2018
Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis
Leonardi C, Papp K, Strober B, Thaçi D, Warren R, Tyring S, Arikan D, Karunaratne M, Valdecantos W. Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2018, 180: 76-85. PMID: 30169904, DOI: 10.1111/bjd.17084.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdultAnti-Inflammatory AgentsClinical Trials as TopicDatasets as TopicFemaleHeadacheHumansIncidenceInjections, SubcutaneousLong-Term CareMaleMiddle AgedNasopharyngitisNeoplasmsOpportunistic InfectionsPsoriasisSeverity of Illness IndexTime FactorsTuberculosisTumor Necrosis Factor-alphaConceptsNonmelanoma skin cancerStandardized incidence ratiosStandardized mortality ratioAdverse eventsLong-term safetyPlaque psoriasisClinical trialsIncidence rateIncidence of NMSCSevere chronic plaque psoriasisTreatment-emergent adverse eventsAE incidence ratesChronic plaque psoriasisCommon adverse eventsSevere plaque psoriasisNew safety signalsUpper respiratory infectionIncidence of malignancyAnalysis of patientsTumor necrosis factorHuman monoclonal antibodyAdalimumab doseAdalimumab exposureLast doseAdult patients
2016
Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data
Strober B, Leonardi C, Papp KA, Mrowietz U, Ohtsuki M, Bissonnette R, Ferris LK, Paul C, Lebwohl M, Braun DK, Mallbris L, Wilhelm S, Xu W, Ljungberg A, Acharya N, Reich K. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data. Journal Of The American Academy Of Dermatology 2016, 76: 432-440.e17. PMID: 27889292, DOI: 10.1016/j.jaad.2016.09.026.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsIxekizumab-treated patientsSerious adverse eventsAdverse eventsIncidence rateClinical trialsMore treatment-emergent adverse eventsExposure-adjusted incidence ratesEtanercept-treated patientsIntegrated safety dataSafety of ixekizumabUnexpected safety findingsAcceptable safety profileLong-term safety outcomesSafety of biologicsAdditional long-term dataSafety findingsSafety profileCandida infectionsSafety dataSafety outcomesIxekizumabPatientsPsoriasisTrialsComparative 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
2013
Topical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides
Lessin S, Duvic M, Guitart J, Pandya A, Strober B, Olsen E, Hull C, Knobler E, Rook A, Kim E, Naylor M, Adelson D, Kimball A, Wood G, Sundram U, Wu H, Kim Y. Topical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides. JAMA Dermatology 2013, 149: 25-32. PMID: 23069814, PMCID: PMC3662469, DOI: 10.1001/2013.jamadermatol.541.Peer-Reviewed Original ResearchConceptsIndex Lesion SeverityClinical end pointsMycosis fungoidesResponse rateMechlorethamine gelAdverse eventsMulticenter trialTreatment armsLesion severityDrug-related serious adverse eventsSeverity-Weighted Assessment ToolPrimary clinical end pointCutaneous T-cell lymphomaEnd pointSecondary clinical end pointsIIA mycosis fungoidesSerious adverse eventsSubset of patientsTreatment of patientsSerum drug levelsT-cell lymphomaComposite assessmentCarmustine therapyStudy medicationTopical mechlorethamine
2011
The Long-Term Safety of Adalimumab Treatment in Moderate to Severe Psoriasis
Leonardi C, Papp K, Strober B, Reich K, Asahina A, Gu Y, Beason J, Rozzo S, Tyring S. The Long-Term Safety of Adalimumab Treatment in Moderate to Severe Psoriasis. American Journal Of Clinical Dermatology 2011, 12: 321-337. PMID: 21834597, DOI: 10.2165/11587890-000000000-00000.Peer-Reviewed Original ResearchConceptsAdverse event incidence ratesAdalimumab-treated patientsEvent incidence ratesAdverse event ratesPlacebo-controlled periodEvents/100 PYLong-term safetyClinical trialsAdverse eventsIncidence rateSevere psoriasisEvent ratesSafety dataSerious infectious adverse eventsSevere chronic plaque psoriasisFavorable benefit-risk profileCumulative safety dataInfectious adverse eventsPYs of exposureChronic plaque psoriasisSerious adverse eventsSubset of patientsPsoriasis clinical trialsBenefit-risk profileYears of treatmentLong-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
2007
Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial
Menter A, Tyring S, Gordon K, Kimball A, Leonardi C, Langley R, Strober B, Kaul M, Gu Y, Okun M, Papp K. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. Journal Of The American Academy Of Dermatology 2007, 58: 106-115. PMID: 17936411, DOI: 10.1016/j.jaad.2007.09.010.Peer-Reviewed Original ResearchConceptsSevere psoriasisPlacebo-treated patientsSafety of adalimumabChronic plaque psoriasisPercentage of patientsPhase III trialsSeverity Index scorePathogenesis of psoriasisKey proinflammatory cytokinesTumor necrosis factorHuman monoclonal antibodyInterrupted therapyAdalimumab therapyPlaque psoriasisWeek 52III trialsPASI scorePsoriasis AreaActive comparatorClinical efficacyMulticenter studyProinflammatory cytokinesWeek 16Necrosis factorAdalimumab
2005
Off-Label Dermatologic Uses of Anti-TNF-a Therapies
Alexis A, Strober B. Off-Label Dermatologic Uses of Anti-TNF-a Therapies. Journal Of Cutaneous Medicine And Surgery 2005, 9: 296-302. PMID: 16699906, DOI: 10.1007/s10227-005-0110-7.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdolescentAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedArthritis, PsoriaticChildChild, PreschoolChi-Square DistributionEtanerceptFemaleHumansImmunoglobulin GInfantInfliximabMalePsoriasisRandomized Controlled Trials as TopicReceptors, Tumor Necrosis FactorSkin DiseasesTime FactorsTumor Necrosis Factor-alphaConceptsDermatologic usesTNF inhibitorsDermatologic diseasesSneddon-Wilkinson diseaseInflammatory skin diseaseSmall case seriesNecrobiosis lipoidica diabeticorumPityriasis rubra pilarisMethodsA MEDLINE searchNumerous inflammatory skin diseasesIndividual case reportsApthous stomatitisBehçet's diseaseEosinophilic fasciitisSAPHO syndromeCase seriesCicatricial pemphigoidCrohn's diseaseMulticentric reticulohistiocytosisImmunomodulatory roleProinflammatory cytokinesCase reportLabel useMEDLINE searchSkin diseases