000135354 001__ 135354 000135354 005__ 20240522124406.0 000135354 0247_ $$2doi$$a10.1111/apt.18004 000135354 0248_ $$2sideral$$a138613 000135354 037__ $$aART-2024-138613 000135354 041__ $$aeng 000135354 100__ $$aGómez, E. 000135354 245__ $$aLongitudinal outcomes of obeticholic acid therapy in ursodiol-nonresponsive primary biliary cholangitis: Stratifying the impact of add-on fibrates in real-world practice 000135354 260__ $$c2024 000135354 5060_ $$aAccess copy available to the general public$$fUnrestricted 000135354 5203_ $$aBackground 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. 000135354 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/ 000135354 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000135354 700__ $$aMontero, J. L. 000135354 700__ $$aMolina, E. 000135354 700__ $$aGarcía-Buey, L. 000135354 700__ $$aCasado, M. 000135354 700__ $$0(orcid)0000-0001-8637-510X$$aFuentes, J.$$uUniversidad de Zaragoza 000135354 700__ $$0(orcid)0000-0003-2041-3147$$aSimón, M. A.$$uUniversidad de Zaragoza 000135354 700__ $$aDíaz-González, A. 000135354 700__ $$aJorquera, F. 000135354 700__ $$aMorillas, R. M. 000135354 700__ $$aPresa, J. 000135354 700__ $$aBerenguer, M. 000135354 700__ $$aConde, M. I. 000135354 700__ $$aOlveira, A. 000135354 700__ $$aMacedo, G. 000135354 700__ $$aGarrido, I. 000135354 700__ $$aHernández-Guerra, M. 000135354 700__ $$aOlivas, I. 000135354 700__ $$aRodríguez-Tajes, S. 000135354 700__ $$aLondoño, M. 000135354 700__ $$aSousa, J. M. 000135354 700__ $$aAmpuero, J. 000135354 700__ $$aRomero-González, E. 000135354 700__ $$aGonzález-Padilla, Sh. 000135354 700__ $$aEscudero-García, D. 000135354 700__ $$aCarvalho, A. 000135354 700__ $$aSantos, A. 000135354 700__ $$aGutiérrez, M. L. 000135354 700__ $$aPérez-Fernández, E. 000135354 700__ $$aAburruza, L. 000135354 700__ $$aUriz, J. 000135354 700__ $$aGomes, D. 000135354 700__ $$aSantos, L. 000135354 700__ $$aMartínez-González, J. 000135354 700__ $$aAlbillos, A. 000135354 700__ $$aFernández-Rodríguez, C. M. 000135354 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000135354 773__ $$g(2024), [12 pp.]$$pAliment. pharmacol. ther.$$tALIMENTARY PHARMACOLOGY & THERAPEUTICS$$x0269-2813 000135354 8564_ $$s1756038$$uhttps://zaguan.unizar.es/record/135354/files/texto_completo.pdf$$yVersión publicada 000135354 8564_ $$s2317553$$uhttps://zaguan.unizar.es/record/135354/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000135354 909CO $$ooai:zaguan.unizar.es:135354$$particulos$$pdriver 000135354 951__ $$a2024-05-22-10:17:48 000135354 980__ $$aARTICLE