PSC-Mom while there has been no clinical trials to prove that Entyvio can cause PSC there have been a small number of patients who were in the clinical trials who had increased liver enzymes that resembled a “cholestatic picture” i.e. (Higher alkaline phosphatase, and elevated AST and ALT but as much as the alkaline phosphatase.) As is common, the authors of the studies don’t include much else in terms of specifics of what happens to those individuals who had the enzyme elevations in terms of follow up imaging, biopsies etc.)
In prelicensure controlled trials, rates of serum ALT elevations during vedolizumab were not reported, although instances of serum enzyme elevations were described. ALT elevations above 5 times the upper limit of normal (ULN) were said to occur in < 2% of vedolizumab and in a similar proportion of placebo recipients, and only rare patients had to stop therapy because of serum enzyme elevations. In the prelicensure trials, 3 patients were reported to have a severe adverse reaction of hepatitis, but the specific details were not given and there have been no case reports of clinically apparent, acute liver injury with symptoms or jaundice attributed to vedolizumab, but experience with its use has been limited. - https://livertox.nlm.nih.gov/Vedolizumab.htm
It looks like the the livertox page on Entyvio hasn’t been updated since 2015. Since then there have been case reports of cholestatic liver injury with Entyvio.
A total of 23 hepatobiliary events were observed among vedolizumab-treated patients, most of which were hepatic steatosis and transaminase increases. Five hepatic events were considered serious and vedolizumab was interrupted. Appropriate treatment resulted in resolution or near resolution of the liver abnormalities. https://www.wjgnet.com/1■■■■/full/v24/i23/2457.htm.
I’m not sure where you’re located at or when the last time you talked with your hepatologist was but the U.S. trial of vedolizumab and psc was stopped in March of 2017 before having anyone enrolled. I’m not sure if there’s any other trials in other countries or why this one was stopped.
DHC Yes, MRI can show fibrosis and PSC on imaging, you may know it as MRCP but it’s the same test just different names. Also, unfortunately yes, PSC is a fibrotic disease. The definition of PSC from the American Association for the Study of Liver Disease " Primary sclerosing cholangitis (PSC) is a chronic, cholestatic liver disease characterized by inflammation and fibrosis of both intrahepatic and extrahepatic bile ducts, leading to the formation of multifocal bile duct strictures."
I don’t want anyone to immediately revolt against Entyvio, that is not my intention with this post. I was just hoping to make sure other people with PSC knew of the possible side effects that have been shown in a small number of patients on Entyvio so that they could discuss with their hepatologist in case they had a situation similar to mine i.e. normal LFTs, no liver damage, then months after starting Entyvio damage shows up.
If you are on Entyvio and suspect anything talk with your hepatologist and gastroenterologist for a treatment plan that you are comfortable with. You can always suggest a trial of stopping the Entyvio, it’s not the only biological or treatment choice out there for UC. It will take close to 3 months to completely leave your system, so a trial of stopping for 6 months is what I think would be acceptable to determine if enzymes improve.