management skills, and exposures to stress will enhance characterization of study participants and provide information about the potential impact these factors can have on mediating the effects of treatment interventions.

Asthma outcomes: quality of life.

BACKGROUND: "Asthma-related quality of life" (QOL) refers to the perceived impact that asthma has on the patient's QOL. OBJECTIVE: National Institutes of Health institutes and other federal agencies convened an expert group to recommend standardized measures of the impact of asthma on QOL for use in future asthma clinical research. METHODS: We reviewed published documentation regarding the development and psychometric evaluation; clinical research use since 2000; and extent to which the content of each existing QOL instrument provides a unique, reliable, and valid assessment of the intended construct. We classified instruments as core (required in future studies), supplemental (used according to the study's aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an National Institutes of Health-organized workshop convened in March 2010 and finalized in September 2011. RESULTS: Eleven instruments for adults and 6 for children were identified for review. None qualified as core instruments because they predominantly measured indicators of asthma control (symptoms and/or functional status); failed to provide a distinct, reliable score measuring all key dimensions of the intended construct; and/or lacked adequate psychometric data. CONCLUSIONS: In the absence of existing instruments that meet the stated criteria, currently available instruments are classified as either supplemental or emerging. Research is strongly recommended to develop and evaluate instruments that provide a distinct, reliable measure of the patient's perception of the impact of asthma on all of the key dimensions of QOL, an important outcome that is not captured in other outcome measures.

Guidelines management of asthma in a busy urban practice.

PURPOSE OF REVIEW: The purpose of this article is to review how optimal asthma management can be applied in a variety of clinical settings that are used to care for high-risk, urban asthma patients, especially those who live in the inner city, utilizing the 2007 National Heart, Lung, and Blood Institute/National Asthma Education Prevention Program 'Guidelines for the diagnosis and management of asthma', and adapting them to be applied in a variety of urban clinical settings, independent of practice infrastructure. RECENT FINDINGS: Previous asthma guidelines stressed asthma severity classification. A renewed focus on asthma control has led to better asthma outcomes. Consequently, it was deemed necessary to establish a new asthma paradigm that characterizes both asthma severity and control within the context of current impairment and future risk. This new paradigm can be effectively applied to high-risk, inner-city asthma patients, while allowing for individualization of care within systems of varied healthcare delivery infrastructures. SUMMARY: Assessment of asthma severity and control, with special emphasis on literacy and ethno-cultural beliefs and philosophies, will facilitate appropriate adaptations of long-term asthma management to provide optimal outcomes in urban asthmatics. It is essential to anticipate the worst-case, while planning for the best-case scenario.

Improved asthma outcomes using a coordinated care approach in a large medical group.

The objective of this study was to review the development of a multidisciplinary asthma disease management program in a large medical group practice in an urban area, and evaluate the impact of the program on processes of care and health care utilization for adults and children with asthma. The disease management intervention included the development of a patient registry, a systematic approach to assessment of asthma control using the Asthma Therapy Assessment Questionnaire (ATAQ), case management, and physician education. An administrative database was used to examine hospital admissions and emergency department (ED) visits. A medical record audit was conducted to examine recorded compliance with asthma guidelines and documentation practices. The baseline study population included 3486 adults and children with asthma. The ATAQ suggested that, at baseline, control problems were frequent, with 34% of adult respondents missing work because of asthma. ATAQ also revealed several areas for care improvement. For example, only 20% of adult respondents reported having a written treatment plan. The chart review and administrative claims analyses showed that the program had beneficial results in several areas. Medical record documentation improved for asthma diagnosis (83.3% vs. 98.6%; p < 0.001) and patient education (15.7% vs. 26.1%; p < 0.001). No improvements were seen in documentation of peak flow ownership/use, smoking cessation advice, or influenza vaccination. ED visits related to asthma decreased from 148 per 1000 to 88 per 1000 (p < 0.001), and hospitalizations related to asthma decreased from 81 per 1000 to 37 per 1000 (p < 0.001). The outcomes suggest that this program was associated with a marked reduction in rates of hospitalization and ED usage for asthma, as well as significant improvement in several essential processes of care.