DDW Research Shows No Efficacy for Vedolizumab in Treating NAFLD

Ashraf Almomani, MD

Despite some promise in early phase trials, vedolizumab has no effect on the disease course for patients with non-alcoholic fatty liver disease (NAFLD).

A team, led by Ashraf Almonani, MD, Cleveland Clinic, examined the impact of vedolizumab on the course of NAFLD in patients with inflammatory bowel disease (IBD) in data presented at the 2022 Digestive Disease Week Annual Meeting in San Diego.

The Risk of NAFLD

Patients with IBD often have a higher risk of incidence and prevalence of NAFLD, largely because inflammation plays a key role in the pathogenesis of NAFLD.

There has been recent research that suggests the inhibition of integrin-mediated CD4 T cell recruitment leads to improvement and overall reversal of NAFLD-related metabolic derangements.

One such option could be vedolizumab, an α4β7 integrin-inhibitor currently approved for patients with IBD.

Analyzing the Data

In the retrospective cohort analysis, the investigators identified 79 patients with NAFLD who were treated with vedolizumab at the Cleveland Clinic Foundation. An additional 79 patients were part of the matching control group.

The investigators sought primary outcomes of the response to vedolizumab, defined as Fibrosis-4 (Fib-4) regression to <1.3 points after 1 year of treatment.

They also sought secondary outcomes of the progression of the disease, defined as Fib-4 rise to >1.3 points, and reduction in the number of decompensated cirrhosis episodes among those with NAFLD cirrhosis.

Patients excluded from the study included those with chronic hepatitis B virus (HBV), hemochromatosis, Wilson’s Disease, alcohol abuse, Alpha 1-antitrypsin deficiency, autoimmune hepatitis, cystic fibrosis, biliary cirrhosis, halactosemia, or glycogen storage disease.

The investigators also applied appropriate weights for all analyses.

The Results Show No Efficacy

Overall, there was no statistically significant difference in response (P = 0.576), progression of disease (P = 1.000), or change in the number of cirrhosis decompensation episodes among those treated with vedolizumab.

“In this retrospective cohort analysis, and unlike in the animal model, Vedolizumab was not associated with statistically significant improvement or progression in the Fib-4 score after one year of treatment, and among those with NAFLD-cirrhosis, there was no statistical difference in the complication rates,” the authors wrote.

The study, “Su1364: VEDOLIZUMAB HAS NO EFFECT ON THE COURSE OF NON-ALCOHOLIC FATTY LIVER DISEASE: A RETROSPECTIVE COHORT ANALYSIS,” was published online by DDW 2022.