Since approximately 5% to 10% of patients with asthma have severe disease, there is an urgent need for improved management and treatment approaches and biologic therapies are an increasingly important treatment option, according to results of a recent study presented at CHEST 2020.
Researchers are presently conducting the CHRONICLE Study, an ongoing, real-world, observational investigation that provides high-quality data on patient characteristics, treatment patterns, and health outcomes among a large, geographically diverse cohort of adults with severe asthma treated by United States subspecialists.
Prior to CHRONICLE, Few Quality Data Were Available
“The CHRONICLE Study will provide a unique opportunity to describe contemporary severe asthma care in the US, including patient disease burden and potential treatment gaps,” says Chris Ambrose, MD, MBA. “Several monoclonal antibody therapies, or biologics, have been approved for the treatment of severe asthma. Before CHRONICLE, however, few quality data were available to describe the real-word use of and outcomes associated with these agents.”
In the CHRONICLE Study, Dr. Ambrose and colleagues aimed to examine data from more than 2,700 patients enrolled since February 2018. The study consists of individuals with specialist-confirmed severe asthma from a diverse sample of more than 130 US allergist/immunologist and pulmonologist practices. Information is collected from patients at enrollment and updated every 6 months, with the goal of following patients for 3 or more years. During the study, there are no required treatments or testing, as the study intent is to collect information on real-life clinical practice and patient experiences, Dr. Ambrose explains.
Treatment With Biologics Linked With Reduction of Disease Severity
“The study has already yielded significant insights into US severe asthma, with results presented at multiple recent conferences and two publications in peer-reviewed journals,” Dr. Ambrose notes. “Results have shown that specialists overestimate patient disease control and that real-world exacerbations of severe asthma require emergency room and hospital care more frequently than previously estimated. Additionally, we have shown that patients with severe asthma have significantly reduced quality of life and work productivity, with less impairment among those receiving biologics and greater impairment among those receiving other treatments. Most recently, we have confirmed that treatment with biologics is associated with a reduction in both the number and severity of exacerbations.”
Despite the strengths of the CHRONICLE study, there are potential limitations. First, patient recall bias and missing data from medical records could limit the utility of the results. To address this issue, study sites routinely request supplementary information regarding each patient’s health care utilization from the patient’s primary care physician; additionally, acquisition of pharmacy claims information is planned. However, information regarding actual treatment costs from patient, insurer, and societal perspectives are not collected, as providers and patients have limited access to accurate payment data. The study collects some information about financial decisions, but a complete assessment of financial decision-making is beyond the scope of the study.
Another limitation is that laboratory testing, pulmonary function testing, and other procedures are not mandated but are performed according to standard clinical practice. As a result, not all patients will contribute data to all outcomes of interest, and those tested represent a selected sample.
There are many more aspects of severe asthma that Dr. Ambrose and the study team seek to explore as the CHRONICLE Study enrolls more patients and accumulates more longitudinal data on those enrolled. “There is significant interest in better understanding how individual biologics are being used as well as outcomes associated with switching between biologic treatments,” he says. “Additionally, we plan to explore the impact of the COVID-19 pandemic on US patient with severe asthma. The ultimate goal is to help improve the US standard of care for patients with severe asthma.”
The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results
https://www.dovepress.com/the-chronicle-study-of-us-adults-with-subspecialist-treated-severe-ast-peer-reviewed-article-POR
