2024
Risankizumab for Ulcerative Colitis
Louis E, Schreiber S, Panaccione R, Bossuyt P, Biedermann L, Colombel J, Parkes G, Peyrin-Biroulet L, D’Haens G, Hisamatsu T, Siegmund B, Wu K, Boland B, Melmed G, Armuzzi A, Levine P, Kalabic J, Chen S, Cheng L, Shu L, Duan W, Pivorunas V, Sanchez Gonzalez Y, D’Cunha R, Neimark E, Wallace K, Atreya R, Ferrante M, Loftus E, Balderramo D, Goncalves S, Lasa J, Novillo A, Ruffinengo O, Heeren S, Reinisch W, Baert F, Bossuyt P, Colard A, Dewit O, Ferrante M, Franchimont D, Louis E, Rahier J, Francesconi C, Kaiser Junior R, Parra R, Sassaki L, Penchev P, Stanchev D, Atkinson K, Beaton M, Bessissow T, Greenbloom S, Lachance J, Lim A, Panaccione R, Samson J, Shulman S, Siffledeen J, Alfaro I, Valenzuela C, Walsen G, An P, Cao Q, Chen Y, Chen Y, Gao X, Hou X, Hu N, Li Y, Liu F, Liu M, Lungen L, Ran Z, Tang T, Wang X, Yang S, Zhan Q, Zhang G, Zhang H, Zhang J, Zhang X, Zhong J, Zou X, Alvarez E, Ricaurte J, Borzan V, Krznaric Z, Puljiz Z, Bortlik M, Svoboda P, Ulbrych J, Vanasek T, Kjeldsen J, Munck L, Poulsen A, Ali E, Salem O, Sawah H, Waked I, Altwegg R, FLAMANT M, Fumery M, Hebuterne X, Laharie D, Peyrin-Biroulet L, Roblin X, Treton X, Atreya R, Deppe H, Hasselblatt P, Kandulski A, Klaus J, Krause T, Kucharzik T, Mertens J, Mross M, Naumann A, Reindl W, Schiefke I, Schreiber S, Schubert S, Siegmund B, Sturm A, Bamias G, Koutroubakis I, Manolakopoulos S, Mantzaris G, Tzouvala M, Viazis N, Avni-Biron I, Goldin E, Katz L, Lahat-Zok A, Segal A, Ardizzone S, Armuzzi A, Cicala M, Colecchia A, Cosintino R, Gasbarrini A, Geccherle A, Giannini E, Gionchetti P, Luzza F, Monteleone G, Privitera A, Saibeni S, Vangeli M, Abe Y, Aoyama N, Asonuma K, Endo Y, Esaki M, Fujii T, Fukuda K, Hirai F, Hisanaga Y, Horiki N, Iguchi M, Ishigami K, Ishiguro Y, Ito H, Kakuta Y, Kamikozuru K, Kato J, Kawanishi T, Kobayashi T, Kuge H, Maemoto A, Masuda T, Matsuoka K, Matsushima K, Matsushima M, Motoya S, Nakai K, Nakajima K, Nakamura M, Nishida A, Nishikawa T, Nishimata N, Ochiai T, Ohmiya N, Ohnishi Y, Oka S, Ozeki K, Saito D, Saruta M, Sasaki M, Shimizu M, Sugimoto K, Sujino T, Suzuki T, Takatori H, Takatsu N, Takedatsu H, Takeuchi K, Tanaka H, Tokito S, Endo T, Toyokawa T, Uenoyama Y, Yamamoto T, Yamamoto T, Yasuda H, Yokoyama K, Derovs A, Pukitis A, Jonaitis L, Kazenaite E, Pinzon Te L, D'Haens G, Lutgens M, Brooker J, Gearry R, Griffiths B, Inns S, Schultz M, Eszyk J, Kierkus J, Kleczkowski D, Kopon A, Petryka R, Regula J, Romanczyk T, Rydzewska-Wyszkowska G, Sikorski P, Talarek M, Cerqueira R, Goncalves T, Lopes S, Ministro P, Portela F, Tavares H, Diculescu M, Goldis A, Seicean A, Agafina A, Edin A, Gerasimova E, Gettueva M, Kashnikov V, Pirmagomedov A, Rafalskiy V, Sharapova K, Smolyarchuk E, Varganova D, Grgov S, Jovanovic I, Svorcan P, Tarabar D, Ling K, Balaz J, Durina J, Gregus M, Laclav M, Drobne D, Deetlefs E, Peter J, Rajabally M, Rosa J, van Zyl J, Wright J, Cheon J, Jang B, Kim J, Kang S, Kim D, Kim T, Kim Y, Lee J, Lee K, Park D, Song G, Arguelles Arias F, Castro Laria L, Echarri Piudo A, Garcia Lopez S, Hernandez Ramirez V, Martin Arranz M, Varela Trastoy P, Vera Mendoza M, Lordal M, Biedermann L, Misselwitz B, Chang C, Chou J, Kuo C, Lin C, Tu C, Alkim H, Erzin Y, Soykan I, Kravchenko T, Tsarynna N, Vyshyvanyuk V, Ahmad T, Cummings F, Kapur K, Kaser A, Kent A, Parkes G, Patel K, Speight R, Steel A, Aberra F, Aguilar H, Al Bawardy B, Ananthakrishnan A, Barnes M, Beck K, Berkelhammer C, Boland B, Bullock J, Chiplunker A, Dalal R, Dalal S, Delgado B, DiGiovanna M, DuVall G, Freedland C, Friedenberg K, Gaidos J, Ginsburg P, Hassanein T, Higgins P, Hong J, Hou J, Huilgol V, Inamdar N, Kapur S, Kerman D, Levine H, Lodhia N, Loftus E, Mayoral J, McNeil D, Melmed G, Mushahwar A, Ojeas H, Patel B, Phillips R, Pouzar J, Sarles H, Schock J, Sedghi S, Shah N, Siddiqui J, Stokesberry D, Su L, Swaminath A, Verma D, Weber J, Younes Z, Zisman T. Risankizumab for Ulcerative Colitis. JAMA 2024, 332: 881-897. PMID: 39037800, PMCID: PMC11264075, DOI: 10.1001/jama.2024.12414.Peer-Reviewed Original ResearchClinical remission rateActive ulcerative colitisRemission rateUlcerative colitisInduction trialsMaintenance trialsClinical centersPhase 3 randomized clinical trialModerately to severely active ulcerative colitisSeverely active ulcerative colitisSafety of risankizumabTreatment of ulcerative colitisHistory of intoleranceMaintenance therapyClinical remissionClinical responseResponse to 1Intravenous treatmentRisankizumabAdverse event signalsConventional therapySubcutaneous treatmentFollow-upPlaceboAdvanced therapiesRates, Predictors, and Outcomes of Ustekinumab Dose Escalation in Inflammatory Bowel Disease.
Petrov J, Al-Bawardy B, Alzahrani R, Mohamed G, Fine S. Rates, Predictors, and Outcomes of Ustekinumab Dose Escalation in Inflammatory Bowel Disease. Journal Of Clinical Gastroenterology 2024 PMID: 38595134, DOI: 10.1097/mcg.0000000000002003.Peer-Reviewed Original ResearchUstekinumab dose escalationDose-escalation groupInflammatory bowel diseaseDose escalationC-reactive proteinEndoscopic healingEscalation groupClinical remissionNormalization of C-reactive proteinSteroid-free clinical remissionBowel diseaseSerum C-reactive proteinNormalization of serum C-reactive proteinMaintenance of remissionReal-world cohortProportion of patientsUstekinumab doseMean hemoglobinBaseline albuminRetrospective studyUstekinumabMale sexMultivariate analysisPrimary outcomeSecondary outcomesUstekinumab Drug Levels and Outcomes in Inflammatory Bowel Disease.
Petrov J, Fine S, Alzahrani R, Mohamed G, Al-Bawardy B. Ustekinumab Drug Levels and Outcomes in Inflammatory Bowel Disease. Journal Of Clinical Gastroenterology 2024 PMID: 38300529, DOI: 10.1097/mcg.0000000000001978.Peer-Reviewed Original ResearchArea under the curveInflammatory bowel diseaseEndoscopic healingTrough levelsBowel diseaseAssociated with favorable outcomesUstekinumab trough levelsHighest area under the curveCohort of patientsTherapeutic drug monitoringClinical remissionCombination therapyMedian ageCRP normalizationRetrospective studyDrug levelsFavorable outcomeUstekinumabDrug monitoringPrimary outcomeSecondary outcomesCRPPatientsOutcomesHealing
2023
Outcomes of Infliximab-Treated inflammatory bowel disease patients undergoing therapeutic drug monitoring with two different assays
Al-Bawardy B, Jenkins S, Snyder M, Frinack J, Ladwig P, Loftus E, Willrich M. Outcomes of Infliximab-Treated inflammatory bowel disease patients undergoing therapeutic drug monitoring with two different assays. Clinical Biochemistry 2023, 119: 110618. PMID: 37507083, DOI: 10.1016/j.clinbiochem.2023.110618.Peer-Reviewed Original ResearchConceptsInflammatory bowel disease patientsBowel disease patientsEndoscopic healingClinical remissionDisease patientsMcg/Normal serum C-reactive proteinDrug monitoringSerum C-reactive proteinLC-MS/MSInfliximab drug levelsFavorable clinical outcomeC-reactive proteinTherapeutic drug monitoringIBD patientsNormal CRPClinical outcomesDrug levelsPatientsECLIARemissionDifferent assaysOutcomesMcgAssaysOutcomes of immunomodulator and advanced therapies for primary sclerosing cholangitis-associated inflammatory bowel disease
Sayed A, Assis D, Silveira M, Deng Y, Ciarleglio M, Gaidos J, Proctor D, Al-Bawardy B. Outcomes of immunomodulator and advanced therapies for primary sclerosing cholangitis-associated inflammatory bowel disease. European Journal Of Gastroenterology & Hepatology 2023, 35: 270-274. PMID: 36708297, DOI: 10.1097/meg.0000000000002510.Peer-Reviewed Original ResearchConceptsPrimary sclerosing cholangitisInflammatory bowel diseasePSC-IBDEndoscopic healingTherapy groupAdvanced therapiesClinical remissionBowel diseaseAcute ascending cholangitisRate of cholangitisSmall bowel involvementThird of patientsAscending cholangitisSclerosing cholangitisAdult patientsBowel involvementSecondary outcomesMedian agePrimary outcomeRetrospective studyHigh riskCholangitisPatientsTherapyLarger study
2022
Impact of thiopurine dose in anti-tumor necrosis factor combination therapy on outcomes in inflammatory bowel disease
Nawaz A, Glick L, Chaar A, Li D, Gaidos J, Proctor D, Al-Bawardy B. Impact of thiopurine dose in anti-tumor necrosis factor combination therapy on outcomes in inflammatory bowel disease. Annals Of Gastroenterology 2022, 36: 39-44. PMID: 36593807, PMCID: PMC9756033, DOI: 10.20524/aog.2022.0766.Peer-Reviewed Original ResearchInflammatory bowel diseaseC-reactive proteinAnti-TNF combination therapySteroid-free clinical remissionCombination therapyThiopurine doseDose groupEndoscopic healingClinical remissionBowel diseaseUlcerative colitisCrohn's diseaseTherapeutic doseNormal serum C-reactive proteinAnti-tumor necrosis factorNormal C-reactive proteinSerum C-reactive proteinAnti-drug antibody formationAnti-TNF immunogenicityCohort of patientsLow-dose groupSignificant differencesSecondary outcomesPrimary outcomeClinical outcomesEffect of obesity on vedolizumab response in inflammatory bowel disease
Levine LJ, Gaidos JKJ, Proctor DD, Viana AV, Al-Bawardy B. Effect of obesity on vedolizumab response in inflammatory bowel disease. Annals Of Gastroenterology 2022, 35: 275-280. PMID: 35599926, PMCID: PMC9062841, DOI: 10.20524/aog.2022.0699.Peer-Reviewed Original ResearchBody mass indexInflammatory bowel diseaseSteroid-free clinical remissionNon-obese groupC-reactive proteinObese groupCRP normalizationEndoscopic remissionIBD patientsBowel diseaseDose escalationNormal serum C-reactive proteinMedian body mass indexSerum C-reactive proteinHigher body mass indexEndoscopic remission ratesEffect of obesityVedolizumab discontinuationVedolizumab levelsClinical remissionMedian followRemission rateSecondary outcomesMedian agePrimary outcome
2018
Vedolizumab Drug Level Correlation With Clinical Remission, Biomarker Normalization, and Mucosal Healing in Inflammatory Bowel Disease
Al-Bawardy B, Ramos GP, Willrich MAV, Jenkins SM, Park SH, Aniwan S, Schoenoff SA, Bruining DH, Papadakis KA, Raffals L, Tremaine WJ, Loftus EV. Vedolizumab Drug Level Correlation With Clinical Remission, Biomarker Normalization, and Mucosal Healing in Inflammatory Bowel Disease. Inflammatory Bowel Diseases 2018, 25: 580-586. PMID: 30165638, DOI: 10.1093/ibd/izy272.Peer-Reviewed Original ResearchConceptsMedian vedolizumab trough levelsVedolizumab trough levelsC-reactive proteinInflammatory bowel diseaseNormal C-reactive proteinMucosal healingCrohn's diseaseUC patientsBowel diseaseTrough levelsUlcerative colitisClinical managementFourth of patientsTrough level measurementMayo endoscopic scoreCross-sectional studyHigh CRP patientsBiomarker normalizationIBD patientsClinical remissionCRP patientsEndoscopic scoreMucosal ulcersDetectable antibodiesBACKGROUND/