Real-world retrospective analysis of patient characteristics, healthcare resource utilization, costs, and treatment patterns among unvaccinated adults with COVID-19 diagnosed in outpatient settings in the United States.

AIMS: This retrospective analysis of the Optum Clinformatics Data Mart database evaluated US patient characteristics, healthcare resource utilization (HCRU), costs, and treatment patterns among unvaccinated adults with outpatient-diagnosed COVID-19 to quantify US economic burden. MATERIALS AND METHODS: The index event was the earliest outpatient diagnosis of confirmed COVID-19 from May 1 to December 10, 2020. Patients had 12 months' continuous enrollment before and were followed for ≥60 days after index date until insurance dis-enrollment or study end. RESULTS: 236,589 patients had outpatient-diagnosed COVID-19 (7,692 with and 228,897 without subsequent COVID-19-related inpatient admission >48 h post-diagnosis). The median age was 51 years (≥65 years, 30.0%); 72.4% had ≥1 risk factor. Patients with versus without subsequent inpatient admission were more often male, older, Black/Hispanic, and had comorbidities/risk factors. With a median follow-up of 162 days, patients had a median of 1 COVID-19-related outpatient visit (with inpatient admission, 5 outpatient visits). Those with inpatient admission had a median of 1 COVID-19-related inpatient visit (median length of stay [LOS], 6 days), 33.3% were admitted to intensive care (median LOS, 8 days), 8.4%, 7.1%, and 13.3% received invasive mechanical ventilation, noninvasive mechanical ventilation, and supplemental oxygen, respectively; 13.5% experienced readmission. Inpatient mortality was 6.0% (0.3% for nonhospitalized patients). Antithrombotic therapy, antibiotics, corticosteroids, and remdesivir use increased among patients with inpatient admission versus without. Median total COVID-19-related non-zero medical costs were $208 for patients without inpatient admission (with inpatient admission, $39,187). LIMITATIONS: Results reflect the circulating SARS-CoV-2 and treatment landscape during the study period. Requirements for continuous enrollment could have biased the population. Cost measurements may have included allowed (typically higher) and charge amounts. CONCLUSIONS: Given the numbers of the US population who are still not fully vaccinated and the evolving epidemiology of the pandemic, this study provides relevant insights on real-world treatment patterns, HCRU, and the cost burden of outpatient-diagnosed COVID-19.

The association between disease activity and patient-reported outcomes in patients with moderate-to-severe ulcerative colitis in the United States and Europe.

BACKGROUND: Patients with ulcerative colitis (UC) experience periods of recurring and episodic clinical signs and symptoms. This study sought to establish the association between disease activity and health-related quality of life (HRQoL) and other patient-reported outcomes. METHODS: United States (US) and European Union 5 ([EU5]; i.e., France, Germany, Italy, Spain, and the United Kingdom) data from the 2015 and 2017 Adelphi Inflammatory Bowel Disease-Specific Programme (IBD-DSP) were used. The IBD-DSP is a database of retrospective patient chart information integrated with patient survey data (EuroQoL-5 Dimensions [EQ-5D], Short Quality of Life in Inflammatory Bowel Disease Questionnaire [SIBDQ], and Work Productivity and Activity Impairment-Ulcerative Colitis [WPAI-UC] questionnaire). Using available chart information, physicians classified their moderate-to-severe patients into one of the following categories: remission with a Mayo endoscopic score = 0 ("deep remission"), remission without a Mayo endoscopic score = 0 ("remission"), or active disease. Differences among disease activity categories with respect to patient-reported outcomes were analyzed using generalized linear models, controlling for confounding variables. RESULTS: N = 289 and N = 1037 patient charts with linked surveys were included from the US and EU5, respectively. The disease activity distribution was as follows: active disease = 40.1% (US) and 33.6% (EU5); remission = 48.0 and 53.0%; deep remission = 11.9 and 13.3%. Patients with active disease reported significantly lower levels of EQ-5D health state utilities (adjusted mean [AdjM] = 0.87 [US] and 0.78 [EU5]) compared with remission (AdjM = 0.92 and 0.91) and deep remission (AdjM = 0.93 and 0.91) (all P < 0.05 compared with active disease within each region). Similar findings were observed with the scores from the SIBDQ and the WPAI-UC. No significant differences were observed between remission categories. CONCLUSIONS: Among patients with moderate-to-severe UC in the US and EU5, active disease was associated with significant impairments in HRQoL, work and leisure activities. These results reinforce the importance, to both the patient and society, of achieving some level of remission to restore generic and disease-related HRQoL and one's ability to work productively.

Treatment patterns among patients with moderate-to-severe ulcerative colitis in the United States and Europe.

OBJECTIVE: The aim of the present study is to examine how moderate-to-severe ulcerative colitis (UC) is currently managed in real-world clinical practice across the United States (US) and European Union Five (EU5; France, Germany, Italy, Spain, and the United Kingdom). METHODS: Data from the 2017 Adelphi Inflammatory Bowel-Disease Specific Programme (IBD-DSP) were used. The IBD-DSP is a database of patient chart information abstracted by selected gastroenterologists across the US and EU5. Eligible gastroenterologists who agreed to participate were asked to complete patient record forms for the next seven consecutive eligible adult patients with UC. Only charts from patients with moderate-to-severe UC were included in the analysis (defined as those with documented administration of either an immunosuppressant [IM] or a biologic). Treatment patterns were reported descriptively. RESULTS: 411 and 1191 patient charts were included in the US and EU5 (mean ages 44.2 and 39.6 years; 53.0% and 43.5% female), respectively. For those with complete treatment history, 40.7% and 52.9% used either an IM or biologic as their first treatment (with or without steroids). Usage of these therapies increased in subsequent lines. The percentage of patients treated with combination therapy (i.e., biologic therapy with a concomitant IM) in first line generally varied between 10-20% (e.g., US: adalimumab (ADA), 10.8%; infliximab (IFX), 18.2%; EU5: ADA, 12.5%; IFX, 19.9%), though increased in later lines in the EU5. Among patients currently using a biologic therapy, between 10-40% of patients used a higher than indicated dose or greater than indicated dosing frequency during maintenance (e.g., US: IFX, 37.1%; ADA, 13.4%; EU5: IFX, 39.1%; ADA, 36.1%). In both the US and EU5, the primary reason for switching therapy was efficacy-related. CONCLUSIONS: In this analysis, many patients with moderate-to-severe UC use an IM or biologic as their first therapy after diagnosis. Combination therapy and dose escalation are also common, and underscore the challenges with managing this patient population.

Relationship between disease activity status or clinical response and patient-reported outcomes in patients with non-radiographic axial spondyloarthritis: 104-week results from the randomized controlled EMBARK study.

BACKGROUND: We assessed the external validity of composite indices Ankylosing Spondylitis Disease Activity Score (ASDAS), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Assessment in SpondyloArthritis international Society (ASAS) 40 response (ASAS40) by evaluating the correlations between the changes in some patient reported outcomes (PROs) for patients with non-radiographic axial spondyloarthritis (nr-axSpA) and the changes in the scores of the composite indices. METHODS: This was a post-hoc analysis of data from the EMBARK study in patients with nr-axSpA treated with etanercept. PROs were grouped according to ASDAS status (inactive [< 1.3], low [≥ 1.3 to < 2.1], high [≥ 2.1 to ≤3.5], and very high [> 3.5]), patient achievement of > 50% improvement in BASDAI (BASDAI50 responders), and > 40% improvement in ASAS (ASAS40 responders) at 104 weeks. Analyses were conducted on observed cases available at Week 104. Changes in PROs from Baseline to Week 104 were assessed using analysis of covariance with adjustment for baseline with linear contrast. RESULTS: Higher ASDAS disease activity at 104 weeks was associated with lower long-term improvement from baseline in PROs (e.g., total back pain [visual analog scale, cm (95% confidence interval): - 4.58 (- 4.95, - 4.21), - 3.86 (- 4.28, - 3.43), - 2.15 (- 2.68, - 1.61), and 1.30 (- 0.51, 3.12) for inactive, low, high, and very high ASDAS disease activity, respectively; Multidimensional Fatigue Inventory (MFI) general fatigue: - 4.77 (- 5.70, - 3.84), - 2.96 (- 4.04, - 1.87), - 1.00 (- 2.32, 0.31), and 2.14 (- 2.10, 6.38); all p < 0.001)]. BASDAI50 non-responders had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: - 1.61 (- 2.05, - 1.18) vs. -4.43 (- 4.69, - 4.18); MFI general fatigue: - 0.01 (- 1.12, 1.09) vs. -4.30 (- 4.98, - 3.62); all p < 0.001). ASAS40 non-responders also had less improvement in PROs from Baseline to Week 104 vs. responders (e.g., total back pain: - 1.91 (- 2.30, - 1.52) vs. -4.75 (- 5.05, - 4.46); MFI general fatigue: - 0.63 (- 1.56, 0.30) vs. -4.64 (- 5.37, - 3.91); all p < 0.001). CONCLUSION: Composite indices are valid for monitoring treatment response and adequately reflect treatment-related changes experienced by patients with nr-axSpA. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01258738. Registered 9 December 2010.

Costs associated with non-medical switching from originator to biosimilar etanercept in patients with rheumatoid arthritis in the UK.

Aims: To estimate the cost impact of non-medical switching from originator to biosimilar etanercept in stable patients with rheumatoid arthritis (RA) in the UK. Materials and methods: A cohort-based decision tree model was developed with a 1-year time horizon. The model population included patients with stable RA (patients who responded to originator etanercept treatment with no treatment changes in the previous 6 months). Patients could undergo a non-medical switch to a biosimilar and then switch treatment again, if medically required, after 3-6 months. Data on the proportion of patients switching therapies, baseline healthcare resource use, and impact of switching on resource use were sourced from a survey of 150 rheumatologists from EU5 markets (France, Germany, Italy, Spain, UK). The average impact of switching was evaluated as mean values for change in resource utilization due to switching. Also, low- and high-impact scenarios (lower and upper values of the 95% confidence intervals for change in resource utilization due to switching) were modelled as sensitivity analyses. Cost data came from published UK sources. Results: The model assumed that 5,000 patients were treated with originator etanercept, with 1,259 (25.2%) switching to a biosimilar. Of those, 875 (69.5%) and 384 (30.5%) switched to SB4 and GP2015, respectively. After 3 months, 26.3% of patients who switched treatments did so again: 8.3% back to originator, 3.8% to the other biosimilar, and 14.2% to another biologic. Although originator etanercept was more expensive than the biosimilars, switching was more costly than continuous originator treatment across all impact scenarios. Switching treatment chains had higher overall annual per-patient costs than continuous originator treatment. Switching was associated with increased healthcare resource use. Limitations: Results from this analysis are not transferable to other (non-RA) etanercept indications. Conclusion: Non-medical switching can result in increased payer costs because of increased healthcare resource use following switching.

Factors influencing the use of biologic therapy and adoption of treat-to-target recommendations in current European rheumatology practice.

OBJECTIVE: The aim of this study was to identify factors that influence treatment adjustments and adoption of a treat-to-target (T2T) strategy in patients with rheumatoid arthritis (RA) in European practices. METHODS: Cross-sectional data were drawn from the Adelphi 2014 RA Disease Specific Programme. Treatment patterns and clinical characteristics were investigated in patients treated with biologic disease-modifying antirheumatic drugs (bDMARDs) vs non-bDMARDs. For the T2T analysis, patients were subdivided into two subsets (RA diagnosis <2 or ≥2 years) and compared according to the approach used (no target = no T2T approach; pragmatic = target different from remission; and aspirational = target set as remission). RESULTS: Data from 2,536 patients were analyzed (mean age: 52.76 years and mean time since RA diagnosis: 6.05 years). Of the 1,438 patients eligible to receive bDMARDs, 55% did not receive them. Initiation of bDMARDs in a bDMARD-naïve patient was prompted by worsening of the disease. In the RA diagnosis <2 years subset, a T2T approach was not adopted in 58% of the patients, whereas 8% and 34% adopted a pragmatic and aspirational approach, respectively. In the RA diagnosis ≥2 years subset, 45%, 19%, and 36% of the patients adopted a no target, pragmatic, and aspirational approach, respectively. Physician satisfaction with RA control was lower in the RA diagnosis <2 years subset than in the RA diagnosis ≥2 years subset (65% vs 77% satisfied, respectively; P<0.0001). CONCLUSION: This analysis shows that the use of bDMARDs remains suboptimal and that a T2T strategy is not universally adopted.

Clinical characteristics and patient-reported outcomes in patients with inadequately controlled rheumatoid arthritis despite ongoing treatment.

BACKGROUND: Despite the wide array of treatments available for rheumatoid arthritis (RA), some patients continue to report unmet clinical needs. We investigated the extent of inadequate disease control in patients with RA. METHODS: Data were drawn from the Adelphi 2014 RA Disease-Specific Program in France, Germany, Italy, Spain and the UK. Rheumatologists provided patient demographics, comorbidities, satisfaction with RA control and other clinical details. Patients reported their level of satisfaction and completed the EuroQoL 5-Dimensions Health Questionnaire and Work Productivity and Activity Impairment Questionnaire. Patients had been on their current therapy ≥3 months and had 28-joint disease activity scores (DAS28) reported. Adequately controlled (DAS28 ≤3.2) and inadequately controlled (DAS28 >3.2) patient cohorts were compared using univariate tests. RESULTS: Of 1147 patients, 74% were women, the mean age was 52 years and the mean time since RA diagnosis was 7 years. Twenty-seven percent of patients had inadequately controlled RA, whereas 73% had adequately controlled RA. Inadequately controlled patients were more affected clinically versus adequately controlled patients; 69% vs 13% had moderate/severe RA, the current level of pain was 4.6 vs 2.3, and 67% vs 41% experienced flares, respectively (all p<0.0001). Inadequately controlled patients had higher rates of depression (16% vs 5%; p<0.0001), worse health state, greater work and activity impairment, and lower satisfaction rates among the patients and their physicians than the adequately controlled cohort. CONCLUSION: RA was insufficiently controlled in over a quarter of patients despite their current therapy and this had a negative impact on the patients.

A structured literature review of the burden of illness and unmet needs in patients with rheumatoid arthritis: a current perspective.

While rheumatologists often focus on treatment targets, for many patients with rheumatoid arthritis (RA), control over pain and fatigue, as well as sustaining physical function and quality of life (QoL), is of primary importance. This literature review aimed at examining patients' and physicians' treatment aspirations, and identifying the unmet needs for patients with RA receiving ongoing treatment. Searches were performed using MEDLINE, Embase, PsycINFO, and Econlit literature databases for articles published from 2004 to 2014 in the English language. Published literature was screened to identify articles reporting the unmet needs in RA. We found that, despite the wide range of available treatments, RA continues to pose a substantial humanistic and economic burden on patients, and there are still unmet needs across key domains such as pain, physical function, mental function, and fatigue. These findings suggest that there is a need for further treatment advances in RA that address these domains of contemporary unmet need.

A European chart review study on early rheumatoid arthritis treatment patterns, clinical outcomes, and healthcare utilization.

This retrospective medical chart review aimed to provide a current, real-world overview of biologic usage in patients with rheumatoid arthritis (RA) in Germany, Spain, and the UK, and estimate clinical and healthcare utilization outcomes associated with early versus late treatment. Adults (≥18 years) with a confirmed RA diagnosis between January 2008 and December 2010, who received biologic treatment for ≥3 months and had ≥12 months of follow-up were included. Early treatment was receipt of biologic agent ≤1 year after RA diagnosis. Outcomes included 28-joint disease activity score (DAS28) reduction of ≥1.2 from biologic start and remission (DAS28 < 2.6). Time to outcome was evaluated using Kaplan-Meier curves and log-rank tests. Of 328 patients enrolled (Germany [n = 111], Spain [n = 106], UK [n = 111]), 58.2 % received early biologic (Germany: 55.0 %, UK: 55.9 %, Spain: 64.2 %; p = 0.321). First-line biologics were more frequent in Spain (26.4 %) and Germany (19.8 %) versus the UK (7.2 %; p < 0.001). Late-treated patients were hospitalized more often than early-treated patients (10.5 vs 2.9 % [p = 0.006] for 9.0 vs 5.4 mean inpatient days [p = 0.408]). DAS28 was 5.1 at biologic initiation (n = 310); 73.5 % of patients had a DAS28 decrease of ≥1.2 and 44.5 % achieved remission. More patients had DAS28 decrease of ≥1.2 (79.2 vs 65.9 %; p = 0.009) and remission (51.1 vs 35.6 %; p = 0.007) with early versus late treatment, with a significant difference in Kaplan-Meier curves when indexing on time since diagnosis (p < 0.001) and biologic start (p = 0.024). In RA patients receiving biologic therapy, over half received biologic therapy early. Early initiation was associated with improved clinical outcomes and reduced hospitalization rates versus late treatment.

Burden of dose escalation with tumour necrosis factor inhibitors in rheumatoid arthritis: a systematic review of frequency and costs.

OBJECTIVES: Optimising therapy to minimise disease activity is the goal for treating rheumatoid arthritis (RA) today. In refractory disease requiring biologics, the ability to modify therapy may be limited. In the case of the most widely used biologics, the TNF inhibitors (TNFi), dose escalation consisting of increasing the dose and/or shortening the interval between doses is often reported. METHODS: We systematically searched PubMed, EMBASE, Cochrane and Centre of Disseminated Reviews for reports of dose escalation of TNFi in RA and the economic effects of such a practice. RESULTS: Of 41 publications, 36 reported dose escalation and a weighted proportion of dose escalators was calculated for each drug. The proportion of dose escalators varied widely (adalimumab 7.5% to 36%, etanercept 0% to 22%, and infliximab 0% to 80%) due to a variety of methods for defining dose escalation. Based on 33 studies, the weighted proportion of dose escalators was adalimumab 14.9%, etanercept 4.9% and infliximab 41.7%. Six studies reported economic data comparing dose escalators with non-dose escalators. Adalimumab drug costs increased 27% to 43%, with total costs increasing 28% to 34%; infliximab drug costs increased 14% to 71%, RA-related costs increased 25% to 54% and total costs increased 14% to 34% and etanercept drug costs increased 3.2% to 19%, RA-related costs increased 4.5% and total costs increased 2.2% to 15%. CONCLUSIONS: Escalating the dose of TNFi in inadequate responders in RA is widespread, occurring most frequently with infliximab and least with etanercept. This practice not only increases drug costs, but also RA-related and total costs.

Early treatment of psoriatic arthritis is associated with improved patient-reported outcomes: findings from the etanercept PRESTA trial.

OBJECTIVES: The present paper aims to investigate the effect of psoriatic arthritis (PsA) disease duration on the outcome of treatment with etanercept (ETN) in patients with PsA who also have moderate-to-severe psoriasis. METHODS: Patients from the PRESTA trial who received ≥1 ETN 50 mg once weekly (QW) dose and had ≥1 post-baseline value were evaluated. Baseline and after-treatment changes were compared between patients with PsA ≤2 years versus PsA >2 years in efficacy measures (physician global assessment [PGA] arthritis, swollen joint count and Psoriasis Area and Severity Index [PASI]) and patient reported outcomes (PROs; joint pain, arthritis activity, Euro-Qol [EQ-5D] utility and visual analogue score [VAS]) using linear regression analysis. RESULTS: Baseline efficacy measures were similar between the PsA ≤2 years (n=103) and PsA >2 years (n=269) groups, with the exception of PGA arthritis (p=0.006). At week 24, improvements in efficacy measures were observed in both groups but were significantly greater for PGA arthritis in the PsA ≤2 years group (p=0.03). Quality of life (QoL), measured using PROs, was generally lower at baseline in patients with PsA >2 years. Clinically meaningful improvements were seen in QoL with ETN treatment in both groups, but the change from baseline scores at week 24 were significantly higher in PsA ≤2 years group for joint pain (p=0.007), arthritis activity (p=0.01), EQ-5D utility (p=0.046) and EQ-5D VAS (p=0.04) responses. CONCLUSIONS: PsA patients responded to ETN 50 mg QW treatment irrespective of disease duration; however, patients with shorter PsA duration had greater improvements in arthritis scores and several PRO measures.

Aspergillosis in Intensive Care Unit (ICU) patients: epidemiology and economic outcomes.

BACKGROUND: Few data are available regarding the epidemiology of invasive aspergillosis (IA) in ICU patients. The aim of this study was to examine epidemiology and economic outcomes (length of stay, hospital costs) among ICU patients with IA who lack traditional risk factors for IA, such as cancer, transplants, neutropenia or HIV infection. METHODS: Retrospective cohort study using Premier Inc. Perspective™ US administrative hospital database (2005-2008). Adults with ICU stays and aspergillosis (ICD-9 117.3 plus 484.6) who received initial antifungal therapy (AF) in the ICU were included. Patients with traditional risk factors (cancer, transplant, neutropenia, HIV/AIDS) were excluded. The relationship of antifungal therapy and co-morbidities to economic outcomes were examined using Generalized linear models. RESULTS: From 6,424 aspergillosis patients in the database, 412 (6.4%) ICU patients with IA were identified. Mean age was 63.9 years and 53% were male. Frequent co-morbidities included steroid use (77%), acute respiratory failure (76%) and acute renal failure (41%). In-hospital mortality was 46%. The most frequently used AF was voriconazole (71% received at least once). Mean length of stay (LOS) was 26.9 days and mean total hospital cost was $76,235. Each 1 day lag before initiating AF therapy was associated with 1.28 days longer hospital stay and 3.5% increase in costs (p < 0.0001 for both). CONCLUSIONS: Invasive aspergillosis in ICU patients is associated with high mortality and hospital costs. Antifungal timing impacts economic outcomes. These findings underscore the importance of timely diagnosis, appropriate treatment, and consideration of Aspergillus as a potential etiology in ICU patients.

Resource utilization and cost of treatment with anidulafungin or fluconazole for candidaemia and other forms of invasive candidiasis: focus on critically ill patients.

BACKGROUND: Candidaemia and other forms of invasive candidiasis (C/IC) are serious and costly events for hospitalized patients, particularly those in the ICU. Both fluconazole and the echinocandins are recommended as first-line therapy for C/IC. Resource use and cost considerations are important in selecting appropriate treatment but little information is available on the economic implications of using echinocandins in this setting. OBJECTIVE: To compare resource utilization and treatment costs (in $US) associated with the echinocandin anidulafungin (200 mg intravenously on day 1, then 100 mg intravenously daily) versus those of fluconazole (800 mg intravenously on day 1, then 400 mg intravenously daily) as first-line treatment for C/IC. METHODS: Available charts from patients enrolled in a recent clinical trial comparing anidulafungin and fluconazole for C/IC were reviewed. Patients who were in the ICU at study entry were identified, and the following data, collected during the 13-week study period, were compared between treatment groups: global response at end of study treatment, number of days patients survived after hospital discharge ('hospital-free' days), hospital resource use, and C/IC-related costs (year 2008 values) to a US hospital payer. These comparisons were also conducted for all non-ICU hospitalized patients, and for survivors in both study populations. Sensitivity analyses explored the cost impact of variability in the hospitalization costs between ICUs and non-ICU wards and of reduced duration intravenous therapy. Statistical comparisons between the two treatment groups were conducted for clinical outcomes, resource use and cost measures, using regression models. All statistical comparisons were adjusted for baseline co-variates (Acute Physiology and Chronic Health Evaluation [APACHE] II score, absolute neutrophil count and catheter removal status). RESULTS: For ICU patients with C/IC (n = 63), global response was significantly higher for anidulafungin than fluconazole (68.6% vs 42.9%; p = 0.03). ICU patients treated with anidulafungin had an average of 13.9 more hospital-free days (18.2 vs 4.3 days; p = 0.04) than those treated with fluconazole. After adjustment for co-variates, although lower costs were observed for anidulafungin vs fluconazole in ICU patients and in ICU patients who survived, no statistical differences were found. For all hospitalized patients (n = 159), global response was also higher for anidulafungin (78.3% vs 60.5%; p < 0.01). There was no difference in average length of hospitalization (29.6 days) or hospital-free days. After adjustment for co-variates, anidulafungin treatment resulted in an incremental C/IC-related cost of $US2680 (p = 0.73). For hospitalized patients who survived (anidulafungin 81.9%, fluconazole 69.7%), anidulafungin treatment was associated with an incremental cost of $US231 (p = 0.98). CONCLUSION: Anidulafungin as first-line treatment of C/IC appears to be of particular benefit to ICU patients, improving clinical outcomes and possibly decreasing costs, driven by reduced ICU and hospital stay, when compared with fluconazole. Anidulafungin also yielded significantly improved treatment outcomes in the general inpatient population, with total costs similar to fluconazole.

US hospital database analysis of invasive aspergillosis in the chronic obstructive pulmonary disease non-traditional host.

OBJECTIVES: Invasive aspergillosis (IA) is reported increasingly in non-traditional hosts, typically patients with chronic obstructive pulmonary disease (COPD). Objectives were to describe the excess burden of IA in COPD, including mortality, resource utilization, and costs, as well as to examine the impact of initial antifungal selection on clinical and economic outcomes. METHODS: This retrospective cohort study used national data from 2005 to 2008, from the Premier Perspective hospital database. IA was identified using proxy ICD-9 codes based on published algorithms. The COPD + IA patient cohort was analyzed using descriptive statistics. Excess resource utilization was analyzed by matching cases (COPD + IA) and controls (COPD patients without aspergillosis) on demographic and clinical variables. Multivariate analyses were used to assess the impact of initial antifungal drug selection on outcomes in COPD + IA. RESULTS: In total, 475 COPD + IA patients were identified (mean age 69 years, 50% male, 76% Caucasian). COPD + IA cases had significantly higher costs, length of stay, intensive care unit (ICU) stay, and mortality compared to COPD controls (all p < 0.01). On average, antifungal therapy was initiated on hospital day 6, with mean length of therapy 15 days, and one-third of patients were in the ICU when antifungal treatment was initiated. Most commonly used antifungals were voriconazole, fluconazole, and caspofungin. Patients receiving fluconazole as the initial antifungal, an agent inactive against moulds, had almost two times greater mortality (p = 0.016), two additional hospital days (p = 0.002), and 25% greater costs (p = 0.007), compared to patients receiving voriconazole first-line. Findings were consistent in sub-analyses including ICU patients. LIMITATIONS: 'Invasive' form of aspergillosis was identified using proxy ICD-9 codes based on published literature. Additional limitations stem from the study's non-randomized, retrospective design that is typical with any database analyses. CONCLUSIONS: COPD + IA patients had significantly higher mortality, resource utilization, and costs versus COPD controls. Treatment with an agent active against Aspergillus was associated with better survival and reduced economic burden, therefore this potential etiology of pneumonia should be considered when contemplating antifungal therapy in COPD patients.

Cost and resource utilization associated with fluconazole as first-line therapy for invasive candidiasis: a retrospective database analysis.

BACKGROUND: Fluconazole is a standard first-line therapy for candidemia/invasive candidiasis (C/IC), based on its efficacy, safety profile, and comparatively low acquisition cost. However, little is known about the total costs associated with fluconazole treatment for this indication, particularly in cases of clinical failure. OBJECTIVE: The aim of this study was to examine overall costs, resource use, and treatment outcomes associated with fluconazole as first-line therapy for invasive Candida infections in the United States. METHODS: A retrospective analysis of data from a US hospital-based (>500 hospitals), service-level database was performed. All patients aged >16 years with primary or secondary International Classification of Diseases, Ninth Revision, Clinical Modification codes for IC or septicemia, receiving intravenous fluconazole treatment, and discharged between October 1, 2004 and September 30, 2005 were selected. Costs and resource use were calculated from the start of antifungal therapy until discharge. Two groups were analyzed: patients who received fluconazole only and those who required a second-line antifungal. Separate analyses for the survivor subpopulations were also conducted. RESULTS: A total of 7170 patients met the inclusion criteria; 21.2% required an additional antifungal agent. Overall mortality was 27.1%, and total mean treatment cost for all patients was $44,482 (in 2005 US dollars). Patients treated with fluconazole alone incurred mean costs of $36,319. Mean hospital and intensive care unit stays in the fluconazole monotherapy group were 17.9 days and 7.1 days, respectively. Patients requiring additional therapy had a mortality rate of 34.5% and a mean treatment cost of $76,329; in this group, the mean hospital and intensive care unit stays were 31.7 days and 14.8 days, respectively. CONCLUSIONS: The overall resource use associated with fluconazole as first-line treatment for C/IC was high, especially in patients who required additional antifungal therapy. Future studies should examine the patterns of care and costs associated with alternative treatment options as first-line C/IC therapy.