2023
Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s240. DOI: 10.25251/skin.7.supp.240.Peer-Reviewed Original ResearchSevere plaque psoriasisPlaque psoriasisParent trialDay 1Exposure-adjusted incidence ratesLong-term extension trialsMajor adverse cardiovascular eventsAdverse cardiovascular eventsConsistent safety profileTreatment of adultsNonresponder imputationOral placeboSerious AEsWeek 148Cardiovascular eventsEfficacy outcomesVenous thromboembolismWeek 52Herpes zosterSystemic therapyDurable efficacySafety profileExtension trialIncidence rateEfficacy resultsDeucravacitinib 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 signalsDeucravacitinib, 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 rateP169 Treatment effects of ixekizumab and adalimumab at the individual digit level with nail and distal interphalangeal joint involvement in patients with psoriatic arthritis
McGonagle D, Kavanaugh A, McInnes I, Kristensen L, Merola J, Strober B, Lisse J, Pustizzi J, Sapin C, Bolce R, Ritchlin C. P169 Treatment effects of ixekizumab and adalimumab at the individual digit level with nail and distal interphalangeal joint involvement in patients with psoriatic arthritis. Rheumatology 2023, 62 DOI: 10.1093/rheumatology/kead104.210.Peer-Reviewed Original ResearchNail Psoriasis Severity IndexProportion of patientsPsoriatic arthritisWeek 24Nail diseaseNail involvementDIP involvementSanofi GenzymeWeek 52Total scoreEli LillyExact testNail bedUCB PharmaDistal interphalangeal (DIP) joint diseaseDistal interphalangeal joint involvementDifferent biological therapiesInterphalangeal joint involvementNail matrix involvementPsoriatic nail diseasePost-baseline assessmentPsoriasis Severity IndexNHS Greater GlasgowFisher's exact testTotal maximum score
2022
Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*
Blauvelt A, Kimball A, Augustin M, Okubo Y, Witte M, Capriles C, Sontag A, Arora V, Osuntokun O, Strober B. Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*. British Journal Of Dermatology 2022, 187: 866-877. PMID: 35791755, PMCID: PMC10087045, DOI: 10.1111/bjd.21743.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisWeek 16Week 52PASI 100Secondary endpointsAdult patientsSafety profileLarge phase III trialsStatic Physician's Global AssessmentGlobal assessmentPhase II clinical trialInterleukin-23 inhibitorsKey secondary endpointNew safety signalsPhysician global assessmentSerious adverse eventsPatient-reported qualityPhase III trialsFavorable safety profilePathogenesis of psoriasisPASI 90PASI 75Coprimary endpointsIII trialsBimekizumab 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 durationPsoriasisPatientsDeucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial
Armstrong A, Gooderham M, Warren R, Papp K, Strober B, Thaçi D, Morita A, Szepietowski J, Imafuku S, Colston E, Throup J, Kundu S, Schoenfeld S, Linaberry M, Banerjee S, Blauvelt A. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. Journal Of The American Academy Of Dermatology 2022, 88: 29-39. PMID: 35820547, DOI: 10.1016/j.jaad.2022.07.002.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisGlobal assessment scorePlaque psoriasisWeek 16Static Physician's Global Assessment scoreResponse ratePhysician Global Assessment scoreCoprimary end pointsAdverse event ratesOne-year durationPASI 75Psoriasis AreaWeek 52Psoriasis treatmentPlaceboSafety resultsDeucravacitinibApremilastEnd pointEvent ratesAssessment scoresPsoriasisSeverity IndexKinase 2 inhibitorTyrosine kinase 2 inhibitorAB0890 Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: 52-Week Efficacy Results From the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials
Warren R, Armstrong A, Gooderham M, Strober B, Thaçi D, Imafuku S, Sofen H, Spelman L, Korman N, Zheng M, Colston E, Throup J, Kundu S, Kisa R, Banerjee S, Blauvelt A. AB0890 Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: 52-Week Efficacy Results From the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials. Annals Of The Rheumatic Diseases 2022, 81: 1570-1571. DOI: 10.1136/annrheumdis-2022-eular.1377.Peer-Reviewed Original ResearchSevere plaque psoriasisGrant/research supportDermatology Life Quality IndexBristol-Myers SquibbPASI 75 responseSanofi GenzymeWeek 52PASI 75Plaque psoriasisGlobal assessment scoreWeek 16LEO PharmaPersonal feesKyowa Hakko KirinWeek 24Tyrosine kinase 2Boehringer IngelheimLecture feesPASI 90Psoriasis RegistrySymptom scoresSpeakers bureauEli LillyStatic Physician's Global Assessment scorePhysician Global Assessment score
2021
Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2*
Reich K, Gordon K, Strober B, Armstrong A, Miller M, Shen Y, You Y, Han C, Yang Y, Foley P, Griffiths C. Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2*. British Journal Of Dermatology 2021, 185: 1146-1159. PMID: 34105767, DOI: 10.1111/bjd.20568.Peer-Reviewed Original ResearchConceptsVOYAGE 2Health-related qualityPatient-reported outcomesWeek 252VOYAGE 1Clinical responseSevere psoriasisWeek 52Open-label guselkumabNew safety signalsProportion of patientsMental component scoreShort Form-36Long-term therapyGuselkumab 100Guselkumab groupHRQOL endpointsWeek 264Week 100Form-36Randomized withdrawalWeek 28Week 16Chronic diseasesLife endpoints
2020
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
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
2017
Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2017, 177: 1562-1574. PMID: 28755394, DOI: 10.1111/bjd.15857.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisBody surface areaABP 501Week 16Adverse eventsAntidrug antibodiesPlaque psoriasisBiosimilar ABP 501New safety signalsPercentage of patientsPhase III trialsSimilar clinical efficacySeverity Index scorePercentage body surface areaLong-term resultsEuropean Medicines AgencyPASI 50PASI improvementWeek 52III trialsPsoriasis AreaAdalimumab patientsImmunogenicity profileClinical efficacyPatient populationPsoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab
Elewski B, Puig L, Mordin M, Gilloteau I, Sherif B, Fox T, Gnanasakthy A, Papavassilis C, Strober B. Psoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab. Journal Of Dermatological Treatment 2017, 28: 492-499. PMID: 28266243, DOI: 10.1080/09546634.2017.1294727.Peer-Reviewed Original ResearchConceptsQuality of lifeSeverity Index (PASI) 90 responseDLQI 0/1 responsePASI 75Skin clearancePASI 90Psoriasis AreaDermatology Life Quality Index responseGreater health-related qualityPatients' QOLGreater skin clearancePhase 3 studyHealth-related qualityNew biological therapiesRelevant therapeutic goalSevere psoriasisWeek 52Psoriasis patientsBiological therapyWeek 12Therapeutic goalsTrial dataSustained levelsIgA resultsClearanceSecukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept
Strober B, Gottlieb A, Sherif B, Mollon P, Gilloteau I, McLeod L, Fox T, Mordin M, Gnanasakthy A, Papavassilis C, Lebwohl M. Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept. Journal Of The American Academy Of Dermatology 2017, 76: 655-661. PMID: 28087133, DOI: 10.1016/j.jaad.2016.11.043.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatologic AgentsDouble-Blind MethodEtanerceptFemaleHumansImmunosuppressive AgentsInjections, SubcutaneousInterleukin-17MaleMiddle AgedPatient SatisfactionPsoriasisQuality of LifeRecurrenceSurveys and QuestionnairesTreatment OutcomeTumor Necrosis Factor-alphaConceptsDermatology Life Quality IndexWeek 24Secukinumab treatmentWeek 52Phase III randomized placebo-controlled clinical trialsRandomized placebo-controlled clinical trialPatient-reported health-related qualityPlacebo-controlled clinical trialGreater sustained improvementsGreater clinical responseHealth-related qualityLife Quality IndexProportion of subjectsQuality of lifeSevere psoriasisClinical responsePlacebo comparisonPsoriasis AreaMedian timePatients' qualityWeek 12Chronic conditionsOutcome benefitsSafe treatmentClinical trials
2015
Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis
Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. New England Journal Of Medicine 2015, 373: 1318-1328. PMID: 26422722, DOI: 10.1056/nejmoa1503824.Peer-Reviewed Original ResearchConceptsPASI 100 response ratesGlobal assessment scoreWeek 12Response rateSevere psoriasisStatic Physician's Global Assessment scorePASI 75 response ratesPhysician Global Assessment scoreRates of neutropeniaSerious infectious episodesPhase 3 studySignificant clinical improvementSeverity Index scoreTreatment of psoriasisEarly clinical studiesAMAGINE-2Brodalumab treatmentSPGA scoreInfectious episodesWeek 52Clinical improvementMaintenance dosePASI scorePsoriasis AreaBrodalumab
2011
A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis
Gordon K, Langley R, Gottlieb A, Papp K, Krueger G, Strober B, Williams D, Gu Y, Valdes J. A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis. Journal Of Investigative Dermatology 2011, 132: 304-314. PMID: 22011907, DOI: 10.1038/jid.2011.304.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsSevere psoriasisWeek 52Adverse eventsWeek 12Placebo-controlled phase III studyMajor adverse cardiovascular eventsPrevious phase II trialGlobal assessmentPlacebo-controlled periodAdverse cardiovascular eventsPhysician global assessmentPhase II trialPhase III studyNonmelanoma skin cancerNonresponder imputationPASI 75Vs. 4.5Cardiovascular eventsII trialIII studyPsoriasis AreaControlled TrialsIL-12/23Maintenance treatment
2007
Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial
Menter A, Tyring S, Gordon K, Kimball A, Leonardi C, Langley R, Strober B, Kaul M, Gu Y, Okun M, Papp K. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. Journal Of The American Academy Of Dermatology 2007, 58: 106-115. PMID: 17936411, DOI: 10.1016/j.jaad.2007.09.010.Peer-Reviewed Original ResearchConceptsSevere psoriasisPlacebo-treated patientsSafety of adalimumabChronic plaque psoriasisPercentage of patientsPhase III trialsSeverity Index scorePathogenesis of psoriasisKey proinflammatory cytokinesTumor necrosis factorHuman monoclonal antibodyInterrupted therapyAdalimumab therapyPlaque psoriasisWeek 52III trialsPASI scorePsoriasis AreaActive comparatorClinical efficacyMulticenter studyProinflammatory cytokinesWeek 16Necrosis factorAdalimumab