1. Urso for PSC - CON Christopher L. Bowlus, MD Professor and Chief
Division of Gastroenterology and Hepatology
University of California Davis

2. Guilty Until Proven Innocent
We should NOT use a treatment until it is proven safe and effective.
All treatments have risk/adverse effects
Often hard to measure (Celebrex, Omeprazole)
Not all treatments have benefits
Improving liver tests is not a benefit

3. New Drug Approval - FDA
Substantial evidence from appropriately designed and analyzed trials Demonstrate an improvement in how a patient feels, functions, or survives After > 20 years of study, Urso has still not met these standards

4. Urso Improves Liver Tests
PSC patients with lower liver tests live longer…..
….so doesn’t this mean that Urso will make me live longer?
Not necessarily

5. What we want Urso to do Without Urso With Urso Alkaline Phosphatase

6. What Urso may actually be doing
Alkaline
Phosphatase
Without Urso
Alkaline
Phosphatase
With Urso

7. Normal Alkaline Phosphatase Predicts Better Prognosis Regardless of Urso
Lindstrom L, et al. Clinic Gastroenterol Hepatol

8. If Urso works, wouldn’t we know by now???
Didn’t work in the US
Didn’t work in Scandnavia
12/9/2018

9. PBC but not PSC Transplants have decreased since Urso was approved
Accessed April 2, 2013

10. High-dose Urso has unintended consequences
12/9/2018

11. Weighing the risks and benefits?
Benefit of Urso
Risk of disease progression
Risk of Urso
Cost of Urso
Take Urso
Don’t Take Urso