2024
Safety 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 2024, 161 PMID: 39602111, 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 periodDeucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Strober B, Imafuku S, Paul C, Gooderham M, Spelman L, Seo S, Passeron T, Hoyt K, Colombo M, Banerjee S, Augustin M, Stein Gold L, Alexis A, Thaci D, Lebwohl M, Issa N, Cameron M. Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s407. DOI: 10.25251/skin.8.supp.407.Peer-Reviewed Original ResearchLong-term extensionModerate to severe plaque psoriasisSevere plaque psoriasisPlaque psoriasisLong-term extension trialsResponse rateModified nonresponder imputationMaintenance of responseYears of continuous treatmentPhase 3 trialLong-term efficacyNonresponder imputationPrimary endpointPsoriasis AreaResponse assessmentClinical efficacyDeucravacitinibPASISafety signalsTreatment durabilityPatientsContinuous treatmentPsoriasisLong-term effectsParent trialBimekizumab Efficacy through Year 1 in Patients with Moderate to Severe Plaque Psoriasis Who Had Not Achieved a PASI 90 Response by Week 16: A Pooled Analysis from Four Phase 3/3B Trials
Han G, Gottlieb A, Armstrong A, Strober B, Soung J, Herr H, Davis L, Lebwohl M. Bimekizumab Efficacy through Year 1 in Patients with Moderate to Severe Plaque Psoriasis Who Had Not Achieved a PASI 90 Response by Week 16: A Pooled Analysis from Four Phase 3/3B Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s369. DOI: 10.25251/skin.8.supp.369.Peer-Reviewed Original ResearchOpen-label extensionSevere plaque psoriasisPASI responseBaseline PASIPlaque psoriasisSkin clearanceModerate to severe plaque psoriasisInhibits interleukin (IL)-17FLevels of skin clearanceDouble-blind periodPhase 3b trialPhase 3 trialProportion of patientsInterleukin (IL)-17FAssociated with improved quality of lifeMonoclonal IgG1 antibodyHigher PASIMaintenance dosePsoriasis AreaBimekizumabAssociated with improved qualityPooled analysisPASIPatientsQuality of lifeDeucravacitinib 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 safetyPlaceboApremilastPsoriasisBimekizumab Efficacy Through 3 Years in Patients with Moderate to Severe Plaque Psoriasis: Long-term Pooled Analysis from BE BRIGHT
Lebwohl M, Strober B, Foley P, Langley R, Tada Y, Hampton P, Davis L, Wiegratz S, Hoepken B, Lambert J, Kokolakis G. Bimekizumab Efficacy Through 3 Years in Patients with Moderate to Severe Plaque Psoriasis: Long-term Pooled Analysis from BE BRIGHT. SKIN The Journal Of Cutaneous Medicine 2024, 8: s307. DOI: 10.25251/skin.8.supp.307.Peer-Reviewed Original ResearchOpen-label extensionDermatology Life Quality IndexSevere plaque psoriasisPhase 3 trialPlaque psoriasisPooled analysisDermatology Life Quality Index 0/1Discontinued treatment due to lackModerate to severe plaque psoriasisOLE weekPooled analysis of patientsTreatment-related adverse eventsPhase 3 clinical trialsEfficacy of bimekizumabPlaque psoriasis patientsTreatment due to lackAnalysis of patientsLong-term treatment efficacyProportion of patientsNext scheduled visitNon-responder imputationLoss of responseQuality of life responsesLife Quality IndexBE VIVID
2023
Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials
Sofen H, Strober B, Imafuku S, Paul C, Gooderham M, Spelman L, Seo S, Passeron T, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Augustin M, Stein Gold L, Alexis A, Thaçi D, Blauvelt A, Lebwohl M. Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s241. DOI: 10.25251/skin.7.supp.241.Peer-Reviewed Original ResearchPASI 75 respondersSevere plaque psoriasisPASI 75PASI 90Week 148Plaque psoriasisWeek 52Week 16Week 24Parent trialClinical efficacyDay 1Response rateLong-term extension trialsNew safety signalsPhase 3 trialSubset of patientsMaintenance of responseLong-term efficacyLong-term effectivenessNonresponder imputationOral placeboPsoriasis AreaExtension trialSafety signals42828 Efficacy and safety of roflumilast cream 0.3% in patients with chronic plaque psoriasis: pooled PASI and PASI-HD results from the DERMIS-1 and DERMIS-2 Phase 3 Trials
Papp K, Lebwohl M, Hong H, Kircik L, Pariser D, Strober B, Krueger G, Krupa D, Burnett P, Berk D, Higham R. 42828 Efficacy and safety of roflumilast cream 0.3% in patients with chronic plaque psoriasis: pooled PASI and PASI-HD results from the DERMIS-1 and DERMIS-2 Phase 3 Trials. Journal Of The American Academy Of Dermatology 2023, 89: ab156. DOI: 10.1016/j.jaad.2023.07.625.Peer-Reviewed Original Research
2022
Bimekizumab in patients with moderate to severe plaque psoriasis by bodyweight: Pooled results from phase 3 trials
Pinter A, Strober B, Rosmarin D, Gisondi P, Vanvoorden V, Peterson L, Madden C, De Cuyper D, Warren R. Bimekizumab in patients with moderate to severe plaque psoriasis by bodyweight: Pooled results from phase 3 trials. SKIN The Journal Of Cutaneous Medicine 2022, 6: s73. DOI: 10.25251/skin.6.supp.73.Peer-Reviewed Original ResearchDeucravacitinib 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 1POS1040 SAFETY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 INHIBITOR: AS ASSESSED BY LABORATORY PARAMETERS – RESULTS FROM A PHASE 2 TRIAL IN PSORIATIC ARTHRITIS AND 2 PHASE 3 TRIALS IN PSORIASIS
Fleischmann R, Thaçi D, Gooderham M, Strober B, Korman N, Banerjee S, Lehman T, Nowak M, Sreih A, Morita A, Mease P. POS1040 SAFETY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 INHIBITOR: AS ASSESSED BY LABORATORY PARAMETERS – RESULTS FROM A PHASE 2 TRIAL IN PSORIATIC ARTHRITIS AND 2 PHASE 3 TRIALS IN PSORIASIS. Annals Of The Rheumatic Diseases 2022, 81: 835.2-836. DOI: 10.1136/annrheumdis-2022-eular.1862.Peer-Reviewed Original ResearchConcomitant conventional synthetic DMARDsPhase 2 trialGrant/research supportKyowa Hakko KirinBristol-Myers SquibbCommon Terminology CriteriaPhase 3 trialSanofi GenzymeWeeks of treatmentLaboratory parametersPsoriatic arthritisLEO PharmaBoehringer IngelheimSun Pharmaceutical IndustriesUCB PharmaSpeaker feesNippon KayakuPlacebo nPsA trialsPsoriasis RegistryTerminology CriteriaWk 1Eli LillyLarge phase 3 trialsMitsubishi Tanabe
2021
25843 Tapinarof cream 1% once daily for plaque psoriasis: Patient-reported outcomes from two pivotal phase 3 trials
Bissonnette R, Strober B, Lebwohl M, Bagel J, Del Rosso J, Merola J, Bhatia N, Yamauchi P, Brown P, Rubenstein D, Tallman A. 25843 Tapinarof cream 1% once daily for plaque psoriasis: Patient-reported outcomes from two pivotal phase 3 trials. Journal Of The American Academy Of Dermatology 2021, 85: ab71. DOI: 10.1016/j.jaad.2021.06.310.Peer-Reviewed Original Research25934 Bimekizumab efficacy for moderate to severe plaque psoriasis across patient subgroups: Pooled results from 3 multicenter, randomized, double-blinded phase 3 trials
Strober B, Warren R, Foley P, Gooderham M, Thaçi D, Cullen E, Cioffi C, Peterson L, Madden C, Armstrong A. 25934 Bimekizumab efficacy for moderate to severe plaque psoriasis across patient subgroups: Pooled results from 3 multicenter, randomized, double-blinded phase 3 trials. Journal Of The American Academy Of Dermatology 2021, 85: ab76. DOI: 10.1016/j.jaad.2021.06.329.Peer-Reviewed Original Research
2020
Tapinarof Cream 1% QD for the Treatment of Plaque Psoriasis: Efficacy and Safety in Two Pivotal Phase 3 Trials
Lebwohl M, Stein Gold L, Strober B, Armstrong A, Hong H, Kircik L, Soung J, Fromowitz J, Guenthner S, Piscitelli S, Rubenstein D, Brown P, Tallman A, Bissonnette R. Tapinarof Cream 1% QD for the Treatment of Plaque Psoriasis: Efficacy and Safety in Two Pivotal Phase 3 Trials. SKIN The Journal Of Cutaneous Medicine 2020, 4: s75. DOI: 10.25251/skin.4.supp.75.Peer-Reviewed Original ResearchEfficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies
Strober B, Menter A, Leonardi C, Gordon K, Lambert J, Puig L, Photowala H, Longcore M, Zhan T, Foley P. Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies. Journal Of The European Academy Of Dermatology And Venereology 2020, 34: 2830-2838. PMID: 32320088, PMCID: PMC7818271, DOI: 10.1111/jdv.16521.Peer-Reviewed Original ResearchConceptsPrior biologic exposureSevere plaque psoriasisBaseline patient demographicsEfficacy of risankizumabPhase 3 trialDisease characteristicsWeek 16Logistic regression analysisPlaque psoriasisPatient demographicsBiologic exposureSuperior efficacyPlacebo-controlled phase 3 trialHumanized IgG monoclonal antibodyPrior biologic therapyProportion of patientsBody mass indexRegression analysisBaseline characteristicsBaseline demographicsBiologic therapyPsoriasis AreaWeek 52Patient characteristicsIgG monoclonal antibodies
2018
Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials
Gordon K, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp K, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes J, Thompson E, Bachelez H. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet 2018, 392: 650-661. PMID: 30097359, DOI: 10.1016/s0140-6736(18)31713-6.Peer-Reviewed Original ResearchConceptsSevere chronic plaque psoriasisSafety of risankizumabChronic plaque psoriasisSevere plaque psoriasisCo-primary endpointsPlaque psoriasisGlobal assessment scoreWeek 16PASI 90SPGA 0Treatment groupsStatic Physician's Global Assessment scoreTreatment-emergent adverse event profilesActive comparator-controlled trialsDouble-blind treatment periodHumanised IgG1 monoclonal antibodyTreatment-emergent adverse eventsPhysician Global Assessment scorePsoriasis Area Severity IndexComparator-controlled trialsUnexpected safety findingsAdverse event profileNecrosis factor inhibitorsPhase 3 trialProportion of patients
2016
Anti-interleukin-17 treatment of psoriasis
Jinna S, Strober B. Anti-interleukin-17 treatment of psoriasis. Journal Of Dermatological Treatment 2016, 27: 311-315. PMID: 26943806, DOI: 10.3109/09546634.2015.1115816.Peer-Reviewed Original ResearchConceptsTreatment of psoriasisPlaque psoriasisTumor necrosis factor alphaIL-17 inhibitorsPhase 3 trialIL-17 receptor subunitNecrosis factor alphaEffective therapeutic targetIL-17Cytokine antagonistsInflammatory dermatosesIL-17RAFactor alphaSafety resultsTherapeutic targetPsoriasisFavorable responseUS populationReceptor subunitsMonoclonal antibodiesDependent pathwayTreatmentTrialsAntibodiesEfficacy