2024
Deucravacitinib 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 inhibitorA randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis
Ehst B, Strober B, Blauvelt A, Maslin D, Macaro D, Carpenter N, Bodmer M, McHale D. A randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis. Frontiers In Medicine 2024, 11: 1292406. PMID: 38813388, PMCID: PMC11133679, DOI: 10.3389/fmed.2024.1292406.Peer-Reviewed Original ResearchPASI-50Double-blindMild to moderate plaque psoriasisMild to moderate psoriasisOff-treatment responseWeeks of follow-upChronic inflammatory skin diseaseParallel-group studySystemic anti-inflammatory responsePhase 2 trialInflammatory skin diseaseAnti-inflammatory responsePlaque psoriasisPlacebo-controlledPsoriasis AreaEfficacy outcomesImmunomodulatory approachesSafety profileAdverse eventsEvaluate safetyFollow-upTreatment periodTherapeutic benefitPsoriasisSkin diseasesDeucravacitinib 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
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 resultsBimekizumab 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 efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials
Kokolakis G, Warren R, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Körber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. British Journal Of Dermatology 2022, 188: 330-340. PMID: 36751950, DOI: 10.1093/bjd/ljac089.Peer-Reviewed Original ResearchConceptsExposure-adjusted incidence ratesTreatment-emergent adverse eventsAdverse eventsDurable improvementMajority of TEAEsDiscontinuation of biologicsNew safety findingsPASI 90 respondersSevere plaque psoriasisHealth-related qualityBody surface areaTime of switchAbsolute PASIIIIb trialPASI 100PASI 90Skin clearancePlaque psoriasisWeek 48Clinical responseEfficacy outcomesPsoriasis AreaSafety findingsWeek 24Week 52