ABSTRACT
Objectives: This analysis was conducted to develop a comprehensive list of ICD-10 CM codes for underlying conditions identified by the CDC as being associated with high-risk of developing severe COVID-19 and assessed the consistency of these codes when applied to large US based datasets. Method(s): The comprehensive list of ICD 10-CM codes for CDC-defined high-risk underlying conditions were mapped from CDC references and FDA Sentinel code lists. These codes were subsequently applied to Optum's de-identified Clinformatics Data Mart Database (claims) and the Optum de-identified Electronic Health Record (EHR) database across 3 years (2018, 2019 and 2020) among continuously enrolled subjects >= 12 years of age to determine the performance and consistency in identifying these high-risk underlying conditions annually over these years. Result(s): A total of 10,276 ICD-10 codes were mapped to 21 underlying conditions. Within the claims data, 62.7% of subjects >= 12 years had >= 1 CDC-defined high-risk condition (excluding age) with 26.6% of patients >= 65 years while in the EHR data 38% had >= 1 high-risk underlying condition (excluding age) with 14.4% >= 65 years. These results were similar and consistent in both datasets across all years. Patients aged 12-64 years in the claims data had a higher rate of >=1 high risk underlying condition relative to the EHR data, 49.3% and 34%, respectively. The top 5 conditions among the >= 65 were identical across both databases: hypertension, immunocompromised status, heart conditions, diabetes (type 1 or 2), and overweight/obesity. The top 5 conditions among the 12-64 age group were also similar among the databases and included: immunocompromised status, hypertension, overweight/obesity, smoking (current or former), and mental health conditions. Conclusion(s): These findings present a comprehensive list of codes that can be used by researchers, clinicians and policy makers to identify and characterize patients that may be at high-risk for severe COVID-19 outcomes.Copyright © 2023
ABSTRACT
INTRODUCTION: Riluzole, a sodium-glutamate antagonist which is FDA approved for ALS has shown promising pre-clinical results and is clinically safe in SCI patients. METHOD(S): The RISCIS trial is an international, multi-center, prospective, double-blinded, randomized, placebo-controlled Phase II/ III trial. Patients with ASIA A-C, C4-C8 SCI and <12 hours from injury were randomized between Riluzole, at an oral dose of 100mg BID for the first 24 hours followed by 50mg BID for the following 13 days, and placebo control. RESULT(S): Due to the impact of the global COVID-19 pandemic this trial was terminated prior to completion. 193 patients were randomized with a follow-up rate of 82.7% at 180-days. No statistical difference was noted in the demographics and baseline injury characteristics between the two groups. At 6 months there was a median gain in total motor scores (TOTM) of 30.0 in the Riluzole group compared to 20.0 for the Placebo group. The improved motor outcomes did not reach statistical significance. Given the decreased sample size, additional sensitivity analyses were conducted. In the ASIA-C population, Riluzole was a significant improver of total motor scores (coefficient estimate: 14.10, p = 0.020) and upper motor scores (CE: 7.68, p = 0.040) at 6 months. ASIA B patients had higher reported independence, as measured by the SCIM score (45.3 vs. 27.3;p = 0.071) and change in mental health scores as measured by the SF-36 mental health domain (2.01 vs. -11.58;p: 0.0205) at 180 days. CONCLUSION(S): Despite the premature termination of the RISCIS trial due to the COVID-19 pandemic, 193 subjects were recruited into this trial. Primary analysis showed a 10-motor point gain in riluzoletreated subjects which did not reach significance. However, on secondary analysis, incomplete cervical SCI subjects (AIS B and C) showed significant gains in functional recovery.
ABSTRACT
Introduction: Real-world evidence on patients with moderate-to-severe asthma treated with dupilumab is limited. Patients included in clinical trials may differ from the ones seen on a clinical office setting. The objective of our study was to characterize real-world effectiveness of dupilumab in US, as an add-on treatment in patients with moderate to severe asthma. Method(s): We retrospectively included patients (>=12 years of age) diagnosed with asthma, initiating dupilumab (index) between November 2018 to September 2020, with 12 months pre- and post-index information. The study employed a pre-post self-control design (TriNetX Dataworks, USA). Asthma exacerbation rates before vs. after dupilumab initiation were analyzed using Generalized Estimating Equations models with Poisson probabilistic link to estimate incidence rate ratios (IRRs). Sensitivity analyses on asthma exacerbations adjusted for COVID-19 confounding effects were performed using natural cubic splines to allow for time-varying effect estimates during pre- and post-pandemic time periods. Result(s): A total of 2400 patients initiating dupilumab met all study criteria and 75.3% were biologic naive. Dupilumab reduced risk of asthma exacerbations by 38% (IRR: 0.62 [95% confidence interval: 0.58-0.65], P=<.0001). Significant reductions in asthma exacerbations were observed in patients with at least 1 or 2, pre-index, asthma exacerbations, by eosinophil count categories, and when adjusted for impact of COVID-19 (Table-1) Conclusion(s): The US ADVANTAGE study demonstrated real-world effectiveness of dupilumab in reducing asthma exacerbation among patients 12 years and older in US clinical practice. These findings are generally consistent with data from previous pivotal clinical trials with dupilumab. Copyright © 2022