Relapse Risk and Safety of Long-Term Tocilizumab Use Among Patients With Giant Cell Arteritis: A Single-Enterprise Cohort Study.

OBJECTIVE: To evaluate the safety and efficacy of tocilizumab (TCZ) in giant cell arteritis (GCA) in a large North American cohort. METHODS: Patients with GCA treated with TCZ between January 1, 2010, and May 15, 2020, were retrospectively identified. Kaplan-Meier methods were used to estimate time to TCZ discontinuation and time to first relapse after TCZ discontinuation. Poisson regression models were used to compare annualized relapse rates before, during, and after TCZ use. Age- and sex-adjusted risk factors associated with relapse on and off TCZ and development of adverse events of significant interest (AESIs) were examined using Cox models. RESULTS: One hundred fourteen patients (60.5% female) were included with mean (SD) age 70.4 (8.2) years. Median duration from GCA diagnosis to TCZ start was 4.5 months. Median overall duration of TCZ treatment was 2.3 years. Relapse rate prior to TCZ start (0.84 relapses/person-year) was 3-fold reduced while on TCZ (0.28 relapses/person-year; P < 0.001) but increased to 0.64 relapses/person-year after TCZ discontinuation. Fifty-two patients stopped TCZ after a median of 16.8 months; 27 relapsed after discontinuation (median: 8.4 months; 58% relapsed within 12 months). Only 14.9% of patients stopped TCZ because of AESIs. Neither dose/route of TCZ, presence of large-vessel vasculitis, nor duration of TCZ therapy prior to discontinuation predicted relapse after TCZ stop. CONCLUSION: TCZ is well tolerated in GCA, with low rates of discontinuation for AESIs. However, relapse occurred in > 50% despite median treatment > 12 months. Since the duration of TCZ prior to discontinuation did not significantly affect subsequent risk of GCA recurrence, further research is needed to determine the optimal duration of therapy.

Lower Frequency of Comorbidities Prior to Onset of Giant Cell Arteritis: A Population-Based Study.

OBJECTIVE: To assess the frequency of comorbidities and metabolic risk factors at and prior to giant cell arteritis (GCA) diagnosis. METHODS: This is a retrospective case control study of patients with incident GCA between January 1, 2000, and December 31, 2019, in Olmsted County, Minnesota. Two age- and sex-matched controls were identified, and each assigned an index date corresponding to an incidence date of GCA. Medical records were manually abstracted for comorbidities and laboratory data at incidence date, 5 years, and 10 years prior to incidence date. Twenty-five chronic conditions using International Classification of Diseases, 9th revision, diagnosis codes were also studied at incidence date and 5 years prior to incidence date. RESULTS: One hundred and twenty-nine patients with GCA (74% female) and 253 controls were identified. At incidence date, the prevalence of diabetes mellitus (DM) was lower among patients with GCA (5% vs 17%; P = 0.001). At 5 years prior to incidence date, patients were less likely to have DM (2% vs 13%; P < 0.001) and hypertension (27% vs 45%; P = 0.002) and had a lower mean number (SD) of comorbidities (0.7 [1.0] vs 1.3 [1.4]; P < 0.001) compared to controls. Moreover, patients had significantly lower median fasting blood glucose (FBG; 96 mg/dL vs 104 mg/dL; P < 0.001) and BMI (25.8 vs 27.7; P = 0.02) compared to controls. Multivariable logistic regression analysis revealed negative associations for FBG with GCA at 5 and 10 years prior to diagnosis/index date. CONCLUSION: DM prevalence and median FBG and BMI were lower in patients with GCA up to 5 years prior to diagnosis, suggesting that metabolic factors influence the risk of GCA.

COVID-19 Outcomes Amongst Patients With Pre-existing Cardiovascular Disease and Hypertension.

INTRODUCTION:  Coronavirus disease 2019 (COVID-19) has multiorgan involvement and its severity varies with the presence of pre-existing risk factors like cardiovascular disease (CVD) and hypertension (HTN). Therefore, it is important to evaluate their effect on outcomes of COVID-19 patients. The objective of this meta-analysis and meta-regression is to evaluate outcomes of COVID-19 amongst patients with CVD and HTN. METHODS: English full-text observational studies having data on epidemiological characteristics of patients with COVID-19 were identified searching PubMed from December 1, 2019, to July 31, 2020, following Meta-analysis Of Observational Studies in Epidemiology (MOOSE) protocol. Studies having pre-existing CVD and HTN data that described outcomes including mortality and invasive mechanical ventilation (IMV) utilization were selected. Using random-effects models, risk of composite poor outcomes (meta-analysis) and isolated mortality and IMV utilization (meta-regression) were evaluated. Pooled prevalence of CVD and HTN, correlation coefficient (r) and odds ratio (OR) were estimated. The forest plots and correlation plots were created using random-effects models. RESULTS: Out of 29 studies (n=27,950) that met the criteria, 28 and 27 studies had data on CVD and HTN, respectively. Pooled prevalence of CVD was 18.2% and HTN was 32.7%. In meta-analysis, CVD (OR: 3.36; 95% CI: 2.29-4.94) and HTN (OR: 1.94; 95% CI: 1.57-2.40) were associated with composite poor outcome. In age-adjusted meta-regression, pre-existing CVD was having significantly higher correlation of IMV utilization (r: 0.28; OR: 1.3; 95% CI: 1.1-1.6) without having any association with mortality (r: -0.01; OR: 0.9; 95% CI: 0.9-1.1) among COVID-19 hospitalizations. HTN was neither correlated with higher IMV utilization (r: 0.01; OR: 1.0; 95% CI: 0.9-1.1) nor correlated with higher mortality (r: 0.001; OR: 1.0; 95% CI: 0.9-1.1). CONCLUSION: In age-adjusted analysis, though we identified pre-existing CVD as a risk factor for higher utilization of mechanical ventilation, pre-existing CVD and HTN had no independent role in increasing mortality.

Trend and Predictors of the Utilization of Endoscopic Retrograde Cholangiopancreatography in Acute Pancreatitis Hospitalizations.

Background Acute pancreatitis is a sudden inflammation of the pancreas, and biliary pancreatitis remains the most common cause of acute pancreatitis. Endoscopic retrograde cholangiopancreatography (ERCP) is both a diagnostic and therapeutic invasive procedure to evaluate and treat pancreaticobiliary system diseases. ERCP is very commonly used in acute pancreatitis with coexisting acute cholangitis or biliary obstruction. There was a need for a nationwide study to evaluate ERCP utilization trends and health-care costs among acute pancreatitis patients. Aim We sought to determine the prevalence trend, hospitalization cost and stay, and predictors of utilization of ERCP amongst patients with acute pancreatitis. Methods We performed a population-based retrospective analysis of national data in adult acute pancreatitis hospitalizations. We evaluated the characteristics of the ERCP cohort, prevalence trend, and hospital utilization cost and stay using univariate analysis. Multivariable survey logistic regression analysis was performed to evaluate predictors of utilization for ERCP among acute pancreatitis hospitalization. Results Among 2,632,309 hospitalizations for acute pancreatitis, 49108 (1.87%) had ERCP. The prevalence trend of ERCP declined from 3.88% in 2003 to 0.97% in 2014.(pTrend<0.0001). Patients with ERCP were older (>55-years old) (53.01% vs 39.36%;p<0.0001), female (58.45% vs 48.04%; p<0.0001), Hispanic (16.30% vs 12.86%; p<0.0001), utilizing Medicare (40.29% vs 31.88%; p<0.0001), elective admission (8.15% vs 4.98%; p<0.0001), and with gallbladder etiology (65.98% vs 26.06%; p<0.0001). Acute pancreatitis hospitalization with ERCP had a higher cost of utilization (Costdiff:+$25077;p<0.0001) and mean stay (LOSdiff:+3.5 days; p<0.0001). In regression analysis, old adults [Odds ratio(OR):1.087; Confidence interval (CI):1.008-1.173), Hispanic (OR:1.086; CI:1.019-1.156), asian (OR:1.146; CI:1.007-1.304), female (OR:1.074; CI:1.028-1.122), elective admission (OR:1.649; CI:1.524-1.785), gallbladder etiology (OR:4.437; CI:4.224-4.662), concurrent chronic pancreatitis (OR:1.643; CI:1.536-1.757), systemic inflammatory response syndrome (SIRS) (OR:1.264; CI:1.112-1.436), pleural effusion (OR:1.874; CI:1.231-2.854), and portal vein thrombosis (OR:1.646; CI:1.221-2.219). Conclusion In nationwide data, we have found a decreased utilization trend and higher hospital utilization cost and stay associated with ERCP. The predictors of utilization will be helpful to examine the cost-utility of ERCP, especially with the advent of acute pancreatitis treatment systems to mitigate the health care burden.

Prevalence and Outcomes Associated with Vitamin D Deficiency among Indexed Hospitalizations with Cardiovascular Disease and Cerebrovascular Disorder-A Nationwide Study.

Background: According to past studies, recovery and survival following severe vascular events such as acute myocardial infarction and stroke are negatively impacted by vitamin D deficiency. However, the national estimate on disability-related burden is unclear. We intend to evaluate the prevalence and outcomes of vitamin D deficiency (VDD) among patients with cardiovascular disease (CVD) and cerebrovascular disorder (CeVD). Methods: We performed a cross-sectional study on the Nationwide Inpatient Sample data (2016-2017) of adult (≥18 years) hospitalizations. We identified patients with a secondary diagnosis of VDD and a primary diagnosis of CVD and CeVD using the 9th revision of the International Classification of Diseases, clinical modification code (ICD-10-CM) codes. A univariate and mixed-effect multivariable survey logistic regression analysis was performed to evaluate the prevalence, disability, and discharge disposition of patients with CVD and CeVD in the presence of VDD. Results: Among 58,259,589 USA hospitalizations, 3.44%, 2.15%, 0.06%, 1.28%, 11.49%, 1.71%, 0.38%, 0.23%, and 0.08% had primary admission of IHD, acute MI, angina, AFib, CHF, AIS, TIA, ICeH, and SAH, respectively and 1.82% had VDD. The prevalence of hospitalizations due to CHF (14.66% vs. 11.43%), AIS (1.87% vs. 1.71%), and TIA (0.4% vs. 0.38%) was higher among VDD patients as compared with non-VDD patients (p < 0.0001). In a regression analysis, as compare with non-VDD patients, the VDD patients were associated with higher odds of discharge to non-home facilities with an admission diagnosis of CHF (aOR 1.08, 95% CI 1.07-1.09), IHD (aOR 1.24, 95% CI 1.21-1.28), acute MI (aOR 1.23, 95% CI 1.19-1.28), AFib (aOR 1.21, 95% CI 1.16-1.27), and TIA (aOR 1.19, 95% CI 1.11-1.28). VDD was associated with higher odds of severe or extreme disability among patients hospitalized with AIS (aOR 1.1, 95% CI 1.06-1.14), ICeH (aOR 1.22, 95% CI 1.08-1.38), TIA (aOR 1.36, 95% CI 1.25-1.47), IHD (aOR 1.37, 95% CI 1.33-1.41), acute MI (aOR 1.44, 95% CI 1.38-1.49), AFib (aOR 1.10, 95% CI 1.06-1.15), and CHF (aOR 1.03, 95% CI 1.02-1.05) as compared with non-VDD. Conclusions: CVD and CeVD in the presence of VDD increase the disability and discharge to non-home facilities among USA hospitalizations. Future studies should be planned to evaluate the effect of VDD replacement for improving outcomes.