Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy

Ki vehet részt

• Adults with diagnosis of PsA fulfilling the classification for PsA (CASPAR) criteria
• Must have:; 1 or more swollen joint(s) and/or one or more active sites of enthesitis
• AND/OR; 1 or more psoriatic plaques
• No changes in the regular medication regimen within the last three months, and no use of systemic and/or chronic steroids within 8 weeks leading up to the study
• Overweight or obese by BMI ≥ 25.0 kg/m2 or ≥ 23.0 for Asian participants
• Patients are starting Guselkumab therapy for PsA as indicated by primary rheumatologist
• Elevated liver fat on controlled attenuation parameter (CAP) ≥ 288 dB/m, which is consistent with NAFLD after exclusion of secondary causes of liver disease

Ki nem vehet részt

• Patients with prior exposure to IL12/23i, IL-17i, JAKi, or TYK2i. Patients with exposure to more than 2 TNFi
• History of known HIV infection
• Evidence of other causes of chronic liver disease; Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg); Previous or current infection with Hepatitis C as defined by presence of hepatitis C virus Abin serum (anti-HCV Ab); Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy; Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis; Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease; Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency; Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D; Drug-induced liver disease as defined on the basis of typical exposure and history; Bile duct obstruction as shown by imaging studies; History of gastrointestinal bypass surgery or ingestion of medications known to produce steatosis, such as corticosteroids, high-dose estrogen, tamoxifen, amiodarone or tetracycline in the previous 6 months; Evidence of cirrhosis or previously known cirrhosis based on the results from previous liver biopsy or history of portal hypertension presented by ascites, hepatic encephalopathy or varices; Presence of regular and/or excessive use of alcohol (defined as >30g/day for males and >15g/day for females) for a period longer than 2 years at any times in the last 10 years; Serum creatinine > 2.0 mg/dL; The subject is a pregnant or nursing female or is planning to become pregnant; Life expectancy less than 5 years