We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Longitudinal outcomes of obeticholic acid therapy in ursodiol‐nonresponsive primary biliary cholangitis: Stratifying the impact of add‐on fibrates in real‐world practice.
- Authors
Gómez, E.; Montero, J. L.; Molina, E.; García‐Buey, L.; Casado, M.; Fuentes, J.; Simón, M. A.; Díaz‐González, A.; Jorquera, F.; Morillas, R. M.; Presa, J.; Berenguer, M.; Conde, M. I.; Olveira, A.; Macedo, G.; Garrido, I.; Hernández‐Guerra, M.; Olivas, I.; Rodríguez‐Tajes, S.; Londoño, M.
- Abstract
Summary: Background: 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. Aims: 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). Methods: 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. Results: 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. Conclusion: Triple therapy was superior in achieving therapeutic goals in UDCA‐nonresponsive PBC. Decompensation was linked to pre‐existing portal hypertension.
- Subjects
PORTUGAL; SPAIN; CHOLANGITIS; ALKALINE phosphatase; URSODEOXYCHOLIC acid; PORTAL hypertension; MULTIVARIATE analysis
- Publication
Alimentary Pharmacology & Therapeutics, 2024, Vol 59, Issue 12, p1604
- ISSN
0269-2813
- Publication type
Article
- DOI
10.1111/apt.18004