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 Achieved
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%

Patients Taking OCALIVA Were 2.5x More Likely to
Achieve a Reduction in 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

No Worsening of Bilirubin Over 12 Months Compared to Baseline1,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,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

b In the 5→10 mg titration group, 36 patients stayed at 5 mg and 33 were titrated to 10 mg after 6 months.2

Impact on Alkaline Phosphatase and Bilirubin Over 1 Year1,5

  • Significant ALP Reductions
  • 12-Month Bilirubin Data
  • Up-titration Efficacy
Significant ALP Reductions

Mean Reductions >30% at 12 Months vs 5% for UDCA Alone1,3,4,5,a

Reductions in alkaline phosphatase over 1 year Interconnect image: Interconnect® Enrollment Form
Reductions in alkaline phosphatase over 1 year Interconnect image: Interconnect® Enrollment Form
12-Month Bilirubin Data

Total Bilirubin over 12 Months5,a

Total Bilirubin over 12 Months
Total Bilirubin over 12 Months
  • 92% of patients had normal bilirubin at baseline
  • Among patients who completed treatment, 95% of patients in the OCALIVA titration group (n=64) and 97% of patients in the OCALIVA 10 mg group (n=63) had bilirubin
    ≤ ULN vs 81% of patients in the placebo group (n=70)1,6
Up-titration Efficacy

OCALIVA Delivered Additional Reductions (~50 U/L)
When Patients Up-titrated to 10 mg4

When patients up-titrated from 5 mg to 10 mg, OCALIVA delivered further reductions (~50 U/L) in alkaline phosphatase
When patients up-titrated from 5 mg to 10 mg, OCALIVA delivered further reductions (~50 U/L) in alkaline phosphatase
  • 39% of patients who were up‑titrated from 5 mg to 10 mg at 6 months achieved the primary endpoint at 12 months1
  • While the trial was designed for up‑titration at 6 months, FDA guidance and product labeling recommend up-titration at 3 months, if tolerated1

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 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.; 2018.
  2. Data on file: GL-PB-MED-00067.
  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.
  4. 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.
  5. 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;375(7):631-643.
  6. Data on file: US-PB-MED-00129.
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