2023
Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials
Lebwohl M, Strober B, Linaberry M, Hoyt K, Banerjee S, Kisa R, Mehta N. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s115. DOI: 10.25251/skin.7.supp.115.Peer-Reviewed Original ResearchSevere plaque psoriasisHDL cholesterolTotal cholesterolWeek 16Plaque psoriasisLDL cholesterolTriglyceride levelsLipid parametersWeeks 0Tyrosine kinase 2Treatment groupsDouble-blind trialBaseline triglyceride levelsLDL cholesterol levelsMean triglyceride levelsTreatment of adultsOral placeboMean triglyceridesAdverse eventsSerum lipidsSystemic therapyDL increasePsoriasis pathogenesisCholesterol levelsMean change
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
Infections from seven clinical trials of ixekizumab, an anti‐interleukin‐17A monoclonal antibody, in patients with moderate‐to‐severe psoriasis
Papp K, Bachelez H, Blauvelt A, Winthrop K, Romiti R, Ohtsuki M, Acharya N, Braun D, Mallbris L, Zhao F, Xu W, Walls C, Strober B. Infections from seven clinical trials of ixekizumab, an anti‐interleukin‐17A monoclonal antibody, in patients with moderate‐to‐severe psoriasis. British Journal Of Dermatology 2017, 177: 1537-1551. PMID: 28600810, DOI: 10.1111/bjd.15723.Peer-Reviewed Original ResearchConceptsIncidence rateTreatment groupsInfection rateSpecific infection rateSevere psoriasisSerious infectionsExposure-adjusted incidence ratesIRs of infectionsMonoclonal antibodiesWeeks of treatmentOverall infection rateIncidence of infectionOesophageal candidiasisBiological therapyPsoriasis trialsAntifungal therapyClinical trialsIxekizumabCandida infectionsPatientsLong-term exposureInfectionPsoriasisIncidenceTrials
2016
Secukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials
Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, Stonkus S, Septe M, Elewski BE, Gottlieb AB, Zhao Y, Tran MH, Karpov A, McLeod LD, Mordin M, Papavassilis C, Nyirady J, Lebwohl M. Secukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials. International Journal Of Dermatology 2016, 55: 401-407. PMID: 26866518, DOI: 10.1111/ijd.13236.Peer-Reviewed Original ResearchConceptsWeek 12Multicenter phase 3 studyPlacebo-controlled clinical trialInterleukin-17A antagonistPsoriasis-related itchingPlacebo treatment groupsSevere plaque psoriasisPhase 3 studyWeeks of treatmentProportion of subjectsPlaque psoriasisSevere psoriasisPsoriasis symptomsSystemic therapySymptom diaryClinical trialsSecukinumabTreatment responsePlaceboItchingPainTreatment groupsPhase 3PsoriasisAdults