2023
Deucravacitinib, 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 analysisPlaceboEfficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial
Morita A, Strober B, Burden A, Choon S, Anadkat M, Marrakchi S, Tsai T, Gordon K, Thaçi D, Zheng M, Hu N, Haeufel T, Thoma C, Lebwohl M. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. The Lancet 2023, 402: 1541-1551. PMID: 37738999, DOI: 10.1016/s0140-6736(23)01378-8.Peer-Reviewed Original ResearchConceptsPhysician Global Assessment scoreGPP flaresGlobal assessment scoreFlare preventionDose-response relationshipPrimary endpointAssessment scoresPhase 2b trialPustular psoriasis flarePlacebo-controlled trialReceptor monoclonal antibodyEligible study participantsQuality of lifeDose-response curveSubcutaneous placeboPlacebo groupWeek 48Pustular psoriasisPrimary outcomePsoriasis flareTreatment armsPatient groupHypersensitivity reactionsPatient morbiditySpesolimab
2022
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
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 durationPsoriasisPatientsSuper‐response to guselkumab treatment in patients with moderate‐to‐severe psoriasis: age, body weight, baseline Psoriasis Area and Severity Index, and baseline Investigator's Global Assessment scores predict complete skin clearance
Reich K, Gordon K, Strober B, Langley R, Miller M, Yang Y, Shen Y, You Y, Zhu Y, Foley P, Blauvelt A. Super‐response to guselkumab treatment in patients with moderate‐to‐severe psoriasis: age, body weight, baseline Psoriasis Area and Severity Index, and baseline Investigator's Global Assessment scores predict complete skin clearance. Journal Of The European Academy Of Dermatology And Venereology 2022, 36: 2393-2400. PMID: 35920762, DOI: 10.1111/jdv.18474.Peer-Reviewed Original ResearchConceptsGlobal assessment scoreInvestigator's Global Assessment scoreSevere psoriasisGuselkumab treatmentChronic immune-mediated inflammatory skin diseaseBody weightImmune-mediated inflammatory skin diseaseAssessment scoresStepwise logistic regression analysisBaseline Psoriasis AreaComplete skin clearanceEarly clinical responseLess obese patientsVOYAGE 2 studiesBaseline body weightSubset of patientsInflammatory skin diseaseLogistic regression analysisHuman monoclonal antibodyPASI 100PASI 75Skin clearanceBaseline characteristicsBaseline demographicsClinical responseDeucravacitinib 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 inhibitorOne-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 1AB0890 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
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
2019
US real-world effectiveness of secukinumab for the treatment of psoriasis: 6-month analysis from the Corrona Psoriasis Registry
Strober B, Germino R, Guana A, Greenberg J, Litman H, Guo N, Lebwohl M. US real-world effectiveness of secukinumab for the treatment of psoriasis: 6-month analysis from the Corrona Psoriasis Registry. Journal Of Dermatological Treatment 2019, 31: 333-341. PMID: 31035822, DOI: 10.1080/09546634.2019.1603361.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesCorrona Psoriasis RegistryGlobal assessment scoreBody surface areaReal-world effectivenessPsoriasis RegistryReal-world studySecukinumab treatmentDisease severityInvestigator's Global Assessment scoreMajority of patientsTreatment of psoriasisQuality of lifeEligible patientsSecukinumabPatientsSignificant improvementFollowAssessment scoresRegistryVisitsWork productivityPsoriasisDaily activitiesTreatment
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
2017
Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study.
Strober B, Bagel J, Lebwohl M, Stein Gold L, Jackson J, Chen R, Goncalves J, Levi E, Callis Duffin K. Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study. Journal Of Drugs In Dermatology 2017, 16: 801-808. PMID: 28809995.Peer-Reviewed Original ResearchConceptsModerate plaque psoriasisSafety of apremilastPlaque psoriasisGlobal assessment scoreStatic Physician's Global Assessment scoreDermatology Life Quality Index scoresUpper respiratory tract infectionPhysician Global Assessment scoreLife Quality Index scoresPercentage changePrior topical therapyMost adverse eventsPrimary efficacy endpointSevere plaque psoriasisTreatment Satisfaction QuestionnaireRespiratory tract infectionsHigh patient satisfactionMean percentage changeQuality Index scoresQuality of lifeGreater percentage changeEfficacy endpointAdverse eventsTopical therapyTract infections
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
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
2014
Efficacy and safety of brodalumab in subpopulations of patients with difficult-to-treat moderate-to-severe plaque psoriasis
Papp K, Menter A, Strober B, Kricorian G, Thompson E, Milmont C, Nirula A, Klekotka P. Efficacy and safety of brodalumab in subpopulations of patients with difficult-to-treat moderate-to-severe plaque psoriasis. Journal Of The American Academy Of Dermatology 2014, 72: 436-439.e1. PMID: 25553889, DOI: 10.1016/j.jaad.2014.10.026.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisBiologic useHistory of PsAPlaque psoriasisDermatology Life Quality Index responseStatic Physician's Global Assessment scorePhysician Global Assessment scoreSafety of brodalumabPlacebo-controlled studySubgroup of patientsSeverity Index scoreSubpopulation of patientsGlobal assessment scoreSelf-reported historyPrior biologicsTreat populationPsoriasis AreaPsoriatic arthritisWeek 12Subset analysisNovel therapiesBrodalumabLife measuresPatientsPsoriasis