2024
Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis For Up to 3 Years
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo M, Scotto J, Banerjee S, Strober B, Thaçi D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis For Up to 3 Years. JAMA Dermatology 2024, 161 PMID: 39602111, DOI: 10.1001/jamadermatol.2024.4688.Peer-Reviewed Original ResearchLong-term extension trialsExposure-adjusted incidence ratesSevere plaque psoriasisLong-term extensionModerate to severe plaque psoriasisAdverse eventsPlaque psoriasisDouble-blind phase 3 trialStatic Physician's Global Assessment scoreDiscontinuation due to adverse eventsDay 1Physician Global Assessment scoreIncidence rateEffective long-term treatmentUpper respiratory tract infectionClinical response rateGlobal Assessment scorePhase 3 trialRespiratory tract infectionsWeeks of treatmentYear of treatmentLong-term treatmentAdverse cardiovascular eventsLong-term safetyCumulative periodDeucravacitinib in Plaque Psoriasis: 4-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Colombo M, Vaile J, Vritzali E, Hoyt K, Daamen C, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 4-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s423. DOI: 10.25251/skin.8.supp.423.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateParent trialAdverse cardiovascular eventsTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsCardiovascular eventsSafety signalsPatientsResponse rateIncidence ratePsoriasisDeucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Colombo M, Vaile J, Vritzali E, Hoyt K, Daamen C, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s406. DOI: 10.25251/skin.8.supp.406.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsSafety signalsPatientsContinuous treatmentResponse rateIncidence rateParent trialPsoriasisAllosteric TYK2 inhibitorDeucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Strober B, Imafuku S, Paul C, Gooderham M, Spelman L, Seo S, Passeron T, Hoyt K, Colombo M, Banerjee S, Augustin M, Stein Gold L, Alexis A, Thaci D, Lebwohl M, Issa N, Cameron M. Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s407. DOI: 10.25251/skin.8.supp.407.Peer-Reviewed Original ResearchLong-term extensionModerate to severe plaque psoriasisSevere plaque psoriasisPlaque psoriasisLong-term extension trialsResponse rateModified nonresponder imputationMaintenance of responseYears of continuous treatmentPhase 3 trialLong-term efficacyNonresponder imputationPrimary endpointPsoriasis AreaResponse assessmentClinical efficacyDeucravacitinibPASISafety signalsTreatment durabilityPatientsContinuous treatmentPsoriasisLong-term effectsParent trialDeucravacitinib 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 2024, 8: s366. DOI: 10.25251/skin.8.supp.366.Peer-Reviewed Original ResearchModified nonresponder imputationPlaque psoriasisModerate to severe plaque psoriasisDiscontinuations due to AEsExposure-adjusted incidence ratesSevere plaque psoriasisParent trialAdverse cardiovascular eventsLong-term extensionTreatment of adultsSystemic therapyNonresponder imputationEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismDeucravacitinibCardiovascular eventsEfficacy resultsPatientsResponse rateIncidence ratePsoriasisAllosteric TYK2 inhibitorEfficacy
2013
SAT0287 Long-Term Safety Of Ustekinumab: 5 Years of Follow-Up from the Psoriasis Clinical Development Program Including Patients with Psoriatic Arthritis
Papp K, Griffiths C, Gordon K, Lebwohl M, Szapary P, Wasfi Y, Chan D, Shen Y, Ho V, Ghislain P, Strober B, Reich K. SAT0287 Long-Term Safety Of Ustekinumab: 5 Years of Follow-Up from the Psoriasis Clinical Development Program Including Patients with Psoriatic Arthritis. Annals Of The Rheumatic Diseases 2013, 72: a680. DOI: 10.1136/annrheumdis-2013-eular.2012.Peer-Reviewed Original ResearchGrant/research supportLong-term safetyAEs of interestOverall populationJanssen ResearchSafety endpointEvent ratesOpen-label long-term extensionLong-term safety experienceLow potency topical steroidsPooled safety dataOverall study populationPhase 3 developmentMajority of ptsClinical development programLong-term extensionHistory of PsAAbsence of PSAPsO patientsSevere PsOTopical steroidsPASI scorePsoriatic arthritisBiologic agentsMedian age