Response to Ursodeoxycholic Acid May Be Assessed Earlier to Allow Second-Line Therapy in Patients with Unresponsive Primary Biliary Cholangitis.
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Cançado Guilherme Grossi Lopes, Couto Cláudia Alves, Terrabuio Debora Raquel Benedita, Cançado Eduardo Luiz Rachid, Villela-Nogueira Cristiane Alves, Ferraz Maria Lucia Gomes, Braga Michelle Harriz, Nardelli Mateus Jorge, Faria Luciana Costa, de Faria Gomes Nathalia Mota, Oliveira Elze Maria Gomes, Rotman Vivian, Oliveira Maria Beatriz, da Cunha Simone Muniz Carvalho Fernandes, Cunha-Silva Marlone, Mendes Liliana Sampaio Costa, Ivantes Claudia Alexandra Pontes, Codes Liana, de Almeida E Borges Valéria Ferreira, de Lima Pace Fabio Heleno, Pessoa Mario Guimarães, Guedes Laura Vilar, Signorelli Izabelle Venturini, Coral Gabriela Perdomo, Levy Cynthia, Bittencourt Paulo Lisboa, Members of the Brazilian Cholestasis Study Group Consortium
Аннотация
AIMS: This study aims to identify whether well-validated response criteria could correctly identify individuals likely to benefit from add-on second-line therapy at 6 months.
METHODS: Analysis of a multicenter retrospective cohort which included only patients with clear-cut PBC.
RESULTS: 206 patients with PBC (96.6% women; mean age 54 ± 12 years) were included. Kappa concordance was substantial for Toronto (0.67), Rotterdam (0.65), Paris 1 (0.63) and 2 (0.63) criteria at 6 and 12 months, whereas Barcelona (0.47) and POISE trial (0.59) criteria exhibited moderate agreement. Non-response rates to UDCA was not statistically different when assessed either at 6 or 12 months using Toronto, Rotterdam or Paris 2 criteria. Those differences were even smaller or absent in those subjects with advanced PBC. Mean baseline alkaline phosphatase was 2.73 ± 1.95 times the upper limit of normal (× ULN) among responders versus 5.05 ± 3.08 × ULN in non-responders (p < 0.001).
CONCLUSIONS: After 6 months of treatment with UDCA, the absence of response by different criteria could properly identify patients who could benefit from early addition of second-line therapies, especially in patients with advanced disease or high baseline liver enzymes levels.