Christopher Bowlus
Staff Affiliate - OtherAbout
Research
Publications
2025
Nebokitug, an anti-CCL24 monoclonal antibody, in patients with primary sclerosing cholangitis: A phase 2 study.
Bowlus C, Thorburn D, Barclay S, Joshi D, Londoño M, Mantry P, Safadi R, Aricha R, Cirillo C, Frankel M, Lawler J, Vaknin I, Mor A. Nebokitug, an anti-CCL24 monoclonal antibody, in patients with primary sclerosing cholangitis: A phase 2 study. The American Journal Of Gastroenterology 2025 PMID: 41257532, DOI: 10.14309/ajg.0000000000003853.Peer-Reviewed Original ResearchPrimary sclerosing cholangitisLiver stiffness measurementPhase 2 studyBaseline to weekDouble-blindSclerosing cholangitisSeverity of treatment-emergent adverse eventsPlacebo-controlled phase 2 studyDuct primary sclerosing cholangitisTreatment-emergent adverse eventsOpen-label extension studyMonoclonal antibodiesDouble-blind periodLiver blood testsSubgroup of patientsWeeks of treatmentAnti-fibrotic propertiesELF scorePrimary endpointSecondary endpointsLiver testsAdverse eventsEligible patientsNo significant changesBiomarker improvementsCilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial
Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, Joshi D, Salminen K, Yimam K, Isayama H, Montano-Loza A, Caldwell S, Danta M, Farkkila M, Gallegos-Orozco J, Gordon S, Hinrichsen H, Invernizzi P, Vuppalanchi R, Zhu K, Xu J, Liu X, Lu X, Crans G, Bolbolan S, Boyette L, Alani M, Barchuk W, Watkins T, Genovese M, Bowlus C. Cilofexor in non-cirrhotic primary sclerosing cholangitis (PRIMIS): a randomised, double-blind, multicentre, placebo-controlled, phase 3 trial. The Lancet Gastroenterology & Hepatology 2025, 11: 46-58. PMID: 41173015, DOI: 10.1016/s2468-1253(25)00208-0.Peer-Reviewed Original ResearchConceptsPrimary sclerosing cholangitisPlacebo groupDouble-blindPlacebo-ControlledPrimary endpointHistological progressionSclerosing cholangitisAdverse eventsFibrosis progressionLarge-duct primary sclerosing cholangitisProportion of serious adverse eventsNatural courseRate of fibrosis progressionInteractive web response systemAnalysis setTreatment-related deathsUrsodeoxycholic acid useWeeks of follow-upPresence of bridging fibrosisUpper abdominal painWeb response systemPhase 3 trialProgression of liver fibrosisSerious adverse eventsInterim futility analysisLinerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial
Hirschfield G, Bowlus C, Jones D, Kremer A, Mayo M, Tanaka A, Andreone P, Jia J, Jin Q, Macías-Rodríguez R, Cobitz A, Currie B, Gorey C, Lazic I, Podmore D, Ribeiro A, Shannon J, Swift B, McLaughlin M, Levy C, Group G, Abe M, Adebayo D, Herrojo J, Anders M, Atsukawa M, Ayoub W, Bessone F, Bocus P, Borg B, Cai D, Calvaruso V, Carlebach M, Carmiel M, Cejas N, Chakrabarty G, Christoph S, Corless L, Corpechot C, Corrigan M, Costentin C, Crosignani A, da Cunha S, Alvares-da-Silva M, Dimitrov D, Dreizin V, Etzion O, Fernandez R, Gaite L, Galron E, Gietka J, Dominguez E, Gordon S, Gruz F, Han H, Han T, Harman D, Hejda V, Invernizzi P, Jacobson I, Jalal P, Janczewska E, Janik K, Kagawa T, Kallis Y, Kappus M, Kawata K, Kimura T, Komori A, Kusano F, de Guevara-Cetina A, Leroy V, Lin B, Liu Y, de Nalda A, Hurtado M, Louvet A, Ma X, Malova E, Manolakopoulos S, Martinez A, Mason A, Mells G, Mendes L, Miele L, Morisco F, Mularczyk A, Mulcahy V, Mumtaz K, Muñoz-Espinosa L, Namisaki T, Nikolov N, Osipenko M, Pagadala M, Patel J, Patel B, Perez F, Pezzoto C, Ramage J, Reddy R, Rochling F, Romeiro F, Safadi R, Plaza M, Sanada T, Sarkar M, Sheridan D, Simon K, Smakotina S, Sperl J, Ständer S, Takaguchi K, Tchernev K, Thorburn D, Trebicka J, Tsuge M, Tsuji K, Tsuji K, Vasura A, Verhelst X, Vetter M, Villamil A, Vinnitskaya E, Weinstein D, Wu X, Yanase M, Zharkova M, Zhong Y. Linerixibat in patients with primary biliary cholangitis and cholestatic pruritus (GLISTEN): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. The Lancet Gastroenterology & Hepatology 2025, 11: 22-33. PMID: 41173016, DOI: 10.1016/s2468-1253(25)00192-x.Peer-Reviewed Original ResearchConceptsPrimary biliary cholangitisGastrointestinal adverse eventsPhase 3 trialAdverse eventsDouble-blindPlacebo-ControlledBiliary cholangitisCholestatic pruritusIleal bile acid transporter inhibitorSymptoms of primary biliary cholangitisDose of study treatmentBile acid transporter inhibitorModerate-to-severe pruritusSerious adverse eventsPatient's lifeTreatment discontinuationPlacebo groupPrimary endpointEfficacy analysisStudy treatmentNo deathsAntipruritic therapyPlaceboPruritus treatmentStratification factorsAssessment of adherence to guidelines for biochemical monitoring and ursodeoxycholic acid treatment response in a retrospective cohort of US patients with primary biliary cholangitis
Gordon S, Sahota A, Schmidt M, Daida Y, Rupp L, Trudeau S, Melkonian C, Bowlus C, Lu M. Assessment of adherence to guidelines for biochemical monitoring and ursodeoxycholic acid treatment response in a retrospective cohort of US patients with primary biliary cholangitis. BMJ Open Gastroenterology 2025, 12: e001899. PMID: 41125399, PMCID: PMC12548585, DOI: 10.1136/bmjgast-2025-001899.Peer-Reviewed Original ResearchConceptsPrimary biliary cholangitisAmerican Association for the StudyUrsodeoxycholic acidFibrotic liver diseaseSpecialist careBiliary cholangitisRetrospective cohortCohort of US patientsResponse to UDCAYear of UDCA treatmentBiochemical monitoringStudy of Liver Diseases guidelinesAmerican Association for the Study of Liver Diseases guidelinesPrimary biliary cholangitis casesLevel of non-adherenceReceipt of careAssociated with significantly higher ratesAlkaline phosphataseEvaluation of adherenceYear of treatmentRates of adherenceAssociated with higher ratesResponse to treatmentRoutine care patientsAssessment of adherenceSpatial heterogeneity in liver stiffness does not predict clinical outcomes in patients with primary sclerosing cholangitis
Grave E, Chan C, Corwin M, Dean R, Dhaliwal S, Yazdanfar M, Bowlus C. Spatial heterogeneity in liver stiffness does not predict clinical outcomes in patients with primary sclerosing cholangitis. Hepatology Communications 2025, 9: e0821. PMID: 41099629, PMCID: PMC12506992, DOI: 10.1097/hc9.0000000000000821.Peer-Reviewed Original ResearchConceptsPrimary sclerosing cholangitisTransplant-free survivalPredictor of transplant-free survivalLiver stiffnessHepatic decompensationClinical outcomesSclerosing cholangitisLiver diseaseMagnetic resonance elastographyAssociated with clinical outcomesCholestatic liver diseaseSteatotic liver diseaseSpatial heterogeneityProgressive diseasePatientsCholangitisLiverDiseaseOutcomesMaximum LSCoVCoefficient of variationPredictorsP36 Non-invasive tests for liver fibrosis are stable in patients with primary biliary cholangitis (PBC) with two years of treatment with elafibranor
Mayo M, Levy C, Swain M, Schattenberg J, Heneghan M, Corpechot C, Bowlus C, Vierling J, Antunes N, Cranham V, Silva H, Raskino C, Phagura A, Kowdley K. P36 Non-invasive tests for liver fibrosis are stable in patients with primary biliary cholangitis (PBC) with two years of treatment with elafibranor. 2025, a36.1-a36. DOI: 10.1136/gutjnl-2025-basl.52.Peer-Reviewed Original ResearchO8 Linerixibat significantly improves cholestatic pruritus in primary biliary cholangitis (PBC): results of the pivotal phase 3 GLISTEN trial
Hirshfield G, Bowlus C, Jones D, Kremer A, Mayo M, Tanaka A, Andreone P, Jia J, Jin Q, Macas-Rodrguez R, Cobitz A, Currie B, Gorey C, Lazic I, Podmore D, Ribeiro A, Shannon J, Swift B, McLaughlin M, Levy C. O8 Linerixibat significantly improves cholestatic pruritus in primary biliary cholangitis (PBC): results of the pivotal phase 3 GLISTEN trial. 2025, a6-a7. DOI: 10.1136/gutjnl-2025-basl.7.Peer-Reviewed Original ResearchPhase II INTEGRIS-PSC trial of bexotegrast, an αvβ6/αvβ1 integrin inhibitor, in primary sclerosing cholangitis
Hirschfield G, Kowdley K, Trivedi P, Eksteen B, Hameed B, Vincent C, Chen T, Goel A, Reddy K, Orman E, Joshi D, Lefebvre É, Schaub J, An M, Clark A, Barnes C, Pencek R, Thorburn D, Montano-Loza A, Schramm C, Bowlus C, Trauner M, Levy C. Phase II INTEGRIS-PSC trial of bexotegrast, an αvβ6/αvβ1 integrin inhibitor, in primary sclerosing cholangitis. Journal Of Hepatology 2025, 84: 86-98. PMID: 41016442, DOI: 10.1016/j.jhep.2025.09.016.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsPrimary sclerosing cholangitisSclerosing cholangitisLiver fibrosisExploratory pharmacodynamicsRates of treatment-emergent adverse eventsIncidence of treatment-emergent adverse eventsProgression of primary sclerosing cholangitisItch Numeric Rating ScalePhase II studyDose-ranging studyAbstractText Label="Background &Liver stiffness measurementNumerical rating scaleAlkaline phosphatase valuesUnmet medical needAbstractText Label="ImpactELF scoreTolerability profileDouble-blindOnce-DailyPlacebo groupStudy drugII studyPharmacodynamic markersLinerixibat significantly improves cholestatic pruritus in primary biliary cholangitis: results of the pivotal Phase 3 GLISTEN trial
Hirschfield G, Bowlus C, Jones D, Kremer A, Mayo M, Tanaka A, Andreone P, Jia J, Jin Q, Macías-Rodríguez R, Cobitz A, Currie B, Gorey C, Lazic I, Podmore D, Ribeiro A, Shannon J, Swift B, McLaughlin M, Levy C. Linerixibat significantly improves cholestatic pruritus in primary biliary cholangitis: results of the pivotal Phase 3 GLISTEN trial. Zeitschrift Für Gastroenterologie 2025, 63: e457-e457. DOI: 10.1055/s-0045-1810779.Peer-Reviewed Original ResearchLong-term efficacy and safety of open-label seladelpar treatment in patients with primary biliary cholangitis: pooled interim results for up to 3 years from the ASSURE study
Lawitz E, Trivedi P, Kowdley K, Gordon S, Bowlus C, Hurtado M, Hirschfield G, Gulamhusein A, Demir M, Crittenden D, Zhuo S, Heusner C, Levy C. Long-term efficacy and safety of open-label seladelpar treatment in patients with primary biliary cholangitis: pooled interim results for up to 3 years from the ASSURE study. Zeitschrift Für Gastroenterologie 2025, 63: e375-e376. DOI: 10.1055/s-0045-1810647.Peer-Reviewed Original Research