Mortality Among Veterans with a Diagnosis of Pyruvate Kinase (PK) Deficiency: A Real-World Study Using US Veterans Health Administration Data

Background: Pyruvate kinase (PK) deficiency is a rare, inherited disorder caused by autosomal recessive mutations in the PKLR gene, whereby a glycolytic defect causes reduced adenosine triphosphate levels and leads to hemolytic anemia. Patients with PK deficiency can experience serious complications associated with the disease and its treatment, including osteoporosis, pulmonary hypertension, sepsis, iron overload, and liver cirrhosis. The current standard of care for PK deficiency is supportive, including blood transfusions, splenectomy, iron chelation therapy and/or interventions for other disease-related morbidity. There is no approved therapy for this condition. Identifying PK deficiency in real-world data is challenging due to a lack of diagnosis codes and treatments that are specific to PK deficiency. As a result, population-based studies of PK deficiency using claims or electronic health record databases are limited. In addition, data on mortality in this patient population are lacking and limited to a few individual case reports. This study aimed to identify patients with a PK deficiency diagnosis as documented by physicians and to compare their mortality to an age- and gender-matched cohort of individuals without PK deficiency. Methods: Patients with ≥ 1 diagnosis code related to PK deficiency (i.e., anemia due to disorders of glycolytic enzymes [International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) D55.2], other hemolytic anemias due to enzyme deficiency [ICD-9-CM 282.3], or unspecified hereditary hemolytic anemia [ICD-9-CM 282.9, ICD-10-CM D58.9]) between January 1995 and July 2019 were selected from the US Veterans Health Administration (VHA) database. To be considered for inclusion, physicians' notes were required to contain the words "pyruvate", "kinase", and "deficiency." A manual review of these physicians' notes was performed to identify patients with a physician-documented diagnosis of PK deficiency (PK deficiency cohort). The index date for the PK deficiency cohort was defined as the date of the first medical record with a diagnosis code related to PK deficiency. Each patient in the PK deficiency cohort was matched 1:5 by age at index, sex, and index year (± 1 year) to patients from the general VHA population with no diagnosis codes related to PK deficiency (non-PK deficiency cohort). The index date for the non-PK deficiency cohort was defined as a random visit date during their match's index year. Survival time from the index date was compared between the PK deficiency cohort and their non-PK deficiency cohort matches using a univariate Cox proportional hazards model with robust standard error estimation. Results: A total of 18 patients met inclusion criteria for the PK deficiency cohort and were matched to 90 individuals in the non-PK deficiency cohort. Baseline characteristics for both cohorts are shown in the Table. For both cohorts, the mean age at index was 57 years and 94% of patients were male; 83-85% were white and the mean Charlson Comorbidity Index score was 0.4-0.5 (no significant differences between cohorts). Imbalances remained between the two cohorts with regard to region and body mass index. The median follow-up was 6.0 years for the PK deficiency cohort and 8.0 years for the non-PK deficiency cohort. Over the follow-up period, there were 9 (50%) observed deaths in the PK deficiency cohort and 28 (31%) observed deaths in the non-PK deficiency cohort. The median time until death was 10.9 years for the PK deficiency cohort and 17.1 years for the non-PK deficiency cohort; the Kaplan-Meier curves for both cohorts are shown in the Figure. Patients in the non-PK deficiency cohort had a significantly longer time to death than the PK deficiency cohort (hazard ratio: 2.3; p = 0.0306); 10 years after index, 42% of patients in the PK deficiency cohort had died compared with 28% of those in the non-PK deficiency cohort. Conclusions: The results of this study suggest that patients with PK deficiency may be at an increased risk of mortality. Further research to understand cause of death in this population is warranted, as is the replication of this study using larger sample sizes and other real-world data sources that better represent females and the pediatric and adolescent PK deficiency age groups. Disclosures Zagadailov: Agios Pharmaceuticals: Current Employment, Current equity holder in publicly-traded company. Boscoe:Agios Pharmaceuticals: Current Employment, Current equity holder in private company. Garcia-Horton:Agios Pharmaceuticals: Consultancy; Analysis Group, Inc.: Current Employment. Shi:Agios Pharmaceuticals: Consultancy; Analysis Group, Inc.: Current Employment. Liu:Analysis Group, Inc.: Consultancy. Shi:Analysis Group, Inc.: Consultancy. Macaulay:Agios Pharmaceuticals: Consultancy; Analysis Group, Inc.: Current Employment.

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Comparable Overall Survival with Rituximab-Bendamustine (R-Benda) and Rituximab-Gemcitabine-Oxaliplatin (R-GemOx) When Used As Second-Line (2L) Treatment for Diffuse Large B-Cell Lymphoma (DLBCL): A Real-World Study Using US Veterans Health Administration Data

Blood ◽

10.1182/blood-2018-99-113039 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 1711-1711 ◽

Cited By ~ 1

Author(s):

Raluca Ionescu-Ittu ◽

Aijing Shang ◽

Nancy Vander Velde ◽

Annie Guérin ◽

Yilu Lin ◽

...

Keyword(s):

Real World ◽

Research Funding ◽

Veterans Health Administration ◽

Treatment Patterns ◽

Veterans Health ◽

Health Administration ◽

Real World Data ◽

Analysis Group ◽

Kaplan Meier

Abstract Introduction: DLBCL is the most common subtype of non-Hodgkin lymphoma. R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone) is established as the standard of care for patients (pts) with previously untreated DLBCL, but ~40% of pts will eventually relapse. For relapsed/refractory pts who are ineligible for transplant, clinical guidelines propose a broad spectrum of therapeutic options. However, little is known about treatment patterns and outcomes associated with 2L therapy in routine practice, particularly for pts less suitable for intensive therapy. Therefore, using real-world data, we evaluated 2L treatment patterns in DLBCL pts and overall survival (OS) in those pts who received 2L R-Benda or R-GemOx. We focused on these 2 treatments as they are typically used in the non-transplant setting in pts less suitable for aggressive therapy, and can typically be administered in an outpatient setting. Methods: DLBCL pts receiving care from the US Veterans Health Administration were identified through their electronic medical records and raw oncology domain. Pts diagnosed with DLBCL (and no prior other types of malignancies) between 2004-2016, with ≥1-month follow-up and who received 2L treatment were included. OS (defined as time from the start of 2L therapy until death) was analyzed in pts who received 2L R-Benda or R-GemOx using the Kaplan-Meier method. Surviving pts were censored at data cutoff (December 31, 2017). Univariate and multivariate Cox regression analyses were undertaken to assess the impact of 2L treatment (in particular, R-GemOx vs R-Benda) on OS. Results: A total of 2600 DLBCL pts were identified: 2039 received 1L and 702 received 1L and 2L therapy. Among the 702 pts treated with 2L therapy, regimens included R-ICE (n=77; 11.0%), R-CHOP (n=75; 10.7%), rituximab monotherapy (n=34; 4.8%), R-Benda (n=32; 4.6%), methotrexate (n=24; 3.4%), R-ESHAP (n=23; 3.3%), R-DHAP/R-EPOCH/R-GDP (n=18; 2.6%), rituximab plus cyclophosphamide-doxorubicin-vinblastine-vincristine (n=14; 2.0%), R-CVP (n=11; 1.6%), rituximab plus cyclophosphamide-etoposide-vincristine (n=11; 1.6%), and R-GemOx (n=10; 1.4%). Of the remaining pts, 267 (38.0%) received regimens with agent(s) included in the NCCN guidelines, while 106 (15.1%) received regimens with at least 1 agent not guideline-recommended. Baseline characteristics for pts treated with 2L R-Benda (n=32) or R-GemOx (n=10) are shown in Table 1. There was an imbalance between the 2 cohorts with regard to race, number of involved lymph nodes, B symptoms, Charlson Comorbidity Index score, and abnormal lactate dehydrogenase results. After 24 deaths in the R-Benda cohort and 7 deaths in the R-GemOx cohort, median OS was estimated at 11 and 13 months, respectively (Figure 1). Median follow-up time after start of 2L treatment was 11.3 and 11.7 months, respectively. The Kaplan-Meier curves of the 2 cohorts overlapped at multiple timepoints during follow-up. Respective 1-year OS rates (95% confidence interval [CI]) with R-Benda and R-GemOx were 50.0% (31.9%, 65.7%) and 60.0% (25.3%, 82.7%). Compared with R-Benda, R-GemOx did not significantly predict longer OS in either the univariate (hazard ratio [HR]: 0.94; 95% CI: 0.41, 2.19; p=0.893) or multivariate (HR: 1.07; 95% CI: 0.46, 2.50; p=0.873) analyses. Conclusions: This real-world study highlights the diversity of 2L treatment regimens used in DLBCL pts. There was no apparent difference in OS between R-Benda- and R-GemOx-treated pts and, with a median OS of approximately 1 year after 2L initiation with either regimen, there is clearly an unmet need in this setting. The main limitation of the study relates to the small sample size of each treatment cohort. Further research using other real-world data sources is warranted. Disclosures Ionescu-Ittu: Analysis Group, Inc.: Employment; F. Hoffman-La Roche Ltd: Consultancy, Other: I am an employee of Analysis Group, Inc., which received consulting fees from Roche for the conduct of this study. Shang:F. Hoffmann-La Roche Ltd.: Employment, Other: Ownership interests non-PLC. Guérin:F. Hoffman-La Roche Ltd: Other: I am an employee of Analysis Group, Inc., which received consulting fees from Roche for the conduct of this study; Analysis Group, Inc.: Employment. Shi:F. Hoffman-La Roche Ltd: Research Funding; Bravo4Health: Other: Ownership interests non-PLC; Genentech: Research Funding; Chiasma: Research Funding; Intuitive Surgical: Consultancy. Shi:F. Hoffman-La Roche Ltd: Other: I am an employee of Analysis Group, Inc., which received consulting fees from Roche for the conduct of this study; Analysis Group, Inc.: Employment. Qayum:F. Hoffmann-La Roche Ltd: Employment.

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Real-world clinical and economic outcomes among newly-diagnosed merkel cell carcinoma (MCC) patients initiating first-line (1L) checkpoint inhibitors (CPIs) or chemotherapy (CT) in the veterans health administration (VHA).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e21002 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e21002-e21002

Author(s):

Hemant Phatak ◽

Shivani Pandya ◽

Ting Yu ◽

Mairead Kearney ◽

Li Wang ◽

...

Keyword(s):

Treatment Failure ◽

Real World ◽

Index Date ◽

Checkpoint Inhibitors ◽

Economic Outcomes ◽

Veterans Health ◽

Newly Diagnosed ◽

Health Administration ◽

Comorbidity Burden

e21002 Background: The use of CPIs among patients (pts) with metastatic MCC, a rare and aggressive skin cancer, has increased since the US FDA approval of avelumab and the National Cancer Comprehensive Network (NCCN) recommendation of CPIs in 2017. Given the growing interest in understanding real-world clinical and economic outcomes associated with CPI use, this study assessed time to treatment failure (TTF), overall survival (OS), healthcare resource utilization (HRU), and costs among MCC pts receiving NCCN-recommended 1L regimens including CPIs and CT in the VHA. Methods: This is a retrospective analysis of pts with newly-diagnosed MCC who initiated 1L treatment between October 2013 and January 2018 (index date = 1L therapy start date) and had continuous enrollment from ≥6 months pre-initial MCC diagnosis date until ≥2 months post-index date (follow-up). The index date to earliest of death or subsequent line of therapy start was used as a proxy for TTF. TTF and OS were estimated using Kaplan Meier method. All-cause HRU and costs (2018 USD) per patient per month (PPPM) were evaluated during TTF or until end of follow-up, whichever occurred first. Results: Of 120 MCC pts (72% pre-2017) initiating 1L therapy, 62% received NCCN-recommended regimens, including 17% and 45% treated with CPIs and CTs. Pts receiving CPIs were on average older with higher baseline comorbidity burden. The clinical and economic outcomes of these two pt groups are summarized in the table below. Conclusions: The current descriptive non-comparative analyses provide new information on the trends in clinical and economic outcomes of MCC pts treated in the VHA. Despite higher costs, the utilization of newly-approved CPIs in 1L setting showed delayed treatment failure and reduced all-cause HRU vs. CTs. These findings require further validation in studies with larger patient cohorts and longer follow-up. [Table: see text]

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Treatment patterns and characteristics of acute promyelocytic leukemia (APL) patients receiving arsenic trioxide (ATO) therapy in a real-world setting.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e18522 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e18522-e18522

Author(s):

Boxiong Tang ◽

Susan Gabriel ◽

Jifang Zhou ◽

Ashutosh K. Pathak ◽

Debra Irwin ◽

...

Keyword(s):

Real World ◽

Index Date ◽

Claims Data ◽

Treatment Patterns ◽

Chronic Obstructive ◽

Administrative Claims ◽

First Line ◽

Real World Data ◽

World Data

e18522 Background: Clinical trials have shown that low-risk APL patients had significantly better outcomes when receiving first-line all-trans retinoic acid (ATRA) + ATO compared with standard ATRA + chemotherapy. Few published studies have used real-world data to describe patients using ATO and their current treatment patterns. This study used United States (US) administrative claims data to describe treatment patterns and characteristics of patients receiving first-line ATO. Methods: This retrospective, observational cohort study used claims data from the MarketScan databases. As there is no ICD-9-CM diagnosis code for APL, ATO treatment was used as a surrogate for the diagnosis of APL since ATO is typically used only in APL patients. Patients were selected if they had ≥1 claims for ATO between January 1, 2000, and June 30, 2015. Date of first use was designated the index date. To identify first-line ATO initiation, patients with ATRA or other APL-indicated chemotherapy claims any time before the index date were excluded. Variable baseline and follow-up periods consisting of ≥3 months of pre-index and ≥30 days of post-index continuous enrollment in medical and pharmacy benefit were used. Results: In total, 331 patients were identified with a subset (n = 265) having ≥2 claims for ATO. The analysis focused on these 265 patients, 54% of whom were male. Mean age was 60.6 years; 45% were covered by Medicare. The most common comorbid conditions measured were diabetes (6%), chronic obstructive pulmonary disease (5%), and congestive heart failure (4%). The most commonly selected APL treatments administered during follow-up were ATRA (17%) and daunorubicin (9%) with the use of idarubicin, cytarabine, and mitoxantrone at less than 3%. Maintenance therapy with methotrexate or 6-mercaptopurine was observed in 7% and 6% of patients, respectively. Conclusions: This is one of the first studies to examine patient characteristics and treatment patterns for first-line ATO using real-world data. Further research is needed to evaluate outcomes for patients receiving ATO as first-line therapy and to re-evaluate treatment guidelines in light of these outcomes.

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Serious infections and cardiovascular complications among patients with chronic lymphocytic lymphoma treated with first-line ibrutinib or bendamustine/rituximab.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e19503 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e19503-e19503

Author(s):

Debra E. Irwin ◽

Stephen Thompson ◽

Rinat Ribalov ◽

Azhar Choudhry

Keyword(s):

Real World ◽

Index Date ◽

Cardiovascular Complications ◽

Administrative Claims ◽

First Line ◽

Real World Data ◽

World Data ◽

Serious Infections ◽

Baseline Characteristics

e19503 Background: Clinical trials have shown positive outcomes associated with ibrutinib monotherapy (IM) and bendamustine / rituximab combination (BR) therapy in patients with chronic lymphocytic lymphoma (CLL) compared to other standard treatments, but limited real-world data exist. This study evaluated serious infections and cardiovascular complications in CLL patients treated with first-line IM or BR therapy using US real-world data. Methods: Administrative claims from the MarketScan® Research Databases were used to identify adult patients enrolled in commercial or Medicare supplemental insurance plans based on a first prescription fill of IM or BR therapy (the index date) from 2/1/14 to 9/1/19. Patients were diagnosed with CLL, treatment naïve, and continuously enrolled for ≥12 months prior to and following the index date. Serious infections and cardiovascular complications requiring hospitalization (diagnosis code in any position) were evaluated during a fixed 12-month follow-up period. Statistical differences in outcome distributions between the treatment groups were tested. Multivariate logistic regression models for lower respiratory tract infection (LRTI) and atrial fibrillation (AF) were also conducted to determine the adjusted odds of hospitalization. Results: Of 2,138 CLL patients, 810 had IM and 512 had BR as index therapy with ≥12 months of follow-up data. Patients receiving IM were older and more likely to have had an LRTI during baseline compared to BR patients, otherwise both groups had similar baseline characteristics. Hospitalization for serious infections was more common during follow-up among IM patients than BR patients (17.7% vs. 13.1%; p = 0.027). Specifically, 10.2% of IM patients had a bacterial infection hospitalization compared to 5.7% of BR patients (p = 0.004) and 10.7% of IM patients had a LRTI hospitalization compared to 6.6% of BR patients (p = 0.012). After adjusting for baseline characteristics, IM patients did not have significantly higher odds of a LRTI hospitalization (OR = 1.51; p = 0.069). Hospitalization for cardiovascular complications was more common during follow-up among IM patients than BR patients (18.3% vs. 11.9%; p = 0.002). Specifically, 8.4% of IM patients had an AF-related hospitalization versus 2.7% of BR patients (p < 0.001). After adjusting for baseline characteristics, IM patients were more likely to have a hospitalization for AF versus BR patients (OR = 3.89; p < 0.001). Conclusions: In a real-world setting, serious infections and cardiovascular complications were more common among CLL patients treated with first-line IM compared to BR during 12 months of follow-up. IM patients were more likely than BR patients to have an inpatient admission due to AF after adjusting for other patient characteristics.

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Real-world incidence and costs of serious infections and cardiovascular complications among patients with indolent non-Hodgkin lymphoma treated with first-line ibrutinib or bendamustine/rituximab.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e19528 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e19528-e19528

Author(s):

Debra E. Irwin ◽

Stephen Thompson ◽

Rinat Ribalov ◽

Azhar Choudhry

Keyword(s):

Hodgkin Lymphoma ◽

Real World ◽

Index Date ◽

Cardiovascular Complications ◽

Hospitalized Patients ◽

First Line ◽

Real World Data ◽

Non Hodgkin Lymphoma ◽

Serious Infections

e19528 Background: Patients with Indolent non-Hodgkin lymphoma (iNHL) have shown positive outcomes with ibrutinib monotherapy (IM) as well as bendamustine/rituximab combination (BR) therapy, but no studies have reported on patient outcomes using real-world data. The current analysis evaluated serious infections and cardiovascular complications in iNHL patients treated with first-line IM or BR therapy using US real-world data. Methods: Administrative claims from the MarketScan® Research Databases were used to identify adult patients enrolled in commercial or Medicare supplemental insurance plans based on a first prescription fill of IM or BR therapy (the index date) from 2/1/14 to 9/1/19. Patients included in the study were diagnosed with iNHL, were treatment naïve, and were continuously enrolled for ≥12 months both prior to and following the index date. Serious infections and cardiovascular complications requiring hospitalization (diagnosis code in any position) and associated inpatient costs were evaluated during a fixed 12-month follow-up period. Statistical differences in outcome distributions and costs (reported per patient per month [PPPM]) between the groups were tested. Results: Of 1,948 iNHL patients, 147 had IM and 1,058 had BR as index therapy with ≥12 months of follow-up data. Patients receiving IM were older, more often male, and more likely to have had a lower respiratory tract infection (LRTI) or atrial fibrillation (AF) during baseline compared to BR patients, otherwise the groups had similar baseline characteristics. Hospitalization for serious infections was similar for IM and BR patients during the follow-up period (17.0% vs. 14.4%; p = 0.397); among hospitalized patients, the IM and BR groups incurred similar PPPM inpatient costs ($2,839 vs. $3,954; p = 0.188). Specifically, 7.5% of IM patients had a bacterial infection hospitalization and incurred $2,561 PPPM vs 7.6% of BR patients who incurred $3,975 PPPM (both p > 0.05); 8.8% of IM patients had a LRTI hospitalization and incurred $3,629 PPPM vs 6.1% of BR patients who incurred $4,980 PPPM (both p > 0.05). Hospitalization for cardiovascular complications was similar during follow-up for IM and BR patients (15.6% vs. 12.2%; p = 0.237); among hospitalized patients, the IM and BR groups incurred similar PPPM costs ($3,777 vs. $3,862; p = 0.948). Specifically, 7.5% of IM patients had a hospitalization for AF and incurred $4,481 PPPM vs 3.6% of BR patients who incurred $4,860 PPPM (p = 0.025 and p = 0.875, respectively). Conclusions: In a real-world setting, serious infections and cardiovascular complications requiring hospitalization, including associated costs, were similar among iNHL patients treated with first-line IM or BR over 12 months, although IM patients were more likely to have an AF-related complication.

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Treatment patterns, healthcare resource use, economic, and survival outcomes associated with nonresectable advanced esophageal cancers in Taiwan.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.3_suppl.180 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 180-180

Author(s):

Yiling Tsai ◽

Chee Jen Chang ◽

Prakash Navaratnam ◽

Howard Steven Friedman ◽

Hong Xiao ◽

...

Keyword(s):

Squamous Cell Carcinoma ◽

Cell Carcinoma ◽

Squamous Cell ◽

Real World ◽

Index Date ◽

Financial Burden ◽

Research Database ◽

Real World Data ◽

Icd 10 ◽

Chemotherapeutic Treatment

180 Background: In Taiwan, limited real-world data indicate that initial EC diagnosis tends to occur at an advanced stage with limited therapeutic options and poor prognosis. Methods: This was a retrospective ‘real world’ observational study using the Taiwan National Health Insurance Research Database (NHIRD). Patients having at least one hospital record with a primary ICD-9 or ICD-10 code of EC were selected from Jan 1st, 2013 through Dec 31st, 2018. The first date of EC diagnosis was defined as the index date. Patients were followed for a minimum ± 30 days from the index date and were stratified by staging, clinical presentation (i.e. resectable vs. non-resectable advanced) and tumor histotype (squamous cell carcinoma, adenocarcinoma, unknown). Key characteristics such as demographics, clinical parameters, medication utilization, health care resource utilization, costs incurred, and survival were tracked for the overall population, resectable and non-resectable, advanced cohorts. Results: Patients identified with non-resectable advanced EC (N = 4,340) had a mean (SD) age of 59.7 (12.3) years and the vast majority were male (n = 4,044, 93.2%). Approximately half (50.4%) had Stage 3 disease and an additional 36.2% with stage 4, with the remainder Stage 1, 2 or Unknown. The majority (91.8%) were diagnosed with squamous cell carcinoma. 71.3% of patients received first line (1L) chemotherapy, most commonly with fluorouracil + cisplatin (69.9% of 1L) or platinum monotherapy (13.8% of 1L). 36.3% of patients survived one year with mean (SD) annualized post-index EC-related costs of New Taiwan (NT) $791,827.4 (NT$ 582,663.8). Conclusions: In Taiwan, the most common 1L chemotherapeutic treatment modality for Taiwanese patients with EC were fluorouracil + cisplatin. The EC-related costs for these patients appear to be a substantial financial burden in Taiwan.

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ICD-10 Coding of Musculoskeletal Conditions in the Veterans Health Administration

Pain Medicine ◽

10.1093/pm/pnab161 ◽

2021 ◽

Author(s):

Brian C Coleman ◽

Joseph L Goulet ◽

Diana M Higgins ◽

Harini Bathulapalli ◽

Todd Kawecki ◽

...

Keyword(s):

Secondary Analysis ◽

Spinal Pain ◽

Veterans Health Administration ◽

Specialty Care ◽

Veterans Health ◽

Health Administration ◽

Musculoskeletal Conditions ◽

Diagnosis Codes ◽

Icd 10 ◽

Musculoskeletal Care

Abstract Objective We describe the most frequently used musculoskeletal diagnoses in Veterans Health Administration (VHA) care. We report the number of visits and patients associated with common musculoskeletal ICD-10 codes and compare trends across primary and specialty care settings. Design Secondary analysis of a longitudinal cohort study. Subjects Veterans included in the Musculoskeletal Diagnosis Cohort with a musculoskeletal diagnosis from October 1, 2015 through September 30, 2017. Methods We obtained counts and proportions of all musculoskeletal diagnosis codes used and the number of unique patients with each musculoskeletal diagnosis. Diagnosis use was compared between primary and specialty care settings. Results Of over 6,400 possible ICD-10 M-codes describing “Diseases of the Musculoskeletal System and Connective Tissue”, 5,723 codes were used at least once. The most frequently used ICD-10 M-code was “Low Back Pain” (18.3%) followed by “Cervicalgia” (3.6%). Collectively, the 100 most frequently used codes accounted for 80% of M-coded visit diagnoses, and 95% of patients had at least one of these diagnoses. The most common diagnoses (spinal pain, joint pain, osteoarthritis) were used similarly in primary and specialty care settings. Conclusion A diverse sample of all available musculoskeletal diagnosis codes were used; however, less than 2% of all possible codes accounted for 80% of the diagnoses used. This trend was consistent across primary and specialty care settings. The most frequently used diagnosis codes describe the types of musculoskeletal conditions, among a large pool of potential diagnoses, that prompt veterans to present to VHA for musculoskeletal care.

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Overall survival (OS) in men with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) receiving bicalutamide (BIC) followed by enzalutamide (ENZA) or abiraterone (ABI).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.6_suppl.40 ◽

2020 ◽

Vol 38 (6_suppl) ◽

pp. 40-40

Author(s):

Daniel J. George ◽

Scott T. Tagawa ◽

Stanislav Lechpammer ◽

Dave Russell ◽

Agnes Hong ◽

...

Keyword(s):

Real World ◽

Index Date ◽

Proportional Hazards ◽

Cox Proportional Hazards ◽

Veterans Health ◽

Health Administration ◽

Castration Resistant Prostate Cancer ◽

First Line ◽

Cox Analysis ◽

The Impact

40 Background: The objective of this study was to evaluate real-world OS in men with chemotherapy-naïve mCRPC treated with first-line ENZA or ABI or sequencing to these agents after treatment with BIC ( > 90 d). Methods: A retrospective analysis was performed using the Veterans Health Administration (VA) database. Men with mCRPC and ≥ 1 pharmacy claim for ABI or ENZA (1st claim date = index date) following surgical or medical castration and with no chemotherapy treatment 12 months pre-index date were identified from 01APR2014 to 31MAR2017. Men had continuous VA enrollment for ≥ 12 months pre- index date and were followed until death or study end. Cox proportional hazards regression models examined the impact of treatment on OS, and the impact of first using BIC ( > 90 d) vs first-line use of ABI and ENZA on OS. Adjusted Kaplan-Meier analysis was conducted to graphically describe OS. Results: This study included 1229 ENZA- and 1945 ABI-treated men with mCRPC with mean ages of 74 and 73 y, respectively. Median follow‐up was 548 and 572 d, and median OS was 892 and 786 d, respectively. ENZA and ABI were first-line treatment in 1068 and 1628 men, but BIC ( > 90 d) was first used before sequencing to ENZA or ABI in 161 and 317 men, respectively. Median duration of BIC treatment was similar in men subsequently treated with ENZA or ABI (251 v 246 d, respectively). Compared with first-line ABI, use of ABI following BIC led to shorter OS (hazard ratio [HR] = 1.30; 95% CI 1.11 -1.52). Compared with first-line ENZA, use of ENZA following BIC resulted in a nonsignificant effect on OS (HR = 0.92; 95% CI 0.72-1.19). In the Cox analysis, ENZA-treated men had longer OS compared with ABI-treated men (HR = 0.84; 95% CI 0.76-0.94). Conclusions: Use of BIC ( > 90 d) before sequencing to ENZA did not negatively effect OS, however BIC before ABI impacted OS adversely in men with chemotherapy-naïve mCRPC. There are significant differences in OS favoring ENZA compared with ABI regardless of prior BIC. Real-world observational data are nonrandomized, and markers for disease severity/volume are not available in the claims database. Further research is required to confirm these findings.

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Impact of mepolizumab on exacerbations in severe asthma: Results from a U.S. insurance claims data base

Allergy and Asthma Proceedings ◽

10.2500/aap.2020.41.200043 ◽

2020 ◽

Vol 41 (5) ◽

pp. 341-347

Author(s):

Hector Ortega ◽

Beth Hahn ◽

Michael Bogart ◽

Christopher F. Bell ◽

Tim Bancroft ◽

...

Keyword(s):

Clinical Trial ◽

Severe Asthma ◽

Real World ◽

Clinical Studies ◽

Index Date ◽

Claims Data ◽

Real World Data ◽

Exacerbation Rate ◽

Asthma Exacerbations

Background: In controlled clinical studies, mepolizumab has been shown to reduce exacerbation rates and the use of oral corticosteroids as well as improve asthma control and health-related quality of life compared with placebo in patients with severe eosinophilic asthma. However, real-world data on the impact of mepolizumab on clinical outcomes are limited. Objective: To evaluate the effect of mepolizumab on asthma exacerbations and asthma exacerbation‐related costs in patients with severe asthma in U.S. clinical practice. Methods: This retrospective cohort study used U.S. administrative claims data from patients ages ≥12 years and with severe asthma at mepolizumab treatment initiation (index date; identification period, January 2015‐June 2017) who had received two or more mepolizumab administrations within 180 days of the index date and had no evidence of treatment with another asthma biologic. The exacerbation rate and exacerbation-related costs were assessed in both the 12 months before mepolizumab initiation (baseline period) and the following 12 months (follow-up period). A clinical trial‐like cohort was identified, defined as patients with two or more baseline exacerbations and ≥10 administrations during follow-up. Results: A total of 201 patients were included in the overall population and 74 patients in the clinical trial‐like cohort. Mepolizumab significantly reduced the exacerbation rate between the baseline and follow-up periods in both the overall population and the clinical trial‐like cohort (p < 0.001), which corresponded to 33.6% and 48.6% reductions, respectively. The rate of exacerbations in patients who required hospitalization between the baseline and follow-up periods was also reduced by 35.3% (p = 0.080) and 68.2% (p = 0.015) in the overall population and in the clinical trial‐like cohort, respectively. Cost data were inconclusive. Conclusion: This study, which used real-world data, demonstrated that mepolizumab is associated with reductions in asthma exacerbations, in line with the findings from controlled clinical studies. These results provided further evidence of the effectiveness of mepolizumab in a real-world setting.

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Real-world demographic and clinical characteristics of patients diagnosed with diffuse large B-cell lymphoma (DLBCL) in the United States (US).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.e18347 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. e18347-e18347

Author(s):

Xiaoqin Yang ◽

François Laliberté ◽

Guillaume Germain ◽

Monika Kumar Raut ◽

Mei Sheng Duh ◽

...

Keyword(s):

B Cell ◽

Hodgkin Lymphoma ◽

Real World ◽

Index Date ◽

Cell Lymphoma ◽

B Cell Lymphoma ◽

The United States ◽

Baseline Period ◽

Real World Data ◽

Icd 10

e18347 Background: DLBCL, the most common type of non-Hodgkin lymphoma in the US, is associated with significant morbidity and mortality. In October 2015, DLBCL was differentiated from other related lymphoma entities with the advent of ICD-10-CM DLBCL-specific codes. With limited real-world data on patients (pts) with DLBCL in the modern treatment era, this study was conducted to characterize these pts. Methods: A retrospective study was conducted using the Optum Clinformatics Data Mart database (01/2013–03/2018). Pts ≥ 18 years of age with ≥ 1 hospitalization or ≥ 2 outpatient visits with an ICD-10-CM diagnosis code for DLBCL (or an antecedent diagnosis of other lymphoma, which may have been assigned before confirmation of DLBCL) after October 1st, 2015 (index date) and no prior ICD-9-CM code for unspecified DLBCL were identified as incident. Pts with an ICD-9-CM code for unspecified DLBCL before October 2015 (index date) were classified as prevalent. At least 12 months of continuous enrollment pre-index date (baseline period) was required. Pts with ICD-10-CM code for primary mediastinal B-cell lymphoma (PMBCL), baseline diagnoses of other malignancies such as Hodgkin lymphoma and multiple myeloma were excluded. Characteristics, including baseline comorbidities, healthcare resource utilization, and costs were assessed. Results: Among 4,074 DLBCL pts (3,201 incident; 873 prevalent), mean age ± standard deviation (SD) was 71 ± 12 years; 46% were female. Incident and prevalent pts had mean Charlson comorbidity index scores of 2.7 and 2.3, respectively. Most common baseline Elixhauser comorbidities were hypertension (68.4%), diabetes (31.1%), and cardiac arrhythmia (25.3%) in incident pts and hypertension (62.5%), diabetes (28.3%), and chronic pulmonary disease (20.6%) in prevalent pts. Mean ± SD number of baseline hospitalizations was 0.32 ± 0.83 and 0.21 ± 0.49 in incident and prevalent pts, respectively. Total mean ± SD baseline healthcare costs (before diagnosis) were $24,621 ± 45,628 for incident pts and $19,137 ± 29,307 for prevalent pts. Conclusions: This study documents substantial co-morbid and economic burden of incident as well as prevalent pts with DLBCL.

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