Cholangitis, the hepatologist: “With obeticholic acid reduction of liver events”

“The results of the real-life study that we are carrying out do not have the strength of a randomized clinical trial, but carrying out a double-blind study” for primary biliary conlangitis (PBC) “becomes complex because it means not allowing treatment to those who could benefit from it. The real-life results suggest, however”, in patients treated with obeticholic acid, “a reduction in liver events, especially when it is used in the right population, that is, in those who have an early-stage disease, well compensated, without any type of liver dysfunction”. Thus Umberto Vespasiani Gentilucci, associate professor of Internal Medicine and PhD in Experimental and Clinical Hepatology, Campus Bio-Medico University of Rome, in his speech this morning at a press conference organized by Omar, Osservatorio Maladie Rare, in collaboration with Amaf Aps Ets – Autoimmune Liver Disease Association and EpaC Ets Association and with the unconditional contribution of Advanz Pharma, close to the World Cbp Awareness Day, which was celebrated on September 8.

“After its commercialization – explains Vespasiani Gentilucci – obeticholic acid was used in 10 thousand subjects throughout Europe, belonging to small cohorts that involved people with more advanced disease, that is, more complex subjects than those considered in the registration clinical trials. In the approximately 760 subjects treated in Italian centers, especially post-menopausal women, with a more advanced and compensated phase of the disease, the liver damage indices, during treatment, stabilized or reduced”. In particular, in real world studies, “about 1 in 2 treated patients – he adds – are rescued with a response, with a slowing down of the disease. The suspensions that are recorded are linked to the problem of itching, which is already an effect of the disease and which disappears with the suspension of the treatment. Treatment with obeticholic acid also involves a 60% reduction in the risk of death or transplant”.