2024
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, 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 dataPsoriasisDeucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Colombo M, Vaile J, Vritzali E, Hoyt K, Daamen C, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s406. DOI: 10.25251/skin.8.supp.406.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsSafety signalsPatientsContinuous treatmentResponse rateIncidence rateParent trialPsoriasisAllosteric TYK2 inhibitorA randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis
Ehst B, Strober B, Blauvelt A, Maslin D, Macaro D, Carpenter N, Bodmer M, McHale D. A randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis. Frontiers In Medicine 2024, 11: 1292406. PMID: 38813388, PMCID: PMC11133679, DOI: 10.3389/fmed.2024.1292406.Peer-Reviewed Original ResearchPASI-50Double-blindMild to moderate plaque psoriasisMild to moderate psoriasisOff-treatment responseWeeks of follow-upChronic inflammatory skin diseaseParallel-group studySystemic anti-inflammatory responsePhase 2 trialInflammatory skin diseaseAnti-inflammatory responsePlaque psoriasisPlacebo-controlledPsoriasis AreaEfficacy outcomesImmunomodulatory approachesSafety profileAdverse eventsEvaluate safetyFollow-upTreatment periodTherapeutic benefitPsoriasisSkin diseasesBrodalumab: 5-Year US Pharmacovigilance Report
Lebwohl M, Koo J, Armstrong A, Strober B, Martin G, Rawnsley N, Goehring E, Jacobson A. Brodalumab: 5-Year US Pharmacovigilance Report. Dermatology And Therapy 2024, 14: 1349-1357. PMID: 38724839, PMCID: PMC11116300, DOI: 10.1007/s13555-024-01162-8.Peer-Reviewed Original ResearchAdverse eventsSystemic therapyInterleukin-17 receptor A antagonistPharmacovigilance dataPsoriasis Longitudinal AssessmentMajor adverse cardiovascular eventsLong-term clinical trialsUS prescribing informationAdverse cardiovascular eventsPlaque psoriasisReported malignanciesSafety profileAdult patientsCardiovascular eventsBrodalumabBox warningUS patientsPharmacovigilance reportsFungal infectionsClinical trialsPrescribing informationSafety signalsSuspected COVID-19 casesPatientsPackage insertsBimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials
Lebwohl M, Merola J, Strober B, Armstrong A, Yoshizaki A, Gisondi P, Szilagyi B, Peterson L, de Cuyper D, Cross N, Davies O, Gottlieb A. Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials. Journal Of The American Academy Of Dermatology 2024, 91: 281-289. PMID: 38588819, DOI: 10.1016/j.jaad.2024.03.041.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdverse eventsModerate to severe plaque psoriasisIncidence of transaminase elevationsLiver parametersMarkers of liver fibrosisAlanine aminotransferaseHepatic adverse eventsSevere plaque psoriasisLiver function abnormalitiesChronic alcohol consumptionControl study periodAspartate aminotransferaseStudy periodAPRI scorePlaque psoriasisTransaminase elevationFibrosis riskHepatic eventsFIB-4Hepatic dysfunctionLaboratory elevationsClinical markersFunctional abnormalitiesLiver fibrosisDeucravacitinib in moderate‐to‐severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO‐1 and PSO‐2)
Strober B, Blauvelt A, Warren R, Papp K, Armstrong A, Gordon K, Morita A, Alexis A, Lebwohl M, Foley P, Kisa R, Colston E, Wang T, Banerjee S, Thaçi D. Deucravacitinib in moderate‐to‐severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO‐1 and PSO‐2). Journal Of The European Academy Of Dermatology And Venereology 2024, 38: 1543-1554. PMID: 38451052, DOI: 10.1111/jdv.19925.Peer-Reviewed Original ResearchPhase 3 trialPlaque psoriasisAdverse eventsTyrosine kinase 2Exposure-adjusted incidence ratesPooled safety dataRate of adverse eventsIncidence rate of adverse eventsVenous thromboembolic eventsExposure-adjusted incidence rates of adverse eventsAdverse cardiovascular eventsOral placeboDiscontinuation ratesLaboratory parametersThromboembolic eventsHerpes zosterDeucravacitinibCardiovascular eventsPooled analysisSafety signalsSafety dataPooled safetyPlaceboApremilastPsoriasis
2023
Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001)
Silverberg J, Strober B, Feinstein B, Xu J, Guttman-Yassky E, Simpson E, Li P, Longphre M, Song J, Guo J, Yun J, Williams B, Pan W, Ho S, Collazo R, Wei Z. Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). Journal Of Allergy And Clinical Immunology 2023, 153: 1040-1049.e12. PMID: 38157942, DOI: 10.1016/j.jaci.2023.11.924.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsEczema Area Severity IndexSevere atopic dermatitisSecondary endpointsAtopic dermatitisWeek 16Serious treatment-emergent adverse eventsNext-generation monoclonal antibodiesPhase 2 trialInjection site reactionsSignificant percent reductionQ4w dosingPrimary endpointTreatment discontinuationAdverse eventsCurrent therapiesLower incidenceQ2WIL-4RαUnspecified causesPandemic-related restrictionsQ4WTrial conductPlaceboMonoclonal antibodiesDeucravacitinib, a selective, allosteric tyrosine kinase 2 inhibitor, in scalp psoriasis: A subset analysis of two phase 3 randomized trials in plaque psoriasis
Blauvelt A, Rich P, Sofen H, Strober B, Merola J, Lebwohl M, Morita A, Szepietowski J, Lambert J, Hippeli L, Colston E, Balagula E, Banerjee S, Thaçi D. Deucravacitinib, a selective, allosteric tyrosine kinase 2 inhibitor, in scalp psoriasis: A subset analysis of two phase 3 randomized trials in plaque psoriasis. Journal Of The American Academy Of Dermatology 2023, 90: 775-782. PMID: 38122848, DOI: 10.1016/j.jaad.2023.11.060.Peer-Reviewed Original ResearchPsoriasis Scalp Severity IndexSevere scalp psoriasisScalp psoriasisPlaque psoriasisSeverity IndexWeek 16Physician's Global Assessment 0/1Physician Global Assessment scoreGlobal phase 3Double-blinded trialEntire study populationGlobal assessment scorePhase 3Pooled secondary analysisOral placeboScalp involvementSevere psoriasisAdverse eventsSubset analysisStudy populationPsoriasisDeucravacitinibResponse rateSecondary analysisPlaceboBimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Analysis of Mental Health and Associated Disorders
Blauvelt A, Armstrong A, Merola J, Strober B, De Cuyper D, Peterson L, Davies O, Stark J, Lebwohl M. Bimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Analysis of Mental Health and Associated Disorders. SKIN The Journal Of Cutaneous Medicine 2023, 7: s300. DOI: 10.25251/skin.7.supp.300.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPHQ-9 scoresPHQ-9Severe plaque psoriasisLonger-term depressionPlaque psoriasisModerate-severe depressionRisk of depressionSuicidal ideationPatient Health Questionnaire (PHQ)-9Moderate to severe plaque psoriasisPHQ-9 dataElevated PHQ-9 scoresGeneral psoriasis populationAnalysis of mental healthDepressionMental healthHigher scoresSuicideLong-term incidence rateAdverse eventsPsoriasis populationScore 0Adjudication committeeWk16Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Evaluation of Creatine Phosphokinase Elevations in the Phase 3 POETYK PSO-1 and PSO-2 Trials
Lebwohl M, Strober B, Scharnitz T, Linaberry M, Hoyt K, Banerjee S, Kisa R, Martin G. Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Evaluation of Creatine Phosphokinase Elevations in the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s244. DOI: 10.25251/skin.7.supp.244.Peer-Reviewed Original ResearchExposure-adjusted incidence ratesSevere plaque psoriasisAdverse eventsPlaque psoriasisCPK levelsWeek 52CTCAE gradeElevated CPKCPK elevationWeek 16Apremilast-treated patientsPooled safety analysisPotential inciting eventsCreatine phosphokinase elevationProportion of patientsTreatment of adultsCreatine phosphokinase levelsKinase 2 inhibitorTyrosine kinase 2 inhibitorLow gradeOral placeboSystemic therapyInciting eventWeeks 0Incidence rateAbrocitinib efficacy and safety in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study
Reich K, Silverberg J, Papp K, Deleuran M, Katoh N, Strober B, Beck L, de Bruin‐Weller M, Werfel T, Zhang F, Biswas P, DiBonaventura M, Chan G, Johnson S, Farooqui S, Kerkmann U, Clibborn C. Abrocitinib efficacy and safety in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 2056-2066. PMID: 37335885, DOI: 10.1111/jdv.19280.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsSevere atopic dermatitisSerious treatment-emergent adverse eventsPhase 3 studyAtopic dermatitisSafety profileAbrocitinib 200Frequent treatment-emergent adverse eventsLong-term extension studyUpper respiratory tract infectionLong-term safety profileChronic atopic dermatitisManageable safety profileProportion of patientsRespiratory tract infectionsFull treatment periodLong-term efficacyLong-term safetyPruritus improvementSkin clearanceEfficacy endpointSafety endpointAdverse eventsTract infectionsAD trialsPS14 Bimekizumab response up to 3 years in patients with moderate-to-severe plaque psoriasis who responded at week 16: post hoc results from the BE BRIGHT open-label extension trial
Warren R, Strober B, Lebwohl M, Foley P, Langley R, Davis L, Hoepken B, Szilagyi B, Ciaravino V, Bewley A. PS14 Bimekizumab response up to 3 years in patients with moderate-to-severe plaque psoriasis who responded at week 16: post hoc results from the BE BRIGHT open-label extension trial. British Journal Of Dermatology 2023, 188: ljad113.366. DOI: 10.1093/bjd/ljad113.366.Peer-Reviewed Original ResearchOpen-label extensionBody surface areaSevere plaque psoriasisWeek 16Plaque psoriasisOpen-label extension trialTreatment-related adverse eventsDermatology Life Quality IndexPASI 90 responseMaintenance of efficacyHealth-related qualityYear 3Long-term efficacyLife Quality IndexLack of efficacyYear 1HRQoL benefitsNonresponder imputationOLE entryPsoriasis AreaResponder rateAdverse eventsWeek 24Study treatmentAnalysed patientsBimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial
Strober B, Paul C, Blauvelt A, Thaçi D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez N, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. Journal Of The American Academy Of Dermatology 2023, 89: 486-495. PMID: 37182701, DOI: 10.1016/j.jaad.2023.04.063.Peer-Reviewed Original ResearchConceptsOpen-label extensionPASI 100 responseSevere plaque psoriasisWeek 96Plaque psoriasisWeek 48Common adverse eventsComplete skin clearanceDouble-blinded periodPhase 3b trialUrinary tract infectionTreatment of psoriasisMonoclonal IgG1 antibodySecukinumab patientsSkin clearanceAdverse eventsTract infectionsMore patientsSafety profilePhase 3bBimekizumabOral candidiasisSafety dataPatientsIgG1 antibodiesE088 Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 Phase 2 and 3 clinical studies in psoriasis and psoriatic arthritis
Strober B, Coates L, Yu J, Rowland K, Leibowitz E, Miller M, Kollmeier A, Li S, Wang Y, Chan D, Chakravarty S, Yang Y, Shawi M, Lebwohl M, Rahman P. E088 Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 Phase 2 and 3 clinical studies in psoriasis and psoriatic arthritis. Rheumatology 2023, 62 DOI: 10.1093/rheumatology/kead104.337.Peer-Reviewed Original ResearchGuselkumab-treated patientsJanssen Scientific AffairsGrant/research supportPlacebo-controlled periodPlacebo-treated patientsAdverse eventsBristol-Myers SquibbBoehringer IngelheimOpportunistic infectionsIncidence rateMeiji Seika PharmaSafety dataLEO PharmaEli LillyUCB PharmaMajor adverse cardiovascular eventsSafety eventsScientific AffairsAdverse cardiovascular eventsOverall adverse eventsSerious adverse eventsSevere plaque psoriasisPhase 2/3 studyActive psoriatic arthritisPharmaceutical companiesDeucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials
Lebwohl M, Strober B, Linaberry M, Hoyt K, Banerjee S, Kisa R, Mehta N. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s115. DOI: 10.25251/skin.7.supp.115.Peer-Reviewed Original ResearchSevere plaque psoriasisHDL cholesterolTotal cholesterolWeek 16Plaque psoriasisLDL cholesterolTriglyceride levelsLipid parametersWeeks 0Tyrosine kinase 2Treatment groupsDouble-blind trialBaseline triglyceride levelsLDL cholesterol levelsMean triglyceride levelsTreatment of adultsOral placeboMean triglyceridesAdverse eventsSerum lipidsSystemic therapyDL increasePsoriasis pathogenesisCholesterol levelsMean changeOral orismilast: Efficacy and safety in moderate‐to‐severe psoriasis and development of modified release tablets
Warren R, Strober B, Silverberg J, Guttman E, Andres P, Felding J, Tutkunkardas D, Kjøller K, Sommer M, French L. Oral orismilast: Efficacy and safety in moderate‐to‐severe psoriasis and development of modified release tablets. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 711-720. PMID: 36478476, DOI: 10.1111/jdv.18812.Peer-Reviewed Original ResearchConceptsPhase 1 trialPhase 2a trialSevere psoriasisAdverse eventsIR formulationPK propertiesWeek 16Psoriasis Area Severity Index (PASI) scorePlacebo-controlled trialSeverity Index scoreHigh-fat mealLow-fat mealPhosphodiesterase 4 inhibitorSimilar PK propertiesImmediate-release formulationGI disordersMR groupPlaceboFood effectPhase 2aIndex scorePsoriasisPharmacokinetic propertiesHealthy participantsMR formulation
2022
Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials
Kokolakis G, Warren R, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Körber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. British Journal Of Dermatology 2022, 188: 330-340. PMID: 36751950, DOI: 10.1093/bjd/ljac089.Peer-Reviewed Original ResearchConceptsExposure-adjusted incidence ratesTreatment-emergent adverse eventsAdverse eventsDurable improvementMajority of TEAEsDiscontinuation of biologicsNew safety findingsPASI 90 respondersSevere plaque psoriasisHealth-related qualityBody surface areaTime of switchAbsolute PASIIIIb trialPASI 100PASI 90Skin clearancePlaque psoriasisWeek 48Clinical responseEfficacy outcomesPsoriasis AreaSafety findingsWeek 24Week 52Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial
Strober B, Thaçi D, Sofen H, Kircik L, Gordon K, Foley P, Rich P, Paul C, Bagel J, Colston E, Throup J, Kundu S, Sekaran C, Linaberry M, Banerjee S, Papp K. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial. Journal Of The American Academy Of Dermatology 2022, 88: 40-51. PMID: 36115523, DOI: 10.1016/j.jaad.2022.08.061.Peer-Reviewed Original ResearchConceptsGlobal assessment scoreSevere plaque psoriasisStatic Physician's Global Assessment scorePhysician Global Assessment scorePlaque psoriasisAdverse eventsPsoriasis AreaWeek 16Assessment scoresFrequent adverse eventsPhase 3 trialSerious adverse eventsSeverity IndexPhase 3 programSecond trialApremilast patientsWeek 52Laboratory parametersPsoriasis pathogenesisSafety resultsPlaceboDeucravacitinibStudy durationPsoriasisPatientsOne-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial
Strober B, Stein Gold L, Bissonnette R, Armstrong A, Kircik L, Tyring S, Piscitelli S, Brown P, Rubenstein D, Tallman A, Lebwohl M. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial. Journal Of The American Academy Of Dermatology 2022, 87: 800-806. PMID: 35772599, DOI: 10.1016/j.jaad.2022.06.1171.Peer-Reviewed Original ResearchConceptsOpen-label treatmentRemittive effectsPlaque psoriasisUpper respiratory tract infectionPhysician Global Assessment scoreComplete disease clearanceOne-year safetyFrequent adverse eventsSevere plaque psoriasisNew safety signalsPhase 3 trialRespiratory tract infectionsDurability of responseForms of psoriasisGlobal assessment scoreLong-term safetyEligible patientsTapinarof creamDisease clearanceAdverse eventsTract infectionsMean durationSafety signalsContact dermatitisCream 1
2021
Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis
Lebwohl M, Stein Gold L, Strober B, Papp K, Armstrong A, Bagel J, Kircik L, Ehst B, Hong H, Soung J, Fromowitz J, Guenthner S, Piscitelli S, Rubenstein D, Brown P, Tallman A, Bissonnette R. Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. New England Journal Of Medicine 2021, 385: 2219-2229. PMID: 34879448, DOI: 10.1056/nejmoa2103629.Peer-Reviewed Original ResearchConceptsPrimary end pointPatient-reported outcomesTapinarof creamGlobal assessment scoreBody surface areaPlaque psoriasisWeek 12End pointPGA responseAdverse eventsPGA scoreMean changeSkin barrier protein filaggrinSecondary efficacy end pointsUpper respiratory tract infectionPhysician Global Assessment scoreNumeric rating scale scoreTotal body surface areaTotal scoreEfficacy end pointIdentical phase 3Local adverse eventsSymptom diary scoresProportion of patientsSecondary end points