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 ResearchMeSH KeywordsAdultCross-Over StudiesDouble-Blind MethodFemaleHumansMaleMiddle AgedPsoriasisSeverity of Illness IndexThalidomideTreatment OutcomeConceptsMaintenance of responseModerate to severe plaque psoriasisOnset of actionSevere plaque psoriasisPlaque psoriasisApremilast-treated patientsEfficacy measuresOral placeboClinical responseCoprimary endpointsDeucravacitinibPsoriasis trialsWeek 8PlaceboPASIPatientsWeek 1WeeksEfficacyPsoriasisSPGABaselineSignificant improvementTrialsApremilast
2023
Efficacy 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 ResearchMeSH KeywordsAdalimumabAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansPsoriasisSeverity of Illness IndexTreatment OutcomeAbrocitinib 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 ResearchMeSH KeywordsDermatitis, AtopicDouble-Blind MethodHumansPatient Reported Outcome MeasuresQuality of LifeSeverity of Illness IndexTreatment OutcomeConceptsSevere 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 ResearchMeSH KeywordsClinical Trials, Phase III as TopicDermatitis, AtopicDouble-Blind MethodHumansImmunoglobulin APruritusSeverity of Illness IndexTreatment OutcomeConceptsTreatment-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 ResearchMeSH KeywordsAntibodies, MonoclonalCOVID-19Double-Blind MethodHumansPandemicsPsoriasisSeverity of Illness IndexTreatment OutcomeConceptsOpen-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 antibodiesBimekizumab 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 ResearchMeSH KeywordsAntibodies, MonoclonalDouble-Blind MethodHumansPsoriasisQuality of LifeSeverity of Illness IndexTreatment OutcomeConceptsOngoing 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 ResearchMeSH KeywordsAdalimumabAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansPsoriasisSeverity of Illness IndexTreatment OutcomeConceptsTreatment-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 ResearchMeSH KeywordsDouble-Blind MethodFastingHumansPhosphodiesterase 4 InhibitorsProspective StudiesPsoriasisTabletsTreatment OutcomeConceptsPhase 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 formulation
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 trialsDeucravacitinib 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 ResearchMeSH KeywordsAdultAnti-Inflammatory Agents, Non-SteroidalDouble-Blind MethodHumansPsoriasisSeverity of Illness IndexTreatment OutcomeConceptsSevere 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 inhibitorTreatment Outcomes Associated With Dupilumab Use in Patients With Atopic Dermatitis
Strober B, Mallya U, Yang M, Ganguli S, Gadkari A, Wang J, Sierka D, Delevry D, Kimball A. Treatment Outcomes Associated With Dupilumab Use in Patients With Atopic Dermatitis. JAMA Dermatology 2022, 158: 142-150. PMID: 34910086, DOI: 10.1001/jamadermatol.2021.4778.Peer-Reviewed Original ResearchConceptsAtopic Dermatitis Control ToolHealth-related qualityPatient-reported outcomesAtopic dermatitisMonth 12Disease controlCohort studySkin symptomsMonths 1AD therapyDermatology Life Quality IndexStand-alone questionsActivity Impairment QuestionnaireSevere atopic dermatitisClinical trial populationsNumerical rating scaleLife Quality IndexPatient support programQuality of lifeAdequate disease controlDupilumab useSystemic corticosteroidsImpairment QuestionnaireMost patientsTreatment satisfaction
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 ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansPsoriasisQuality of LifeSeverity of Illness IndexTreatment OutcomeConceptsVOYAGE 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 endpointsEfficacy and safety of apremilast in patients with moderate‐to‐severe plaque psoriasis of the scalp: results up to 32 weeks from a randomized, phase III study
Van Voorhees A, Gold L, Lebwohl M, Strober B, Sofen H, Papp K, Bagel J, Zhang Z, Paris M, Wang Y. Efficacy and safety of apremilast in patients with moderate‐to‐severe plaque psoriasis of the scalp: results up to 32 weeks from a randomized, phase III study. British Journal Of Dermatology 2021, 185: 840-842. PMID: 33763874, PMCID: PMC8518877, DOI: 10.1111/bjd.20083.Peer-Reviewed Original ResearchBimekizumab versus Secukinumab in Plaque Psoriasis
Reich K, Warren R, Lebwohl M, Gooderham M, Strober B, Langley R, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. New England Journal Of Medicine 2021, 385: 142-152. PMID: 33891380, DOI: 10.1056/nejmoa2102383.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisWeek 48Week 16Bimekizumab groupSecukinumab groupPASI scoreInterleukin-17AOral candidiasisGreater skin clearanceInterleukin-17 inhibitorsPASI 100 responsePhase 3b trialSafety of bimekizumabPrimary end pointSeverity Index scoreMonoclonal IgG1 antibodySkin clearanceSevere psoriasisPsoriasis AreaLarge trialsBimekizumabSecukinumabWeek 4Patients
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 ResearchMeSH KeywordsAntibodies, MonoclonalBiological TherapyDemographyDouble-Blind MethodHumansPsoriasisSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsPrior 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 antibodiesEfficacy 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