2024
OP-1 LONG-TERM EFFICACY AND SAFETY OF OPEN-LABEL SELADELPAR TREATMENT IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: INTERIM 2-YEAR RESULTS FROM THE ASSURE STUDY
Trivedi P, Levy C, Kowdley K, Gordon S, Bowlus C, Hurtado M, Hirschfield G, Gulamhusien A, Lawitz E, Villamil A, de Guevara Cetina A, Mayo M, Younes Z, Shibolet O, Yimam K, Pratt D, Heo J, Morgera U, Andreone P, Kremer A, Corpechot C, Goel A, Peyton A, Elbeshbeshy H, Crittenden D, Heusner C, Proehl S, Zhou S, McWherter C. OP-1 LONG-TERM EFFICACY AND SAFETY OF OPEN-LABEL SELADELPAR TREATMENT IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS: INTERIM 2-YEAR RESULTS FROM THE ASSURE STUDY. Annals Of Hepatology 2024, 29: 101599. DOI: 10.1016/j.aohep.2024.101599.Peer-Reviewed Original ResearchPrimary biliary cholangitisCrossover patientsBiliary cholangitisBiochemical markers of cholestasisBiochemical markersMarkers of cholestasisPhase 3 trialLong-term efficacyNumerical rating scaleLong-term usePlacebo patientsOpen-labelMethods PatientsAdverse eventsComposite endpointSafety resultsSeladelparUrsodeoxycholic acidPlaceboPhase 3 responsePruritusPatientsEndpointAssurance studyCholangitisPatient-focused drug development in primary sclerosing cholangitis: Insights on patient priorities and involvement in clinical trials
Li M, Pai R, Gomel R, Vyas M, Callif S, Hatchett J, Bowlus C, Lai J. Patient-focused drug development in primary sclerosing cholangitis: Insights on patient priorities and involvement in clinical trials. Hepatology Communications 2024, 8: e0433. PMID: 38727680, PMCID: PMC11093571, DOI: 10.1097/hc9.0000000000000433.Peer-Reviewed Original ResearchConceptsPrimary sclerosing cholangitisClinical trialsSclerosing cholangitisDrug trialsTrial participantsMultivariate logistic regressionAssociated with willingnessInflammatory bowel diseaseLong-term riskReferral of patientsDrug developmentTherapy trialsDisease progressionTrial interestBowel diseasePatient-focused drug developmentTreatment trialsPatientsBiopsy requirementsPruritusPatient interestPredictors of patients' willingnessLogistic regressionCholangitisPatients' willingness
2023
Seladelpar treatment reduces IL-31 and pruritus in patients with primary biliary cholangitis
Kremer A, Mayo M, Hirschfield G, Levy C, Bowlus C, Jones D, Johnson J, McWherter C, Choi Y. Seladelpar treatment reduces IL-31 and pruritus in patients with primary biliary cholangitis. Hepatology 2023, 80: 27-37. PMID: 38117036, PMCID: PMC11191048, DOI: 10.1097/hep.0000000000000728.Peer-Reviewed Original ResearchAnti-pruritic effectsIL-31 levelsPrimary biliary cholangitisBile acid levelsIL-31PBC patientsBile acidsPruritus improvementBiliary cholangitisInterleukin-31Acid levelsIL-31 signalingSerum IL-31Pruritic skin diseaseDaily oral dosesSerum bile acidsNumerical rating scaleTotal bile acidsDose-dependent reductionPPAR-delta agonistOral dosesENHANCE studyPruritusHealthy volunteersPatients