ABSTRACT
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.
Subject(s)
Asthma , Pulmonary Disease, Chronic Obstructive , Humans , Administration, Inhalation , Adrenal Cortex Hormones/therapeutic use , Asthma/drug therapy , Asthma/epidemiology , Bronchodilator Agents/therapeutic use , Delivery of Health Care , Drug Therapy, Combination , Muscarinic Antagonists/therapeutic use , Retrospective Studies , Tiotropium Bromide/therapeutic use , Child , Adolescent , AdultABSTRACT
Clinical decision-making in allergic rhinoconjunctivitis management involves a significant degree of complexity given the number of pharmaceutical agents; the option for allergen immunotherapy (AIT); and the risk for disease advancement, including the development of asthma as well as new environmental allergic sensitivities. Given the complex array of treatment options that are currently available, there is an opportunity to use a shared decision-making (SDM) approach with associated aids and tools that facilitate the interactive participation of practitioners and patients in the SDM process. This article reviews the general constructs of SDM, the unmet need for SDM aids, the collection of patient preference data for allergic rhinoconjunctivitis, the utility of SDM aids which have been specifically created for AIT, and outlines actionable steps to implement AIT SDM in clinical practice.
Subject(s)
Patient Participation , Humans , Decision Making , Decision Making, Shared , Desensitization, ImmunologicABSTRACT
It has been more than a decade since the most recent allergen immunotherapy (AIT) practice parameter was published and 5 years since a focused practice parameter on sublingual immunotherapy (SLIT) was issued. There is an unmet need, therefore, for a more up-to-date, concise summary of AIT to be published to provide allergy/immunology practitioners, allergy/immunology fellows-in-training, medical students, residents, and other health-care practitioners with the most current information available on AIT. The Allergen Immunotherapy Primer (AITP) is not intended to define a standard of care or to be inclusive of all proper methods of care, nor is it intended to replace or supplant established AIT practice parameters; rather, the goal of this AITP is to supplement the established practice parameters and to serve primarily as an updated tool for the practicing allergist/immunologist, allergy/immunology trainees, and health-care professionals seeking practical and concise information with regard to AIT. Primer topics include the history of AIT; descriptions of the mechanisms and biomarkers of subcutaneous immunotherapy (SCIT) and SLIT; the efficacy and safety of SCIT; the efficacy and safety of SLIT, pediatric SLIT, and SCIT; the long-term efficacy of SLIT and SCIT; long-term adherence strategies for AIT; the implications of real-world data for AIT; the role of AIT for asthma; patterns of cross-allergenicity among pollens; a practical implementation guide for optimized construction of AIT vaccines; standardization of allergen extracts; updated information on federal regulations about the United States Pharmacopeia and the compounding of allergenic extracts; an update on AIT venom immunotherapy; the advantages and disadvantages of accelerated immunotherapy regimens; the important role of shared decision-making in AIT and how it can be incorporated into the informed consent process; and a forecast of future directions in allergen immunotherapy.
Subject(s)
Asthma , Sublingual Immunotherapy , Allergens/therapeutic use , Child , Desensitization, Immunologic , Health Personnel , HumansABSTRACT
Subject(s)
Angioedemas, Hereditary/epidemiology , Anxiety/epidemiology , Depression/epidemiology , Absenteeism , Angioedemas, Hereditary/economics , Animals , Cost of Illness , Disease Progression , Humans , Prevalence , Quality of LifeABSTRACT
Clinical decision-making in hereditary angioedema (HAE) management involves a high degree of complexity given the number of therapeutic agents that are available and the risk for significant morbidity and potential mortality attributable to the disease. Given this complexity, there is an opportunity to develop shared decision-making (SDM) aids and/or tools that would facilitate the interactive participation of practitioners and patients in the SDM process. This article reviews the general constructs of SDM, the unmet need for SDM in HAE, and the steps necessary to create a SDM tool specific for HAE, and outlines the challenges that must be navigated to guide the establishment and widespread implementation of SDM in the management of HAE.
Subject(s)
Angioedemas, Hereditary/diagnosis , Decision Making, Shared , Angioedemas, Hereditary/therapy , Humans , Patient Participation , Physician-Patient RelationsABSTRACT
Background: A step-up approach (increasing inhaled corticosteroid [ICS] dose and/or add-on treatment) is recommended for asthma that is uncontrolled despite ICS plus long-acting beta-2-agonist (LABA) combination treatment. Understanding the impact of different treatment options on health outcomes can help guide treatment decision-making. Objective: To compare the effectiveness of add-on tiotropium 1.25 µg (two puffs once daily) versus an increased ICS plus LABA dose in a real-world cohort of patients with asthma initiated on ICS plus LABA. Methods: De-identified data from patients ages ≥12 years and with asthma who were initiated on ICS plus LABA, and then had tiotropium added (Tio group; index date) or an ICS plus LABA dose increased (inc-ICS group; index date) were collected from two medical and pharmacy claims data bases (2014-2018). To account for population/group differences, propensity score matching was performed. The primary end point was the exacerbation risk after the index date. Secondary end points included exacerbation rates 6 and 12 months postindex, health-care resource utilization, costs, and short-acting beta-2-agonist (SABA) refills 12 months postindex. Results: Overall, 7857 patients (Tio group, 2619; inc-ICS group, 5238) were included. The exacerbation risk was 35% lower in the Tio group than in the inc-ICS group (hazard ratio 0.65 [95% confidence interval, 0.43-0.99]; p = 0.044). Exacerbation rates in the Tio group also were significantly lower within 6 and 12 months postindex (64% and 73%, respectively). All-cause and asthma-related emergency department (ED) visits were 47% and 74% lower, respectively (p < 0.0001 for both), and all-cause and asthma-related hospitalizations were 48% (p < 0.01) and 76% (p < 0.001) lower, respectively, in the Tio group. Also, significantly fewer patients in the Tio group versus the inc-ICS group required SABA refills (56% versus 67%, p < 0.0001). Conclusion: Add-on tiotropium significantly decreased the risk and rate of exacerbations, decreased all-cause and asthma-related ED visits and hospitalizations, and reduced SABA refills compared with increasing the ICS plus LABA dose. The findings supported the use of add-on tiotropium for patients with uncontrolled asthma taking ICS plus LABA.
Subject(s)
Adrenergic beta-2 Receptor Agonists/administration & dosage , Asthma/drug therapy , Bronchodilator Agents/therapeutic use , Glucocorticoids/administration & dosage , Tiotropium Bromide/therapeutic use , Administration, Inhalation , Adolescent , Adrenergic beta-2 Receptor Agonists/therapeutic use , Adult , Asthma/physiopathology , Disease Progression , Dose-Response Relationship, Drug , Drug Therapy, Combination , Emergency Service, Hospital , Female , Glucocorticoids/therapeutic use , Humans , Male , Proportional Hazards Models , Young AdultABSTRACT
BACKGROUND: Despite the low prevalence for all patients with asthma, those with severe disease account for a disproportionately large economic burden. OBJECTIVE: To evaluate current direct health care and productivity loss costs associated with patients with asthma receiving Global Initiative for Asthma Step 4/5 therapy ("G4/5 asthma") in the United States. METHODS: Asthma patients aged 12 years or older were identified in the IBM MarketScan Research Databases between January 1, 2012 and December 31, 2015. Patients were indexed on their earliest medical claim for asthma and were required to have at last 2 years of continuous eligibility. The G4/5 asthma classification required 1 or more medium- or high-dosage inhaled corticosteroids (ICS)/long-acting beta-agonist (LABA) claims, 1 or more omalizumab claims, or systemic corticosteroids covering at least 50% of the 12-month baseline period. The European Respiratory Society/American Thoracic Society criteria for severe uncontrolled asthma were modified for claims data and used to identify patients with exacerbations or high rescue medication use ("Ex/Râ³). Direct health care costs and productivity loss costs attributable to workplace absence or short-term or long-term disability were measured during the 12-month post-index period. RESULTS: A total of 605,614 patients with asthma were identified. Annual health care costs were $4,384 greater for G4/5 asthma vs non-G4/5 patients with asthma; asthma-related costs contributed $2,183 of this difference (P < .001). Differences were primarily driven by G4/5 patients with asthma with Ex/R, whose costs were $5,019 greater than G4/5 patients without Ex/R (P < .001). For patients with 1 or more absences or short-term disability claims, G4/5 patients missed 7.2 more work hours for absence and had 3.9 more days of work lost for short-term disability than non-G4/5 patients with asthma, respectively (P < .05). CONCLUSION: G4/5 patients with asthma incurred significantly greater direct and indirect costs than non-G4/5 patients with asthma. Differences were largely driven by those with Ex/R.