2023
Emerging Therapies for Ulcerative Colitis: Updates from Recent Clinical Trials
AlAmeel T, AlMutairdi A, Al-Bawardy B. Emerging Therapies for Ulcerative Colitis: Updates from Recent Clinical Trials. Clinical And Experimental Gastroenterology 2023, 16: 147-167. PMID: 37609124, PMCID: PMC10441644, DOI: 10.2147/ceg.s375969.Peer-Reviewed Original ResearchManagement of UCToll-like receptor 9Ulcerative colitisAdvanced therapiesSubcutaneous tumor necrosis factor (TNF) inhibitorsPhosphodiesterase 4 inhibitor apremilastTumor necrosis factor inhibitorsInnovative clinical trial designsNecrosis factor inhibitorsRecent clinical trialsProgressive inflammatory disorderClinical trial designFurther drug developmentRemission rateBiologic agentsFactor inhibitorsInflammatory disordersTherapeutic armamentariumReceptor 9Clinical trialsAvailable agentsTrial designTherapyColitisDrug developmentUse, Durability, and Risks for Discontinuation of Initial and Subsequent Biologics in a Large Pediatric‐Onset IBD Cohort
Kaplan J, Liu C, King E, Bass J, Patel A, Tung J, Chen S, Lissoos T, Candela N, Saeed S, Colletti R, Network I, Adler J, Baron H, Cabrera J, Dorsey J, Dykes D, Ebach D, Garin‐Laflam M, Gold B, Grunow J, Higuchi L, Jester T, Lapsia S, Leibowitz I, Linvlle T, Morhardt T, Moses J, Moulton D, Nasiri‐Blomgren S, Niklinska‐Schirtz B, Ogunmola N, Palomo P, Park K, Pashankar D, Pasternak B, Radano M, Samson C, Sandberg K, Schaefer M, Shashidhar H, Steiner S, Sullivan J, Tomer G, Verstraete S. Use, Durability, and Risks for Discontinuation of Initial and Subsequent Biologics in a Large Pediatric‐Onset IBD Cohort. Journal Of Pediatric Gastroenterology And Nutrition 2023, 76: 566-575. PMID: 36804501, PMCID: PMC10097486, DOI: 10.1097/mpg.0000000000003734.Peer-Reviewed Original ResearchConceptsCrohn's diseaseUlcerative colitisLoss of responseFirst biologicSubsequent biologicsBiologic agentsBiologic medicationsBiologic treatmentAnti-tumor necrosis factor agentsUpper gastrointestinal tract involvementGastrointestinal tract involvementNecrosis factor agentsActive Crohn's diseaseFirst biologic agentIBD cohortInitial biologicSecond biologicTract involvementCorticosteroid useFactor agentsPediatric IBDBiologic initiationDisease courseUnivariate analysisSevere diseaseComparative Safety of Biologic Agents in Patients With Inflammatory Bowel Disease With Active or Recent Malignancy: A Multi-Center Cohort Study
Holmer A, Luo J, Russ K, Park S, Yang J, Ertem F, Dueker J, Nguyen V, Hong S, Zenger C, Axelrad J, Sofia A, Petrov J, Al-Bawardy B, Fudman D, Llano E, Dailey J, Jangi S, Khakoo N, Damas O, Barnes E, Scott F, Ungaro R, Singh S, Helping-IBD R. Comparative Safety of Biologic Agents in Patients With Inflammatory Bowel Disease With Active or Recent Malignancy: A Multi-Center Cohort Study. Clinical Gastroenterology And Hepatology 2023, 21: 1598-1606.e5. PMID: 36642291, DOI: 10.1016/j.cgh.2023.01.002.Peer-Reviewed Original ResearchConceptsNon-TNF biologicsInflammatory bowel diseaseProgression-free survivalRecurrence-free survivalTNFα antagonistsActive cancerPrior cancerCohort studyBiologic agentsBowel diseaseRecent cancerMulticenter retrospective cohort studyMulti-center cohort studyIBD disease severityRetrospective cohort studyChoice of biologicsTumor necrosis factorCohort BPrimary outcomeComparable safetyΑ antagonistsComparative safetyCancer recurrenceNecrosis factorPatients
2022
A Practical Approach to IBD Care in the Pregnant Patient
Sahyoun L, Gaidos J. A Practical Approach to IBD Care in the Pregnant Patient. Current Gastroenterology Reports 2022, 24: 201-209. PMID: 36422770, DOI: 10.1007/s11894-022-00856-3.Peer-Reviewed Original ResearchConceptsInflammatory bowel diseaseManagement of IBDPrior inflammatory bowel diseaseNew IBD therapiesNew biologic agentsPouch-anal anastomosisSimilar success ratesPurpose of ReviewAsIBD careIBD patientsIBD therapyActive diseaseDisease remissionFetal outcomesIBD treatmentPregnant patientsIBD populationPreconception counselingPregnancy outcomesBiologic agentsBowel diseasePeripartum periodMedication safetyPrevious guidelinesPregnancyComparative Safety and Effectiveness of Biologic Therapy for Crohn’s Disease: A CA-IBD Cohort Study
Singh S, Kim J, Luo J, Paul P, Rudrapatna V, Park S, Zheng K, Syal G, Ha C, Fleshner P, McGovern D, Sauk J, Limketkai B, Dulai P, Boland B, Eisenstein S, Ramamoorthy S, Melmed G, Mahadevan U, Sandborn W, Ohno-Machado L. Comparative Safety and Effectiveness of Biologic Therapy for Crohn’s Disease: A CA-IBD Cohort Study. Clinical Gastroenterology And Hepatology 2022, 21: 2359-2369.e5. PMID: 36343846, PMCID: PMC12145724, DOI: 10.1016/j.cgh.2022.10.029.Peer-Reviewed Original ResearchConceptsTNF-α antagonistsRisk of hospitalizationUstekinumab-treated patientsCrohn's diseaseSerious infectionsLower riskMulticenter cohortInflammatory bowel disease-related surgeryTumor necrosis factor α antagonistsNecrosis factor α antagonistsDisease-related surgeryHigher comorbidity burdenVedolizumab-treated patientsNew biologic agentsPropensity-score matchingComorbidity burdenCause hospitalizationAdult patientsBiologic therapyCohort studyPrior hospitalizationBiologic agentsΑ antagonistsBiologic classesComparative safetyEffect of Obesity on Risk of Hospitalization, Surgery, and Serious Infection in Biologic-Treated Patients With Inflammatory Bowel Diseases: A CA-IBD Cohort Study
Gu P, Luo J, Kim J, Paul P, Limketkai B, Sauk J, Park S, Parekh N, Zheng K, Rudrapatna V, Syal G, Ha C, McGovern D, Melmed G, Fleshner P, Eisenstein S, Ramamoorthy S, Dulai P, Boland B, Grunvald E, Mahadevan U, Ohno-Machado L, Sandborn W, Singh S. Effect of Obesity on Risk of Hospitalization, Surgery, and Serious Infection in Biologic-Treated Patients With Inflammatory Bowel Diseases: A CA-IBD Cohort Study. The American Journal Of Gastroenterology 2022, 117: 1639-1647. PMID: 35973139, DOI: 10.14309/ajg.0000000000001855.Peer-Reviewed Original ResearchConceptsInflammatory bowel diseaseBiologic-treated patientsRisk of hospitalizationBody mass indexNormal body mass indexSerious infectionsBiologic agentsBowel diseaseCox proportional hazards analysisWorld Health Organization classificationEffect of obesityProportional hazards analysisElectronic health recordsCause hospitalizationVisceral obesityAdult patientsBaseline demographicsBiologic initiationBiologic therapyCohort studyEndoscopic outcomesMass indexOrganization classificationTreatment characteristicsStratified analysisEffectiveness and Safety of Biologic Therapy in Hispanic Vs Non-Hispanic Patients With Inflammatory Bowel Diseases: A CA-IBD Cohort Study
Nguyen N, Luo J, Paul P, Kim J, Syal G, Ha C, Rudrapatna V, Park S, Parekh N, Zheng K, Sauk J, Limketkai B, Fleshner P, Eisenstein S, Ramamoorthy S, Melmed G, Dulai P, Boland B, Mahadevan U, Sandborn W, Ohno-Machado L, McGovern D, Singh S. Effectiveness and Safety of Biologic Therapy in Hispanic Vs Non-Hispanic Patients With Inflammatory Bowel Diseases: A CA-IBD Cohort Study. Clinical Gastroenterology And Hepatology 2022, 21: 173-181.e5. PMID: 35644340, PMCID: PMC9701245, DOI: 10.1016/j.cgh.2022.05.008.Peer-Reviewed Original ResearchConceptsInflammatory bowel diseaseNon-Hispanic patientsBiologic-treated patientsHispanic patientsSerious infectionsBiologic therapyBowel diseasePropensity score-matched cohortBurden of inflammationRisk of hospitalizationHigh ratePropensity-score matchingCause hospitalizationAdult patientsBiologic initiationCohort studyBiologic agentsMedication useHigh burdenHigh riskHospitalizationPatientsSurvival analysisSurgeryAbstractText
2021
A Survey of Community Dermatologists Reveals the Unnecessary Impact of Trial-and-Error Behavior on the Psoriasis Biologic Treatment Paradigm
Strober B, Pariser D, Deren-Lewis A, Dickerson T, Lebwohl M, Menter A. A Survey of Community Dermatologists Reveals the Unnecessary Impact of Trial-and-Error Behavior on the Psoriasis Biologic Treatment Paradigm. Dermatology And Therapy 2021, 11: 1851-1860. PMID: 34275121, PMCID: PMC8484423, DOI: 10.1007/s13555-021-00573-1.Peer-Reviewed Original ResearchPatient outcomesCommunity dermatologistsPsoriasis treatment responseNon-responding patientsFirst-line therapySuboptimal patient outcomesBiologic switchingBiologic agentsPsoriasis managementTherapy utilizationBiologic classesTherapeutic responseTreatment paradigmTreatment responseClinical utilityBiologic drugsPatientsDrug selectionMethodsA surveyPrior authorizationDermatologistsFirst choiceTrialsBiologic responsePrecision medicineTHE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF BIOLOGICS/SMALL MOLECULE THERAPY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND CIRRHOSIS
Li M, Khan S, Proctor D, Gaidos J, Al-Bawardy B. THE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF BIOLOGICS/SMALL MOLECULE THERAPY IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE AND CIRRHOSIS. Inflammatory Bowel Diseases 2021, 27: s45-s46. DOI: 10.1093/ibd/izaa347.110.Peer-Reviewed Original ResearchInflammatory bowel diseaseBiologic agentsAdverse eventsSmall molecule therapiesClinical remissionMucosal healingBowel diseaseConcomitant cirrhosisConcomitant corticosteroid therapyDifferent biologic agentsPrimary sclerosing cholangitisQuarter of patientsCohort of patientsEffectiveness of biologicsSmall molecule agentsConcomitant thiopurinesCorticosteroid therapyIBD patientsIBD therapyCertolizumab pegolSclerosing cholangitisAdult patientsBiologic therapyInfusion reactionsSecondary outcomes
2019
Acute liver injury in the context of immune checkpoint inhibitor-related colitis treated with infliximab
Zhang H, Luo W, Wang Y. Acute liver injury in the context of immune checkpoint inhibitor-related colitis treated with infliximab. Journal For ImmunoTherapy Of Cancer 2019, 7: 47. PMID: 30777137, PMCID: PMC6380028, DOI: 10.1186/s40425-019-0532-1.Peer-Reviewed Original ResearchConceptsImmune-related adverse reactionsGrade 3 colitisGastrointestinal reactionsLiver injuryClinical historyImmune checkpoint inhibitor-related colitisBackgroundImmune checkpoint inhibitorsElevated liver enzymesPD-1 inhibitorsTNF-α agentsAcute liver injuryInflammatory bowel diseaseOne-time infusionInfliximab therapyAcute hepatitisCheckpoint inhibitorsRescue therapyAdvanced malignanciesBiologic agentsBowel diseaseLiver profileCase presentationWePatient populationCTLA-4Final diagnosisJoint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics
Menter A, Strober BE, Kaplan DH, Kivelevitch D, Prater EF, Stoff B, Armstrong AW, Connor C, Cordoro KM, Davis DMR, Elewski BE, Gelfand JM, Gordon KB, Gottlieb AB, Kavanaugh A, Kiselica M, Korman NJ, Kroshinsky D, Lebwohl M, Leonardi CL, Lichten J, Lim HW, Mehta NN, Paller AS, Parra SL, Pathy AL, Rupani RN, Siegel M, Wong EB, Wu JJ, Hariharan V, Elmets CA. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal Of The American Academy Of Dermatology 2019, 80: 1029-1072. PMID: 30772098, DOI: 10.1016/j.jaad.2018.11.057.Peer-Reviewed Original ResearchConceptsTreatment of psoriasisAAD-NPF GuidelinesInflammatory multisystem diseaseImportant clinical questionsBiologic agentsPsoriasis managementMultisystem diseaseTreatment recommendationsClinical questionsUS populationPsoriasisAvailable evidenceCareTreatmentGuidelinesPatientsDermatologistsDiseaseBiologicsUstekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs
Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Safety 2019, 42: 751-768. PMID: 30739254, PMCID: PMC6520311, DOI: 10.1007/s40264-019-00797-3.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsPsoriatic arthritisRegistrational trialsCrohn's diseaseMajor adverse cardiovascular eventsUstekinumab-treated patientsAdverse cardiovascular eventsSevere plaque psoriasisConsistent safety profileSevere Crohn's diseaseActive psoriatic arthritisClinical development programUstekinumab doseCardiovascular eventsPlaque psoriasisBiologic agentsPsoriatic patientsInduction doseSafety profileIncidence rateSafety dataPatientsDiseaseSafety eventsWeeks
2018
Microfracture of subchondral bone leads to persistent subchondral sclerosis and poorer functional outcomes following distraction arthroplasty of the ankle joint while biologic augment may improve recovery times
Gianakos A, Kennedy J. Microfracture of subchondral bone leads to persistent subchondral sclerosis and poorer functional outcomes following distraction arthroplasty of the ankle joint while biologic augment may improve recovery times. Foot & Ankle Orthopaedics 2018, 3: 2473011418s00056. DOI: 10.1177/2473011418s00056.Peer-Reviewed Original ResearchAnkle distractionFunctional outcomeLong-term clinical outcomesSubchondral boneTerm clinical outcomesAnkle Outcome ScoreGood functional outcomeRecords of patientsPoor functional outcomeTreatment of ankleSubchondral bone sclerosisJoint spaceChi-square testingJoint space changesMean followPostoperative rangeAnkle osteoarthritisComplication rateArthroplasty resultsBiologic agentsClinical outcomesAnkle arthritisOutcome scoresMean ageBone sclerosisNeutrophilic dermatoses Pathogenesis, Sweet syndrome, neutrophilic eccrine hidradenitis, and Behçet disease
Nelson CA, Stephen S, Ashchyan HJ, James WD, Micheletti RG, Rosenbach M. Neutrophilic dermatoses Pathogenesis, Sweet syndrome, neutrophilic eccrine hidradenitis, and Behçet disease. Journal Of The American Academy Of Dermatology 2018, 79: 987-1006. PMID: 29653210, DOI: 10.1016/j.jaad.2017.11.064.Peer-Reviewed Original ResearchMeSH KeywordsAdrenal Cortex HormonesAntineoplastic AgentsAutoimmune DiseasesBehcet SyndromeChemotaxis, LeukocyteCytokinesDermisDiagnosis, DifferentialDrug EruptionsEpidermisEthnicityGenetic Predisposition to DiseaseHidradenitisHumansImmunity, InnateImmunosuppressive AgentsInflammationNeoplasmsNeutrophilsSweet SyndromeVasculitisConceptsNeutrophilic eccrine hidradenitisNeutrophilic dermatosisSweet's syndromeBehçet's diseaseInflammatory skin disorderSignificant patient morbidityUnique clinical featuresMedical education seriesSystemic corticosteroidsBiologic agentsClinical featuresNeutrophilic infiltrateCutaneous lesionsHistopathologic featuresPatient morbidityTherapeutic modalitiesNeoplastic processSkin disordersDermatosesHeterogeneous groupDiseaseDiagnosisHidradenitisDisordersSyndromeNeutrophilic dermatoses Pyoderma gangrenosum and other bowel- and arthritis-associated neutrophilic dermatoses
Ashchyan HJ, Nelson CA, Stephen S, James WD, Micheletti RG, Rosenbach M. Neutrophilic dermatoses Pyoderma gangrenosum and other bowel- and arthritis-associated neutrophilic dermatoses. Journal Of The American Academy Of Dermatology 2018, 79: 1009-1022. PMID: 29653213, DOI: 10.1016/j.jaad.2017.11.063.Peer-Reviewed Original ResearchMeSH KeywordsAnti-Inflammatory AgentsArthritisArthritis, RheumatoidDiagnosis, DifferentialDigestive System Surgical ProceduresDisease ManagementHumansImmunosuppressive AgentsInflammationInflammatory Bowel DiseasesNeutrophilsPostoperative ComplicationsPyoderma GangrenosumReoperationSkin UlcerStill's Disease, Adult-OnsetWound HealingConceptsNeutrophilic dermatosisBowel-associated dermatosis-arthritis syndromeDermatosis-arthritis syndromeRheumatoid neutrophilic dermatitisInflammatory skin disorderSignificant patient morbidityUnique clinical featuresMedical education seriesNeutrophilic dermatitisSystemic corticosteroidsPyoderma gangrenosumClinical characteristicsBiologic agentsClinical featuresNeutrophilic infiltrateCutaneous lesionsHistopathologic featuresPatient morbidityTherapeutic modalitiesNeoplastic processSkin disordersDermatosesHeterogeneous groupDiagnosisGangrenosum
2017
Novel Molecular Targets for Chemoprevention in Malignancies of the Head and Neck
Bhatia A, Burtness B. Novel Molecular Targets for Chemoprevention in Malignancies of the Head and Neck. Cancers 2017, 9: 113. PMID: 28858212, PMCID: PMC5615328, DOI: 10.3390/cancers9090113.Peer-Reviewed Original ResearchNeck cancerSecond primary tumorsExtensive clinical researchCancer-related mortalityNovel molecular targetsWhole-exome sequencingBiologic agentsOral leukoplakiaInvasive cancerPrimary tumorClinical trialsPrecursor lesionsNovel molecular pathwaysPrimary headMucosal fieldTumor specimensNeck regionCare optionsClinical researchCancerDriver mutationsExome sequencingMolecular targetsGenetic mutationsMolecular pathwaysNoninfectious Causes
Chow J, deLuise V. Noninfectious Causes. Essentials In Ophthalmology 2017, 93-105. DOI: 10.1007/978-3-319-50404-9_9.Peer-Reviewed Original ResearchPeripheral ulcerative keratitisImmunosuppressive therapyInflammatory processFirst-line immunosuppressive therapyLife-threatening vasculitisNew biologic agentsTNF-alpha inhibitorsConnective tissue diseaseNoninfectious inflammatory diseasesConnective tissue disordersPotential side effectsSystemic corticosteroidsCorneal involvementNoninfectious causesRefractory casesSystemic inflammationAutoimmune destructionBiologic agentsSentinel signSystemic involvementTissue diseaseGlobe integrityImmunomodulatory agentsUlcerative keratitisInflammatory diseasesManaging IBD Therapies in Pregnancy
Gaidos JK, Kane SV. Managing IBD Therapies in Pregnancy. Current Treatment Options In Gastroenterology 2017, 15: 71-83. PMID: 28181180, DOI: 10.1007/s11938-017-0123-5.Peer-Reviewed Original ResearchDisease remissionAnti-tumor necrosis factor agentsInflammatory bowel disease treatmentNecrosis factor agentsIBD medicationsIBD therapyDisease activityFactor agentsQuiescent diseaseBiologic agentsBowel diseaseHealthy pregnancyTreatment regimenMedication adherenceCombination therapyPatient's desireCurrent evidenceLower riskMost womenPregnancyAdverse effectsLess evidenceDisease treatmentRemissionBreastfeeding
2016
Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR])
Strober B, Bissonnette R, Fiorentino D, Kimball A, Naldi L, Shear N, Goyal K, Fakharzadeh S, Calabro S, Langholff W, You Y, Galindo C, Lee S, Lebwohl M. Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR]). Journal Of The American Academy Of Dermatology 2016, 74: 851-861.e4. PMID: 26853180, DOI: 10.1016/j.jaad.2015.12.017.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdultBiological ProductsConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleEtanerceptFemaleFollow-Up StudiesGlobal HealthHumansInfliximabLongitudinal StudiesMaleMiddle AgedOdds RatioPatient SatisfactionProspective StudiesPsoriasisQuality of LifeRegistriesSeverity of Illness IndexTime FactorsTreatment OutcomeUstekinumabConceptsPhysician Global Assessment scoreGlobal assessment scoreBody surface areaReal-world settingAssessment scoresPsoriasis Longitudinal AssessmentProportion of patientsTreatment of psoriasisEffectiveness of biologicsTreatment selection biasTumor necrosis factorBiologic agentsEfficacy dataTherapeutic responseTumor necrosisNecrosis factorObservational studyTreatment decisionsAnalysis of covarianceEtanerceptComparative effectivenessAdalimumabInfliximabLongitudinal assessmentLogistic regression
2013
SAT0287 Long-Term Safety Of Ustekinumab: 5 Years of Follow-Up from the Psoriasis Clinical Development Program Including Patients with Psoriatic Arthritis
Papp K, Griffiths C, Gordon K, Lebwohl M, Szapary P, Wasfi Y, Chan D, Shen Y, Ho V, Ghislain P, Strober B, Reich K. SAT0287 Long-Term Safety Of Ustekinumab: 5 Years of Follow-Up from the Psoriasis Clinical Development Program Including Patients with Psoriatic Arthritis. Annals Of The Rheumatic Diseases 2013, 72: a680. DOI: 10.1136/annrheumdis-2013-eular.2012.Peer-Reviewed Original ResearchGrant/research supportLong-term safetyAEs of interestOverall populationJanssen ResearchSafety endpointEvent ratesOpen-label long-term extensionLong-term safety experienceLow potency topical steroidsPooled safety dataOverall study populationPhase 3 developmentMajority of ptsClinical development programLong-term extensionHistory of PsAAbsence of PSAPsO patientsSevere PsOTopical steroidsPASI scorePsoriatic arthritisBiologic agentsMedian age
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