The study looked at a pre-defined group of patients with PBC who were treated with OCA and a comparable group of PBC patients who were eligible, but who were not treated with OCA.
HEROES-US leveraged the Komodo Health database in a fully real-world study to assess the potential benefits of OCA treatment on death, liver transplant and hospitalization for hepatic decompensation in PBC patients with compensated liver disease. Results of the HEROES Study: Treatment Efficacy of Obeticholic Acid on Hepatic Real-World Outcomes in Patients with Primary Biliary Cholangitis (oral presentation, Sunday, Nov. “We believe that the real-world data we have generated to date demonstrate long-term benefits to people with PBC who are receiving OCA, specifically improved event-free survival, which we know to be the most important treatment goal for patients and clinicians.” Michelle Berrey, M.D., MPH, President, Research & Development and Chief Medical Officer of Intercept. “We have long understood the challenges of running placebo-controlled, post-marketing studies, which is why we initiated real-world analyses and leveraged rigorously matched external controls for COBALT to provide additional opportunities to understand the effect of OCA on clinical outcomes in PBC,” said M. Results from the EC group as-treated analysis showed statistical significance in both the original and the FDA-expanded primary endpoints comparing the OCA-treated subjects in COBALT with the non-OCA-treated patients in EC:įrom the Original Primary Composite Endpoint: 17 (10%) events occurred in subjects in the COBALT OCA arm and 35 (22%) in patients from the non-OCA-treated EC arm (HR=0.39 95% CI 0.22, 0.69 p<0.01), reflecting a 61% reduction in risk of events at any time during follow-up.įrom the FDA Expanded Primary Endpoint: 28 (17%) events occurred in subjects in the COBALT OCA arm and 46 (28%) in patients from the non-OCA-treated EC arm (HR=0.48 95% CI 0.30, 0.77 p<0.01), reflecting a 52% reduction in risk of events at any time during follow-up.
#Meld score 5 year survival trial#
Endpoints in this comparison were the same as in the primary analysis of the COBALT trial to the extent possible however certain variables, such as MELD (model for end-stage liver disease), were not available in the Komodo database and thus not included.
The EC group was comparable to OCA-treated patients in COBALT on all measured baseline variables. The EC group, created from Komodo Health claims database, had to meet COBALT inclusion and exclusion criteria and were weighted using propensity score-derived standardized morbidity ratios (SMRs). In anticipation of feasibility challenges, the COBALT analysis plan included an EC group as a second comparator arm. The placebo-controlled analysis of COBALT showed no statistically significant difference in either the Original Primary Composite Endpoint (time to first occurrence of death, liver transplant or serious liver-related events) or the FDA Expanded Primary Endpoint, which also included additional liver-related events. As previously disclosed, the study was terminated in December 2021, before it was fully enrolled, for lack of feasibility.
claims database.ĬOBALT was a randomized, double-blind, placebo-controlled confirmatory trial designed to assess efficacy and safety of OCA in patients with advanced PBC. This analysis assessed the effect of OCA treatment on time to first occurrence of PBC disease progression (hepatic decompensation), liver transplant or death of OCA-treated subjects in the Phase 3b/4 COBALT trial compared to placebo and compared to a non-OCA-treated external control (EC) group created from the Komodo Health U.S. Placebo and External Control (EC) on Clinical Outcomes in Primary Biliary Cholangitis (PBC) (late-breaker poster, Monday, Nov.
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