Greater Transplant-Free Survival in Patients Receiving Obeticholic Acid for Primary Biliary Cholangitis in a Clinical Trial Setting Compared to Real-World External Controls.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Murillo Perez C Fiorella, Fisher Holly, Hiu Shaun, Kareithi Dorcas, Adekunle Femi, Mayne Tracy, Malecha Elizabeth, Ness Erik, van der Meer Adriaan J, Lammers Willem J, Trivedi Palak J, Battezzati Pier Maria, Nevens Frederik, Kowdley Kris V, Bruns Tony, Cazzagon Nora, Floreani Annarosa, Mason Andrew L, Parés Albert, Londoño Maria-Carlota, Invernizzi Pietro, Carbone Marco, Lleo Ana, Mayo Marlyn J, Dalekos George N, Gatselis Nikolaos K, Thorburn Douglas, Verhelst Xavier, Gulamhusein Aliya, Janssen Harry L A, Smith Rachel, Flack Steve, Mulcahy Victoria, Trauner Michael, Bowlus Christopher L, Lindor Keith D, Corpechot Christophe, Jones David, Mells George, Hirschfield Gideon M, Wason James, Hansen Bettina E, GLOBAL PBC Study Group and the members of the UK-PBC Consortium
Аннотация
METHODS: Propensity scores were generated for external control patients meeting POISE eligibility criteria from 2 registry studies (Global PBC and UK-PBC) using an index date selected randomly between the first and last date (inclusive) on which eligibility criteria were met. Cox proportional hazards models weighted by inverse probability of treatment assessed time to death or liver transplantation. Additional analyses (Global PBC only) added hepatic decompensation to the composite end point and assessed efficacy in patients with or without cirrhosis.
RESULTS: During the 6-year follow-up, there were 5 deaths or liver transplantations in 209 subjects in the POISE cohort (2.4%), 135 of 1381 patients in the Global PBC control (10.0%), and 281 of 2135 patients in the UK-PBC control (13.2%). The hazard ratios (HRs) for the primary outcome were 0.29 (95% CI, 0.10-0.83) for POISE vs Global PBC and 0.30 (95% CI, 0.12-0.75) for POISE vs UK-PBC. In the Global PBC study, HR was 0.20 (95% CI, 0.03-1.22) for patients with cirrhosis and 0.31 (95% CI, 0.09-1.04) for those without cirrhosis; HR was 0.42 (95% CI, 0.21-0.85) including hepatic decompensation.
CONCLUSIONS: Patients treated with OCA in a trial setting had significantly greater transplant-free survival than comparable external control patients.