Pruritus Experience in Patients with PBC Treated with Obeticholic Acid Through 6 Years: Patient-Reported Quality of Life
Bibliographic record
Abstract
Question Obeticholic acid (OCA) is approved as second-line treatment for PBC in patients with an incomplete response or intolerance to ursodeoxycholic acid. We evaluated the impact of OCA on patient-reported outcome measures (PROs) of pruritus through 6 years. Methods POISE was a randomized, double-blind (DB) phase 3 study evaluating OCA 5–10 mg or 10 mg vs placebo over 12 months. A 5-year open-label extension (OLE) followed during which patients received OCA 5‒10 mg, or up-titrated to OCA 25 mg. PROs of pruritus were assessed every 3 months: pruritus severity visual analogue scale (VAS; 0 [none]–100 [severe]), 5-D pruritus questionnaire (5-D; 5 [none]–25 [severe]) and PBC-40 itch domain (0 [none]–15 [severe]). Pruritus was managed with concomitant medications, temporary OCA dose interruption or OCA dose reduction. Results Median (Q1, Q3) scores on the pruritus severity VAS were not significantly different in the OCA 5‒10 mg group vs placebo and remained in the mild-to-moderate range in the DB phase. VAS scores in the OCA 10 mg groups were higher than placebo at DB month 3 but similar across groups by DB month 12 ( Figure ). Similar findings were observed during the DB phase for the 5-D and PBC-40 itch median scores. Median VAS ( Figure ), 5-D, and PBC-40 itch scores remained stable through the 5-year OLE phase. All VAS scores remained in the mild-to-moderate category. Conclusions In POISE, with effective management and correct dose titration, a subset of patients experienced consistently mild pruritus with little impact on quality of life, which was sustained through the OLE phase. Publication History Article published online: 04 January 2021 © 2020. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.004 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".