2025
Long-Term Efficacy and Safety of Selective PPARδ Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results.
Levy C, Trivedi P, Kowdley K, Gordon S, Bowlus C, Londoño M, Hirschfield G, Gulamhusein A, Lawitz E, Vierling J, Mayo M, Jacobson I, Kremer A, Corpechot C, Jones D, Buggisch P, Zhuo S, Proehl S, Heusner C, McWherter C, Crittenden D. Long-Term Efficacy and Safety of Selective PPARδ Agonist Seladelpar in Primary Biliary Cholangitis: ASSURE Interim Study Results. The American Journal Of Gastroenterology 2025 PMID: 40553148, DOI: 10.14309/ajg.0000000000003603.Peer-Reviewed Original ResearchPrimary biliary cholangitisMonths of treatmentNumerical rating scaleLong-term efficacyBiliary cholangitisResponse ratePruritus Numerical Rating ScaleSerious adverse eventsYear of treatmentInterim study resultsComposite response rateInterim cutoffLong-term useOpen-labelPlacebo-ControlledPlacebo-treatedTrial patientsAdverse eventsSeladelparPatientsResponse completenessAssurance studyCholangitisMonthsRating ScaleP232 Long-term safety of seladelpar 10 mg with up to 5 years of treatment in patients with primary biliary cholangitis
Trivedi P, Gordon S, Gulamhusein A, Villamil A, Lawitz E, Vierling J, Londoño M, Kremer A, Bowlus C, Proehl S, Zhuo S, Crittenden D, McWherter C. P232 Long-term safety of seladelpar 10 mg with up to 5 years of treatment in patients with primary biliary cholangitis. 2025, a228-a228. DOI: 10.1136/gutjnl-2025-bsg.366.Peer-Reviewed Original Research719-P: Oral Disposition Index (oDI) as an Outcome Measure in Type 1 Diabetes (T1D) Clinical Trials—Evidence from Stage 1 and Stage 2 Trials
GALDERISI A, CUTHBERTSON D, PETRELLI A, MORAN A, SOSENKO J, JACOBSEN L, LIBMAN I, REDONDO M, ISMAIL H. 719-P: Oral Disposition Index (oDI) as an Outcome Measure in Type 1 Diabetes (T1D) Clinical Trials—Evidence from Stage 1 and Stage 2 Trials. Diabetes 2025, 74 DOI: 10.2337/db25-719-p.Peer-Reviewed Original ResearchOral disposition indexC-peptide indexAUC C-peptideC-peptideMarkers of treatment effectivenessStage 1B cell functionYear of treatmentC-peptide measurementsType 1 diabetesPlacebo armMeasure of B-cell functionStage 2T1D prevention trialsTreatment responseTreated armClinical trialsDisposition indexSensitive markerPrevention trialsMetabolic endpointsLong-term effectsInsulin secretionOutcome measuresTeplizumabWS16.05Impact of elexacaftor/tezacaftor/ivacaftor on glucose tolerance in adolescents with cystic fibrosis. Data from the MODUL-CF study
Bonnel A, Galderisi A, Weiss L, Sermet-Gaudelus I, Besancon A, Letierce A, Sahki D, Group M. WS16.05Impact of elexacaftor/tezacaftor/ivacaftor on glucose tolerance in adolescents with cystic fibrosis. Data from the MODUL-CF study. Journal Of Cystic Fibrosis 2025, 24: s33. DOI: 10.1016/j.jcf.2025.03.586.Peer-Reviewed Original ResearchOral glucose tolerance testAbnormal glucose toleranceNormal glucose toleranceCF-related diabetesBaseline oral glucose tolerance testAbnormal glucose tolerance groupCystic fibrosisGlucose toleranceNormal glucose tolerance groupEffective CFTR modulatorsOGTT glucoseBMI z-scoreYear of treatmentImpaired fasting glucoseImpaired glucose toleranceGlucose tolerance testForced expiratory volumeCFTR modulatorsPulmonary infectionDecrease recurrenceBaseline characteristicsRelated diabetesFasting GlucoseTolerance testInsulin treatmentTHU-333 Non-invasive tests for liver fibrosis are stable in patients with primary biliary cholangitis 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, da Silva H, Raskino C, Kowdley K. THU-333 Non-invasive tests for liver fibrosis are stable in patients with primary biliary cholangitis with two years of treatment with elafibranor. Journal Of Hepatology 2025, 82: s332-s333. DOI: 10.1016/s0168-8278(25)01009-8.Peer-Reviewed Original ResearchInvestigation on the factors associated with maintenance of paliperidone long-acting injection in the real-world treatment of patients with schizophrenia
Kang N, Jo A, Joo S, Lee J, Lee K, Kim Y, Jeong J, Lee J, Lee J, Kim H. Investigation on the factors associated with maintenance of paliperidone long-acting injection in the real-world treatment of patients with schizophrenia. Therapeutic Advances In Psychopharmacology 2025, 15: 20451253251333987. PMID: 40296870, PMCID: PMC12035106, DOI: 10.1177/20451253251333987.Peer-Reviewed Original ResearchPaliperidone LAIPaliperidone long-acting injectionLong-acting injectionDiscontinuation ratesRisk of treatment discontinuationClozapine useLong-term treatment continuationEarly phase of treatmentSchizophrenia treatmentAugmentation agentsConcurrent antipsychoticsPhase of treatmentAntipsychoticsSchizophreniaMultivariate Cox proportional hazards modelLong-actingKaplan-Meier survival analysisStandard dosing regimenRisk of discontinuationBaseline clinical factorsTreatment of patientsRetrospective observational studyYear of treatmentCox proportional hazards modelsReal-world treatmentDeucravacitinib in Moderate to Severe Plaque Psoriasis: 5-year, Long-term Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Warren R, Strober B, Blauvelt A, Tada Y, Passeron T, Thaçi D, Daamen C, Li J, Popmihajlov Z, Vaile J, Scotto J, Lebwohl M. Deucravacitinib in Moderate to Severe Plaque Psoriasis: 5-year, Long-term Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2025, 9: s532. DOI: 10.25251/skin.10.supp.532.Peer-Reviewed Original ResearchLong-term extensionLong-term extension trialsSevere plaque psoriasisPlaque psoriasisLong-term safetyTyrosine kinase 2Moderate to severe plaque psoriasisSafety signalsExposure-adjusted incidence ratesModified nonresponder imputationClinical response rateClinical efficacy rateParent trialYears of continuous treatmentLong-term efficacyYear of treatmentAssess adverse eventsTreatment of adultsOral placeboSystemic therapyNonresponder imputationEfficacy rateTargeted therapySafety profileEfficacy profileDeucravacitinib in plaque psoriasis: Four‐year safety and efficacy results from the Phase 3 POETYK PSO‐1, PSO‐2 and long‐term extension trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Paul C, Papp K, Colombo M, Scotto J, Vaile J, Zhuo J, Vritzali E, Berger V, Schroeder G, Banerjee S, Thaçi D, Strober B. Deucravacitinib in plaque psoriasis: Four‐year safety and efficacy results from the Phase 3 POETYK PSO‐1, PSO‐2 and long‐term extension trials. Journal Of The European Academy Of Dermatology And Venereology 2025, 39: 1336-1351. PMID: 40045918, PMCID: PMC12188513, DOI: 10.1111/jdv.20553.Peer-Reviewed Original ResearchLong-term extension trialsLong-term extensionModerate to severe plaque psoriasisSevere plaque psoriasisPlaque psoriasisAdverse eventsTyrosine kinase 2Person yearsData cut-offYear of treatmentAdverse cardiovascular eventsTreatment of adultsPatient-reported outcomesSystemic therapyHerpes zosterSafety profileVenous thromboembolismDeucravacitinibCardiovascular eventsEfficacy resultsPatientsPsoriasisOutcome ratesExtension trialParent trialBimekizumab efficacy and safety through 3 years in patients with moderate-to-severe plaque psoriasis: long-term results from the BE RADIANT phase IIIb trial open-label extension period
Warren R, Lebwohl M, Thaçi D, Gooderham M, Pinter A, Paul C, Gisondi P, Szilagyi B, White K, Deherder D, Staelens F, Lambert J, Strober B. Bimekizumab efficacy and safety through 3 years in patients with moderate-to-severe plaque psoriasis: long-term results from the BE RADIANT phase IIIb trial open-label extension period. British Journal Of Dermatology 2025, 193: 44-55. PMID: 39862230, DOI: 10.1093/bjd/ljaf032.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsOpen-label extensionComplete skin clearanceIL-17APlaque psoriasisSkin clearanceIL-17FRates of treatment-emergent adverse eventsTreatment-emergent adverse event ratesModerate to severe plaque psoriasisOpen-label extension periodSafety of bimekizumabUpper respiratory tract infectionDouble-blind periodSevere plaque psoriasisInterleukin (IL)-17ARespiratory tract infectionsYear of treatmentLong-term resultsInflammatory bowel diseaseMonoclonal IgG1 antibodyOral candidiasisClinical responseMaintenance doseTract infectionsCharacterizing Loss of Response Occurring in a Small Number of Patients During 3 Years of Long-Term Maintenance Therapy with Baricitinib 4-mg: Results From BRAVE-AA1 and -AA2 Trials
Senna M, Taylor S, Piraccini B, Shapiro J, Somani N, Jedynak J, Ogwu S, Buchanan A, Craiglow B, Ohyama M. Characterizing Loss of Response Occurring in a Small Number of Patients During 3 Years of Long-Term Maintenance Therapy with Baricitinib 4-mg: Results From BRAVE-AA1 and -AA2 Trials. SKIN The Journal Of Cutaneous Medicine 2025, 9: s522. DOI: 10.25251/skin.9.supp.522.Peer-Reviewed Original ResearchSeverity of Alopecia ToolLoss of responseSeverity of Alopecia Tool scoreBaricitinib 4 mgLost responseMaintenance treatmentAlopecia areataLong-term maintenance therapyYears of initial treatmentWeeks of maintenance treatmentBaseline disease characteristicsSevere alopecia areataPhase 3 trialYear of treatmentPost Hoc AnalysisBaricitinib monotherapySevere AAMaintenance therapySALT scoreMaintained responseInitial treatmentBaseline characteristicsAdjunctive therapyTreatment responseCOVID-19 infectionSafety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo M, Scotto J, Banerjee S, Strober B, Thaçi D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis for Up to 3 Years. JAMA Dermatology 2025, 161: 56-66. PMID: 39602111, PMCID: PMC11736510, DOI: 10.1001/jamadermatol.2024.4688.Peer-Reviewed Original ResearchLong-term extension trialsExposure-adjusted incidence ratesSevere plaque psoriasisLong-term extensionModerate to severe plaque psoriasisAdverse eventsPlaque psoriasisDouble-blind phase 3 trialStatic Physician's Global Assessment scoreDiscontinuation due to adverse eventsDay 1Physician Global Assessment scoreIncidence rateEffective long-term treatmentUpper respiratory tract infectionClinical response rateGlobal assessment scorePhase 3 trialRespiratory tract infectionsWeeks of treatmentYear of treatmentLong-term treatmentAdverse cardiovascular eventsLong-term safetyCumulative period
2024
Incremental hemodialysis transition in veterans and nonveterans with kidney failure
Rhee C, Kovesdy C, Unruh M, Crowley S, Geller D, Goldfarb D, Kraut J, Rastegar M, Rifkin I, Kalantar-Zadeh K. Incremental hemodialysis transition in veterans and nonveterans with kidney failure. Current Opinion In Nephrology & Hypertension 2024, 34: 33-40. PMID: 39611277, DOI: 10.1097/mnh.0000000000001040.Peer-Reviewed Original ResearchConceptsHealth-related quality of lifeEnd-stage kidney diseaseResidual kidney functionAssociated with impaired health-related quality of lifeImpaired health-related quality of lifeTwice-weekly hemodialysisLow patient burdenHigher mortality riskQuality of lifeRandomized Controlled TrialsTransition to dialysisReceive careResidual kidney function preservationIncremental hemodialysisInitiation of hemodialysis treatmentMortality riskPatient burdenESKD populationPragmatic studyYear of treatmentVeteransStandard of careThrice-weekly hemodialysisDialysis transitionCareSorafenib or anthracycline‐based chemotherapy for progressive desmoid tumors
Costa P, Arora A, Fernandez Y, Yi I, Bakkila B, Tan H, Coelho P, Campoverde L, Hardy N, Bialick S, Freire A, D’Amato G, Chang Y, Mesenger J, Subhawong T, Haims A, Hurwitz M, Olino K, Turaga K, Deshpande H, Trent J. Sorafenib or anthracycline‐based chemotherapy for progressive desmoid tumors. Cancer 2024, 131: e35647. PMID: 39543805, DOI: 10.1002/cncr.35647.Peer-Reviewed Original ResearchProgression-free survivalAnthracycline-containing regimensAnthracycline-based therapyDesmoid tumorsAdverse eventsOne-year progression-free survivalMulti-institutional retrospective analysisAnthracycline-containing regimenCommon grade 1Desmoid tumor patientsGrade 3 eventsAnthracycline-based chemotherapyHand-foot syndromeSecondary end pointsActivity of sorafenibProgressive desmoid tumorsYear of treatmentMedian TTRBaseline characteristicsTumor patientsLocal invasionTreatment responseSorafenibAnthracyclinesEnd pointsTirzepatide for Obesity Treatment and Diabetes Prevention
Jastreboff A, le Roux C, Stefanski A, Aronne L, Halpern B, Wharton S, Wilding J, Perreault L, Zhang S, Battula R, Bunck M, Ahmad N, Jouravskaya I. Tirzepatide for Obesity Treatment and Diabetes Prevention. New England Journal Of Medicine 2024, 392: 958-971. PMID: 39536238, DOI: 10.1056/nejmoa2410819.Peer-Reviewed Original ResearchType 2 diabetesProgression to type 2 diabetesDose escalation periodRisk of progression to type 2 diabetesBody weightDoses of tirzepatideBaseline to weekOnce-weekly dosingOff-treatment periodSustained weight reductionYear of treatmentDiagnosis of type 2 diabetesAssigned doseDouble-blindPlacebo groupAdverse eventsTirzepatideTirzepatide groupsPlaceboCausal precursorsSafety signalsObesity treatmentSustained reductionDelay progression to type 2 diabetesObesity52671 Bimekizumab safety and tolerability in moderate to severe plaque psoriasis: Pooled analysis from up to 4 years of treatment in 5 phase 3/3b clinical trials
Gordon K, Thaçi D, Gooderham M, Okubo Y, Strober B, Peterson L, Deherder D, Pinto J, Gisondi P. 52671 Bimekizumab safety and tolerability in moderate to severe plaque psoriasis: Pooled analysis from up to 4 years of treatment in 5 phase 3/3b clinical trials. Journal Of The American Academy Of Dermatology 2024, 91: ab145. DOI: 10.1016/j.jaad.2024.07.577.Peer-Reviewed Original Research52675 Bimekizumab efficacy across subgroups of patients with moderate to severe plaque psoriasis: Pooled analysis from up to 3 years of treatment in 5 phase 3/3b clinical trials
Strober B, Krueger J, Magnolo N, Vender R, Boehncke W, Hong H, Tilt N, Staelens F, Wiegratz S, Paul C. 52675 Bimekizumab efficacy across subgroups of patients with moderate to severe plaque psoriasis: Pooled analysis from up to 3 years of treatment in 5 phase 3/3b clinical trials. Journal Of The American Academy Of Dermatology 2024, 91: ab142. DOI: 10.1016/j.jaad.2024.07.572.Peer-Reviewed Original ResearchBimekizumab Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Pooled Analysis from Up to 4 Years of Treatment in 5 Phase 3/3b Clinical Trials
Gordon K, Thaçi D, Gooderham M, Okubo Y, Strober B, Peterson L, Deherder D, López Pinto J, Gisondi P. Bimekizumab Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Pooled Analysis from Up to 4 Years of Treatment in 5 Phase 3/3b Clinical Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s404. DOI: 10.25251/skin.8.supp.404.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsSevere plaque psoriasisOpen-label extensionPlaque psoriasisOral candidiasisPatient yrModerate to severe plaque psoriasisUpper respiratory tract infectionLong-term safety of treatmentRespiratory tract infectionsNext scheduled visitYear of treatmentSafety of treatmentLong-term safetySafety findingsTract infectionsLong-term managementBimekizumabSafety profileAdverse eventsPooled analysisClinical trialsQ8WSafety dataPsoriasisPatterns of Care for T1 Glottic Squamous Cell Carcinomas from 2004–2020
Malik D, Jacobs D, Fereydooni S, Park H, Mehra S. Patterns of Care for T1 Glottic Squamous Cell Carcinomas from 2004–2020. The Laryngoscope 2024, 134: 3633-3644. PMID: 38411338, DOI: 10.1002/lary.31363.Peer-Reviewed Original ResearchGlottic squamous cell carcinomaT1 glottic squamous cell carcinomaSquamous cell carcinomaDual-modality treatmentOver-treatmentT1a tumorsCell carcinomaTreatment regimensOverall treatment modalityNational Cancer DatabaseRate of surgeryYear of treatmentMultivariate logistic regressionCochran-Armitage testT1b tumorsT1b diseaseCancer DatabaseOver-treatedTreatment modalitiesTreatment patternsAssociated with greater likelihoodSurgeryPatientsTumorLogistic regression533 - Long-term 5-year safety of upadacitinib in moderate-to-severe atopic dermatitis: an integrated analysis including over 7000 patient-years of exposure
Bunick C, Chovatiya R, Guttman E, Shahriari M, Boguniewicz M, Gao X, Greiwe J, Blauvelt A, Schuttelaar M, Irvine A, Levy G, Platt A, Dilley D, Teixeira H, Altman K, Grada A, Silverberg J. 533 - Long-term 5-year safety of upadacitinib in moderate-to-severe atopic dermatitis: an integrated analysis including over 7000 patient-years of exposure. British Journal Of Dermatology 2024, 190: ii35-ii36. DOI: 10.1093/bjd/ljad498.037.Peer-Reviewed Original ResearchNon-melanoma skin cancerMajor adverse cardiovascular eventsVenous thromboembolic eventsAtopic dermatitisAdverse eventsAdjudicated major adverse cardiovascular eventsOral Janus kinase 1Rate of serious infectionTreatment-emergent adverse eventsLong-term safety dataDuration of follow-upConcomitant topical corticosteroidsEfficacy of upadacitinibDouble-blind periodRate of adverse eventsPhase 3 studyDoses of upadacitinibEczematous skin lesionsExposure-adjusted ratesMATERIALS & METHODSYear of treatmentAdverse cardiovascular eventsBenefit-risk profileInflammatory skin diseaseLong-term safetyPlain language summary of a study looking at the long-term benefits of enzyme replacement therapy in children and teenagers with Gaucher disease type 3
El-Beshlawy A, Tylki-Szymanska A, Belmatoug N, Mistry P. Plain language summary of a study looking at the long-term benefits of enzyme replacement therapy in children and teenagers with Gaucher disease type 3. Future Rare Diseases 2024, 4: frd52. DOI: 10.2217/frd-2023-0015.Peer-Reviewed Original ResearchBeta-glucosidase enzymePlain Language SummaryGaucher diseaseSlow growthBeta-glucosidaseEnzyme replacement therapyLanguage SummaryQuality of life of peopleLife-prolonging treatmentInternational Collaborative Gaucher GroupQuality of lifeGenetic conditionsEnzymeType 3Year of treatmentImproved most symptomsLong-term symptoms
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