RESUMO
BACKGROUND: We investigate the geographical and racial disparities in accessing CAR-T and bispecific antibodies trials for DLBCL. MATERIALS AND METHODS: ClinicalTrials.gov was searched, and 75 trials with at least 1 open site in the US were included. 2020 US Census Bureau data was used to obtain data on race and ethnicity. SPSS version 26 was used for analysis. RESULTS: There were 62 CAR-T and 13 bispecific antibodies trials with 6221 enrolled or expected to enroll patients. Eighty-five percent of the clinical trials were only open in the US, and the majority 64% were pharmaceutical-funded. There were 126 unique study sites distributed over 31 states with 11 (0-51) mean number of trials per state and 4.5 (1-26) and 4.4 (1-24) mean number of CAR-T and bispecific antibodies trials per site, respectively. Southern states had the most number of trials 31%, followed by Midwestern 25%, Northeastern 24%, and Western 20%. The highest number of study locations were in California 13, New York 9, and Pennsylvania 9, while the highest number of open studies were in California 51, Texas 32, and New York 23. Twenty states had no open CAR-T or bispecific antibodies trials. Only 33% of African Americans (AA) lived in a county with a trial, and 7 out of 10 states with the highest proportion of AA residents (18.6%-41.4%) have no or less than 4 trial sites. Of the 62 counties analyzed, 92% were White predominant, while only 8% were AA predominant (P = .009). CONCLUSIONS: Strategies should be framed to address the observed disparities and to improve access.
Assuntos
Anticorpos Biespecíficos , Linfoma Difuso de Grandes Células B , Humanos , Anticorpos Biespecíficos/uso terapêutico , Linfoma Difuso de Grandes Células B/terapia , Linfoma Difuso de Grandes Células B/imunologia , Ensaios Clínicos como Assunto , Receptores de Antígenos Quiméricos/uso terapêutico , Receptores de Antígenos Quiméricos/imunologia , Disparidades em Assistência à Saúde/estatística & dados numéricos , Estados Unidos , Imunoterapia Adotiva/métodos , Acessibilidade aos Serviços de Saúde/estatística & dados numéricosRESUMO
Chimeric antigen receptor (CAR) T cell therapy is changing the paradigm in hematologic malignancies, but disparities in access exist in the real-world setting. Efforts to address and eliminate these disparities will ensure availability of this life-saving therapy. This study aimed to determine patterns of racial/ethnic distribution, socioeconomic strata, insurance coverage, and travel time of CAR T cell recipients. We used the Vizient Clinical Database (CDB) to capture and analyze elective encounters for CAR T administration as well as encounters for any reason other than CAR T administration (non-CAR T) in patients with lymphoma, myeloma, and acute lymphoblastic leukemia. Travel time and median household income were calculated based on ZIP code of residence. We found that African Americans (AA) were less likely than other racial/ethnic groups to receive CAR T cell therapy. In addition, AA and Hispanic participants were underrepresented in clinical trials. Among the patients with myeloma, all of whom received CAR T cell therapy on a clinical trial, only 1% were African American and 5.4% were Hispanic, and only 7.3% of CAR T cell therapy-related admissions were of patients from neighborhoods with a mean income <$40,000. Almost one-third of the CAR T cell recipients lived >2 hours away from the center in which they were treated; the majority of these patients were from the higher socioeconomic stratum (P < .001). There were fewer patients with Medicare and uninsured patients in the CAR T cell group. Our data indicate that socioeconomic stratum and insurance coverage are important underlying determinants of the identified disparities. Low clinical trial enrollment of minorities also feeds the inequity. Strategies to improve access need to be framed around addressing the causes for the observed disparities.
Assuntos
Mieloma Múltiplo , Receptores de Antígenos Quiméricos , Idoso , Terapia Baseada em Transplante de Células e Tecidos , Humanos , Imunoterapia Adotiva , Medicare , Mieloma Múltiplo/terapia , Fatores Socioeconômicos , Estados Unidos/epidemiologiaRESUMO
AIM: Heart failure (HF) constitutes a major public health problem in the USA due to its high morbidity and mortality. Age at diagnosis of HF would refine burden quantification, budgeting, disease surveillance and assessment of interventions. We set out to determine the median age at diagnosis of HF and drivers of young age at diagnosis among patients 20â¯years or older in the USA. METHODS AND RESULTS: We utilized NHANES data collected across five survey cycles (2007-2016). Included were individuals aged 20 to 80â¯years diagnosed of HF with valid entries for age at diagnosis. Differences in age at diagnosis between groups and major drivers for younger age at diagnosis were assessed using linear regression models with p-values <0.05 considered statistically significant. The prevalence of HF in the USA was 2.44% with a median age at diagnosis of 59â¯years (IQR 47-70). Non-Hispanic (NH) Blacks -4.94â¯years (95% CI -7.95 to -1.93), individuals living below the poverty line -5.79â¯years (95% CI -10.36 to -1.01), obese persons -5.63â¯years (95% CI -8.35 to -2.92), individuals without health insurance -4.31â¯years (95% CI -7.87 to -0.75) and those without hypertension -3.99â¯years (95% CI -7.19 to -0.78) were diagnosed at significantly younger ages than their respective counterparts. CONCLUSION: The median age at diagnosis of HF in the USA is 59â¯years. NH Blacks, living in poverty, lack of health insurance and obesity are the main drivers of early age at diagnosis of HF in the USA.