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 studyCholangitisA Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis
Hirschfield G, Bowlus C, Mayo M, Kremer A, Vierling J, Kowdley K, Levy C, Villamil A, Ladrón de Guevara Cetina A, Janczewska E, Zigmond E, Jeong S, Yilmaz Y, Kallis Y, Corpechot C, Buggisch P, Invernizzi P, Londoño Hurtado M, Bergheanu S, Yang K, Choi Y, Crittenden D, McWherter C. A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis. New England Journal Of Medicine 2024, 390: 783-794. PMID: 38381664, DOI: 10.1056/nejmoa2312100.Peer-Reviewed Original ResearchConceptsPrimary biliary cholangitisAlkaline phosphatase levelsPruritus Numerical Rating ScalePercentage of patientsNumerical rating scaleBiliary cholangitisAdverse eventsPhosphatase levelsPlacebo groupUrsodeoxycholic acidPeroxisome proliferator-activated receptor delta agonistBaseline to month 6Severity of adverse eventsAlkaline phosphatase normalizationModerate-to-severe pruritusPlacebo-controlled trialPhase 3 trialUnacceptable side effectsRating ScaleBiochemical responsesBackground therapyDouble-blindDelta agonistsBilirubin levelsMonth 6
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 volunteersPatientsEfficacy and Safety of Elafibranor in Primary Biliary Cholangitis
Kowdley K, Bowlus C, Levy C, Akarca U, Alvares-da-Silva M, Andreone P, Arrese M, Corpechot C, Francque S, Heneghan M, Invernizzi P, Jones D, Kruger F, Lawitz E, Mayo M, Shiffman M, Swain M, Valera J, Vargas V, Vierling J, Villamil A, Addy C, Dietrich J, Germain J, Mazain S, Rafailovic D, Taddé B, Miller B, Shu J, Zein C, Schattenberg J. Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis. New England Journal Of Medicine 2023, 390: 795-805. PMID: 37962077, DOI: 10.1056/nejmoa2306185.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAlkaline PhosphataseBilirubinChalconesCholagogues and CholereticsCholestasisDouble-Blind MethodGastrointestinal AgentsHumansLiver Cirrhosis, BiliaryPeroxisome Proliferator-Activated ReceptorsPPAR alphaPPAR deltaPropionatesPruritusTreatment OutcomeUrsodeoxycholic AcidConceptsPrimary biliary cholangitisBiliary cholangitisAlkaline phosphatase levelsPeroxisome proliferator-activated receptorPhosphatase levelsDual peroxisome proliferator-activated receptorLeast-squares mean changeChronic cholestatic liver diseaseItch Numeric Rating ScaleDestruction of interlobular bile ductsModerate-to-severe pruritusPlacebo-controlled trialCholestatic liver diseaseNumerical rating scaleInterlobular bile ductsWorst Itch Numeric Rating ScaleIndicator of cholestasisProliferator-activated receptorsAbdominal painDouble-blindPlacebo groupRelevant biochemical indicatorsAdverse eventsPruritus intensityUrsodeoxycholic acid