2024
Deucravacitinib onset of action and maintenance of response in phase 3 plaque psoriasis trials
Korman N, Warren R, Bagel J, Armstrong A, Gooderham M, Strober B, Thaçi D, Morita A, Imafuku S, Foley P, Sofen H, Zheng M, Hippeli L, Kisa R, Banerjee S, Blauvelt A. Deucravacitinib onset of action and maintenance of response in phase 3 plaque psoriasis trials. Journal Of Dermatological Treatment 2024, 35: 2371045. PMID: 38945549, DOI: 10.1080/09546634.2024.2371045.Peer-Reviewed Original ResearchConceptsMaintenance of responseModerate to severe plaque psoriasisOnset of actionSevere plaque psoriasisPlaque psoriasisApremilast-treated patientsEfficacy measuresOral placeboClinical responseCoprimary endpointsDeucravacitinibPsoriasis trialsWeek 8PlaceboPASIPatientsWeek 1WeeksEfficacyPsoriasisSPGABaselineSignificant improvementTrialsApremilast
2023
Impact of psoriasis disease severity and special area involvement on patient-reported outcomes in the real world: an analysis from the CorEvitas psoriasis registry
Strober B, Duffin K, Lebwohl M, Sima A, Janak J, Patel M, Photowala H, Garg V, Bagel J. Impact of psoriasis disease severity and special area involvement on patient-reported outcomes in the real world: an analysis from the CorEvitas psoriasis registry. Journal Of Dermatological Treatment 2023, 35: 2287401. PMID: 38073528, DOI: 10.1080/09546634.2023.2287401.Peer-Reviewed Original ResearchConceptsDermatology Life Quality IndexPatient-reported outcomesArea involvementActivity impairmentDisease severityPsoriasis RegistryPatients' HRQOLPsoriasis symptomsSymptom severityImproved disease severityPsoriasis disease severityBaseline disease severityImpact of psoriasisHealth-related qualityWork abilityPatients' physical functioningLife Quality IndexImpaired work abilitySevere psoriasisSystemic treatmentWorse outcomesPhysical functioningHRQoLAdequate treatmentGreater HRQOLLong-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Strober B, Coates L, Lebwohl M, Deodhar A, Leibowitz E, Rowland K, Kollmeier A, Miller M, Wang Y, Li S, Chakravarty S, Chan D, Shawi M, Yang Y, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Safety 2023, 47: 39-57. PMID: 37906417, PMCID: PMC10764399, DOI: 10.1007/s40264-023-01361-w.Peer-Reviewed Original ResearchConceptsGuselkumab-treated patientsPlacebo-controlled periodBody mass indexPrior biologic usePsoriatic diseaseAE ratesSerious AEsBiologic usePsoriatic arthritisOpportunistic infectionsSerious infectionsPsoriasis studiesWeeks 0Clinical studiesWeek 4Phase II/III studyPhase II/III clinical studiesMajor adverse cardiovascular eventsLong-term safety profileBenefit/risk profileFavorable AE profilePlacebo-treated patientsAdverse cardiovascular eventsActive psoriatic arthritisSubgroup of patientsThe Epidemiology of Palmoplantar Pustulosis: An Analysis of Multiple Health Insurance Claims and Electronic Health Records Databases
Ramcharran D, Strober B, Gordon K, DeKlotz C, Fakharzadeh S, Yang Y, Swerdel J, Hardin J, Dronavalli S, Paller A. The Epidemiology of Palmoplantar Pustulosis: An Analysis of Multiple Health Insurance Claims and Electronic Health Records Databases. Advances In Therapy 2023, 40: 5090-5101. PMID: 37737889, PMCID: PMC10567878, DOI: 10.1007/s12325-023-02669-w.Peer-Reviewed Original ResearchConceptsElectronic health record databaseHealth record databasePPP patientsRecord databaseHigher baseline useChronic inflammatory conditionsPost-diagnosis treatmentHealth insurance claimsConclusionsThe burdenPotential miscodingPalmoplantar pustulosisSterile pustulesBaseline characteristicsMetabolic syndromeBaseline useInflammatory conditionsIncidence ratePopulation-based approachPrevalence estimatesPPP prevalenceEpidemiologyAdditional studiesPustulosisDisease treatmentPatientsEfficacy 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 morbiditySpesolimabImmunogenicity and pharmacokinetics of guselkumab among patients with moderate‐to‐severe psoriasis in VOYAGE‐1 and VOYAGE‐2
Armstrong A, Eyerich K, Conrad C, Zhu Y, Yang Y, Miller M, You Y, Shen Y, Foley P, Griffiths C, Strober B. Immunogenicity and pharmacokinetics of guselkumab among patients with moderate‐to‐severe psoriasis in VOYAGE‐1 and VOYAGE‐2. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: e1375-e1379. PMID: 37415560, DOI: 10.1111/jdv.19309.Peer-Reviewed Original ResearchAbrocitinib 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 trialsBimekizumab 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 antibodiesTreatment of plaque psoriasis with deucravacitinib (POETYK PSO-1 study): a plain language summary
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. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-1 study): a plain language summary. Immunotherapy 2023, 15: 963-973. PMID: 37150952, DOI: 10.2217/imt-2023-0061.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisSide effectsNew treatmentsBasic everyday tasksStudy treatment phaseCommon side effectsMonths of treatmentSymptoms of psoriasisPsoriasis plaquesDaily pillPsoriasis treatmentAcceptable safetyClinical trialsPsoriasisTreatment phasePlaceboDeucravacitinibNasal passagesLarger studyApremilastSkin appearanceEmotional distressTreatmentPillsTreatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary
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. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary. Immunotherapy 2023, 15: 787-797. PMID: 37150956, DOI: 10.2217/imt-2023-0062.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisSide effectsNew treatmentsBasic everyday tasksCommon side effectsMonths of treatmentUndesirable side effectsPatch of skinDaily pillPsoriasis treatmentClinical trialsPlaceboPsoriasisDeucravacitinibLarger studyTreatmentApremilastGreater improvementMore participantsSimilar ratesPillsMedical journalsParticipantsSimilar numberBimekizumab maintenance of response through 3 years in patients with moderate-to-severe plaque psoriasis: results from the BE BRIGHT open-label extension trial
Strober B, Tada Y, Mrowietz U, Lebwohl M, Foley P, Langley R, Warren R, Wang M, Vanvoorden V, Szilagyi B, Ciaravino V, Paul C. Bimekizumab maintenance of response through 3 years in patients with moderate-to-severe plaque psoriasis: results from the BE BRIGHT open-label extension trial. British Journal Of Dermatology 2023, 188: 749-759. PMID: 36967713, DOI: 10.1093/bjd/ljad035.Peer-Reviewed Original ResearchConceptsOngoing open-label extensionSevere plaque psoriasisBody surface areaDermatology Life Quality IndexWeek 16Plaque psoriasisNonresponder imputationPASI 100Investigator's Global Assessment 0/1Open-label extension trialDLQI 0/1 responsePASI 90 respondersOpen-label extensionHealth-related qualityLong-term efficacyLife Quality IndexLong-term treatmentLoss of responseYear 3Absolute PASIPASI 90Efficacy outcomesClinical responsePsoriasis AreaExtension trialSafety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial
Thaçi D, Vender R, de Rie M, Conrad C, Pariser D, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball A. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. British Journal Of Dermatology 2023, 188: 22-31. PMID: 36689515, DOI: 10.1093/bjd/ljac021.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsOpen-label extensionSevere plaque psoriasisWeek 104Week 24PASI 100PASI 90Plaque psoriasisWeek 16Safety dataCommon treatment-emergent adverse eventsSerious treatment-emergent adverse eventsUpper respiratory tract infectionInitial randomization groupUnexpected safety findingsNew safety signalsRespiratory tract infectionsWeeks of treatmentLong-term resultsBaseline PASIBimekizumab groupBRIGHT trialMaintenance dosingPsoriasis AreaSafety findingsOral 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 formulationPharmacology of orismilast, a potent and selective PDE4 inhibitor
Silverberg J, French L, Warren R, Strober B, Kjøller K, Sommer M, Andres P, Felding J, Weiss A, Tutkunkardas D, Skak‐Nielsen T, Guttman E. Pharmacology of orismilast, a potent and selective PDE4 inhibitor. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 721-729. PMID: 36527389, DOI: 10.1111/jdv.18818.Peer-Reviewed Original ResearchConceptsChronic inflammatory skin diseasePeripheral blood mononuclear cellsEar thicknessPhosphodiesterase 4Clinical developmentBroad-spectrum anti-inflammatory activityPDE4 inhibitorsEx vivoHuman peripheral blood mononuclear cellsTumor necrosis factor αSecond-generation PDE4 inhibitorsEar skin inflammationWhole bloodMarkers of inflammationAnti-inflammatory effectsInflammatory skin diseasePro-inflammatory cytokinesBlood mononuclear cellsNovel treatment optionsNecrosis factor αPre-clinical modelsAnti-inflammatory activitySelective PDE4 inhibitorLong-term managementPBMC production
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 durationPsoriasisPatientsImpact of secukinumab on patient-reported 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. Impact of secukinumab on patient-reported outcomes in biologic-naive patients with psoriasis in a US real-world setting. Journal Of Dermatological Treatment 2022, 33: 3178-3187. PMID: 36026543, DOI: 10.1080/09546634.2022.2116266.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesBiologic-naive patientsDermatology Life Quality IndexUS real-world settingEuroQol visual analogue scaleImpact of secukinumabVisual analog scaleLife Quality IndexPatient's treatment journeyReal-world studyPsoriasis RegistrySecukinumab treatmentBaseline characteristicsClinical characteristicsAnalog scaleSkin painActivity impairmentMean improvementSecukinumabTreatment journeyPatientsPsoriasisReal-world settingFollowPotential biologicSuper‐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 response