Diagnosis and Management of PBC

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1 Diagnosis and Management of PBC Cynthia Levy, MD, FAASLD University of Miami Miller School of Medicine Miami, Florida 1

2 Primary Biliary Cholangitis (PBC) Chronic cholestatic liver disease Autoimmune in nature Inflammation and destruction of small interlobular bile ducts Affects predominantly middle-aged females Rising incidence and prevalence Carey E, et al. Lancet

3 PBC Diagnosis Unexplained Elevation of ALP 1.5x ULN Positive antimitochondrial antibody Non-suppurative destructive cholangitis on histology Two out of these 3 criteria are required for the diagnosis of PBC

4 Variant Syndromes AMA-negative PBC 50% will have antinuclear antibodies (ANA) PBC-specific ANA anti gp210, anti sp100 Same clinical presentation Overlap syndrome with autoimmune hepatitis Consider when ALP: transaminase ratio <1.5, IgG is elevated and smooth muscle antibodies are present with titer >1:80 Premature Ductopenic Variant 5-10% Very rapid onset of ductopenia, severe icteric cholestasis and fast progression towards cirrhosis

5 Clinical Features Vary Greatly Between Patients o Fatigue 1,2 o Pruritus 1,2 o Concurrent autoimmune diseases 1,2 o Reduced bone density 1,2 o Hypercholesterolemia 1,2 o Xanthoma and Xanthelasma 2,3 PBC can range from asymptomatic and slowly progressive to symptomatic and rapidly evolving Selmi C, et al. Lancet. 2011;377(9777): ; 2. Carey EJ, et al. Lancet. 2015;386(10003): ; 3. Lindor KD, et al. Hepatology. 2009;50(1):

6 First Line Therapy: Ursodeoxycholic Acid o Orally administered, naturally occurring, hydrophilic secondary bile acid o Dose: mg/kg/day o Improvement in liver tests may be seen within a few weeks and 90% of the improvement usually occurs within 6-9 months Lindor K, et al. Hepatology. 2009;50:

7 Therapeutic Effects UDCA Improves TB, ALP, GGT, AST and ALT Improves survival free of liver transplantation Improves cholesterol, IgM UDCA mg/kg/day Delays development of esophageal varices Delays histological progression Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyl transferase; IgM, immunoglobulin M; TB, total bilirubin; UDCA, ursodeoxycholic acid. Levy C and Lindor KD. In: Zakim and Boyer's Hepatology: A Textbook of Liver Disease. Elsevier Inc;2011: Graphic courtesy of Dr. Cynthia Levy.

8 Combined Effect of TB and ALP on Transplant-Free Survival Transplant-Free Survival (%) a-b: P.001 c-d: P.001 ALP and TB at 1 Year Follow-up Time (Years) a b c d a b c d Normal bilirubin and ALP 2.0 x ULN Normal bilirubin and ALP > 2.0 x ULN Abnormal bilirubin and ALP 2.0 x ULN Abnormal bilirubin and ALP > 2.0 x ULN Lammers, et al. Gastroenterology. 2014; 147:

9 Hazard Ratio for LT/Death According to ALP A Hazard Ratio for Liver Transplantation or Death At Baseline* Hazard Ratio for Liver Transplantation or Death At One Year Follow-up* Thresholds (xuln) for Alkaline 5 Phosphatase Values Thresholds (xuln) for Alkaline Phosphatase Values *3710/4635 patients were included for this analysis Lammers, et al. Gastro

10 New Targets for Treatment of Cholestatic Diseases PPAR + MDR3 Trauner M. Hepatology

11 OCA in Patients with PBC: POISE Study Design Placebo (n=73) Screening OCA 5 mg OCA 10 mg (n=73) Titrate to OCA 10 mg (n=33) Remain at OCA 5 mg (n=36) OCA 5 mg OCA 5-10 mg dose adjustment option Months in Open-Label Phase 0 W2 M3 M6 M9 M12 Modified from Nevens F, et al. N Engl J Med. 2016;375:

12 Primary Endpoint in the Double-Blind and Open-Label Extension Phases Placebo Obeticholic acid, 5 10 mg Obeticholic acid, 10 mg 100 Double-Blind Phase Open-Label Phase Patients with Response (%) Month in Double-Blind Phase Month in Open-Label Phase No. of Patients Placebo Obeticholic acid, 5 10 mg Obeticholic acid, 0 mg Nevens F, et al. N Engl J Med. 2016;375:

13 Other Effects of OCA During POISE Trial Significant drop in ALP, AST, ALT, GGT, TB Significant reduction in inflammatory markers Reduction in HDL-cholesterol (20% in 10mg/day, 9% in 5-10 mg/day) No change in liver stiffness scores (50% had LS measured) Significant reduction in serum bile acid levels and increase in FGF 19 levels Main side effect: Pruritus è mitigated by starting at 5 mg/day and only titrating up IF well tolerated Nevens F, et al. NEJM

14 Obeticholic Acid Is Approved: o In combination with UDCA for patients with PBC who have been treated with UDCA for > 1 year and have incomplete response o As monotherapy for patients with PBC who are intolerant to UDCA Improvement in survival free of liver transplantation has not yet been demonstrated. Conditional approval granted

15 Cumulative Incidence of Advanced Stages of PBC Cumulative Incidences 20% 15% 10% 5% 0% 20% A. Decompensated Cirrhosis UDCA OCA plus UDCA Year C. Liver Transplants Cumulative Incidences 20% 15% 10% 5% 0% 20% B. Hepatocellular Carcinoma UDCA OCA plus UDCA Year D. Liver-Related Deaths In patients with inadequate response to UDCA, OCA decreased 15-yr cumulative incidences of: Decompensated cirrhosis from 12.2% to 4.5% HCC from 9.1% to 4% Cumulative Incidences 15% 10% 5% 0% UDCA OCA plus UDCA Year Cumulative Incidences 15% 10% 5% 0% UDCA OCA plus UDCA Year OLT from 4.5% to 1.2% Liver-related deaths from 16.2% to 5.7% Samur S, et al. Hepatology

16 Cost-Effectiveness Study of OCA in PBC o Treating 10,000 patients would prevent: 770 cases of decompensated cirrhosis,510 cases of HCC, 330 OLTs and 1050 liver-related deaths o Lifetime treatment cost of PBC increased from $63,100 to $902,200 (1,330%) with addition of OCA to UDCA o ICER: $473,400/QALY è NOT cost-effective o Recommended price reduction: 73% Samur S, et al. Hepatology

17 WHO SHOULD RECEIVE ADJUVANT THERAPY? WHO IS AT RISK FOR PROGRESSION?

18 PBC - Risk Stratification Pre-Treatment After 1 year of treatment with UDCA Staging: Transient elastography, histology, enhanced liver fibrosis score Age, gender, ethnicity Anti gp 210, anti-centromere Variant syndromes Response to UDCA ALP, TB Mathematical models: Globe PBC, UK PBC Levy C. Hepatology

19 Value of Liver Stiffness in PBC A Survival Without Adverse Outcome Survival According to Baseline LSM 9.6 kpa >9.6 kpa Total Follow-up (Years) B Survival Without Adverse Outcome Survival According to LSM/ t 2.1 kpa/yr >2.1 kpa/yr Extended Follow-up (Years) -LS > 9.6 at baseline associated with 5x increase in risk of adverse outcomes -LS increase >2.1 kpa/year associated with 8x increase in risk of adverse outcomes Corpechot, et al. Hepatology

20 Novel Therapies Under Evaluation for PBC Compound NCT Mechanism of Action Status Bezafibrate Fenofibrate NCT NCT Pan PPAR agonist PPAR alpha agonist Phase 3, Europe has results Phase 2, China NGM 282 NCT FGF 19 analog Phase 2, has results LJN452 NCT FXR agonist Phase 2, recruiting MBX-8025 NCT PPAR delta agonist Phase 2, recruiting FFP104 NCT CD40 Inhibitor Phase 1/2 - Europe Abatacept NCT Inhibits T cell activation Phase 4, ongoing LUM001 NCT ASBT inhibitor Phase 2, complete; primary endpoint: itching GS9674 NCT FXR agonist Phase 2, recruiting GSK 672 NCT IBAT inhibitor Phase 2, recruiting; primary endpoint: itching Genfit PPAR delta agonist Phase 2, not yet recruiting

21 Bezafibrate+UDCA vs. Placebo+UDCA o 100 patients with incomplete response to UDCA o Randomized to BZF 400 mg/day or placebo, for 2 years o Primary endpoint* at 2 years: 30% BZF vs. 0% Placebo o Itch score, LSM and ELF all improved in BZF group 67% 70% 60% 50% 40% 30% 20% 10% 0% 0% normalization ALP BZF Placebo Corpechot C, et al. LB-4195, EASL

22 Summary: Updated Management Strategy Imaging & Labs Pruritus Assess symptoms Fatigue Baseline Evaluation Staging* Sicca Syndrome New Diagnosis Initiate PBC-specific therapy DEXA UDCA mg/kg/day Clinical evaluation Cirrhosis? MRS > 4.1? Thrombocytopenia EGD; HCC surveillance Long-term monitoring Biochemistries Risk stratification after 1 year of therapy Evaluate need for adjuvant therapy Transient elastography Approved: Ocaliva Off label: Fibrates, budesonide

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