Trial reportAlimentary pharmacology & therapeutics2026
Long-Term Safety and Efficacy of Obeticholic Acid in Patients With Primary Biliary Cholangitis: Final Results of the POISE Long-Term Safety Extension.
Trial report in Alimentary pharmacology & therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01473524 (A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Double-Blind, Placebo-Controlled Trial and Long-Term Safety Extension of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
Who cites it
1 citing paper in PubMed.
- Long-Term Safety and Efficacy of Obeticholic Acid in Patients With Primary Biliary Cholangitis: Final Results of the POISE Long-Term Safety Extension.Alimentary pharmacology & therapeutics · 2026Trial
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Authors and funding
9 authors.
Funding
Abstract
backgroundObeticholic acid (OCA) has been evaluated in patients with primary biliary cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (UDCA) in the 12-month, double-blind, phase 3 POISE trial. A 3-year interim analysis of the open-label extension (OLE) demonstrated a favourable safety profile with sustained improvements in liver biochemistries.
aimTo present the final long-term safety and efficacy data from the 5-year POISE OLE.
methodsAll patients who entered the OLE (N = 193) were started on OCA 5 mg daily for a minimum of 3 months, after which the dose could be increased. Safety and efficacy were evaluated in the overall OLE population. Additional analyses censored data points following OCA titration > 10 mg to align with the prescribing label.
resultsPOISE was terminated after it was determined that the OLE had achieved its study objectives of sustained efficacy with no unexpected safety findings. With censoring of data points following OCA titration to > 10 mg, the most common treatment-emergent adverse event (TEAE) was pruritus (70%); serious hepatic-related TEAEs were reported in five patients (3%). The serious hepatic-related TEAEs and deaths (n = 2, 1%) were assessed by the Investigators as unrelated to OCA. Liver biochemistries improved throughout the OLE; the response rate for the POISE primary endpoint was 63% at Month 72. Liver stiffness, as measured by transient elastography, was stable over the study duration.
conclusionsFindings from the POISE OLE support the safety and efficacy profile of long-term OCA treatment for patients with PBC with inadequate response or intolerance to UDCA (NCT01473524).
trial registrationPhase 3 study of obeticholic acid in patients with primary biliary cirrhosis (POISE) ClinicalTrials.gov identifier: NCT01473524.
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