Sulfasalazine for the Treatment of Primary Sclerosing Cholangitis

Exclusion Criteria

• •1. Anticipated need for liver transplant within one year as determined by Mayo PSC risk score treatment
• •2. Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy.
• •3. Evidence of advanced liver disease including MELD score \> 10, bilirubin \> 3.0, platelet count \< 100,000; or INR \> 1.4
• •4. Concomitant chronic liver disease including alcohol related liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliary cholangitis
• •5. Secondary causes of sclerosing cholangitis
• •6. Known intolerance to sulfasalazine (including but not limited to allergy to sulfa or mesalamine) or folic acid
• •7. History of cholangiocarcinoma or colon cancer within 5 years
• •8. History of colectomy with \> 1/3 bowel resected
• •9. Treatment with any investigational agents, within two months or 5 half-lives of the investigational product, whichever is longer.
• •10. Active illicit drug or alcohol abuse
• •11. Current or past use of sulfasalazine within 6 months of enrollment.
• •12. Need for chronic use of antibiotics
• •13. Evidence of bacterial cholangitis within 6 months of enrollment
• •14. In patients with Ulcerative Colitis, simple clinical colitis activity index of \> 4 or, if Crohn's disease, a Harvey-Bradshaw index of \> 5
• •15. Chronic kidney injury (eGFR \< 59)
• •16. Pregnancy or lactation