Navigating biologic therapies in elderly asthma.

The prevalence of asthma among the elderly population has witnessed a notable rise, presenting unique challenges in diagnosis and management. Biologic therapies, such as omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab, have demonstrated efficacy in targeting specific pathways associated with severe asthma in elderly individuals. However, a significant research gap exists in the application of these therapies in elderly asthma patients. Despite the considerable size of the elderly asthma population and the social and economic burden that this specific demographic imposes on society, the available body of research catering to this group is limited. Notably, no RCTs have been expressly designed for the elderly across all asthma biologic therapies. Moreover, most RCTs have set upper age cutoffs, commonly 75 years old, and exclusion criteria for common comorbidities in the elderly, thus marginalizing this group from pivotal research. This underscores the crucial need for intentional inclusion of elderly participants in separately designed clinical trials and more researches, aiming to augment the generalizability of findings and enhance therapeutic outcomes. Given the distinct physiological changes associated with aging, there may be a concern regarding the efficacy and safety of biologic therapies in the elderly compared to non-elderly adults, posing a barrier to their use in this population. However, observational studies have shown similar benefits of these therapies in elderly individuals as seen in non-elderly adults. Other anticipated challenges related to initiating biologic therapy in elderly people with asthma including dosing consideration and monitoring strategies, which are important areas of investigation for optimizing asthma management will be discussed in this review. In summary, this review navigates the current landscape of biologic therapies for elderly asthma, offering valuable insights for various stakeholders, including researchers, healthcare providers, and policymakers, to advance asthma care in this vulnerable population. We propose that future research should concentrate on tailored, evidence-based approaches to address the undertreatment of elderly asthma patients.

Navigating the Healthcare Conundrum: Leadership Perspective from a Premier Healthcare Organization in Loma Linda's Blue Zone.

Navigating the healthcare conundrum in the Blue Zone of Loma Linda, California, requires understanding the unique factors that make this region stand out in terms of health and longevity. But more important is understanding the healthcare system sustaining the Blue Zone in Loma Linda, California. In an era marked by soaring healthcare costs and diminishing reimbursement rates, hospitals and physicians face an unprecedented challenge: providing excellent patient care while maintaining financial sustainability. This leadership perspective publication paper delves into the multifaceted struggles encountered by healthcare and hospital leaders, exploring the root causes, implications, and potential solutions for this complex issue. As we examine the evolving healthcare landscape, we aim to shed light on the critical need for innovative approaches to sustain the future of healthcare excellence in one of the five original Blue Zones.

Evaluation of tracheostomy suctioning procedure among nursing and respiratory therapy students: wearable manikin vs. standard manikin.

Introduction: This study aims to evaluate cognitive load (CL), emotional levels (EL), and stress levels (SL) of students when using a wearable manikin vs. a standard manikin for tracheostomy suctioning (TS). Methods: This study was approved by the Institutional Review Board. Subjects were recruited by email. Subjects completed a baseline demographics questionnaire, then they were randomized into two groups: wearable manikin group (WMG) or standard manikin group (SMG). For the WMG, an actor simulated a patient by wearing the device. In phase I, both groups were educated on how to perform TS by video and offered hands-on practice. Then I put through a tracheostomy suctioning clinical simulation and completed a post sim-survey. In phase II, the same survey was repeated after encountering a real patient as part of their clinical rotation. Results: A total of 30 subjects with a mean age 26.0 ± 5.5 years participated. 20 (66.7%) were respiratory care students and 10 (33.3%) were nursing students. In the WMG, the median stress level dropped significantly post phase II compared to post phase I [2(1,4) vs.3(1,5), p = 0.04]. There were no significant changes in median CL, confidence, and satisfaction levels between post phase II and post phase I (p > 0.05). In the SMG, the satisfaction level increased significantly post phase II compared to post phase I [5(4,5) vs.4(2,5), p = 0.004], but there were no significant changes in CL, SL, and confidence levels between post phase I and phase II. There was no significant difference in mean EL scores over time and these changes did not differ by group. Subjects in the WMG showed a higher mean competency score than those in the SMG (85.5 ± 13.6 vs. 78.5 ± 20.8, p = 0.14, Cohen's d = 0.4), yet not significant. Conclusion: Our results showed that the WMG is beneficial in helping bridge the gap of learning TS from the sim setting to the real-world clinical setting. More studies with higher sample size and use of other CL scales that assesses the different types of CL are needed to validate our findings.

Transient TKI-resistant CD44+pBAD+ blasts undergo intrinsic homeostatic adaptation to promote the survival of acute myeloid leukemia in vitro.

Acute myeloid leukemia (AML) patients have frequent mutations in FMS-like receptor tyrosine kinase 3 (FLT3-mut AML), who respond poorly to salvage chemotherapies and targeted therapies such as tyrosine kinase inhibitors (TKIs). Disease relapse is a common reason of treatment failures in FLT3-mut AML patients, but its intracellular refractory mechanism remains to be discovered. In this study, we designed serial in vitro time-course studies to investigate the biomarkers of TKI-resistant blasts and their survival mechanism. First, we found that a group of transient TKI-resistant blasts were CD44+Phosphorylated-BAD (pBAD)+ and that they could initiate the regrowth of blast clusters in vitro. Notably, TKI-treatments upregulated the compensation pathways to promote PIM2/3-mediated phosphorylation of BAD to initiate the blast survival. Next, we discovered a novel process of intracellular adaptive responses in these transient TKI-resistant blasts, including upregulated JAK/STAT signaling pathways for PIM2/3 expressions and activated SOCS1/SOCS3/PIAS2 inhibitory pathways to down-regulate redundant signal transduction and kinase phosphorylation to regain intracellular homeostasis. Finally, we found that the combination of TKIs with TYK2/STAT4 pathways-driven inhibitors could effectively treat FLT3-mut AML in vitro. In summary, our findings reveal that TKI-treatment can activate a JAK/STAT-PIM2/3 axis-mediated signaling pathways to promote the survival of CD44+pBAD+blasts in vitro. Disrupting these TKIs-activated redundant pathways and blast homeostasis could be a novel therapeutic strategy to treat FLT3-mut AML and prevent disease relapse in vivo.

Real-world severe asthma biologic administration and adherence differs by biologic: CHRONICLE study results.

BACKGROUND: Patient adherence to biologic therapies is crucial for clinical benefits. Previous assessments of US patient adherence to severe asthma (SA) biologic therapies have relied on health care insurance claims data that have limitations. OBJECTIVE: To describe real-world, specialist-reported, biologic administration and adherence among US adults with SA. METHODS: CHRONICLE (ClinicalTrials.gov identifier: NCT03373045) is an ongoing real-world, noninterventional study of patients with SA treated by US subspecialists. Sites report date and location for all biologic administrations. We evaluated biologic (benralizumab, dupilumab, mepolizumab, omalizumab, reslizumab) adherence as the proportion of days covered (PDC) during the first 52 weeks and the mean number of days until patients received the expected number of doses for 13, 26, and 52 weeks of treatment. RESULTS: A total of 2117 patients received biologic administrations between February 2018 and February 2022. Most patients (84%) received biologic administrations at a subspecialist site. Over time, administrations at specialist sites decreased, whereas at-home administrations increased. The median PDC was 87%; the mean number of days to receive a 52-week (364-day) equivalent number of doses was 423 for all biologics (average delay of 58 days). Dupilumab had the lowest PDC and highest mean delays in dosing across all intervals; better adherence was observed among commercially insured patients. CONCLUSION: Patients with SA are mostly adherent to biologic therapies. Biologics with shorter dosing intervals and at-home administration had worse adherence, likely because of greater opportunities for delays. Specialist-reported administration data provide a unique perspective on biologic adherence, which may be overestimated for at-home administrations by insurance claims data. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03373045.

Measurement and changes of exhaled nitric oxide fraction while vaping with a brief education intervention session.

A brief, 15-min education intervention session might be helpful to highlight the dangers of vaping and aid in cessation. In addition, post-washout period (15 min), F ENO levels increased significantly. https://bit.ly/3Xu4X5Y.

Asthma Care in the Elderly: Practical Guidance and Challenges for Clinical Management - A Framework of 5 "Ps".

Uncontrolled asthma in the elderly is a public health issue recognized in developed countries such as the United States and among the European Union, both from patient safety and economic perspectives. Variations in the cutoff, which defines elderly age, contribute to epidemiological study difficulties. Nonetheless, the relevance of elderly asthma from a socioeconomic perspective is inarguable. The projected growth of the enlarging geriatric population in the United States portends an impending national health burden that may or may not be preventable with pharmacologic and non-pharmacologic treatments. Asthma in the elderly might be a consequence of uncontrolled disease that is carried throughout a lifetime. Or elderly asthmatics could suffer from uncontrolled asthma, which overlaps with other ailments common with advancing ages that merit consideration, eg, COPD, heart disease, OSA, diabetes mellitus, and other comorbidities. Because of the heterogeneity of asthma phenotypes and other conditions that could mimic the symptoms of elderly asthma, further cohort studies are needed to elucidate the elderly asthmatic pathophysiology and management. More studies to characterize elderly asthma can help address these patients' unmet need for evidence-based guidelines. We introduce the 5 "Ps" (phenotypes, partnership, pharmacology, practice in acute exacerbations, and problems or barriers for the elderly asthmatics) that establish a framework approach for clinical practice.

Heart failure alters diagnostic yield for pulmonary embolism in patients undergoing computed tomography pulmonary angiogram.

INTRODUCTION: There is limited evidence regarding the effects of a pre-existing heart failure (HF) on the diagnostic yield of pulmonary embolism (PE) evaluation in the Emergency Department (ED). METHODS: Electronic medical record of consecutive adults who underwent a computed tomography pulmonary angiogram (CTPA) in the ED at Loma Linda University Medical Center between June 1, 2019 and March 25, 2022 were reviewed. Repeat studies for the same patient and patients with unspecified HF diagnoses or isolated right ventricular HF were excluded. Key demographics, lab values and vital signs, relevant medications were collected. Primary outcome was the incidence of PE on CTPA compared between patients with and without pre-existing HF. RESULTS: A total of 2846 patients were included in the study (602 patients with HF and 2244 without). In total cohort, 11.7% (n = 334) of patients had PE found on CTPA. The incidence of PE on CTPA was lower among patients with a history of HF than patients without a history of HF (12.5% vs 9%). A history of pre-existing HF was associated with a lower odds ratio for a positive PE study (OR 0.13, 95%CI: 0.03-0.57) in multivariable analyses. CONCLUSIONS: In this study, we observed that the incidence of PE among patients who undergo CTPA was lower among patients with pre-existing HF compared to those without. Further studies should determine if HF is an important mitigating factor when risk stratifying patients for PE.

Surgical mask wearing behaviour in COVID-19 pandemic and influenza seasons: a cross-sectional study on healthcare professional students and staff's perspective in Southern California.

OBJECTIVE: To investigate healthcare professional staff and students' perception of wearing surgical masks before and after their experience with the COVID-19 pandemic, and to evaluate the impact on mask wearing behaviour in future influenza seasons. DESIGN: Cross-sectional study using anonymous survey. SETTING AND PARTICIPANTS: Healthcare students and staff from a healthcare academic institution in Southern California participated in the mask survey study. Survey results were collected from June to November 2021. A total of 305 respondents responded to the survey, with 173 being healthcare students and 132 being working healthcare staff. OUTCOMES: The study examined respondents' perceptions and hospital mask wearing behaviour before and after their COVID-19 pandemic experience, as well as during previous and future influenza seasons. RESULTS: Two hundred and sixty-four (86.6%) respondents agreed that wearing a surgical mask reduces infection and limits transmission of infectious disease, yet prior to the pandemic, only a small proportion wore a mask in the hospital or during patient care. After experiencing the COVID-19 pandemic, more respondents indicated that they would continue to wear a mask when they are in a hospital in general (n=145, 47.5%), during patient care (n=262, 85.9%), during influenza seasons throughout the hospital (n=205, 67.2%) and during influenza seasons during patient care (n=270, 88.5%). CONCLUSION: The pandemic experience has greatly influenced the health prevention behaviours of healthcare students and staff. After the pandemic, many respondents will continue to practice surgical mask wearing behaviour in the hospital, especially during face-to-face patient care. This demonstrates a significant change in health prevention perceptions among the current and the future generation of healthcare professionals.

Anxiety level in severe asthmatics undergoing bronchial thermoplasty procedure: An observational study.

Bronchial thermoplasty (BT) is one of the novel approved modalities in treating severe asthmatics to overcome their exacerbating symptoms such as increased anxiety. The purpose of this study was to evaluate anxiety level among severe asthmatics while undergoing BT procedure. This was an observational study where subjects self-evaluated their overall anxiety level using the burns anxiety inventory (BAI) questionnaire at baseline and prior to each of three BT treatments (broncho thermoplasty procedure 1, broncho thermoplasty procedure 2, and broncho thermoplasty procedure 3). The BAI questionnaire consisted of three different categories with each category having specific symptoms. Categories were grouped as: Anxious feelings, Anxious thoughts, and Physical symptoms. Subjects' Asthma Control Tests were also collected for analysis before and after the BT procedure. A total of 17 subjects with a mean age of 55.9 ±â€…14.5 years participated in the study. Fifty three percent were females (n = 9) and 41.2% (n = 7) were on prescribed anxiety medications. There was a significant drop in the patients' overall BAI anxiety level over time, P < .0001, in Anxious feelings (P = .0001), anxious thoughts (P = .001), and physical symptoms (P = .025). When analyzing the change in anxiety level among those who were not on prescribed anxiety medications, significant drop in overall anxiety level and in the subcategories were also noted. (P < .05). In addition, ACT scores showed a significant improvement (post vs pre) (18.5 ±â€…4.0 vs 13.3 ±â€…6.3, P = .03; Cohen's d = 0.73). This study shows the effectiveness of BT in decreasing severe asthmatic anxiety levels from baseline to last BT treatment and this benefit was mostly noted in those who were not on any anxiety medications. A limitation of this study is that all subjects were recruited from a single center. Therefore, to further validate the study findings, a multi-center study needs to be conducted with a larger sample size.

Management of Uncontrolled Asthma: A Framework for Novel and Legacy Biologic Treatments.

Asthma continues to be a complex respiratory disease to control for many despite optimal standard inhaler therapy. The increased dependence on steroid-sparing biologic treatments in the 21st century has created a dilemma between identifying the patient's intrinsic biomarkers and their "life markers." With Tezepelumab being the most recent FDA-approved biologic for asthma, it is even more critical for asthma specialists to better understand and establish a framework to determine which biologic would work best for their patients. While cost and payor approvals limit access to certain asthma biologics, medical decisions on which biologic to select should be centered around shared decision-making, the rationale for biologic initiation, and critical biologic education to help achieve successful asthma control.

Development and Evaluation of a Small Airway Disease Index Derived From Modeling the Late-Expiratory Flattening of the Flow-Volume Loop.

Excessive decrease in the flow of the late expiratory portion of a flow volume loop (FVL) or "flattening", reflects small airway dysfunction. The assessment of the flattening is currently determined by visual inspection by the pulmonary function test (PFT) interpreters and is highly variable. In this study, we developed an objective measure to quantify the flattening. We downloaded 172 PFT reports in PDF format from the electronic medical records and digitized and extracted the expiratory portion of the FVL. We located point A (the point of the peak expiratory flow), point B (the point corresponding to 75% of the expiratory vital capacity), and point C (the end of the expiratory portion of the FVL intersecting with the x-axis). We did a linear fitting to the A-B segment and the B-C segment. We calculated: 1) the AB-BC angle (∠ABC), 2) BC-x-axis angle (∠BCX), and 3) the log ratio of the BC slope over the vertical distance between point A and x-axis [log (BC/A-x)]. We asked an expert pulmonologist to assess the FVLs and separated the 172 PFTs into the flattening and the non-flattening groups. We defined the cutoff value as the mean minus one standard deviation using data from the non-flattening group. ∠ABC had the best concordance rate of 80.2% with a cutoff value of 149.7°. We then asked eight pulmonologists to evaluate the flattening with and without ∠ABC in another 168 PFTs. The Fleiss' kappa was 0.320 (lower and upper confidence intervals [CIs]: 0.293 and 0.348 respectively) without ∠ABC and increased to 0.522 (lower and upper CIs: 0.494 and 0.550) with ∠ABC. There were 147 CT scans performed within 6 months of the 172 PFTs. Twenty-six of 55 PFTs (47.3%) with ∠ABC <149.7° had CT scans showing small airway disease patterns while 44 of 92 PFTs (47.8%) with ∠ABC ≥149.7° had no CT evidence of small airway disease. We concluded that ∠ABC improved the inter-rater agreement on the presence of the late expiratory flattening in FVL. It could be a useful addition to the assessment of small airway disease in the PFT interpretation algorithm and reporting.

Clinical and economic burden of uncontrolled severe noneosinophilic asthma.

OBJECTIVES: To quantify the clinical and economic burden of patients with severe asthma with low blood eosinophil counts (BECs) untreated with biologics. STUDY DESIGN: Retrospective cohort study in IBM MarketScan claims database. METHODS: Patients 12 years and older with severe asthma with BEC data were selected between January 1, 2013, and June 30, 2018 (date of the most recent BEC was used as the index date). Inclusion criteria were (1) presence of BEC laboratory test result, (2) continuous enrollment for 12 months preceding and following the index date, (3) meeting the Healthcare Effectiveness Data and Information Set definition of persistent asthma, (4) meeting the Global Initiative for Asthma definition of severe asthma, and (5) an absence of biologic treatment, other respiratory diagnoses, and malignancies 12 months preceding and following the index date. Asthma exacerbations, levels of disease control, and all-cause and asthma-related health care costs were reported during the 12-month postindex period for patients with a BEC less than 300 cells/mcL. RESULTS: The sample included 8073 patients with severe asthma; 78% (n = 6260) presented with a BEC less than 300 cells/mcL. Mean (SD) age of the sample was 54.8 (14.2) years; 64% were female. Eighteen percent of patients had an asthma exacerbation; 19% had either uncontrolled or suboptimally controlled asthma based on the frequency of asthma-related hospital admissions, emergency department visits, or corticosteroid prescription fills. One-year all-cause and asthma-related total health care costs were $25,845 and $2802, respectively. Patients with suboptimally controlled and uncontrolled asthma spent $1471 and $3872 more, respectively, on asthma-related claims compared with patients with controlled asthma. CONCLUSIONS: Among patients with severe asthma with low eosinophils untreated with biologics, there is a high burden of disease among those who have suboptimal disease control, highlighting an unmet need in severe asthma treatment.

Asthma guidelines: comparison of the National Heart, Lung, and Blood Institute Expert Panel Report 4 with Global Initiative for Asthma 2021.

PURPOSE OF REVIEW: Asthma continues to be a prevalent respiratory disease that affects lives within the United States and worldwide. Clinical asthma guidelines based on scientific evidence on testing and therapeutic interventions are needed to control this disease better. To meet this need, the NAEPP (National Asthma Education and Prevention Program) and GINA (Global Initiative for Asthma) were formed to assist with best practice diagnosis and treatments for asthma. This paper reviews the subtle differences and similarities between the most recent recommendations put forth by NAEPP 2020 and GINA 2021, mainly examining the six selected topics, as well as methodology, guidance on emerging topics, and implementation. RECENT FINDINGS: In December 2020, the National Asthma Education and Prevention Program Coordinating Committee released their focused update on fraction of exhaled nitric oxide, indoor allergen mitigation, inhaled corticosteroids, long-acting muscarinic antagonists, allergen immunotherapy, and bronchial thermoplasty. The Global Initiative for Asthma comprehensive document is published annually as a framework for all nations. Therefore, it is timely to consider the National Asthma Education and Prevention Program Coordinating Committee 2020 in relation to the GINA 2021. SUMMARY: The comparison provides a better understanding of evidence-based recommendations for asthma. The NAEPP 2020 and GINA 2021 will equip providers with the knowledge to provide their patients with the best and most updated asthma care.

Randomized, placebo controlled, double blinded pilot superiority phase 2 trial to evaluate the effect of curcumin in moderate to severe asthmatics.

BACKGROUND: Curcumin, a derivative of the spice turmeric, has been adopted by Eastern medicine for centuries as an adjunct to treat several medical conditions (e.g., anorexia and arthritis) because of its well-established anti-inflammatory properties. Studies have shown that the use of curcumin in mice models has led to reduction in several inflammatory markers as well as key inflammatory pathway enzymes. As a result, studies in Western medicine have developed to determine if this recognized benefit can be utilized for patients with inflammatory lung diseases, such as asthma. This study will seek to better understand if curcumin can be used as an adjunctive therapy for improving asthma control of patients with moderate to severe asthma; a finding we hope will allow for a more affordable treatment. METHODS: This study will utilize a randomized, placebo controlled, double blinded pilot superiority phase 2 trial at an outpatient pulmonary clinic in Southern California, USA. Subjects will be receiving Curcumin 1500 mg or matching placebo by mouth twice daily for the study period of 12 weeks. Subjects will be randomized to either a placebo or intervention Curcumin. Subjects will have 6 clinic visits: screening visit, a baseline visit, monthly clinic visits (weeks 4, 8, and 12), at weeks 4, 8, and a follow-up clinic visit or phone-call (week 16). Changes in asthma control test scores, number of days missed from school/work, FEV1 (% predicted), FEV1/FVC ratio, FVC (% predicted), blood eosinophil count, blood total IgE, and FeNO levels will be compared by group over time. DISCUSSION: The therapeutic effects of curcumin have been studied on a limited basis in asthmatics and has shown mixed results thus far. Our study hopes to further establish the benefits of curcumin, however, there are potential issues that may arise from our study design that we will address within this paper. Moreover, the onset of the COVID-19 pandemic has resulted in safety concerns that have delayed initiation of our study. This study will contribute to existing literature on curcumin's role in reducing lung inflammation as it presents in asthmatics as well as patients suffering from COVID-19. TRIAL REGISTRATION: This study protocol has been approved by the Institutional Review Board at Loma Linda University Health, (NCT04353310). IND# 145101 Registered April 20th, 2020. https://clinicaltrials.gov/ct2/show/NCT04353310 .

Clinical and economic burden of severe asthma among US patients treated with biologic therapies.

BACKGROUND: Patients with severe asthma may remain uncontrolled despite biologic therapy in addition to standard therapy, but this disease burden has not been quantified. OBJECTIVE: To estimate the clinical and economic burden in a US national sample. METHODS: Patients who have severe asthma with indicated biologic treatment (earliest use = index date) were selected from the MarketScan database between January 1, 2013, and June 30, 2018. Inclusion criteria were continuous enrollment for 12 months postindex with a minimum of 2 biologic fills, greater than or equal to 12 years of age, evidence of medium- to high-dose inhaled corticosteroids and long-acting ß-agonist combination before the index, and absence of other respiratory diagnoses and malignancies. Disease exacerbations (used to classify asthma control), health care costs, and treatment characteristics were reported during the 12-month postindex period. RESULTS: The sample included 3262 biologic patients; 88% with anti-immunoglobulin E therapy (omalizumab) and 12% non-anti-immunoglobulin E (reslizumab, mepolizumab, benralizumab). The mean age was 49 (±15) years; 64% were women. Prescriptions included inhaled corticosteroids and long-acting ß-agonist (82%), systemic corticosteroids (76%), and leukotriene receptor antagonists (68%). Notably, 63% of patients presented greater than or equal to 1 asthma exacerbation (mean 1.3 per patient/year). Furthermore, 35% of patients were categorized as having controlled asthma, whereas 28% were suboptimally controlled and 29% were uncontrolled. Patients with uncontrolled disease had higher all-cause and asthma-related costs ($69,206 and $45,693, respectively) than patients with suboptimally controlled ($59,407 and $40,793, respectively) or controlled disease ($53,083 and $38,393, respectively). Furthermore, 62% of newly treated patients were persistent with their index biologic. CONCLUSION: Biologic therapies are effective in reducing exacerbations, but a substantial proportion of patients with severe asthma treated with current biologics continue to experience uncontrolled disease, highlighting a remaining unmet need for patients with severe uncontrolled asthma.

Association of Nonmedical Switches in Inhaled Respiratory Medications with Disruptions in Care: A Retrospective Prescription Claims Database Analysis.

INTRODUCTION: There are limited data on the effects of forced medication switching for a nonmedical reason in patients with obstructive airway conditions. This study evaluated disruption in care resulting from a nonmedical medication switch for patients with asthma and/or chronic obstructive pulmonary disease who previously received the inhaled corticosteroid/long-acting ß2-agonist budesonide/formoterol. METHODS: This retrospective pharmacy benefit prescription claims analysis evaluated Medicare Part D patients who filled a prescription for budesonide/formoterol as their last inhaled corticosteroid/long-acting ß2-agonist in 2016 and were affected by a formulary block of budesonide/formoterol in 2017. Changes to respiratory maintenance therapy, length of gaps in care during which a patient was not in possession of a respiratory controller medication, acute medication use indicative of disease exacerbations, and medication adherence were assessed. RESULTS: A total of 42,553 patients were included in the analysis. Following the formulary block, 30,016 patients (71%) switched to another controller; 20,628 of these patients (69%) switched to a new inhaled corticosteroid/long-acting ß2-agonist, 7081 (23%) stepped down to a monotherapy, and 2307 (8%) switched to a non-inhaled corticosteroid-containing controller. Despite the formulary block, 22,903 patients (54%) attempted to fill budesonide/formoterol as their first postblock controller, and 6624 patients (16%) attempted to return to budesonide/formoterol after switching to another controller. On average, patients experienced a gap in care of approximately 4 months without a controller medication. Also, 9674 (23%) did not fill any controller over the 1-year postblock period. Of those patients who experienced a gap in care, 14,926 (47%) filled a prescription indicative of a possible exacerbation during the gap period (i.e., oral corticosteroids for patients with asthma and oral corticosteroids and/or antibiotics for patients with chronic obstructive pulmonary disease). CONCLUSIONS: The Medicare Part D formulary block was associated with disruption in the management of patients' respiratory conditions and may have adversely impacted disease control.

Self-Administered Mepolizumab in the Management of Severe Asthma: Usability and Patient Acceptance.

The increasing use of advanced biologic therapies for patients with severe asthma is transforming the standard of care, clinic workflow, and the clinic business model. Expanded patient access to at-home injection treatment possibilities with some biologics has the potential to improve patient adherence and outcomes. Simultaneously, transition to the home setting can address the escalating costs that limit access for certain patients and healthcare facilities. Such moves come with recognized risks. Garnering input from physicians and other healthcare specialists as well as scrutinizing best practice position statements are vital to implementing truly patient-safe and cost-effective strategies in medicine. Mepolizumab is the first anti-IL-5 inhibitor to receive FDA approval in late 2015. We focus on this injectable medication and discuss the specific indications and contraindications for transitioning patients to at-home injection with mepolizumab. In doing so, we review our recent real-world experiences in the University of California, Davis and Loma Linda University severe asthma clinics, which can provide the foundation for building a comprehensive clinic and home-based biologics asthma program. In addition, we offer insight into the barriers to implementing a successful program and strategies for overcoming them.