2024
Spesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial
Gottlieb A, Strober B, Merola J, Mostaghimi A, Farberg A, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s490. DOI: 10.25251/skin.8.supp.490.Peer-Reviewed Original ResearchGeneralized pustular psoriasisPhysician global assessmentSkin symptomsPustular psoriasisGlobal assessmentProportion of patientsPercentage of patientsTreating generalized pustular psoriasisLife-threatening skin diseaseSignificant patient burdenYears of ageDosing regimenPediatric patientsClear skinSpesolimabPatientsContinuous treatmentMonoclonal antibodiesSkin diseasesPatient burdenSymptomsPsoriasisTotal scoreSkinTreatmentP101 Sustained improvement in atopic dermatitis disease control and treatment satisfaction with dupilumab in clinical practice: 4-year follow-up results from the RELIEVE-AD study
Wang Z, Yang M, Chao J, Martins B, Chuang C, Shumel B, Sierka D, Carboni M, Strober B. P101 Sustained improvement in atopic dermatitis disease control and treatment satisfaction with dupilumab in clinical practice: 4-year follow-up results from the RELIEVE-AD study. British Journal Of Dermatology 2024, 191: i63-i64. DOI: 10.1093/bjd/ljae090.128.Peer-Reviewed Original ResearchAtopic dermatitisEpisodes of itchingTreatment satisfactionMonth 1Disease controlClinical practiceProportion of patientsPatient survey studyPercentage of patientsSustained improvementFollow-up resultsPrescribed dupilumabGeneralized estimating equationsQuality of lifePatient support programmeSingle-armDupilumabSkin symptomsBaseline surveyPatientsSupport programmesPatient satisfactionPractice guidelinesStatistical significanceMonthsBimekizumab 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 lifeEffect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis
Strober B, Augustin M, Tada Y, Garg A, Jullien D, Gottlieb A, Gudjonsson J, Hu N, Hofmann P, Thoma C, Marzano A. Effect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s371. DOI: 10.25251/skin.8.supp.371.Peer-Reviewed Original ResearchGeneralized pustular psoriasisProportion of patientsGeneralized pustular psoriasis flaresWeek 4Pustular psoriasisGeneralized Pustular Psoriasis Physician Global AssessmentPhysician global assessmentTotal scoreLife-threatening skin diseaseRandomized controlled trialsPlacebo groupMaintenance doseLoading doseSterile pustulesSkin manifestationsSpesolimabApproved treatmentPlaceboTreatment periodGlobal assessmentPatientsMonoclonal antibodiesTreatment groupsSkin diseasesBaseline scoresBimekizumab 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 VIVIDEfficacy of long‐term risankizumab treatment for moderate‐to‐severe plaque psoriasis: Subgroup analyses by baseline characteristics and psoriatic disease manifestations through 256 weeks (LIMMitless trial)
Strober B, Bachelez H, Crowley J, Elewski B, Gooderham M, Menter A, Strohal R, Chen M, Wu T, Zhan T, Photowala H, Armstrong A. Efficacy of long‐term risankizumab treatment for moderate‐to‐severe plaque psoriasis: Subgroup analyses by baseline characteristics and psoriatic disease manifestations through 256 weeks (LIMMitless trial). Journal Of The European Academy Of Dermatology And Venereology 2024, 38: 864-872. PMID: 38179809, DOI: 10.1111/jdv.19748.Peer-Reviewed Original ResearchSevere plaque psoriasisLong-term efficacyPlaque psoriasisDisease manifestationsWeek 256Palmoplantar psoriasisSubgroup analysisDurable long-term efficacyOpen-label extension studyBaseline patient characteristicsProportion of patientsBody mass indexInflammatory skin diseaseMultiple clinical manifestationsPASI 90/100Psoriatic manifestationsRisankizumab treatmentBaseline characteristicsPatient characteristicsPsoriasis AreaSkin psoriasisMass indexClinical manifestationsArthritis statusPatient subgroups
2023
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
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 effect on patient‐reported outcomes 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, Farooqui S, Kerkmann U, Clibborn C. Abrocitinib effect on patient‐reported outcomes 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: 2047-2055. PMID: 37319109, DOI: 10.1111/jdv.19254.Peer-Reviewed Original ResearchConceptsSevere atopic dermatitisPatient-reported outcomesAbrocitinib 200Phase 3 studyAtopic dermatitisWeek 48POEM scoresDermatology Life Quality Index scoresLong-term extension studyLife Quality Index scoresEczema Measure scoreManageable safety profilePatient-reported endpointsMean DLQI scorePatient-reported symptomsProportion of patientsPatient-reported responsesFull treatment periodPhase 3Quality Index scoresDLQI 0/1DLQI scoreWeek 12AD trialsSafety profileAbrocitinib 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 trialsP169 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
Utilization Trends and Impact of Secukinumab Treatment on Clinical Outcomes in Biologic-Naive Patients with Psoriasis in a US Real-World Setting
Strober B, Patil D, McLean R, Moore-Clingenpeel M, Guo N, Levi E, Lebwohl M. Utilization Trends and Impact of Secukinumab Treatment on Clinical Outcomes in Biologic-Naive Patients with Psoriasis in a US Real-World Setting. Dermatology And Therapy 2022, 12: 1351-1365. PMID: 35551619, PMCID: PMC9100304, DOI: 10.1007/s13555-022-00740-y.Peer-Reviewed Original ResearchBiologic-naive patientsInvestigator's Global AssessmentBody surface areaClinical outcomesUS real-world settingGlobal assessmentBiologic-experienced patientsEffectiveness of secukinumabMethodsThis observational studyPrior biologic useFirst-line therapyProportion of patientsSeverity Index scoreTreatment of psoriasisSimilar improvementsBiologic experiencePsoriasis RegistryResultsBetween 2015Secukinumab treatmentIGA scoreBiologic useClinical characteristicsPatient characteristicsPsoriasis AreaPatient cohort
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 pointsFive‐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 antibodiesPGAxBSA composite versus PASI: Comparison across disease severities and as therapeutic response measure for Cal/BD foam in plaque psoriasis
Gold L, Hansen J, Patel D, Veverka K, Strober B. PGAxBSA composite versus PASI: Comparison across disease severities and as therapeutic response measure for Cal/BD foam in plaque psoriasis. Journal Of The American Academy Of Dermatology 2020, 83: 131-138. PMID: 32430142, DOI: 10.1016/j.jaad.2020.02.077.Peer-Reviewed Original ResearchConceptsCal/BD foamSevere psoriasisWeek 4Disease severityPhysician global assessmentProportion of patientsBody surface areaSpearman correlationTherapeutic response measuresCalcipotriol/Dipropionate foamMild psoriasisPlaque psoriasisPsoriasis AreaBland-Altman plotsPsoriasis severityTherapeutic responseMean improvementWeek 1PsoriasisGlobal assessmentSeverity IndexInterrater reliabilitySeverityPASIEfficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study
Van Voorhees A, Stein Gold L, Lebwohl M, Strober B, Lynde C, Tyring S, Cauthen A, Sofen H, Zhang Z, Paris M, Wang Y. Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study. Journal Of The American Academy Of Dermatology 2020, 83: 96-103. PMID: 32032692, DOI: 10.1016/j.jaad.2020.01.072.Peer-Reviewed Original ResearchConceptsSevere scalp psoriasisNumeric rating scaleItch Numeric Rating ScaleDermatology Life Quality IndexSafety of apremilastScalp psoriasisPhase 3bWeek 16Inadequate response/intolerancePhysician Global Assessment responseCommon adverse eventsPhysician global assessmentPlacebo-controlled studySevere plaque psoriasisDouble-blind studyProportion of patientsLife Quality IndexPruritic areaPlaque psoriasisPrimary endpointSecondary endpointsAdverse eventsMore patientsMild diseasePsoriasis therapy
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
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
2012
Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo‐controlled dose‐ranging study
Papp K, Menter A, Strober B, Langley R, Buonanno M, Wolk R, Gupta P, Krishnaswami S, Tan H, Harness J. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo‐controlled dose‐ranging study. British Journal Of Dermatology 2012, 167: 668-677. PMID: 22924949, DOI: 10.1111/j.1365-2133.2012.11168.x.Peer-Reviewed Original ResearchConceptsOral Janus kinase inhibitorSafety of tofacitinibDose-ranging studyJanus kinase inhibitorPlaque psoriasisAdverse eventsWeek 12Mean serum high density lipoproteinPlacebo-controlled dose-ranging studyResponse ratePASI 75 response ratesSevere chronic plaque psoriasisKinase inhibitorsPASI 75 responseTwice daily groupChronic plaque psoriasisSerum high-density lipoproteinSevere plaque psoriasisProportion of patientsSignificant clinical improvementSeverity Index scoreTreatment of psoriasisDose-dependent increaseShort-term treatmentHigh-density lipoproteinA randomized, double‐blind, placebo‐controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis
Gottlieb A, Langley R, Strober B, Papp K, Klekotka P, Creamer K, Thompson E, Hooper M, Kricorian G. A randomized, double‐blind, placebo‐controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis. British Journal Of Dermatology 2012, 167: 649-657. PMID: 22533447, PMCID: PMC3504074, DOI: 10.1111/j.1365-2133.2012.11015.x.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisCombination therapyAdverse eventsWeek 24Etanercept monotherapyMonotherapy groupPlaque psoriasisWeek 12Necrosis factor inhibitor therapyStatic Physician's Global AssessmentGlobal assessmentMethotrexate combination therapyPhysician global assessmentPlacebo-controlled studySerious adverse eventsCombination therapy groupProportion of patientsAddition of methotrexatePASI 50PASI 75PASI 90Primary endpointSevere psoriasisAcceptable tolerabilityPsoriasis Area