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according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.
Although previous retrospective studies have suggested that increased liver stiffness, as measured by VCTE (FibroScan), is associated with increases in liver-related events, there is a paucity of prospective data, reported Samer Gawrieh, MD, from Indiana University, Carmel and Indianapolis. VCTE is a noninvasive measure of cirrhosis progression.
In their prospective cohort study of patients representing the entire spectrum of NAFLD, the progression to LSM-defined cirrhosis was independently associated with the risk for a composite clinical outcome of death, decompensation, hepatocellular carcinoma, or a Model for End Stage Liver Disease (MELD) score of greater than 15, he said.
Their findings show that “progression to LSM-defined cirrhosis by VCTE is strongly associated with poor clinical outcomes,” Dr. Gawrieh said.
Study findings
Investigators looked at prospective data on 894 patients with biopsy-proven NAFLD in the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network database. The sample included patients with a minimum of two LSM readings taken from 2014 through 2022.
They defined LSM-defined cirrhosis as reaching LSM of greater than 14.9 kPa (90% specificity cutoff) among patients without cirrhosis on the baseline VCTE (a 90% sensitivity cutoff of LSM less than 12.1 kPa).
They also performed a histology-based subanalysis, including data only from those patients who had LSM within 6 months of a liver biopsy.
The median patient age was 60 years, 37% were male, and 80.9% were White and 11.5% were Hispanic/Latino. The median body mass index (BMI) was 32.
Out of all the patients, 119 (13.3%) had progression to LSM-defined cirrhosis.
At a median follow-up of 3.69 years for the 775 patients without LSM progression, 79 (10.2%) had one or more of the events in the composite clinical outcome.
In contrast, after a median 5.48 years of follow-up, 31 of the 119 patients with progression (26.1%) had one or more of the composite events (P < .0001).
The median rates of progression to LSM-defined cirrhosis in the overall cohort were 2% at 1 year, 11% at 3 years, and 16% at 5 years.
Researchers found a correlation between progression to LSM-defined cirrhosis and baseline histological fibrosis stage on biopsy, with a rate of 7% among those with no baseline fibrosis, 9% each for patients with stage I A-C or stage II fibrosis, 24% of those with baseline bridging fibrosis, and 25% of those with baseline cirrhosis.
A comparison of the time to a composite clinical outcome event between patients with progression to LSM-defined cirrhosis and those without progression showed that LSM-defined progression was associated with near doubling in risk, with a hazard ratio of 1.84 (P = .0039).
In a multivariate Cox regression analysis controlling for age, sex, race, BMI, diabetes status, and baseline LSM, only LSM-defined progression (HR, 1.93; P < .01) and age (HR, 1.03; P < .01) were significant predictors.
Dr. Gawrieh noted that while age was a statistically significant factor, it was only weakly associated.
“These data suggest that development of cirrhosis LSM criteria is a promising surrogate for clinical outcomes in patients with NAFLD,” Dr. Gawrieh concluded.
Progression definition questioned
Following the presentation, Nezam Afdhal, MD, chief of the division of gastroenterology, hepatology, and nutrition at Beth Israel Deaconess Hospital in Boston, questioned how 25% of patients who had biopsy-proven cirrhosis could progress to LSM-defined cirrhosis.
Dr. Gawrieh said that, according to inclusion criteria, the patients could not have LSM-defined cirrhosis with the sensitivity cutoff of 12.1 kPa, and that of the 10 patients with baseline cirrhosis in the cohort, all had LSM of less than 12.1 kPa. However, he admitted that because those 10 patients were technically not progressors to cirrhosis, they should have been removed from the analysis for clinical outcomes.
Mark Hartman, MD, a clinical researcher at Eli Lilly and Company in Indianapolis, said the study is valuable but noted that those patients who progressed tended to have higher LSM at baseline as well as a higher [fibrosis-4 score].
Dr. Gawrieh added that the investigators are exploring variables that might explain progression to cirrhosis among patients without high baseline liver stiffness, such as alcohol use or drug-induced liver injury.
The study was supported by the National Institutes of Health and the NASH Clinical Research Network institutions. Dr. Gawrieh disclosed research grants from NIH, Zydus, Viking, and Sonic Incytes, and consulting for TransMedics and Pfizer. Dr. Afdhal and Dr. Hartman reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.
Although previous retrospective studies have suggested that increased liver stiffness, as measured by VCTE (FibroScan), is associated with increases in liver-related events, there is a paucity of prospective data, reported Samer Gawrieh, MD, from Indiana University, Carmel and Indianapolis. VCTE is a noninvasive measure of cirrhosis progression.
In their prospective cohort study of patients representing the entire spectrum of NAFLD, the progression to LSM-defined cirrhosis was independently associated with the risk for a composite clinical outcome of death, decompensation, hepatocellular carcinoma, or a Model for End Stage Liver Disease (MELD) score of greater than 15, he said.
Their findings show that “progression to LSM-defined cirrhosis by VCTE is strongly associated with poor clinical outcomes,” Dr. Gawrieh said.
Study findings
Investigators looked at prospective data on 894 patients with biopsy-proven NAFLD in the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network database. The sample included patients with a minimum of two LSM readings taken from 2014 through 2022.
They defined LSM-defined cirrhosis as reaching LSM of greater than 14.9 kPa (90% specificity cutoff) among patients without cirrhosis on the baseline VCTE (a 90% sensitivity cutoff of LSM less than 12.1 kPa).
They also performed a histology-based subanalysis, including data only from those patients who had LSM within 6 months of a liver biopsy.
The median patient age was 60 years, 37% were male, and 80.9% were White and 11.5% were Hispanic/Latino. The median body mass index (BMI) was 32.
Out of all the patients, 119 (13.3%) had progression to LSM-defined cirrhosis.
At a median follow-up of 3.69 years for the 775 patients without LSM progression, 79 (10.2%) had one or more of the events in the composite clinical outcome.
In contrast, after a median 5.48 years of follow-up, 31 of the 119 patients with progression (26.1%) had one or more of the composite events (P < .0001).
The median rates of progression to LSM-defined cirrhosis in the overall cohort were 2% at 1 year, 11% at 3 years, and 16% at 5 years.
Researchers found a correlation between progression to LSM-defined cirrhosis and baseline histological fibrosis stage on biopsy, with a rate of 7% among those with no baseline fibrosis, 9% each for patients with stage I A-C or stage II fibrosis, 24% of those with baseline bridging fibrosis, and 25% of those with baseline cirrhosis.
A comparison of the time to a composite clinical outcome event between patients with progression to LSM-defined cirrhosis and those without progression showed that LSM-defined progression was associated with near doubling in risk, with a hazard ratio of 1.84 (P = .0039).
In a multivariate Cox regression analysis controlling for age, sex, race, BMI, diabetes status, and baseline LSM, only LSM-defined progression (HR, 1.93; P < .01) and age (HR, 1.03; P < .01) were significant predictors.
Dr. Gawrieh noted that while age was a statistically significant factor, it was only weakly associated.
“These data suggest that development of cirrhosis LSM criteria is a promising surrogate for clinical outcomes in patients with NAFLD,” Dr. Gawrieh concluded.
Progression definition questioned
Following the presentation, Nezam Afdhal, MD, chief of the division of gastroenterology, hepatology, and nutrition at Beth Israel Deaconess Hospital in Boston, questioned how 25% of patients who had biopsy-proven cirrhosis could progress to LSM-defined cirrhosis.
Dr. Gawrieh said that, according to inclusion criteria, the patients could not have LSM-defined cirrhosis with the sensitivity cutoff of 12.1 kPa, and that of the 10 patients with baseline cirrhosis in the cohort, all had LSM of less than 12.1 kPa. However, he admitted that because those 10 patients were technically not progressors to cirrhosis, they should have been removed from the analysis for clinical outcomes.
Mark Hartman, MD, a clinical researcher at Eli Lilly and Company in Indianapolis, said the study is valuable but noted that those patients who progressed tended to have higher LSM at baseline as well as a higher [fibrosis-4 score].
Dr. Gawrieh added that the investigators are exploring variables that might explain progression to cirrhosis among patients without high baseline liver stiffness, such as alcohol use or drug-induced liver injury.
The study was supported by the National Institutes of Health and the NASH Clinical Research Network institutions. Dr. Gawrieh disclosed research grants from NIH, Zydus, Viking, and Sonic Incytes, and consulting for TransMedics and Pfizer. Dr. Afdhal and Dr. Hartman reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.
Although previous retrospective studies have suggested that increased liver stiffness, as measured by VCTE (FibroScan), is associated with increases in liver-related events, there is a paucity of prospective data, reported Samer Gawrieh, MD, from Indiana University, Carmel and Indianapolis. VCTE is a noninvasive measure of cirrhosis progression.
In their prospective cohort study of patients representing the entire spectrum of NAFLD, the progression to LSM-defined cirrhosis was independently associated with the risk for a composite clinical outcome of death, decompensation, hepatocellular carcinoma, or a Model for End Stage Liver Disease (MELD) score of greater than 15, he said.
Their findings show that “progression to LSM-defined cirrhosis by VCTE is strongly associated with poor clinical outcomes,” Dr. Gawrieh said.
Study findings
Investigators looked at prospective data on 894 patients with biopsy-proven NAFLD in the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network database. The sample included patients with a minimum of two LSM readings taken from 2014 through 2022.
They defined LSM-defined cirrhosis as reaching LSM of greater than 14.9 kPa (90% specificity cutoff) among patients without cirrhosis on the baseline VCTE (a 90% sensitivity cutoff of LSM less than 12.1 kPa).
They also performed a histology-based subanalysis, including data only from those patients who had LSM within 6 months of a liver biopsy.
The median patient age was 60 years, 37% were male, and 80.9% were White and 11.5% were Hispanic/Latino. The median body mass index (BMI) was 32.
Out of all the patients, 119 (13.3%) had progression to LSM-defined cirrhosis.
At a median follow-up of 3.69 years for the 775 patients without LSM progression, 79 (10.2%) had one or more of the events in the composite clinical outcome.
In contrast, after a median 5.48 years of follow-up, 31 of the 119 patients with progression (26.1%) had one or more of the composite events (P < .0001).
The median rates of progression to LSM-defined cirrhosis in the overall cohort were 2% at 1 year, 11% at 3 years, and 16% at 5 years.
Researchers found a correlation between progression to LSM-defined cirrhosis and baseline histological fibrosis stage on biopsy, with a rate of 7% among those with no baseline fibrosis, 9% each for patients with stage I A-C or stage II fibrosis, 24% of those with baseline bridging fibrosis, and 25% of those with baseline cirrhosis.
A comparison of the time to a composite clinical outcome event between patients with progression to LSM-defined cirrhosis and those without progression showed that LSM-defined progression was associated with near doubling in risk, with a hazard ratio of 1.84 (P = .0039).
In a multivariate Cox regression analysis controlling for age, sex, race, BMI, diabetes status, and baseline LSM, only LSM-defined progression (HR, 1.93; P < .01) and age (HR, 1.03; P < .01) were significant predictors.
Dr. Gawrieh noted that while age was a statistically significant factor, it was only weakly associated.
“These data suggest that development of cirrhosis LSM criteria is a promising surrogate for clinical outcomes in patients with NAFLD,” Dr. Gawrieh concluded.
Progression definition questioned
Following the presentation, Nezam Afdhal, MD, chief of the division of gastroenterology, hepatology, and nutrition at Beth Israel Deaconess Hospital in Boston, questioned how 25% of patients who had biopsy-proven cirrhosis could progress to LSM-defined cirrhosis.
Dr. Gawrieh said that, according to inclusion criteria, the patients could not have LSM-defined cirrhosis with the sensitivity cutoff of 12.1 kPa, and that of the 10 patients with baseline cirrhosis in the cohort, all had LSM of less than 12.1 kPa. However, he admitted that because those 10 patients were technically not progressors to cirrhosis, they should have been removed from the analysis for clinical outcomes.
Mark Hartman, MD, a clinical researcher at Eli Lilly and Company in Indianapolis, said the study is valuable but noted that those patients who progressed tended to have higher LSM at baseline as well as a higher [fibrosis-4 score].
Dr. Gawrieh added that the investigators are exploring variables that might explain progression to cirrhosis among patients without high baseline liver stiffness, such as alcohol use or drug-induced liver injury.
The study was supported by the National Institutes of Health and the NASH Clinical Research Network institutions. Dr. Gawrieh disclosed research grants from NIH, Zydus, Viking, and Sonic Incytes, and consulting for TransMedics and Pfizer. Dr. Afdhal and Dr. Hartman reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LIVER MEETING