Christopher Bowlus
Staff Affiliate - OtherAbout
Research
Publications
2024
P21 Improvement in lipid profiles with elafibranor treatment in primary biliary cholangitis during the phase III ELATIVE® trial
Mayo M, Antunes N, Pedersen M, Tonev D, Shu J, Bowlus C, Kowdley K, Zein C, Levy C. P21 Improvement in lipid profiles with elafibranor treatment in primary biliary cholangitis during the phase III ELATIVE® trial. 2024, a22.2-a23. DOI: 10.1136/gutjnl-2024-basl.32.Peer-Reviewed Original ResearchCOBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls.
Kowdley K, Hirschfield G, Coombs C, Malecha E, Bessonova L, Li J, Rathnayaka N, Mells G, Jones D, Trivedi P, Hansen B, Smith R, Wason J, Hiu S, Kareithi D, Mason A, Bowlus C, Muller K, Carbone M, Berenguer M, Milkiewicz P, Adekunle F, Villamil A. COBALT: A Confirmatory Trial of Obeticholic Acid in Primary Biliary Cholangitis With Placebo and External Controls. The American Journal Of Gastroenterology 2024 PMID: 39140490, DOI: 10.14309/ajg.0000000000003029.Peer-Reviewed Original ResearchPrimary biliary cholangitisObeticholic acidClinical outcomesFunctional unblindingPlacebo armBiliary cholangitisConfirmatory trialsUS healthcare claims databasePrimary biliary cholangitis patientsOCA therapyObeticholic acid treatmentPrimary composite endpointAs-treated analysisHealthcare claims databaseNegative clinical outcomesUncontrolled ascitesPlacebo patientsHepatic decompensationPrimary endpointLiver transplantationComposite endpointCommercial therapySafety signalsPlaceboTreatment crossoverFecal deoxycholic acid associates with diet, intestinal microbes and total bilirubin in primary sclerosing cholangitis
Chan C, Lemos M, Finnegan P, Gagnon W, Dean R, Yazdanafar M, Zepeda J, Vohl M, Trauner M, Korzenik J, Barbier O, Marco M, Bowlus C. Fecal deoxycholic acid associates with diet, intestinal microbes and total bilirubin in primary sclerosing cholangitis. JHEP Reports 2024, 101188. DOI: 10.1016/j.jhepr.2024.101188.Peer-Reviewed Original ResearchPrimary sclerosing cholangitisMarkers of BA synthesisFecal deoxycholic acidInflammatory bowel diseaseCholestatic liver diseaseFarnesoid X receptorFarnesoid X receptor activationSclerosing cholangitisDisease progressionFecal bile acidsTotal bilirubinDuct primary sclerosing cholangitisBile acidsLiver diseaseMarker of clinical outcomeBA synthesisChronic cholestatic liver diseaseRRNA gene sequencesUrsodeoxycholic acid useDeoxycholic acidAbundance of BlautiaMarkers of disease progressionVariable disease progressionAssociated with total bilirubinSerum total bilirubinSerologic extracellular matrix remodeling markers are related to fibrosis stage and prognosis in a phase 2b trial of simtuzumab in patients with primary sclerosing cholangitis
Thorburn D, Leeming D, Barchuk W, Wang Y, Lu X, Malkov V, Ito K, Bowlus C, Levy C, Goodman Z, Karsdal M, Muir A, Xu J. Serologic extracellular matrix remodeling markers are related to fibrosis stage and prognosis in a phase 2b trial of simtuzumab in patients with primary sclerosing cholangitis. Hepatology Communications 2024, 8: e0467. PMID: 38967589, PMCID: PMC11227354, DOI: 10.1097/hc9.0000000000000467.Peer-Reviewed Original ResearchConceptsPrimary sclerosing cholangitisELF scoreAdvanced fibrosisFibrosis stageFibrosis progressionClinical eventsSclerosing cholangitisExtracellular matrix remodeling markersRemodeling markersPredictors of disease severityPhase 2b trialBaseline to weekPRO-C3Progression to cirrhosisWilcoxon rank sum testMarker of collagen formationType III procollagenModerate diagnostic abilityDiagnosing fibrosis stagesRank sum testSerum markersNoninvasive predictorPrognostic markerModerate prognosisMedian changeProtocol for the development of a core outcome set for clinical trials in primary sclerosing cholangitis
Hussain N, Ma C, Hirschfield G, Walmsley M, Hanford P, Vesterhus M, Kowdley K, Bergquist A, Ponsioen C, Levy C, Assis D, Schramm C, Bowlus C, Trauner M, Aiyegbusi O, Jairath V, Trivedi P. Protocol for the development of a core outcome set for clinical trials in primary sclerosing cholangitis. BMJ Open 2024, 14: e080143. PMID: 38926149, PMCID: PMC11216047, DOI: 10.1136/bmjopen-2023-080143.Peer-Reviewed Original ResearchConceptsPrimary sclerosing cholangitisClinical trialsSclerosing cholangitisCore outcome setImmune-mediated liver diseasesPrimary sclerosing cholangitis treatmentOutcome measuresEvaluate novel therapiesSlow disease progressionPatient-reported outcome measuresMedical therapyNovel therapiesLiver fibrosisDisease progressionHistological assessmentLiver diseaseInternational two-round Delphi surveyImaging-based biomarkersIntervention trialsTherapyConsensus meetingHealthcare payersCholangitisSemistructured qualitative interviewsTwo-round Delphi surveyTHU-105 Improvement in lipid profiles with elafibranor treatment in primary biliary cholangitis during the phase III Elativetrial
Mayo M, Antunes N, Pedersen M, Tonev D, Shu J, Bowlus C, Kowdley K, Zein C, Levy C. THU-105 Improvement in lipid profiles with elafibranor treatment in primary biliary cholangitis during the phase III Elativetrial. Journal Of Hepatology 2024, 80: s312-s313. DOI: 10.1016/s0168-8278(24)01090-0.Peer-Reviewed Original ResearchLBP-039 Oral alpha-v/beta-6 and alpha-v/beta-1 integrin inhibitor bexotegrast in primary sclerosing cholangitis: updated 12-week interim safety and efficacy analysis of the INTEGRIS-PSC phase 2a trial
Trauner M, Kowdley K, Hirschfield G, Lefebvre E, Decaris M, Schaub J, Clark A, Lin M, An M, Balasubramanyam A, Barnes C, Pencek R, Thorburn D, Montano-Loza A, Bowlus C, Schramm C, Levy C, Trivedi P. LBP-039 Oral alpha-v/beta-6 and alpha-v/beta-1 integrin inhibitor bexotegrast in primary sclerosing cholangitis: updated 12-week interim safety and efficacy analysis of the INTEGRIS-PSC phase 2a trial. Journal Of Hepatology 2024, 80: s97-s98. DOI: 10.1016/s0168-8278(24)00606-8.Peer-Reviewed Original ResearchPatient-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' willingnessAssessment of fatigue and its impact in chronic liver disease
Younossi Z, Kremer A, Swain M, Jones D, Bowlus C, Trauner M, Henry L, Gerber L. Assessment of fatigue and its impact in chronic liver disease. Journal Of Hepatology 2024, 81: 726-742. PMID: 38670320, DOI: 10.1016/j.jhep.2024.04.008.Peer-Reviewed Original ResearchLevels of fatigueHealth related qualityBurden of chronic liver diseaseRelated qualityHepatitis C viral infectionPatients' health related qualityImpact of fatiguePrimary biliary cholangitisAssessment of fatigueChronic liver diseaseExpert reviewComplexity of fatigueSelf-report instrumentImproved HRQLPRO dataSelf-report measuresHRQLLiver diseaseOutcome measuresPeripheral causesChronic hepatitis C viral infectionChronic liver disease severityComprehensive burdenStage of chronic liver diseasePresence of cirrhosisImpact of itch on quality of life in people with primary biliary cholangitis: A plain language summary
Mayo M, Carey E, Smith H, Mospan A, McLaughlin M, Thompson A, Morris H, Sandefur R, Bowlus C, Investigators O, Levy C. Impact of itch on quality of life in people with primary biliary cholangitis: A plain language summary. Future Rare Diseases 2024, 0 DOI: 10.2217/frd-2023-0016.Peer-Reviewed Original ResearchPrimary biliary cholangitisSignificant itchBiliary cholangitisMild itchImpact of itchQuality of lifeTreatment guidelinesTreatment optionsWorse scoresItchPerson's qualityItchingMedicationsPerson's sleepSleepCholangitisWorse qualitySymptomsOne-thirdPoor qualityProfessional societiesGuidelinesHigh levelsLifeDisease