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 ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedDouble-Blind MethodDrug Administration ScheduleHumansInterleukin-23PsoriasisSeverity of Illness IndexTreatment OutcomeConceptsSevere 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 trials
2021
Bimekizumab 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 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
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 resultsClearance
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
2011
Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials
Lebwohl M, Leonardi C, Griffiths C, Prinz J, Szapary P, Yeilding N, Guzzo C, Li S, Hsu M, Strober B. Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials. Journal Of The American Academy Of Dermatology 2011, 66: 731-741. PMID: 21930328, DOI: 10.1016/j.jaad.2011.06.011.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug-Related Side Effects and Adverse ReactionsEtanerceptEvaluation Studies as TopicFemaleFollow-Up StudiesHumansImmunoglobulin GMaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorRisk AssessmentSafety ManagementSeverity of Illness IndexTime FactorsTreatment OutcomeUstekinumabConceptsRate of AEsUstekinumab-treated patientsAdverse eventsSerious AEsSevere psoriasisSafety profileLong-term safety experiencePrevious short-term reportsCumulative safety dataGeneral safety parametersPlacebo-controlled periodSerious adverse eventsYears of treatmentShort-term reportsCases of demyelinationUstekinumab exposureIL-23Clinical trialsOverall infectionSafety dataACCEPT trialPatientsSimilar findingsSafety experienceTrials
2010
Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study.
Leonardi C, Strober B, Gottlieb A, Elewski B, Ortonne J, van de Kerkhof P, Chiou C, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. Journal Of Drugs In Dermatology 2010, 9: 928-37. PMID: 20684143.Peer-Reviewed Original ResearchConceptsLong-term safetyExtension studyOpen-label etanercept treatmentPrevious phase 3 studyOpen-label extension studyEfficacy of etanerceptOpen-label studySevere plaque psoriasisPhase 3 studySymptoms of psoriasisEligible patientsEtanercept treatmentInterrupted therapySubcutaneous etanerceptEtanercept therapyPlaque psoriasisAdverse eventsPsoriatic patientsEtanerceptPatientsSkin diseasesPsoriasisWeeksYears of experiencePredetermined criteria
2009
Alefacept for Severe Alopecia Areata: A Randomized, Double-blind, Placebo-Controlled Study
Strober B, Menon K, McMichael A, Hordinsky M, Krueger G, Panko J, Siu K, Lustgarten J, Ross E, Shapiro J. Alefacept for Severe Alopecia Areata: A Randomized, Double-blind, Placebo-Controlled Study. JAMA Dermatology 2009, 145: 1262-1266. PMID: 19917955, DOI: 10.1001/archdermatol.2009.264.Peer-Reviewed Original ResearchMeSH KeywordsAcademic Medical CentersAdolescentAdultAgedAlefaceptAlopecia AreataDermatologic AgentsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansInjections, IntramuscularMaleMiddle AgedNew York CityProbabilityRecombinant Fusion ProteinsRisk AssessmentSeverity of Illness IndexStatistics, NonparametricTreatment OutcomeYoung AdultConceptsSevere alopecia areataAlopecia areataPlacebo-controlled clinical trialEfficacy of alefaceptPlacebo-receiving groupSevere plaque psoriasisMain outcome measuresPlaque psoriasisPrevious therapyAlopecia ToolClinical trialsAlefaceptOutcome measuresUS FoodDrug AdministrationConsecutive weeksBiologic inhibitorsScalp hairAreataTreatmentWeeksSignificant improvementMulticenterPlaceboPsoriasis
2008
Efalizumab-Associated Guillain-Barré Syndrome
Victor F, Menon K, Latkowski J, Fernandez-Obregon A, Strober B. Efalizumab-Associated Guillain-Barré Syndrome. JAMA Dermatology 2008, 144: 1396-1397. PMID: 18936412, DOI: 10.1001/archderm.144.10.1396.Peer-Reviewed Original ResearchAn open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast*
Gottlieb A, Strober B, Krueger J, Rohane P, Zeldis J, Hu C, Kipnis C. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast*. Current Medical Research And Opinion 2008, 24: 1529-1538. PMID: 18419879, DOI: 10.1185/030079908x301866.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAnti-Inflammatory AgentsBiopsy, NeedleConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleEpidermisFemaleFollow-Up StudiesHumansImmunohistochemistryMaleMiddle AgedPhosphodiesterase 4 InhibitorsPilot ProjectsPsoriasisSeverity of Illness IndexThalidomideTreatment OutcomeConceptsSevere plaque-type psoriasisPlaque-type psoriasisAdverse eventsTumor necrosis factor-alpha levelsAbnormal laboratory test resultsStatic Physician's Global AssessmentOpen-label pilot studyNecrosis factor-alpha levelsGlobal assessmentSingle-arm pilot studyOral anti-inflammatory agentsPilot studyClinical efficacy scoresMultiple inflammatory factorsPhysician global assessmentLesional skin biopsiesPathogenesis of psoriasisBody surface areaAnti-inflammatory agentsPhosphodiesterase 4 inhibitorCD11c cellsInflammatory markersPASI scorePsoriasis AreaInflammatory factors
2006
Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis
Elewski B, Leonardi C, Gottlieb A, Strober B, Simiens M, Dunn M, Jahreis A. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. British Journal Of Dermatology 2006, 156: 138-142. PMID: 17199580, DOI: 10.1111/j.1365-2133.2006.07585.x.Peer-Reviewed Original ResearchConceptsPhase 3 studyWeeks of etanerceptGlobal phase 3 studyExtension study baselineExtension studyPK profilesEfficacy endpointStudy baselinePharmacokinetic profileTumor necrosis factor antagonistsOpen-label extension studyDermatology Life Quality IndexGlobal assessmentMean PASI scoreNew safety findingsNecrosis factor antagonistsPhysician global assessmentSevere plaque psoriasisSubset of patientsLife Quality IndexSet of patientsPlaque psoriasisAdult patientsPASI scorePsoriasis AreaOn multiple courses of alefacept
Leonardi C, Strober B. On multiple courses of alefacept. Journal Of The American Academy Of Dermatology 2006, 55: 916-917. PMID: 17052512, DOI: 10.1016/j.jaad.2006.04.075.Peer-Reviewed Original ResearchAlefaceptChronic DiseaseDrug Administration ScheduleHumansInjections, IntravenousPsoriasisRecombinant Fusion ProteinsRetreatmentComparison of Tazarotene and Minocycline Maintenance Therapies in Acne Vulgaris: A Multicenter, Double-blind, Randomized, Parallel-Group Study
Leyden J, Thiboutot D, Shalita A, Webster G, Washenik K, Strober B, Shupack J. Comparison of Tazarotene and Minocycline Maintenance Therapies in Acne Vulgaris: A Multicenter, Double-blind, Randomized, Parallel-Group Study. JAMA Dermatology 2006, 142: 605-612. PMID: 16702498, DOI: 10.1001/archderm.142.5.605.Peer-Reviewed Original ResearchConceptsGreater global improvementMaintenance therapyTazarotene gelGlobal improvementLesion countsAcne vulgarisOpen-label treatment phaseParallel-group studyInflammatory lesion countSevere acne vulgarisOverall disease severityPlacebo capsulesMaintenance regimensReferral centerWeek 24Severe acneVehicle gelAmbulatory patientsWeek 12Minocycline therapyAntibiotic exposureMean reductionTreatment phasePatientsGreater efficacy