%0 Journal Article
%T Longitudinal outcomes of obeticholic acid therapy in ursodiol-nonresponsive primary biliary cholangitis: Stratifying the impact of add-on fibrates in real-world practice.
%A Gómez E
%A Montero JL
%A Molina E
%A García-Buey L
%A Casado M
%A Fuentes J
%A Simón MA
%A Díaz-González A
%A Jorquera F
%A Morillas RM
%A Presa J
%A Berenguer M
%A Conde MI
%A Olveira A
%A Macedo G
%A Garrido I
%A Hernández-Guerra M
%A Olivas I
%A Rodríguez-Tajes S
%A Londoño M
%A Sousa JM
%A Ampuero J
%A Romero-González E
%A González-Padilla S
%A Escudero-García D
%A Carvalho A
%A Santos A
%A Gutiérrez ML
%A Pérez-Fernández E
%A Aburruza L
%A Uriz J
%A Gomes D
%A Santos L
%A Martínez-González J
%A Albillos A
%A Fernández-Rodríguez CM
%J Aliment Pharmacol Ther
%V 59
%N 12
%D 2024 06 1
%M 38690746
%F 9.524
%R 10.1111/apt.18004
%X Suboptimal response to ursodeoxycholic acid occurs in 40% of primary biliary cholangitis (PBC) patients, affecting survival. Achieving a deep response (normalisation of alkaline phosphatase [ALP] and bilirubin ≤0.6 upper limit of normal) improves survival. Yet, the long-term effectiveness of second-line treatments remains uncertain.<BR>To evaluate the long-term effectiveness of obeticholic acid (OCA) ± fibrates. Focusing on biochemical response (ALP ≤1.67 times the upper limit of normal, with a decrease of at least 15% from baseline and normal bilirubin levels), normalisation of ALP, deep response and biochemical remission (deep response plus aminotransferase normalisation).<BR>We conducted a longitudinal, observational, multicentre study involving ursodeoxyccholic acid non-responsive PBC patients (Paris-II criteria) from Spain and Portugal who received OCA ± fibrates.<BR>Of 255 patients, median follow-up was 35.1 months (IQR: 20.2-53). The biochemical response in the whole cohort was 47.2%, 61.4% and 68.6% at 12, 24 and 36 months. GLOBE-PBC and 5-year UK-PBC scores improved (p < 0.001). Triple therapy (ursodeoxycholic acid plus OCA plus fibrates) had significantly higher response rates than dual therapy (p = 0.001), including ALP normalisation, deep response and biochemical remission (p < 0.001). In multivariate analysis, triple therapy remained independently associated with biochemical response (p = 0.024), alkaline phosphatase normalisation, deep response and biochemical remission (p < 0.001). Adverse effects occurred in 41.2% of cases, leading to 18.8% discontinuing OCA. Out of 55 patients with cirrhosis, 12 developed decompensation. All with baseline portal hypertension.<BR>Triple therapy was superior in achieving therapeutic goals in UDCA-nonresponsive PBC. Decompensation was linked to pre-existing portal hypertension.