scholarly journals Real-world treatment patterns and clinical outcomes for inpatients with COVID-19 in the US from September 2020 to February 2021

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261707
Author(s):  
Olulade Ayodele ◽  
Kaili Ren ◽  
Jing Zhao ◽  
James Signorovitch ◽  
Michele Jonsson Funk ◽  
...  

The objective of this retrospective cohort study was to describe pre-treatment characteristics, treatment patterns, health resource use, and clinical outcomes among adults hospitalized with COVID-19 in the United States (US) who initiated common treatments for COVID-19. The Optum® COVID-19 electronic health records database was used to identify patients >18 years, diagnosed with COVID-19, who were admitted to an inpatient setting and received treatments of interest for COVID-19 between September 2020 and January 2021. Patients were stratified into cohorts based on index treatment use. Patient demographics, medical history, care setting, medical procedures, subsequent treatment use, patient disposition, clinical improvement, and outcomes were summarized descriptively. Among a total of 26,192 patients identified, the most prevalent treatments initiated were dexamethasone (35.4%) and dexamethasone + remdesivir (14.9%), and dexamethasone was the most common subsequent treatment. At day 14 post-index, <10% of patients received any treatments of interest. Mean (standard deviation [SD]) patient age was 65.6 (15.6) years, and the most prevalent comorbidities included hypertension (44.8%), obesity (35.4%), and diabetes (25.7%). At the end of follow-up, patients had a mean (SD) 8.1 (6.6) inpatient days and 1.4 (4.1) days with ICU care. Oxygen supplementation, non-invasive, or invasive ventilation was required by 4.5%, 3.0%, and 3.1% of patients, respectively. At the end of follow-up, 84.2% of patients had evidence of clinical improvement, 3.1% remained hospitalized, 83.8% were discharged, 4% died in hospital, and 9.1% died after discharge. Although the majority of patients were discharged alive, no treatments appeared to alleviate the inpatient morbidity and mortality associated with COVID-19. This highlights an unmet need for effective treatment options for patients hospitalized with COVID-19.

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 43-43
Author(s):  
Amanda Wilson ◽  
Ahmed Daak ◽  
Jun Su

Introduction ITP is an autoimmune disorder characterized by platelet destruction and impaired production. Some patients with ITP are refractory or unresponsive to existing therapies, indicating significant unmet medical needs. An assessment of current real-world treatment patterns among patients with ITP should enhance understanding of the ITP disease population and current unmet need. Here we present real-world data describing the ITP population in the United States in terms of demographic and clinical characteristics and use of available ITP therapies. Methods This was a longitudinal, retrospective, observational cohort study utilizing data from the Optum® Clinformatics® claims database. Patients with newly diagnosed ITP were included; defined as patients with ≥1 inpatient claim or ≥2 outpatient claims within 90 days of ITP-related diagnosis codes (International Classification of Diseases [ICD], Ninth and Tenth Revision; ICD-9: 287.3x; ICD-10: D69.3x or D69.4x) between October 1, 2015 and March 31, 2020. The index date was the date these criteria were met. Patients were excluded if they had &lt;12 months continuous coverage or any record of thrombopoietin receptor agonist (TPO-RA) use before the index date. All patients were required to have ≥1 prescription during follow-up. Primary ITP was defined as patients who met the inclusion criteria and also had no ICD codes for secondary ITP, and no causes of secondary ITP in an identified time period prior to the index date. Here we describe clinical characteristics and medication use among newly diagnosed patients with primary ITP and the proportion of patients who went on to develop persistent (90 days to &lt;12 months) or chronic (≥12 months) ITP. Results There were 19,376 newly diagnosed patients who met inclusion criteria; 15,798 (82%) had primary ITP and 3,578 (18%) had secondary ITP. Among patients with primary ITP, median (min-max) duration of follow-up was 16 (0-55) months and 61% had ≥12 months of follow-up (median duration: 26 months). At baseline, mean (standard deviation [SD]) age was 67 (16) years and 53% of patients were male. Mean (SD) Charlson Comorbidity Index (CCI) was 0.94 (1.41) and 11% of patients fell into a CCI category ≥3. The most common comorbid conditions were hypertension (60%), cardiovascular disease (37%), diabetes (29%), and anemia (27%). The most commonly used concomitant medications were lipid-lowering medications (44%), pain medications (24%), corticosteroids (23%), and anticoagulants (11%). During follow-up, use of these medications increased (lipid-lowering medications [46%], pain medications [38%], corticosteroids [39%], and anticoagulants [15%]). The most commonly used ITP medications during follow-up were corticosteroids (33%), rituximab (3.3%), TPO-RA (2.8%), immunosuppressants (2.6%), intravenous immunoglobulin (2.5%), and immunomodulators (2.4%). There were 1935 (12%) deaths during follow-up, and 87 (0.6%) patients underwent a splenectomy. Of the patients with ≥12 months of follow-up (n=9610), 16% and 32% developed persistent ITP and chronic ITP, respectively. Among the patients with persistent/chronic ITP and ≥12 months of follow-up, 242 (5.3%) received TPO-RA during follow-up. Of these, 93% concomitantly received ≥1 additional ITP treatment-related medication (TRM), 73% of the patients who received TPO-RA and ≥1 other TRM received ≥2 additional ITP TRMs, and 68% of patients who received TPO-RA and ≥2 other TRMs received ≥3 additional ITP TRMs. Of the 242 patients with ≥12 months of follow-up and persistent/chronic ITP who received TPO-RA, 55 (23%) either received an additional TPO-RA therapy or received another newly initiated ITP-related medication ≥30 days after starting TPO-RA. Almost half of the patients with primary ITP developed persistent/chronic disease. However, only a small percentage of these patients in the Optum® Clinformatics® claims database with no history of TPO-RA use received TPO-RA during follow-up. The majority of patients treated with TPO-RA received ≥1 other ITP TRM during follow-up and nearly 1 in 4 persistent/chronic patients receiving TPO-RA required ≥1 additional TPO-RA or switched to another ITP medication. Conclusion Even with the availability of many ITP drug therapies, there is still a considerable current unmet need for effective treatments among patients with primary ITP. The authors acknowledge Rajeshwari Punekar for contributions to study design. Disclosures Wilson: Sanofi: Current Employment, Current equity holder in publicly-traded company. Daak:Sanofi: Current Employment. Su:Sanofi: Current Employment.


VASA ◽  
2016 ◽  
Vol 45 (6) ◽  
pp. 497-504 ◽  
Author(s):  
Tom De Beule ◽  
Jan Vranckx ◽  
Peter Verhamme ◽  
Veerle Labarque ◽  
Marie-Anne Morren ◽  
...  

Abstract. Background: The technical and clinical outcomes of catheter-directed embolization for peripheral arteriovenous malformations (AVM) using Onyx® (ethylene-vinyl alcohol copolymer) are not well documented. The purpose of this study was to retrospectively assess the safety, technical outcomes and clinical outcomes of catheter-directed Onyx® embolisation for the treatment of symptomatic peripheral AVMs. Patients and methods: Demographics, (pre-)interventional clinical and radiological data were assessed. Follow-up was based on hospital medical records and telephone calls to the patients’ general practitioners. Radiological success was defined as complete angiographic eradication of the peripheral AVM nidus. Clinical success was defined as major clinical improvement or complete disappearance of the initial symptoms. Results: 25 procedures were performed in 22 patients. The principal indications for treatment were pain (n = 10), limb swelling (n = 6), recurrent bleeding (n = 2), tinnitus (n = 3), and exertional dyspnoea (n = 1). Complete radiological success was obtained in eight patients (36 %); near-complete eradication of the nidus was achieved in the remaining 14 patients. Adjunctive embolic agents were used in nine patients (41 %). Clinical success was observed in 18 patients (82%). Major complications were reported in two patients (9 %). During follow-up, seven patients (32 %) presented with symptom recurrence, which required additional therapy in three patients. Conclusions: Catheter-directed embolisation of peripheral AVMs with Onyx® resulted in major clinical improvement or complete disappearance of symptoms in the vast majority of patients, although complete angiographic exclusion of the AVMs occurred in only a minority of patients.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18727-e18727
Author(s):  
Robert Smith ◽  
Mei Xue ◽  
Natalie Dorrow ◽  
Prateesh Varughese ◽  
Cosima Hogea ◽  
...  

e18727 Background: Treatment for multiple myeloma (MM) over the past decade has significantly improved survival. In particular, 3 drug classes have altered the treatment paradigm for MM patients: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and CD38 monoclonal antibodies (anti-CD38s). Despite these advances, the majority of patients with MM will become refractory to PIs, IMiDs, and anti-CD38s, and limited evidence indicates these patients have poor outcomes. A retrospective study in the US showed that 275 patients treated at 14 academic institutions with prior exposure to a PI, IMiD, and anti-CD38 had median overall survival of 9.2 months. The aim of this study was to evaluate real-world treatment patterns and outcomes (duration of therapy and overall survival) of patients who had been treated with a PI, IMiD, and anti-CD38 in community practices in the US. Methods: This retrospective observational study was conducted using the Integra Connect (IC) database. The IC database includes electronic health data from structured and unstructured fields from 12 community practices on the East and West Coast of the US. Adult patients with ≥2 ICD-9/ICD-10 codes for MM on at least 2 separate dates, who received MM treatment between Jan 1, 2016, and Dec 31, 2019, with treatment history that included at least one PI, one IMiD, and one anti-CD38 (triple exposed), and initiated a subsequent line of therapy (s-LOT) after becoming triple exposed, were included. Duration of length of s-LOT was defined as number of days from start of s-LOT to last-day supply of s-LOT. Overall survival was defined as the length of time from start of s-LOT through death or the date of the last office visit. Results: A total of 501 patients were included in this analysis. The median age of patients was 64.9 years; 50% were male; 50% had commercial insurance. 82.8% of patients had ECOG 0 or 1 at diagnosis and had received a median of 3 prior lines of therapy (LOTs) before initiating s-LOT. Prior to initiating s-LOT, 91% had been exposed to bortezomib, 81% to carfilzomib, 94% to lenalidomide, 82% to pomalidomide, and 100% to daratumumab. In s-LOT, 95% received treatment that included same drug or same drug class (30% received bortezomib, 48% carfilzomib, 31% lenalidomide, 47% pomalidomide, and 31% daratumumab). The median duration of s-LOT was 78 days and median survival was 10.3 months (308 days) from initiation of s-LOT. Conclusions: For triple-class exposed patients, there is a lack of consensus on the most efficacious approach to subsequent treatment. The present study shows a significant amount of retreatment with previously used agents or classes among these patients with short duration of therapy and poor survival. As has been previously noted, new strategies and agents targeting novel aspects of MM are needed to improve outcomes for these patients. Disclosures: This study (213286) was sponsored by GlaxoSmithKline.


2021 ◽  
pp. 019459982110616
Author(s):  
Shaan N. Somani ◽  
Katherine M. Yu ◽  
Alexander G. Chiu ◽  
Kevin J. Sykes ◽  
Jennifer A. Villwock

Objective Consumer wearables, such as the Apple Watch or Fitbit devices, have become increasingly commonplace over the past decade. The application of these devices to health care remains an area of significant yet ill-defined promise. This review aims to identify the potential role of consumer wearables for the monitoring of otolaryngology patients. Data Sources PubMed. Review Methods A PubMed search was conducted to identify the use of consumer wearables for the assessment of clinical outcomes relevant to otolaryngology. Articles were included if they described the use of wearables that were designed for continuous wear and were available for consumer purchase in the United States. Articles meeting inclusion criteria were synthesized into a final narrative review. Conclusions In the perioperative setting, consumer wearables could facilitate prehabilitation before major surgery and prediction of clinical outcomes. The use of consumer wearables in the inpatient setting could allow for early recognition of parameters suggestive of poor or declining health. The real-time feedback provided by these devices in the remote setting could be incorporated into behavioral interventions to promote patients’ engagement with healthy behaviors. Various concerns surrounding the privacy, ownership, and validity of wearable-derived data must be addressed before their widespread adoption in health care. Implications for Practice Understanding how to leverage the wealth of biometric data collected by consumer wearables to improve health outcomes will become a high-impact area of research and clinical care. Well-designed comparative studies that elucidate the value and clinical applicability of these data are needed.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
David M. Kern ◽  
M. Soledad Cepeda ◽  
Frank Defalco ◽  
Mila Etropolski

Abstract Background Understanding how patients are treated in the real-world is vital to identifying potential gaps in care. We describe the current pharmacologic treatment patterns for the treatment of depression. Methods Patients with depression were identified from four large national claims databases during 1/1/2014–1/31/2019. Patients had ≥2 diagnoses for depression or an inpatient hospitalization with a diagnosis of depression. Patients were required to have enrollment in the database ≥1 year prior to and 3 years following their first depression diagnosis. Treatment patterns were captured at the class level and included selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, other antidepressants, anxiolytics, hypnotics/sedatives, and antipsychotics. Treatment patterns were captured during all available follow-up. Results We identified 269,668 patients diagnosed with depression. The proportion not receiving any pharmacological treatment during follow-up ranged from 29 to 52%. Of the treated, approximately half received ≥2 different classes of therapy, a quarter received ≥3 classes and more than 10% received 4 or more. SSRIs were the most common first-line treatment; however, many patients received an anxiolytic, hypnotic/sedative, or antipsychotic prior to any antidepressive treatment. Treatment with a combination of classes ranged from approximately 20% of first-line therapies to 40% of fourth-line. Conclusions Many patients diagnosed with depression go untreated and many others receive a non-antidepressant medication class as their first treatment. More than half of patients received more than one type of treatment class during the study follow up, suggesting that the first treatment received may not be optimal for most patients.


2020 ◽  
Vol 11 ◽  
pp. 215013272093126
Author(s):  
Kimberly A. Siniscalchi ◽  
Marion E. Broome ◽  
Jason Fish ◽  
Joseph Ventimiglia ◽  
Julie Thompson ◽  
...  

The health issue addressed is the unmet need to universally screen and treat depression, which is one of the most common mental health disorders among adults in the United States. The US Preventive Services Task Force recommends screening adults for depression in primary care and using evidence-based protocols. This quality improvement project implemented VitalSign6, a measurement-based care program, to improve depression screening and treatment of adults in primary care at an academic medical center. A pre-post design was used to determine effectiveness of changes in screening, outcomes, and satisfaction. Of 1200 unique adult patients, 95.4% received initial screening. Providers diagnosed and administered measurement-based care to 236 patients. After 14 weeks, 27.5% returned for at least 1 follow-up. Results showed a statistically significant decrease in self-reported depression scores from baseline to follow-up. VitalSign6 was effective in improving identification and management of depression in primary care.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 12-12
Author(s):  
Hsu-Chih Chien ◽  
Deborah Kay Morreall ◽  
Vikas Patil ◽  
Kelli M Rasmussen ◽  
Christina Yong ◽  
...  

Background Waldenström's Macroglobulinemia (WM) is a rare indolent lymphoma with an estimated 1,500 new cases diagnosed each year in the United States (US). Over the last decade, several treatments have been introduced into the WM therapeutics landscape including, bendamustine, bortezomib, and most recently oral Bruton's kinase inhibitor (ibrutinib). There is limited information in the adoption of these WM treatments in real-world clinical settings in the US. We describe the practice patterns and clinical outcomes of first-line (1L) treatment of WM in a nationwide cohort of Veterans. Methods Using Veteran Affairs electronic health records (EHR) data, we identified Veterans who were diagnosed and received 1L treatment for WM between January 2006 and December 2018 in the Veterans Health Administration (VHA). Human annotation of EHR clinical records confirmed the diagnosis and 1L treatment regimens. Patients with another cancer diagnosis or patients with documentation that 1L treatment was received outside the VHA were excluded. Eligible patients were followed until loss to follow-up, death, or the end of the study period (June 30, 2019). Patient demographics, disease characteristics, and treatment patterns were identified. Local polynomial regression model curves were generated to demonstrate treatment changes over time. Unadjusted progression-free survival (PFS) and the unadjusted overall survival (OS) are also provided. Results We identified 505 patients diagnosed with WM in VHA between January 2006 thru December 2018. Of these, 318 patients received 1L treatment, with a median time from diagnosis to 1L treatment of 1.2 months (95% confidence interval [CI]: 0.5-5 months). The median age of WM patients was 69.9 years (standard deviation [SD]: 9.4 years), with approximately 73% of WM patients ≥65 years old. Prior to 1L treatment, the median hemoglobin and platelets observed were similar across all treatment groups, regardless of first 1L treatment. However, the median immunoglobulin M (IgM) was substantially lower in patient's treated with ibrutinib (2,570 mg/dL [range: 422-9,001 mg/dL]) and single-agent rituximab (R), 2,855 mg/dL (range: 84-7,880 mg/dL) when compared to those treated with chlorambucil +/- rituximab (4,416 mg/dL [range: (9-8,130 mg/dL]) and bortezomib/dexamethasone +/- rituximab (BDR), 4,086 mg/dL (range: 16-9,944 mg/dL). MYD88 testing occurred in 40 (13%) of patients, with testing most frequently occurring in patients treated with bendamustine +/- rituximab (BR), ibrutinib, and BDR- likely reflecting increased adoption in later periods. Hepatitis C testing occurred in 61 (19%) of patients, with testing most frequently occurring in patients treated with dexamethasone, rituximab, and cyclophosphamide (DRC), BDR, and BR. Over the study observation period, 1L practice patterns shift significantly with increased adoption of BR, BDR and ibrutinib and de-adoption of chemotherapy (Figure 1). The median follow-up time for all patients was 44 months (range: 1-147 months), although a shorter median follow-up time was observed in patients treated with therapeutics in recent years, such as ibrutinib (18 months [range: 2-53 months]) and BR (23 months [range: 4-86 months]). The median unadjusted PFS for all WM patients was 44 months (95% CI: 37-58 months) and the median unadjusted overall survival (OS) was 94 months (95% CI: 82-117 months). Conclusions The introduction of numerous therapeutic options throughout the past decade has profoundly altered the treatment landscape for WM, suggesting a shift in 1L practices from chlorambucil to BDR, BR, and most recently ibrutinib which has been increasingly adopted, since its approval in 2015, especially in older patients, suggesting that it may provide an effective therapeutic option for patients who may not be able to tolerate more aggressive treatment regimens. Limitations of this study include the differences observed in follow-up time as well as the limited number of patients in some 1L treatment groups. Further research is required to establish the long-term benefits and potential treatment-related toxicities of WM treatments in real-world clinical settings. Disclosures Sauer: Roche: Research Funding; Genentech, Inc.: Research Funding; Pharmacyclics: Research Funding; AbbVie: Research Funding. Halwani:AbbVie: Research Funding; Takeda: Research Funding; Roche: Research Funding; Genentech, Inc.: Research Funding; Miragen: Research Funding; Immunedesign: Research Funding; Kyowa Hakko Kirin: Research Funding; Seattle Genetics: Research Funding; Amgen: Research Funding; Pharmacyclics: Research Funding; Bristol Myers Squibb: Research Funding.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17589-e17589 ◽  
Author(s):  
Ronda Copher ◽  
Oluwakayode Adejoro ◽  
Stacey DaCosta Byfield ◽  
Mary DuCharme ◽  
Debanjana Chatterjee ◽  
...  

e17589 Background: Describe the treatment patterns of patients initiated on NCCN-recommended small molecular kinase inhibitors (SMKIs) for radioiodine-refractory differentiated thyroid cancer (DTC) approved in the United States. Methods: A large national US claims database was used to identify adult patients diagnosed with thyroid cancer (≥2 non-DX medical claims, ≥ 30 days apart) from 1/1/2006 - 6/30/2016 (study period) with claims for SMKIs from 1/1/2010 - 5/31/2016. Continuous enrollment required participation in a commercial or Medicare Advantage health plan ≥3 months before and ≥1 month following index date (date of first pharmacy claim for SMKI). Line of therapy (LOT) periods were defined by receipt and timing of SMKIs. Patient follow up was earliest disenrollment, death or end of the study period. Patient characteristics and SMKI treatment patterns were described. Results: A total of 217 DTC patients were identified; 63% commercially insured and 37% Medicare Advantage. Almost half were male (48%); mean age was 61.2 years (standard deviation SD 12.5 years) and mean follow-up period was 499 days (SD 414 days). In the study period, 35% (n = 77) of patients had ≥2 LOTs and 18% (n = 39) had ≥3 LOTs. Mean treatment duration was 5.4 months (SD 6.7 mos) for LOT1, 4.9 months (SD 3.8 mos) for LOT2, and 4.2 months (SD 4.9 mo) for LOT3. During the full study period, the most used regimens were Sorafenib for both LOT1 (37%) and LOT2 (25%), pazopanib (18%) and sunitinib (18%) in LOT3. Also, in the study period, 33 patients had sorafenib in LOT1 of which 16 were treated with sorafenib again (48%) in LOT2. Post FDA approval in 2015, Lenvatinib became the predominant first-line regimen (47%, n = 29) during study period. Across all first line therapies, for those patients with ≥12 months of follow-up, 53% (n = 60) initiated LOT2. Conclusions: Sorafenib was the most common first line of therapy for DTC, with Lenvatinib adoption increasing as first-line therapy since the drug’s approval in 2015. Depending on the period evaluated, almost half to 2/3 of patients are not receiving a second line of treatment, efficacious and patient appropriate therapy is of importance in treating this rare cancer.


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 92-92
Author(s):  
Feng Lin ◽  
Raluca Ionescu-Ittu ◽  
Irina Pivneva ◽  
Willy Wynant ◽  
Sherry Shi ◽  
...  

92 Background: Tenosynovial giant cell tumor (TGCT) is a rare locally aggressive tumor causing pain, swelling, joint destruction, and limited mobility. This study assessed the disability burden and the associated costs in TGCT patients from an employer’s perspective. Methods: A retrospective analysis was performed using medical and disability claims from the OptumHealth database. Incident patients 18-64 years old with a diagnosis of TGCT (as identified by ICD-9: 727.02, 719.2x; ICD-10: D48.1, D21.x, M12.2) were matched 1:10 to controls without TGCT based on age, gender, index year, and follow-up duration. Patients without earning and disability data were excluded. Days of work loss due to disability claims and absenteeism associated with medical visits were compared using Poisson regression models. Costs were compared using generalized linear models. Results: A total of 1,395 eligible TGCT patients were matched with 13,950 controls without TGCT. Despite similar demographics (36% female, mean age 45-47) and only slightly higher comorbidity burden (mean Charlson Comorbidity Index (CCI): 0.3 versus 0.2), TGCT patients had increased usage of analgesic drugs (44% versus 20%) and MRI tests (37% versus 3%), prior to their diagnosis, compared with controls. During follow-up, TGCT patients were more likely to have disability claims (15.1% vs. 5.6%; p < 0.001), had more disability claim days (9.5 versus 2.0; p < 0.001), medically related absenteeism days (9.9 versus 4.3; p < 0.001), and total days of work loss (19.4 versus 6.3; p < 0.001) per person-year compared with their matched controls. After adjusting for age, gender, index year and CCI score, the average annual indirect cost per person was greater for patients with TGCT than controls ($4,653 versus $1,902; p < 0.001). Conclusions: In addition to the known problems of pain, limitation of mobility, and eventual joint destruction, TGCT patients had substantial indirect costs associated with increased work absenteeism and disability. These findings highlight the unmet need for more effective treatments to reduce not only the medical, but also the economic burden of TGCT.


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