Mean Charlson Comorbidity Index Score Research Articles

Oral Health Status Using the Revised Oral Assessment Guide and Mortality in Older Orthopaedic Patients: A Cross-Sectional Study.

Orthogeriatric hospitalised patients with fractures of the lower limb constitute a vulnerable population with increased risk of morbidity, polypharmacy, and mortality as well as impaired oral health. The aim of this cross-sectional study was to investigate whether any relationship existed between oral health issues in older orthopaedic patients and mortality. The study population consisted of older orthopedic patients emergently admitted to a hospital in southern Sweden due to mainly fractures of the hip. Their oral health at admission was assessed by trained nurses using the revised oral assessment guide (ROAG), as well as examined by dental hygienists. Medical and demographic data were collected from medical records and mortality from the national population registry. Comorbidity was assessed using the Charlson Comorbidity Index (CCI). Data were analysed using foremost dichotomized data derived from mean values and then processed using multiple logistic regression adjusted for identified probable confounders. Of the 187 study patients (≥65 years) with a mean age of 81 (SD 7.9) years, 71% were women, mean CCI score was 6.7 and 90-days mortality 12.3%. Oral health issues (ROAG >8, 73%) consisted mainly of problems with teeth/dentures (41%), tongue (36%), lips (35%), and saliva (28%). In patients with any oral health impairment (ROAG >8) the 90-days mortality was significantly increased (p=0.040), using logistic regression analysis adjusted for age, gender, comorbidity, and use of ≥5 drugs. In patients with a ROAG score ≥10 (≥mean) the association remained at 90-days (p=0.029) and 180-days (p=0.013). Decayed teeth were present in 24% and was significantly associated with ROAG >8 (p=0.020). The main finding of this study was a possible relationship between oral health impairment at admission and early mortality in orthogeriatric hospitalised patients. The opportunity to identify their oral health problems can help improving further care planning and care.

Characteristics, treatment patterns, health care resource utilization and costs in patients with bullous pemphigoid: A retrospective analysis of US health insurance claims data

Real-world data describing the impact of incident bullous pemphigoid (BP) on patients and health care resource utilization (HCRU) are limited. To examine characteristics, treatment patterns, HCRU, and costs for incident BP. Retrospective analysis of 2015 to 2019 US health insurance claims for patients ≥18years with an incident BP diagnosis. Patients with BP were matched to those without on demographic and clinical characteristics. Statistics were descriptive. The mean Charlson Comorbidity Index score was higher for patients with BP (n=1108) than without (n=4621) at baseline (mean [SD]: 3.3 [2.7] vs 2.8 [2.4]) and during follow-up (5.0 [4.9] vs 3.7 [3.0]). Hypertension, diabetes, skin ulcers, chronic pulmonary disease, dyslipidemia, sleep disorders, and congestive heart failure were higher with BP. Most patients with BP received antibiotics (>80%) and/or corticosteroids (>90%). Hospitalizations were more common (44.0% vs 17.1%) and monthly all-cause health care costs more than double ($3214 vs $1353) in patients with BP than without. Diagnoses were based on billing codes. HCRU claims data may not reflect the true number of encounters. Incident BP is associated with considerable morbidity, HCRU, and costs. More effective, targeted treatments are needed to improve quality of life, while minimizing exposure to systemic corticosteroids.

Gender differences in the discharge outcomes post-TMVR among us patients 65 years and above: a review of 4,678 patients from the national inpatient sample

Abstract Funding Acknowledgements Type of funding sources: None. Background Though the Transcatheter mitral valve repair (TMVR) procedure has been shown to be beneficial among patients with moderate to severe mitral regurgitation, the effect of sex on the discharge outcomes post-TMVR remains unclear. Purpose We evaluated the gender differences in the outcomes, including death, next-day discharge, and discharge disposition among patients who underwent TMVR in the United States National Inpatient Sample (NIS) Database. We hypothesized that there would be no difference in the outcome of TMVR by gender in this study population. Methods Using the United States NIS Database 2016 – 2019, we identified all patients aged ≥ 65 years with a first listed ICD-10 procedure code of 02UG3JZ corresponding to the TMVR procedure. We classified patients with length of stay (LOS) ≤ 1 day as next day discharge (NDD) and LOS >1 day as non-NDD. Discharge disposition was classified as home/short-term facility, long term facility, or death. Home/short-term facility was defined as patients who were discharged to home, to a short-term hospital, against medical advice, alive with an unknown destination, to home health care, or transferred to court/law enforcement. Disposition was defined as long-term facility if patients were discharged to a skilled nursing facility or intermediate care facility, or another type of facility. Multivariable logistic regression was used to estimate the odds of death and non-NDD, comparing all male patients who had a TMVR to all female patients who underwent TMVR adjusting for age, race, sex, Charlson Co-morbidity Index (CCI) score, median household income, primary insurance, hospital region, teaching status of the hospital and hospital bed size. Results Our study included 4,678 patients (mean age ± SD = 80.4 ± 6.8) who had TMVR between 2016 to 2019. In our study population, 47.5% were females (mean age ± SD = 80.7 ± 6.7) and 52.5% (mean age ± SD = 80.0 ± 6.8) were males. The mean CCI score was lower in females compared to men (mean CCI score ± SD = 2.8 ± 1.9 vs. 3.2 ± 2.0; p<0.0001). Of the seventy-four (74) patients that died, 42 (56.8%) were female and 32 (43.2%) were male (p=0.10). Males were more likely to be discharged to a home/short-term facility than females (53.8% vs. 46.2%; p<0.0001), while females were more likely to be discharged to a long-term facility than males (57.3% vs. 42.7%; p<0.0001). Males were more likely to be discharged within the next day than females (56.1% vs. 43.9%; p<0.0001). Compared to males, females had a higher odds of death (odds ratio (OR), 1.71 [95% CI, 1.03-2.83]; p=0.04) post-TMVR. Females also had higher odds of non-NDD compared to their male counterparts (odds ratio (OR), 1.42 [95% CI, 1.25-1.60]; p<0.0001) post-TMVR. Conclusion Among patients aged 65 years and above who had a TMVR procedure, females were more likely to be discharged to a long-term facility and had higher odds of death and non-next-day discharge than males.

The Clinical and Economic Impact of Employees Who Are Care Partners of Patients with Multiple Sclerosis by Disease Severity

Background: Research on employee care partners of patients with multiple sclerosis (MS) is limited. Objectives: The clinical and economic impact on employee care partners was evaluated by MS disease severity. Methods: Employees with spouses/domestic partners with MS from the Workpartners database (Jan. 1, 2010–Dec. 31, 2019) were eligible if: spouse/partner had at least 3 MS-related (ICD-9-CM/ICD-10-CM:340.xx/G35) inpatient/outpatient/disease-modifying therapy claims within 1 year (latest claim = index date); 6-month pre-index/1-year post-index enrollment; and age 18 to 64 years. Employee care partners’ demographic/clinical characteristics and direct/indirect costs were compared across predetermined MS severity categories. Logistic and generalized linear regression modeled the costs. Results: Among 1041 employee care partners of patients with MS, 358 (34.4%) patients had mild MS, 491 (47.2%) moderate, and 192 (18.4%) severe. Mean (standard error [SE]) employee care partner age was 49.0 (0.5) for patients with mild disease, 50.5 (0.4) for moderate, 51.7 (0.6) for severe; percent female care partners was 24.6% [2.3%] mild, 19.8% [1.8%] moderate, 27.6% [3.2%] severe; and mean care partner Charlson Comorbidity Index scores 0.28 (0.05) mild, 0.30 (0.04) moderate, 0.27 (0.06) severe. More care partners of patients with moderate/severe vs mild MS had hyperlipidemia (32.6%/31.8% vs 21.2%), hypertension (29.5%/29.7% vs 19.3%), gastrointestinal disease (20.8%/22.9% vs 13.1%), depression (9.2%/10.9% vs 3.9%), and anxiety 10.6%/8.9% vs 4.2%). Adjusted mean medical costs were greater for employee care partners of patients with moderate vs mild/severe disease (P<.001). Pharmacy costs (SE) were lower for employee care partners of mild vs severe/moderate patients (P<.005). Sick leave costs (SE) were greater for employee care partners of mild/severe vs moderate patients (P<.05). Discussion: Employee care partners of patients with moderate/severe vs mild MS had more comorbidities (ie, hypertension, gastrointestinal disease, depression, and anxiety) and higher pharmacy costs. Employee care partners of patients with moderate vs mild/severe MS had higher medical and lower sick leave costs. Treatment strategies that improve patient outcomes may reduce employee care partner burden and lower costs for employers in some instances. Conclusions: Comorbidities and direct/indirect costs of employees whose spouses/partners have MS were considerable and varied with MS severity.

The Clinical and Economic Impact of Employees Who Are Care Partners of Patients with Multiple Sclerosis by Disease Severity.

Background: Research on employee care partners of patients with multiple sclerosis (MS) is limited. Objectives: The clinical and economic impact on employee care partners was evaluated by MS disease severity. Methods: Employees with spouses/domestic partners with MS from the Workpartners database (Jan.1, 2010-Dec.31, 2019) were eligible if: spouse/partner had at least 3 MS-related (ICD-9-CM/ICD-10-CM:340.xx/G35) inpatient/outpatient/disease-modifying therapy claims within 1 year (latest claim = index date); 6-month pre-index/1-year post-index enrollment; and age 18 to 64 years. Employee care partners' demographic/clinical characteristics and direct/indirect costs were compared across predetermined MS severity categories. Logistic and generalized linear regression modeled the costs. Results: Among 1041 employee care partners of patients with MS, 358 (34.4%) patients had mild MS, 491 (47.2%) moderate, and 192 (18.4%) severe. Mean (standard error [SE]) employee care partner age was 49.0 (0.5) for patients with mild disease, 50.5 (0.4) for moderate, 51.7 (0.6) for severe; percent female care partners was 24.6% [2.3%] mild, 19.8% [1.8%] moderate, 27.6% [3.2%] severe; and mean care partner Charlson Comorbidity Index scores 0.28 (0.05) mild, 0.30 (0.04) moderate, 0.27 (0.06) severe. More care partners of patients with moderate/severe vs mild MS had hyperlipidemia (32.6%/31.8% vs 21.2%), hypertension (29.5%/29.7% vs 19.3%), gastrointestinal disease (20.8%/22.9% vs 13.1%), depression (9.2%/10.9% vs 3.9%), and anxiety 10.6%/8.9% vs 4.2%). Adjusted mean medical costs were greater for employee care partners of patients with moderate vs mild/severe disease (P<.001). Pharmacy costs (SE) were lower for employee care partners of mild vs severe/moderate patients (P<.005). Sick leave costs (SE) were greater for employee care partners of mild/severe vs moderate patients (P<.05). Discussion: Employee care partners of patients with moderate/severe vs mild MS had more comorbidities (ie, hypertension, gastrointestinal disease, depression, and anxiety) and higher pharmacy costs. Employee care partners of patients with moderate vs mild/severe MS had higher medical and lower sick leave costs. Treatment strategies that improve patient outcomes may reduce employee care partner burden and lower costs for employers in some instances. Conclusions: Comorbidities and direct/indirect costs of employees whose spouses/partners have MS were considerable and varied with MS severity.

The effects of early initiation of aripiprazole once-monthly on healthcare resource utilization and healthcare costs in individuals with schizophrenia: real-world evidence from US claims data

AimTo evaluate the impact of timing of aripiprazole once-monthly (AOM) initiation on healthcare resource utilization (HCRU), risk of hospitalization, and healthcare costs in patients with schizophrenia.MethodsA retrospective cohort study was conducted using data from the Merative MarketScan database (01/01/2013–12/31/2019). Adults aged ≥18 years with a new episode of care for schizophrenia and an AOM claim were included. Patients were classified into two cohorts based on the time between the first schizophrenia diagnosis and the first AOM claim (early cohort: ≤1 year; late cohort: >1 year). All-cause and psychiatric-specific HCRU, risk of hospitalization, and healthcare costs were evaluated over 1-year post-AOM initiation. The relationship between the timing of AOM initiation and HCRU was evaluated using negative binomial regression, and healthcare costs using generalized linear models (log-link with gamma distribution). Logistic regression was used to estimate the likelihood of hospitalization during the follow up period for both all-cause and psychiatric-specific hospitalization.ResultsA total of 945 patients were included (early cohort: n = 525; late cohort: n = 420). At baseline, the early cohort had lower mean age, a greater proportion of males, and a lower mean Charlson Comorbidity Index score than the late cohort (all p < .05). After adjusting for baseline demographic and clinical characteristics, all-cause and psychiatric-specific hospitalization during the 1-year follow-up period were statistically significantly higher for the late cohort versus the early cohort (all-cause: incident rate ratio [IRR] = 1.63, 95% confidence interval [CI]: 1.28–2.07, p < .01; psychiatric-specific: IRR = 1.93, 95% CI: 1.46–2.55, p < .01). The early cohort had statistically significantly lower adjusted all-cause ($21,686 versus $29,033; p = .0002) and psychiatric-specific ($24,414 versus $32,461; p = .0002) healthcare costs versus the late cohort.LimitationsThis study utilized claims data, which are intended for administrative purposes rather than for research.ConclusionsThis analysis extends previous evidence for the benefits of AOM in patients with new episodes of schizophrenia, by demonstrating lower HCRU, risk of hospitalization, and healthcare costs with early AOM initiation compared with later initiation.

The Charlson comorbidity index and short-term readmission in patients with heart failure: A retrospective cohort study.

The relationship between the Charlson comorbidity index (CCI) and short-term readmission is as yet unknown. Therefore, we aimed to investigate whether the CCI was independently related to short-term readmission in patients with heart failure (HF) after adjusting for other covariates. From December 2016 to June 2019, 2008 patients who underwent HF were enrolled in the study to determine the relationship between CCI and short-term readmission. Patients with HF were divided into 2 categories based on the predefined CCI (low < 3 and high > =3). The relationships between CCI and short-term readmission were analyzed in multivariable logistic regression models and a 2-piece linear regression model. In the high CCI group, the risk of short-term readmission was higher than that in the low CCI group. A curvilinear association was found between CCI and short-term readmission, with a saturation effect predicted at 2.97. In patients with HF who had CCI scores above 2.97, the risk of short-term readmission increased significantly (OR, 2.66; 95% confidence interval, 1.566-4.537). A high CCI was associated with increased short-term readmission in patients with HF, indicating that the CCI could be useful in estimating the readmission rate and has significant predictive value for clinical outcomes in patients with HF.

Episode-of-care costs of total hip arthroplasty: day surgery versus same-day admission.

Although day surgery (DS) total hip arthroplasty (THA) has good patient satisfaction and a good safety profile, accurate episode-of-care cost (EOCC) calculations for this procedure compared to standard same-day admission (SDA) THA are not well known. We determined the EOCCs for patients who underwent THA, comparing DS and SDA pathways. We evaluated the EOCCs for consecutive patients who underwent DS or SDA THA for osteoarthritis or osteonecrosis performed by a single surgeon at 1 academic centre from July 2018 to January 2020. Patient demographic and clinical data were recorded, as were preoperative diagnosis, type of anesthesia, type of implant used, surgical time and estimated blood loss. We determined direct and indirect costs from time of arrival at the presurgical unit to hospital discharge. We determined the EOCCs using an ABC method. The study included 50 patients who underwent THA (25 DS, 25 SDA). The mean length of stay in the SDA group was 45.1 (standard deviation [SD] 21.4) hours. Differences were observed between the 2 groups in mean age, mean Charlson Comorbidity Index score, surgical technique and mean surgical time (p ≤ 0.001). The mean total EOCC for SDA THA was $10 911 (SD $706.12, range $9944.07-$12 871.95), compared to $9672 (SD $546.55, range $8838.30-$11 058.07) for DS THA, a difference of 11.4%, mostly attributable to hospital resources such as laboratory tests, radiologic studies and cost of the surgical admission. Day surgery THA is cost-effective in selected patient populations. With the savings identified in this study, every 10 additional DS THA procedures would save sufficient resources to perform an additional THA operation.

The Increased Clinical and Economic Burden of Hyperkalemia in Medicare Patients Admitted to Long-Term Care Settings.

Older patients are at increased risk for hyperkalemia (HK). This study describes the prevalence, recurrence, and clinical and economic burden of HK in Medicare patients admitted to a long-term care (LTC) setting. Retrospective cohort study using 100% Medicare Fee-for-Service (FFS) claims identified patients aged≥65years with index admission between 2017 and 2019 to a LTC setting (skilled nursing, home health, inpatient rehabilitation, or long-term acute care). Beneficiaries were required to have 12months continuous medical and pharmacy coverage prior to index LTC admission and≥30days after LTC discharge (follow-up). Patient characteristics, healthcare resource utilization, and costs were assessed. HK was defined as ICD-10 diagnosis code E87.5 in any claim position or Medicare Part D fill for oral potassium binder. Of 4,562,231 patients with a LTC stay, the prevalence of HK was 14.7% over the full study period (pre-index, index stay, and follow-up). Excluding those with HK only during the follow-up period resulted in 4,081,103 patients. Of these, 290,567 (7.1%) had HK and 3,790,536 (92.9%) did not have HK during or within 14days prior to index LTC stay. The HK recurrence rate during index stay and follow-up was 48.3%. Unmatched HK versus non-HK patients were more often male (43.0% vs. 35.4%), Black (13.5% vs. 8.0%), dual eligible for Medicaid (34.2% vs. 25.0%), with higher mean Charlson Comorbidity Index scores (6.2 vs. 3.9) (all p<0.0001). After propensity matching, HK patients were 2.2times more likely to be hospitalized, with higher mortality (30.8% vs. 21.5%) and higher total healthcare costs during both index stay (US$26,520 vs. $18,021; p<0.0011) and follow-up ($57,948 vs. $41,744 (p<0.0011) versus matched non-HK patients. Prevalence and recurrence of HK was high among LTC patients, and HK was associated with significantly greater clinical and economic burden during and post-LTC.

Single Versus Dual Surgeon Approaches to Oncoplastic Surgery: A Comparison of Outcomes

IntroductionOncoplastic surgery (OPS) is traditionally performed using a dual surgeon (DS) approach that involves both a breast surgeon and a plastic surgeon. It is also performed using a single surgeon (SS) approach with a surgeon trained in both breast surgical oncology and plastic surgery. We sought to determine if outcomes differed between SS versus DS OPS approaches. MethodsA retrospective chart review was conducted of all OPS performed in a single health system over a 6-y period by either an SS or a DS approach. Primary outcomes were rates of positive margins and the overall complication rate; secondary outcomes were loco-regional recurrence, disease-free survival, and overall survival. ResultsA total of 217 patients were identified; 117 were SS cases and 100 were DS cases. Baseline preoperative patient characteristics were similar between the two groups as there was no difference in mean Charlson Comorbidity Index scores (P = 0.07). There was no difference in tumor stage (P = 0.09) or nodal status (P = 0.31). Rates of positive margins were not significantly different (10.9% (SS) versus 9% (DS); P = 0.81), nor were rates of complications (11.1% (SS) versus 15% (DS); P = 0.42). Rates of locoregional recurrence were also not significantly different (1.7% (SS) versus 0% (DS); P = 0.5). Disease-free survival and overall survival were not significantly different at 1-y, 3-y, and 5-y time points (P = 0.20 and P = 0.23, respectively) although follow-up time was not sufficient for definitive analysis regarding survival. ConclusionsBoth SS and DS approaches to OPS have similar outcomes with regards to positive margin rates and surgical complication rates and are comparably safe.

Real-World Treatment Patterns and Transfusion Burden Among Newly Diagnosed Older Adults with Acute Myeloid Leukemia

Background: The approval of Venetoclax (VEN; a BCL-2 inhibitor) has changed the treatment paradigm for older/unfit newly-diagnosed AML patients (ND AML) and improved outcomes in the landmark randomized phase 3 clinical trial, VIALE-A. However, real world evidence of population-level clinical benefit is still limited, especially on the impact of transfusion burden and achievement of transfusion independence (TI). Repeated transfusions are associated with significant risks and costs and impair quality of life for patients. This study examined real-world treatment patterns and clinical outcomes focusing on transfusion independence in a contemporary cohort of Medicare beneficiaries with newly diagnosed AML. Methods: This cohort study examined newly diagnosed Medicare beneficiaries (age ≥65 years) with AML using claims from the Centers for Medicare & Medicaid Services, representing 100% of Medicare fee-for-service beneficiaries. The identification period was July 2016-June 2020, with an observational period from January 2016 to December 2020. The first active AML treatment identified in the data was categorized into four different treatment categories; 1) Venetoclax combination (VEN; Venetoclax in combination with hypomethylating agents (HMA) or low-dose cytarabine (LDAC)), 2) low-intensity treatment (LOW; HMA monotherapy or LDAC), 3) high-intensity chemotherapy (HIGH; patients with an inpatient stay lasting ≥22 days or ≥7 days where a non-specific antineoplastic treatment or cytotoxic chemotherapy was documented), and 4) other targeted therapies (OTHER; ivosidenib, glasdegib, gilteritinib, enasidenib, midostaurin, gemtuzumab ozogamicin). Patients who received any AML therapy prior to the index date except for treatments for myelodysplastic syndromes (e.g., HMAs and lenalidomide) were excluded. Transfusion independence (TI) was defined as a rolling period of no red blood cell (RBC) or platelet (PLT) transfusions for a consecutive 56-days. Results: We identified 5,855 ND AML Medicare beneficiaries, with 734 patients who met eligibility criteria and were categorized as VEN, 2,562 patients as LOW, 1,318 patients as HIGH, and 146 patients as OTHER. The median follow-up duration was 8 months and the median age at diagnosis was 76 years old in all patients. Patients had a mean Charlson Comorbidity Index score of 3, including common comorbidities: 23.4% with congestive heart failure and 27.6% with chronic pulmonary disease. The VEN cohort initiated their first line (1L) treatment on an average of 30 days from their diagnosis. Median duration of 1L therapy was 4.8 months (IQR: 1.9-6.6) in the VEN cohort, 3.1 months (IQR: 1.1-8.1) for the LOW cohort, 1.7 months (IQR: 0.9-1.8) for the HIGH cohort, and 2.1 months (IQR: 1.0-6.1) in the OTHER cohort. The mean daily dose in the VEN cohort over the 1L treatment period was 287 mg (median: 332). 15.4% of VEN patients had overlapping hospitalizations, indicating that patients may initiate Venetoclax at inpatient setting. Within 56-days prior to treatment initiation, 86.4% of VEN cohort had PLT-TI and 54.5% had RBC-TI, and similar proportions of TI were observed in other treatment groups. When evaluating the transfusion status every 56-days on a rolling weekly basis (Figures 1 & 2): a trend of decreased proportion of TI were observed from 56-days prior to the treatment initiation across treatment groups. By weeks 0-7 post-treatment initiation, 49.5% in VEN cohort achieved TI in PLT and 18.0% in RBC, which was lower than the LOW cohort (58.2% were TI in PLT vs. 29.4% in RBC). However, there was an apparent increasing trend of TI rate in both RBC and PLT since the first week after the patients initiating VEN, while the TI rate only slightly increased over time since the treatment initiation in the other treatment group. At weeks 8-15, a higher proportion of patients achieved TI in PLT and RBC in the VEN cohort, compared with the other treatment groups (PLT-TI: 74.2% in VEN, 70.1% in LOW, 40.0% in HIGH, and 57.6% in OTHER; RBC-TI: 52.2% in VEN, 41.9% in LOW, 35.6% in HIGH, and 41.3% in OTHER). At week 12-19, 62.1% in VEN achieved RBC-TI, versus 47.7% in LOW, 44.2% in HIGH, and 48.1% in OTHER. Conclusions: In the Medicare elderly population, ND AML patients treated with VEN had a longer median duration of therapy compared with other treatment groups. A larger proportion of VEN patients were able to achieve transfusion independence over time compared to the other treatment groups. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

The Use of Fedratinib for Myelofibrosis As a Potential Bridge to Hematopoietic Stem Cell Transplantation after Ruxolitinib Failure: Real-World Assessment of Treatment Characteristics and Spleen, Symptom, and Hematologic Response

Introduction: Janus kinase (JAK) inhibitors provide therapeutic benefits and symptom control in patients with myelofibrosis (MF) regardless of line of therapy. However, their use as a treatment pathway to hematopoietic stem cell transplantation (HSCT), the only curative option for patients with MF, is poorly understood. In August 2019, the JAK inhibitor fedratinib (FEDR) became the second treatment to be approved in the US for treatment of intermediate- or high-risk primary or secondary MF. We previously observed that 18% (12/67) of patients discontinued FEDR following failure of treatment with ruxolitinib (RUX) to undergo HSCT (Mascarenhas J, et al. Blood 2021;138(Suppl 1):1980). Here we describe patient characteristics, treatment characteristics, spleen and symptom changes, and outcomes following discontinuation of FEDR to undergo HSCT among real-world patients prescribed FEDR after treatment with RUX. Methods: Treating physicians from community oncology practices in the US selected eligible patients and completed electronic case report forms from February to March 2021. Eligible patients were adults with intermediate- or high-risk MF, who were treated with RUX and subsequently initiated FEDR on or after August 16, 2019, with ≥ 90 days of follow-up, and who had completed ≥ 1 cycle of FEDR and had discontinued FEDR prior to data cutoff to undergo HSCT. Physicians abstracted demographic and disease characteristics, RUX and FEDR treatment characteristics, spleen size, symptoms derived from the Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v.4.0), platelet count, hemoglobin (Hb), white blood cell (WBC) count, peripheral blasts, disease transformation, and death. Descriptive analyses characterized patient demographic and clinical characteristics, as well as disease transformation and death. Mean spleen size (length determined by palpation), symptom count, platelet count, Hb, WBC count, and mean proportion of peripheral blasts at FEDR initiation versus 3 months post-FEDR initiation were compared via paired 2-sided t-tests; P values < 0.05 were considered statistically significant. Results: A total of 12 patients underwent HSCT; 58% were male. At FEDR initiation, mean age was 56 years (interquartile range [IQR], 50-63), 42% of patients had ECOG performance status ≥ 2, and the mean Charlson Comorbidity Index score was 0.3 (standard deviation [SD], 0.6). Median RUX treatment duration prior to FEDR was 10.3 months (IQR, 6.3-25.4), and median time from RUX failure to RUX discontinuation was 23 days (IQR, 7-39). Median time from RUX failure to FEDR initiation was 1.1 months (IQR, 0.9-1.9). All patients received starting FEDR doses of 400 mg once daily; median FEDR treatment duration was 5.3 months (IQR, 4.1-7.9). From FEDR initiation to 3 months post-FEDR initiation, patients showed a statistically significant reduction in mean spleen size and mean number of symptoms (Table). Median follow-up after FEDR initiation was 9.4 months (IQR, 4.4-13.5). Disease transformation to acute myeloid leukemia occurred in 1 patient. No deaths were recorded as of the data cutoff in March 2021. Conclusions: This is the first real-world evidence on baseline characteristics and outcomes of patients with intermediate- or high-risk MF receiving FEDR after RUX failure, as a potential bridge to HSCT. Based on this dataset, HSCT following FEDR appears to be an effective and safe treatment option to consider. Larger prospective studies in patients treated with FEDR prior to HSCT should be conducted to determine efficacy and safety in this setting. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Treatment Patterns and Characteristics Among Patients with Myelodysplastic Syndromes Initiating Oral Decitabine and Cedazuridine or Intravenous/Subcutaneous Hypomethylating Agents in a Real-World Setting

Introduction: Hypomethylating agents (HMAs) are recommended as standard of care treatment for patients with higher-risk myelodysplastic syndromes (MDS); however, intravenous (IV) and subcutaneous (SC) administration of HMA therapy has been associated with additional patient burden. In July 2020, the HMA oral decitabine and cedazuridine (DEC-C) was approved by the US Food and Drug Administration (FDA) for the treatment of MDS, as an alternative to IV or SC HMAs. This study reports initial results evaluating DEC-C and IV/SC HMA treatment patterns and population characteristics among MDS patients in a real-world setting. Methods: This retrospective observational study utilized the IQVIA PharMetrics® Plus database which comprises adjudicated claims for more than 190 million unique patients across the US. Adults with ≥1 claim for HMAs between July 1, 2020 and November 30, 2021, and continuous enrollment for 6-months prior to and ≥1-month following the index date were included. Patients newly initiating HMA therapy were identified, where index was the date of the first claim for DEC-C (DEC-C-new cohort) or IV/SC HMA therapy (IV/SC-new cohort), and patients had no claims for HMA therapy in the prior 6 months; a third cohort including all patients initiating DEC-C as either new HMA therapy or switching from IV/SC HMAs was also identified, where index was the date of first claim for DEC-C (DEC-C-all cohort). Patients in the IV/SC-new cohort also had to have ≥1 diagnosis codes for high-grade MDS lesions and/or refractory anemia with excess blasts. Patients had a variable follow-up period of up to 1-year post-index and were followed through December 31, 2021. Demographic/clinical characteristics and treatment patterns were evaluated across the 3 cohorts according to HMA therapy. Results: Of 208 patients meeting inclusion criteria, 90 initiated DEC-C (DEC-C-all) and 118 initiated IV/SC HMAs (IV/SC-new) during the study period; 59 patients newly initiated HMA therapy with DEC-C (DEC-C-new). Demographic and clinical characteristics were similar across the 3 cohorts (Table), with no statistically significant differences observed between the DEC-C and IV/SC cohorts newly initiating HMA therapy. Overall, the proportion of males was higher (vs females) across the DEC-C-all, DEC-C-new, and IV/SC-new cohorts (61.1%, 62.7%, and 53.4%, respectively), and most patients were aged ≥55 years (93.4%, 91.5%, and 80.4%; median age 65, 67, and 64 years, respectively). All 3 groups had high levels of comorbidity, with mean Charlson Comorbidity Index (CCI) scores of 3.4, 3.3, and 3.1, respectively, and 27.8%, 27.1%, and 24.6% having CCI scores ≥5. Across the DEC-C-all, DEC-C-new, and IV/SC-new groups, common comorbidities included malignancy (58.9%, 55.9%, and 46.6%, respectively), chronic pulmonary disease (25.6%, 27.1%, and 22.9%) and congestive heart failure (20.0%, 15.3%, and 17.8%). In all groups, some patients had a diagnosis of acute myeloid leukemia (AML) during the pre-index period (20.0%, 10.2%, and 21.2%, respectively), and a small proportion received hematopoietic stem cell transplantation (HSCT) pre-index (6.7%, 1.7%, and 1.7%). Red blood cell transfusions were reported in 57.8%, 54.2%, and 53.4%, and platelet transfusions in 28.9%, 25.4%, and 22.9%, for the DEC-C-all, DEC-C-new, and IV/SC-new groups, respectively. Among patients with ≥6-months continuous enrollment post-index, mean number of HMA cycles of therapy (based on number of claims) over the 6-months post-index were similar (4.1, 4.1, and 4.2 cycles in the DEC-C-all, DEC-C-new, and IV/SC-new cohorts, respectively). Conclusions: To our knowledge, this study provides the first real-world data on treatment patterns and characteristics among MDS patients initiating oral DEC-C. Characteristics were similar among patients initiating DEC-C and IV/SC HMAs; data also suggest ongoing off-label use of HMAs post-HSCT transplant and in AML. The similar number of HMA claims between groups suggests comparable compliance with oral therapy at home vs IV/SC treatment in the clinical setting, with a possible advantage of DEC-C in reducing the treatment burden associated with existing IV/SC HMA therapy. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Characterization of Real-World Chronic Graft-Versus-Host-Disease Patients Receiving Belumosudil

Introduction Chronic graft-versus-host-disease (cGVHD) is a common complication of hematopoietic stem cell transplant (HSCT). cGVHD is characterized by inflammation and fibrosis that negatively impact multiple organ systems, resulting in substantial morbidity and mortality. While many systemic therapies are available to treat cGVHD, these therapies are associated with adverse events that may limit treatment adherence or lead to discontinuation. In July 2021, the Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor belumosudil was approved by the United States Food and Drug Administration for the treatment of cGVHD for patients 12 years and older after failure of at least two prior lines of systemic therapy based on the efficacy observed in a randomized, open-label, multicenter trial (NCT03640481). Characteristics of patients being treated with belumosudil outside of a clinical trial have not been described previously. The objective of this study is to understand the real-world, non-clinical trial use of belumosudil for patients with cGVHD. Methods This retrospective study describes cGVHD patients recorded in the Komodo closed claims dataset between January 2016 and March 2022. The final cohort of interest included patients who were diagnosed with cGVHD (≥1 medical claim with the International Classifications of Disease Version 10 [ICD-10] diagnosis code D89.811), received belumosudil (≥1 claims with National Drug Code 79802020030), and were 12 years of age or older in the year of belumosudil initiation. Patients were required to have at least 36 months of continuous medical and pharmacy enrollment prior to their initial belumosudil prescription to ensure a complete medical diagnosis, treatment, and healthcare utilization history. Results A total of 151 patients were identified [median (interquartile range) age of 53 (40-62) years old; 54% female]. Sixty percent (92/151) of the patients had an HSCT within the 36-month observation period, and 73% (67/92) of the patients with an observable HSCT also had a diagnosis for a hematologic cancer in the 3 months prior to their HSCT. The median times from HSCT (in those with a recorded event) and cGVHD diagnoses (in all patients available) to belumosudil initiation were 3.2 (1.7-4.0) and 1.5 (0.5-3.1) years, respectively. During the 36 months pre-belumosudil treatment, common diagnoses included dyspnea (81%, 123/151), cytopenia (79%, 119/151; includes anemia, neutropenia, and thrombocytopenia), and "complications of stem cell transplant" (76%, 115/151; ICD-10 code T86.5). In the 12 months immediately prior to belumosudil initiation, the mean (standard deviation) Charlson Comorbidity Index score was 3.6 (2.2); a median of 9 (4-20) cGVHD-related healthcare encounters occurred; and nearly half of all patients had a hospitalization (all-cause 48%, 73/151; cGVHD-related, 27%, 41/151), with the most frequent primary diagnoses for admission attributed to respiratory illnesses and transplant complications. The majority of patients had received ≥3 lines of cGVHD treatment (85%, 128/151) in the 36 months pre-belumosudil, with a median of 5 (4-6) systemic therapies. Combination therapies containing either calcineurin inhibitors (17%; 25/151) or ruxolitinib (15% 23/151) were the most common lines of therapy immediately prior to belumosudil prescription. Use of strong Cytochrome P450 Family 3 Subfamily A (CYP3A) inducers was not observed during the observation period. In the 12 months prior to belumosudil initiation, 55% (83/151) patients were prescribed proton pump inhibitors. For the first belumosudil prescription that a patient received, 74% (111/151) of patients received once-daily dosing, and 26% (40/151) of patients received twice-daily dosing. Conclusions In this real-world data, prior to receiving belumosudil, patients received a median of 5 lines of systemic therapies at a median of 1.5 years from cGVHD diagnosis. Patients displayed multiple comorbidities and frequent hospitalizations that could complicate clinical management with existing cGVHD therapies. There is an unmet need for safe and effective treatment for cGVHD patients. Further research is needed to describe outcomes for patients being treated with belumosudil.

MDS-094 Characteristics and Management of Medicare Beneficiaries With Advanced Systemic Mastocytosis

Advanced systemic mastocytosis (AdvSM) (subtypes: aggressive SM, SM with associated hematological neoplasm, mast cell leukemia) is a rare clonal mast cell neoplasm driven by the KIT D816V mutation. Uncontrolled proliferation, accumulation, and activation of mast cells result in severe symptoms in various organ systems, making SM difficult to diagnose. Clinical guidelines recommend comprehensive testing and specialist care management. To describe AdvSM patient characteristics and use of healthcare services before AdvSM diagnosis in the US Medicare population. Design, Patients, and Outcomes: Medical and pharmacy encounter data for the full US Medicare Fee-for-Service population and a claims-based algorithm were used to identify patients with newly diagnosed AdvSM (≥2 medical claims for AdvSM-related diagnoses [ICD-10 C94.3, D47.02, C96.21] or other qualifying mast cell neoplasm codes by subtype) between January 1, 2017, and December 31, 2019. Continuous enrollment in Medicare for 12 months pre- and post-AdvSM diagnosis was required. Demographics, comorbidity profile, and pre-diagnosis healthcare resource utilization were analyzed. A total of 468 patients with AdvSM met the criteria for analysis; most received their index diagnosis from a hematologist/oncologist. The mean (SD) age was 66.8 (13.6) years, 62% were female, 91% were Caucasian, 30% were dually eligible for Medicare/Medicaid (indicating lower socioeconomic status), and 31% qualified for Medicare due to non-age-related factors (e.g., disability). The mean (SD) Charlson Comorbidity Index score was 4.1 (3.2). Comorbidities included hypertension, 65%; malignancies (including mast cell neoplasms, solid tumors, and hematologic cancers), 62%; pulmonary disease, 43%; depression, 32%; anxiety, 29%; diabetes, 29%; asthma, 26%; and osteoporosis, 22%. In the year before AdvSM diagnosis, patients had a mean (SD) of 4.6 (5.1) primary care visits and 19.6 (18.5) physician specialist visits; 22% underwent bone marrow biopsy, 5% KIT D816V mutation testing, and 48% serum tryptase testing. The majority of patients were prescribed anti-mediator drug therapy (67% corticosteroids, 41% proton pump inhibitors, 29% antileukotrienes, 28% montelukast); 20% were prescribed epinephrine injectors for treatment or prevention of anaphylaxis. Medicare patients newly diagnosed with AdvSM had evidence of high rates of comorbid disease, specialist visits, and symptom management regimens prior to confirmed diagnosis. Care should be closely coordinated by specialists to optimize timely AdvSM diagnosis and management.

Understanding Flares in Patients With Generalized Pustular Psoriasis Documented in US Electronic Health Records

Other than single-center case studies, little is known about generalized pustular psoriasis (GPP) flares. To assess GPP flares and their treatment, as well as differences between patients with and patients without flares documented in US electronic health records (EHRs). This retrospective cohort study included adult patients with GPP (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code L40.1) identified in Optum deidentified EHR data between July 1, 2015, and June 30, 2020. The index GPP diagnosis was the first occurrence in the EHR, with no coded history of GPP for at least 6 months prior. Flare episodes were identified using an algorithm based on diagnosis coding, care setting, type of clinician, GPP disease terms, and flare terms and attributes in the EHR. Flare episodes were characterized by the frequency of occurrence per patient, the care setting in which they were identified, the type of specialist managing the episode, associated symptoms, and the type of treatment before, during, and after the episode. Patients were divided into groups based on whether or not they had a flare episode documented in their EHR. Comparisons were made between the groups based on demographic characteristics, comorbidity burden, health care use, and treatments. Of 1535 patients with GPP (1018 women [66.3%]; mean [SD] age, 53.4 [14.7] years), 271 had 513 flares documented. Compared with patients without flares, patients with flares had a 34% higher mean (SD) Charlson Comorbidity Index score (2.80 [3.11] vs 2.09 [2.52]), were almost 3 times more likely to have inpatient visits (119 of 271 [44%] vs 194 of 1264 [15%]), were more than twice as likely to have emergency department (ED) visits (126 of 271 [47%] vs 299 of 1264 [24%]), and had higher use of almost all treatment classes. Flares were identified in outpatient (271 of 513 [53%]), inpatient (186 of 513 [36%]), and ED (48 of 513 [9%]) settings. The most common treatments during flares were topical corticosteroids (35% of episodes [178 of 513]), opioids (21% [106 of 513]), other oral treatments, (eg, methotrexate, cyclosporine, tacrolimus; 13% [67 of 513]), and oral corticosteroids (11% [54 of 513]). Almost one-fourth of flare episodes (24% [122 of 513]) had no dermatologic treatment 30 days before, during, or 30 days after a flare episode. This cohort study suggests that there is significant unmet need for the treatment of GPP and its flares, as evidenced by patients seeking treatment in inpatient and ED settings, as well as the lack of advanced treatments.

Validity and safety of laparoscopic gastrectomy with D1+ lymphadenectomy for very elderly advanced gastric cancer patients; retrospective cohort study.

It remains unclear whether laparoscopic gastrectomy with optimal lymphadenectomy is appropriate for very elderly patients with advanced gastric cancer. This study aimed to assess the validity of laparoscopic gastrectomy with D1+ lymphadenectomy performed for advanced gastric cancer in patients aged 80years or more. Included in this retrospective study were 122 patients who underwent curative laparoscopic gastrectomy for advanced gastric cancer between 2013 and 2018. All patients over 80years old underwent laparoscopic gastrectomy with D1+ lymphadenectomy. We divided patients by age between those who were very elderly (age≥80years; very elderly group [n=57]) and those who were non-very elderly (age<80years; control group [n=65]), and we compared patient and clinicopathological characteristics, intraoperative outcomes, and short- and long-term outcomes between the two groups. We also performed multivariate analyses to identify predictors of postoperative prognosis. Eastern Cooperative Oncology Group Performance Status of grade 2 or higher and mean Charlson comorbidity index score and body mass index were significantly different between the very elderly group and the control group. Adjuvant chemotherapy was used in relatively few very elderly group patients. Operation time, blood loss volume, and postoperative morbidity and mortality did not differ between the two groups. The overall survival and disease-specific survival rate of very elderly group patients with the Charlson comorbidity index score of <3 was not significantly different from that of the control group patients. The treatment of advanced gastric cancer by laparoscopic gastrectomy with D1+ lymphadenectomy to be both safe and effective in the very elderly group patients with the Charlson comorbidity index score of <3.

P657: REAL-WORLD TREATMENT PATTERNS OF PATIENTS DIAGNOSED WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) IN THE UNITED STATES (US)

Background: CLL represents the most common type of leukemia among adults in the US, but current data on the treatment patterns of patients in clinical practice is limited. Standard of care frontline therapy consists of various types of targeted therapy or chemoimmunotherapy (CIT), but it is reserved for patients with advanced-stage disease. Aims: This study aims to describe real-world treatment patterns among patients diagnosed with CLL in the US, with a focus on ibrutinib therapy. Methods: A retrospective database analysis was conducted using the Optum Clinformatics DataMartTM database (01/2007–07/2020). Patients with ≥2 medical encounters with a diagnosis code for CLL or small lymphocytic lymphoma (SLL) on different dates were selected (earliest date was defined as the index date). At least 12 months of continuous enrollment pre-index date (baseline period) and ≥18 years of age as of the index date were required. Patients with a diagnosis for mantle cell lymphoma or with evidence of anticancer therapy (antineoplastic, radiation, or cell therapy) during baseline were excluded. A subset of patients with ≥1 pharmacy claim for ibrutinib was identified. An adapted algorithm developed from previously published studies was used to identify lines of therapy (LOTs). Treatment patterns, including duration of therapy (DOT) and regimens were reported. DOT spanned from LOT initiation up to discontinuation of all agents in the LOT, a switch to another LOT, or the addition of a new agent. Median time to the first line (1L) and from 1L to second line (2L) were evaluated using a Kaplan-Meier analysis (KM) to account for censoring. Results: Among 23,087 patients with CLL, the median age was 74 years and 43% were female. Of these, 1,387 were treated with ibrutinib (median age: 75; female: 38%). Patients had a mean Charlson comorbidity index score of 1.9. Analysis of treatment patterns (Table 1) showed that 7,192 patients (31%) were treated with ≥1 LOT (mean ± standard deviation [SD] DOT of 1L: 1.6 ± 2.0 years), and 10% of patients were treated with ≥2 LOT (mean ± SD DOT of 2L: 1.2 ± 1.7 years). Ibrutinib was used by 907 patients in 1L (DOT in 1L: 1.0 ± 1.1 years) and 617 in subsequent LOTs (DOT in 2L+: 0.9 ± 1.1 years). Median time from index date to 1L initiation was 8.1 years. Of the patients who used antineoplastics therapies in 1L, a majority used CLL-related ones (79%). Most treated patients received targeted therapy (37%; rituximab: 19% and ibrutinib: 12%) and CIT (32%; bendamustine + rituximab: 13% and cyclophosphamide + fludarabine + rituximab: 5%). In 2L, 16% of patients used ibrutinib, 12% a bendamustine + rituximab regimen, and 4% chlorambucil. Median time from 1L initiation to 2L initiation was 4.4 years. Proportion of patients treated with CIT tended to diminish with subsequent LOT, whereas the proportion treated with ibrutinib tended to increase. Image:Summary/Conclusion: This real-world long-term data shows that patients receive their 1L many years after a first CLL diagnosis, with a median time to treatment of ~8 years. Among US patients with CLL, rituximab, bendamustine + rituximab, and ibrutinib were identified as the most used 1L regimens, and the latter two as the most used 2L regimens. As novel therapies are increasingly used, and genetic testing becomes more available, further research will be needed to evaluate the changes in the way CLL is treated and its effects on clinical outcomes.

Comorbidity and comedication burden among people living with HIV in the United States

Objective To describe the burden of comorbid conditions and comedications among people living with HIV (PLWH) vs. people living without HIV (PLWoH). Methods This was a case–control study conducted among insured patients using administrative claims data. Adult PLWH were identified by antiretroviral therapy (ART) claims or HIV/AIDS diagnosis codes from 1 January 2018 to 31 December 2018 (index date was set by the earliest claim). Continuous enrollment was required for ≥12 months pre-index (baseline) and ≥30 days post-index (follow-up). Patients were required to have ≥1 HIV diagnosis during baseline or follow-up. Those with only HIV prophylaxis were excluded. PLWoH were matched 2:1 to PLWH on demographic characteristics. Study outcomes were compared using z-tests with robust standard errors in an ordinary least squares regression or Rao–Scott tests. Results The study included 20,256 PLWH and 40,512 matched PLWoH, mean age 52 years. PLWH vs. PLWoH had higher mean (SD) Charlson comorbidity index scores (0.93 [1.59] vs. 0.61 [1.28]; p < .001) and a greater proportion had ≥1 comorbidity (69.1% vs. 54.5%, p < .001). The most prevalent comorbidities included hypertension (33.9% vs. 32.2%; p < .001), hyperlipidemia (29.4% vs. 24.6%; p < .001), chronic kidney disease (13.6% vs. 9.4%, p < .001), depression (13.1% vs. 7.3%, p < .001) and substance abuse (12.8% vs. 7.1%, p < .001). Mean (SD) non-ART prescription fills were higher among PLWH vs. PLWoH (11.9 [10.1] vs. 9.2 [9.4]; p < .001). Conclusions Multimorbidity and polypharmacy were more prevalent among PLWH vs. matched PLWoH. Findings support the need to consider comorbidities and comedications when choosing ART and to minimize drug–drug interactions and adverse events to improve patient outcomes.

Endoscopic Sinus Surgery in Older Patients With Significant Medical Comorbidities.

Endoscopic sinus surgery (ESS) offers excellent outcomes for patients with chronic rhinosinusitis (CRS) in the general population. It is unclear whether older patients with significant medical comorbidities experience similar benefits. The purpose of this study is to evaluate whether increasing medical comorbidity is associated with worse sinonasal quality of life outcomes after ESS in older patients. This is a retrospective study of CRS patients 55 years or older who underwent elective ESS at an academic institution from July 2017 to June 2019. 22-Item Sino-Nasal Outcomes Test (SNOT-22) scores were gathered at baseline as well as at 3 and 6 months following surgery. Data on demographics, medical comorbidities, preoperative Lund-Mackay (LM) scores, and postoperative complications were extracted from the medical record. The Charlson Comorbidity Index (CCI) was calculated for each patient. Multivariate linear regression was used to evaluate a potential association between CCI and change in SNOT-22 scores at 3 months postoperatively. A total of 205 patients met inclusion criteria with a mean (SD) CCI score of 2 (2.4) and a CCI score range of 0 to 11. The mean (SD) LM score was 8 (5.3). Rates of asthma and nasal polyposis were 28.3% and 36.6%, respectively. The mean (SD) improvement in SNOT-22 scores at 3 and 6 months compared to baseline was 17.9 (19.7) and 20.9 (18.1) points, respectively. After adjusting for covariates, there was no significant association between CCI and change in SNOT-22 scores. Greater medical comorbidity is not associated with worse SNOT-22 outcomes postoperatively, although future studies are needed to determine if comorbidities are associated with higher complication rates. A multidisciplinary approach to perioperative care is critical in maintaining the safety and efficacy of ESS in this patient population.