Analysis of CT scans may help predict disease progression in PPF
Trial data also show potential of analyses to track treatment response
Written by |
Computer-based analyses of CT scans can help to predict future disease progression and track response to treatment among people with progressive pulmonary fibrosis (PPF), according to a new analysis of clinical trial data.
These findings “suggest that quantitative CT methods can facilitate the prediction of clinically relevant outcomes and be used to assess the efficacy of drugs in clinical trials,” researchers wrote.
The study, “Quantitative Computed Tomography in Progressive Pulmonary Fibrosis: Data from a Sub-Study of the Double Blind, Randomized, Placebo-controlled INBUILD Trial,” was published in the American Journal of Respiratory and Critical Care Medicine. The work was funded by Boehringer Ingelheim, which markets Ofev (nintedanib), an approved oral therapy for PPF and other forms of pulmonary fibrosis.
Detailed computer algorithms analyze CT scans
Pulmonary fibrosis refers to scarring (fibrosis) in the lungs, which prevents them from efficiently taking in oxygen. PPF encompasses various lung diseases that are marked by pulmonary fibrosis that gets worse as time goes on.
In order to track disease progression in PPF, researchers usually rely on a standardized assessment called forced vital capacity (FVC), which basically measures how much air someone can blow out in a single big breath. FVC is a useful metric of lung function, but since it reflects overall breathing ability, FVC doesn’t capture the progressive damage to lung tissue that drives PPF.
CT scan is a type of imaging technology that uses a series of X-rays to create three-dimensional images of the body’s internal structures. Quantitative CT, or qCT, uses detailed computer algorithms to analyze CT scans and track changes in tissue structure. In this study, a team of scientists at Boehringer Ingelheim and other institutions wanted to assess whether qCT might be a useful way to track lung tissue damage in PPF.
These findings suggest that quantitative CT measures provide complementary information to that provided by FVC and assess structural changes in the lungs that are not completely reflected in changes in FVC.
To find out, the researchers analyzed data from more than 400 patients who participated in a Phase 3 clinical trial called INBUILD (NCT02999178), which tested Ofev against a placebo in hundreds of PPF patients. The main results from INBUILD showed that Ofev outperformed the placebo at reducing the risk of FVC decline or disease progression.
The researchers used statistical models to evaluate whether qCT-based metrics correlated with FVC changes over the course of the trial. Results showed moderately strong correlations — in other words, FVC changes and qCT measures showed similar trends, but did not perfectly track with each other.
“These findings suggest that quantitative CT measures provide complementary information to that provided by FVC and assess structural changes in the lungs that are not completely reflected in changes in FVC,” the researchers wrote.
They added that these data suggest that in the future, “quantitative CT may have a role in monitoring progression of [PPF] in clinical practice.”
‘Quantitative CT may have a role in the design of future clinical trials’
The researchers also found that qCT measurements taken at the start of the trial correlated with changes in FVC over the course of one year in individuals given the placebo. This finding could be important for future clinical trials, they said, as it may allow trials to selectively enroll patients who are more likely to experience a worsening of lung function (which would make the beneficial effects of a therapy easier to detect).
“Quantitative CT may have a role in the design of future clinical trials in patients with … PPF, enabling trials to be enriched for patients at higher risk of progression,” the team wrote.
Results also showed significant differences in qCT trends over time among patients given Ofev or the placebo, suggesting that this type of imaging might also be helpful for tracking the impact of treatments.
For their analyses, the researchers deployed two different tools designed to analyze lung scarring: one developed at the University of California, Los Angeles (UCLA), and one called e-Lung that was created by the company Brainomix. Both algorithms yielded broadly consistent results.
“The INBUILD trial has provided important insights into the treatment of patients with progressive pulmonary fibrosis, and these new analyses demonstrate the potential value of quantitative CT as an additional measure of disease progression and treatment response,” Susanne Stowasser, MD, a co-author of the study who works at Boehringer Ingelheim, said in a press release from Brainomix. “The ability to detect meaningful changes in lung structure alongside established clinical measures could help strengthen the evidence base for antifibrotic therapies and inform the design of future clinical trials.”
Leave a comment
Fill in the required fields to post. Your email address will not be published.