2023
Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s240. DOI: 10.25251/skin.7.supp.240.Peer-Reviewed Original ResearchSevere plaque psoriasisPlaque psoriasisParent trialDay 1Exposure-adjusted incidence ratesLong-term extension trialsMajor adverse cardiovascular eventsAdverse cardiovascular eventsConsistent safety profileTreatment of adultsNonresponder imputationOral placeboSerious AEsWeek 148Cardiovascular eventsEfficacy outcomesVenous thromboembolismWeek 52Herpes zosterSystemic therapyDurable efficacySafety profileExtension trialIncidence rateEfficacy resultsDeucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials
Sofen H, Strober B, Imafuku S, Paul C, Gooderham M, Spelman L, Seo S, Passeron T, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Augustin M, Stein Gold L, Alexis A, Thaçi D, Blauvelt A, Lebwohl M. Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s241. DOI: 10.25251/skin.7.supp.241.Peer-Reviewed Original ResearchPASI 75 respondersSevere plaque psoriasisPASI 75PASI 90Week 148Plaque psoriasisWeek 52Week 16Week 24Parent trialClinical efficacyDay 1Response rateLong-term extension trialsNew safety signalsPhase 3 trialSubset of patientsMaintenance of responseLong-term efficacyLong-term effectivenessNonresponder imputationOral placeboPsoriasis AreaExtension trialSafety signalsBimekizumab 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 ResearchConceptsOngoing 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 trial
2022
Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension trial
Strober B, Tada Y, Mrowietz U, Lebwohl M, Foley P, Langley R, Barker J, Wang M, Vanvoorden V, Szilagyi B, Ciaravino V, Paul C. Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension trial. SKIN The Journal Of Cutaneous Medicine 2022, 6: s65. DOI: 10.25251/skin.6.supp.65.Peer-Reviewed Original ResearchTapinarof Cream 1% Once Daily for Plaque Psoriasis: Long-Term Extension Trial of a Novel Therapeutic Aryl Hydrocarbon Receptor Modulating Agent
Strober B, Stein Gold L, Bissonnette R, Armstrong A, Blauvelt A, Kircik L, Brown P, Tallman A, Lebwohl M. Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Long-Term Extension Trial of a Novel Therapeutic Aryl Hydrocarbon Receptor Modulating Agent. SKIN The Journal Of Cutaneous Medicine 2022, 6: s5. DOI: 10.25251/skin.6.supp.5.Peer-Reviewed Original Research
2021
Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Long-Term Extension Trial of a Novel Therapeutic Aryl Hydrocarbon Receptor Modulating Agent
Strober B, Stein Gold L, Bissonnette R, Armstrong A, Blauvelt A, Brown P, Kircik L, Tallman A, Lebwohl M. Tapinarof Cream 1% Once Daily for Plaque Psoriasis: Long-Term Extension Trial of a Novel Therapeutic Aryl Hydrocarbon Receptor Modulating Agent. SKIN The Journal Of Cutaneous Medicine 2021, 5: s35. DOI: 10.25251/skin.5.supp.35.Peer-Reviewed Original ResearchBimekizumab response maintenance through two years of treatment in patients with moderate to severe plaque psoriasis who responded after 16 weeks: Interim results from the BE BRIGHT open-label extension trial
Strober B, Asahina A, Mrowietz U, Lebwohl M, Foley P, Langley R, Barker J, Cioffi C, Cross N, Wang M, Paul C. Bimekizumab response maintenance through two years of treatment in patients with moderate to severe plaque psoriasis who responded after 16 weeks: Interim results from the BE BRIGHT open-label extension trial. SKIN The Journal Of Cutaneous Medicine 2021, 5: s52. DOI: 10.25251/skin.5.supp.52.Peer-Reviewed Original Research
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