OCALIVA Efficacy: Combination Data

Nearly 5x as Many Patients Taking OCALIVA Achieved the Primary Endpoint vs UDCA Alone1,a

  • Primary Endpoint
  • ALP <1.67x ULN
  • ALP Reduction ≥15%
  • Bilirubin ≤ ULN
  • Study Design
Primary Endpoint

46% of Patients Met the Primary Endpoint
Compared to 10% of Patients Taking UDCA Alone1,a

Patients who met the primary endpoint
Patients who met the primary endpoint
ALP <1.67x ULN

47% of Patients Taking OCALIVA Demonstrated
Alkaline Phosphatase <1.67x ULN1,a

Patients with alkaline phosphatase <1.67x ULN, one of the composite efficacy endpoints
Patients with alkaline phosphatase <1.67x ULN, one of the composite efficacy endpoints
ALP Reduction ≥15%

77% of Patients Taking OCALIVA
Reduced Alkaline Phosphatase ≥15%1,a

Patients with alkaline phosphatase reductions of ≥15%, one of the composite efficacy endpoints
Patients with alkaline phosphatase reductions of ≥15%, one of the composite efficacy endpoints
Bilirubin ≤ ULN

89% of Patients Taking OCALIVA
Demonstrated Total Bilirubin ≤ ULN1,a

Patients with total bilirubin ≤ ULN, one of the composite efficacy endpoints
Patients with total bilirubin ≤ ULN, one of the composite efficacy endpoints
Study Design

OCALIVA Was Studied in Patients Already Taking UDCA
Who Had an Inadequate Response1,2,a

OCALIVA was studied in patients already taking UDCA who had an inadequate response
OCALIVA was studied in patients already taking UDCA who had an inadequate response
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a16 patients (7%) who were intolerant did not receive concomitant UDCA: 6 patients (8%) in the OCALIVA 10 mg arm, 5 patients (7%) in the OCALIVA 5→10 mg titration arm, and 5 patients (7%) in the placebo arm.1

OCALIVA Maintained Reductions in Alkaline Phosphatase Over 1 Year1,a

Mean Alkaline Phosphatase Over 12 Months1

Reductions in alkaline phosphatase efficacy were maintained over 1 year with OCALIVA Reductions in alkaline phosphatase efficacy were maintained over 1 year with OCALIVA

a16 patients (7%) who were intolerant did not receive concomitant UDCA: 6 patients (8%) in the OCALIVA 10 mg arm, 5 patients (7%) in the OCALIVA 5→10 mg titration arm, and 5 patients (7%) in the placebo arm.1

ALP, alkaline phosphatase; PBC, primary biliary cholangitis; UDCA, ursodeoxycholic acid; ULN, upper limit of normal.

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References:

  1. OCALIVA [package insert]. New York, NY: Intercept Pharmaceuticals, Inc.; 2017.
  2. Supplementary appendix to: Nevens F, Andreone P, Mazzella G, et al; for the POISE Study Group. A placebo-controlled trial of obeticholic acid in primary biliary cholangitis. N Engl J Med. 2016:1-37.
  3. European Association for the Study of the Liver. EASL clinical practice guidelines: the diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-172.
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