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
2017
Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: Results from the Corrona Psoriasis Registry
Strober B, Karki C, Mason M, Guo N, Holmgren S, Greenberg J, Lebwohl M. Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: Results from the Corrona Psoriasis Registry. Journal Of The American Academy Of Dermatology 2017, 78: 323-332. PMID: 29051036, DOI: 10.1016/j.jaad.2017.10.012.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnti-Inflammatory Agents, Non-SteroidalBiological ProductsBody Surface AreaComorbidityCost of IllnessCross-Sectional StudiesFatigueFemaleHumansInterleukin-12Interleukin-17Interleukin-23MaleMiddle AgedPainPatient Reported Outcome MeasuresProspective StudiesPsoriasisQuality of LifeRegistriesSeverity of Illness IndexThalidomideTumor Necrosis Factor-alphaUnited StatesConceptsCorrona Psoriasis RegistryPsoriasis RegistryDisease durationComparative safetyBody surface area involvementTumor necrosis factor inhibitorsIL-12/23 inhibitorsInterleukin-17A inhibitorInvestigator's Global AssessmentNecrosis factor inhibitorsSurface area involvementLonger disease durationCross-sectional studyLong-term safetyEfficacy of treatmentPsoriatic arthritis diagnosisQuality of lifeEfficacy of foodMultiple comorbiditiesRegistry cohortSystemic medicationsSystemic therapyFactor inhibitorsArea involvementBiologic treatment
2012
Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open‐label extension trial of the interleukin‐12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis
Langley R, Papp K, Gottlieb A, Krueger G, Gordon K, Williams D, Valdes J, Setze C, Strober B. Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open‐label extension trial of the interleukin‐12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis. Journal Of The European Academy Of Dermatology And Venereology 2012, 27: 1252-1261. PMID: 23157612, DOI: 10.1111/j.1468-3083.2012.04705.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Basal CellCarcinoma, Squamous CellCardiovascular DiseasesClinical Trials as TopicFemaleHumansInterleukin-12Interleukin-23MaleMiddle AgedPrevalencePsoriasisRandomized Controlled Trials as TopicSeverity of Illness IndexSkin Diseases, InfectiousSkin NeoplasmsTreatment OutcomeConceptsOpen-label extension studyMajor adverse cardiovascular eventsPotential safety signalsSevere psoriasisAdverse eventsParent studyClinical trialsSafety signalsSafety resultsAnti-IL-12/23 treatmentInterleukin-12/23 monoclonal antibodyOpen-label extension trialPhase IIAdverse cardiovascular eventsCardiovascular risk factorsBaseline blood pressureBody mass indexRate of infectionCardiovascular eventsFirst doseSafety findingsBlood pressureIL-12/23Mass indexExtension trial
2011
A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis
Gordon K, Langley R, Gottlieb A, Papp K, Krueger G, Strober B, Williams D, Gu Y, Valdes J. A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis. Journal Of Investigative Dermatology 2011, 132: 304-314. PMID: 22011907, DOI: 10.1038/jid.2011.304.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsSevere psoriasisWeek 52Adverse eventsWeek 12Placebo-controlled phase III studyMajor adverse cardiovascular eventsPrevious phase II trialGlobal assessmentPlacebo-controlled periodAdverse cardiovascular eventsPhysician global assessmentPhase II trialPhase III studyNonmelanoma skin cancerNonresponder imputationPASI 75Vs. 4.5Cardiovascular eventsII trialIII studyPsoriasis AreaControlled TrialsIL-12/23Maintenance treatmentAssociation Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events: A Meta-analysis of Randomized Controlled Trials
Ryan C, Leonardi C, Krueger J, Kimball A, Strober B, Gordon K, Langley R, de Lemos J, Daoud Y, Blankenship D, Kazi S, Kaplan D, Friedewald V, Menter A. Association Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events: A Meta-analysis of Randomized Controlled Trials. JAMA 2011, 306: 864-871. PMID: 21862748, DOI: 10.1001/jama.2011.1211.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCardiovascular DiseasesDouble-Blind MethodEtanerceptHumansImmunoglobulin GImmunologic FactorsInfliximabInterleukin-12Interleukin-23Middle AgedMyocardial InfarctionPlacebosPsoriasisRandomized Controlled Trials as TopicReceptors, Tumor Necrosis FactorRiskStrokeTumor Necrosis Factor-alphaUstekinumabYoung AdultConceptsMajor adverse cardiovascular eventsChronic plaque psoriasisAnti-IL-12/23 agentsPlacebo-controlled phaseΑ agentsCardiovascular eventsPlaque psoriasisBiologic therapyControlled TrialsAnti-tumor necrosis factor α agentsRate of MACEAnti-IL-12/ILMantel-Haenszel fixed-effect methodAnti-IL-12/23 therapyAdverse cardiovascular eventsCochrane Central RegisterComposite end pointAbsolute risk differencePrimary outcome measureRandomized Controlled TrialsSignificant differencesCardiovascular deathMonotherapy studiesΑ treatmentCentral Register
2010
Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis
Griffiths C, Strober B, van de Kerkhof P, Ho V, Fidelus-Gort R, Yeilding N, Guzzo C, Xia Y, Zhou B, Li S, Dooley L, Goldstein N, Menter A. Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis. New England Journal Of Medicine 2010, 362: 118-128. PMID: 20071701, DOI: 10.1056/nejmoa0810652.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedEtanerceptFemaleHumansImmunoglobulin GImmunologic FactorsImmunosuppressive AgentsInterleukin-12Interleukin-23MaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorSeverity of Illness IndexTumor Necrosis Factor-alphaUstekinumabConceptsHigh-dose etanerceptPhysician global assessmentWeek 12Global assessmentSevere psoriasisAdverse eventsBiologic agentsMinimal diseaseRelative benefit-risk profilesEnd pointMore adverse eventsPrimary end pointSecondary end pointsProportion of patientsSerious adverse eventsTreatment of psoriasisBenefit-risk profileNew therapeutic optionsPsoriasis AreaTherapeutic optionsSuch therapySubcutaneous injectionUstekinumabEtanerceptPatients