Portal de investigação
Longitudinal outcomes of obeticholic acid therapy in ursodiol-nonresponsive primary biliary cholangitis: Stratifying the impact of add-on fibrates in real-world practice
Data de publicação:
Data Ahead of Print:
Autores da FMUP
Participantes de fora da FMUP
- Gomez, E.
- Montero, J. L.
- Molina, E.
- Garcia-Buey, L.
- Casado, M.
- Fuentes, J.
- Simon, M. A.
- Diaz-Gonzalez, A.
- Jorquera, F.
- Morillas, R. M.
- Presa, J.
- Berenguer, M.
- Conde, M. I.
- Olveira, A.
- Garrido, I.
- Hernandez-Guerra, M.
- Olivas, I.
- Rodriguez-Taje, S.
- Londono, M.
- Sousa, J. M.
- Ampuero, J.
- Romero-Gonzalez, E.
- Gonzalez-Padilla, Sh.
- Escudero-Garcia, D.
- Carvalho, A.
- Santos, A.
- Gutierrez, M. L.
- Perez-Fernandez, E.
- Aburruza, L.
- Uriz, J.
- Gomes, D.
- Santos, L.
- Martinez-Gonzalez, J.
- Albillos, A.
- Fernandez-Rodriguez, C. M.
Unidades de investigação
Abstract
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.
Dados da publicação
- ISSN/ISSNe:
- 0269-2813, 1365-2036
- Tipo:
- Article
- Páginas:
- 1604-1615
- DOI:
- 10.1111/apt.18004
- PubMed:
- 38690746
- Link para outro recurso:
- www.scopus.com
ALIMENTARY PHARMACOLOGY & THERAPEUTICS Wiley-Blackwell Publishing Ltd
Citações Recebidas na Web of Science: 2
Citações Recebidas na Scopus: 2
Documentos
- Não há documentos
Filiações
Keywords
- PLACEBO-CONTROLLED TRIAL; URSODEOXYCHOLIC ACID; BIOCHEMICAL RESPONSE; CIRRHOSIS; BEZAFIBRATE; SURVIVAL
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