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 periodBimekizumab Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Pooled Analysis from Up to 4 Years of Treatment in 5 Phase 3/3b Clinical Trials
Gordon K, Thaçi D, Gooderham M, Okubo Y, Strober B, Peterson L, Deherder D, López Pinto J, Gisondi P. Bimekizumab Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Pooled Analysis from Up to 4 Years of Treatment in 5 Phase 3/3b Clinical Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s404. DOI: 10.25251/skin.8.supp.404.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsSevere plaque psoriasisOpen-label extensionPlaque psoriasisOral candidiasisPatient yrModerate to severe plaque psoriasisUpper respiratory tract infectionLong-term safety of treatmentRespiratory tract infectionsNext scheduled visitYear of treatmentSafety of treatmentLong-term safetySafety findingsTract infectionsLong-term managementBimekizumabSafety profileAdverse eventsPooled analysisClinical trialsQ8WSafety dataPsoriasis
2023
Abrocitinib efficacy and safety in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study
Reich K, Silverberg J, Papp K, Deleuran M, Katoh N, Strober B, Beck L, de Bruin‐Weller M, Werfel T, Zhang F, Biswas P, DiBonaventura M, Chan G, Johnson S, Farooqui S, Kerkmann U, Clibborn C. Abrocitinib efficacy and safety in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 2056-2066. PMID: 37335885, DOI: 10.1111/jdv.19280.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsSevere atopic dermatitisSerious treatment-emergent adverse eventsPhase 3 studyAtopic dermatitisSafety profileAbrocitinib 200Frequent treatment-emergent adverse eventsLong-term extension studyUpper respiratory tract infectionLong-term safety profileChronic atopic dermatitisManageable safety profileProportion of patientsRespiratory tract infectionsFull treatment periodLong-term efficacyLong-term safetyPruritus improvementSkin clearanceEfficacy endpointSafety endpointAdverse eventsTract infectionsAD trialsSafety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial
Thaçi D, Vender R, de Rie M, Conrad C, Pariser D, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball A. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. British Journal Of Dermatology 2023, 188: 22-31. PMID: 36689515, DOI: 10.1093/bjd/ljac021.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsOpen-label extensionSevere plaque psoriasisWeek 104Week 24PASI 100PASI 90Plaque psoriasisWeek 16Safety dataCommon treatment-emergent adverse eventsSerious treatment-emergent adverse eventsUpper respiratory tract infectionInitial randomization groupUnexpected safety findingsNew safety signalsRespiratory tract infectionsWeeks of treatmentLong-term resultsBaseline PASIBimekizumab groupBRIGHT trialMaintenance dosingPsoriasis AreaSafety findings
2022
One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial
Strober B, Stein Gold L, Bissonnette R, Armstrong A, Kircik L, Tyring S, Piscitelli S, Brown P, Rubenstein D, Tallman A, Lebwohl M. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial. Journal Of The American Academy Of Dermatology 2022, 87: 800-806. PMID: 35772599, DOI: 10.1016/j.jaad.2022.06.1171.Peer-Reviewed Original ResearchConceptsOpen-label treatmentRemittive effectsPlaque psoriasisUpper respiratory tract infectionPhysician Global Assessment scoreComplete disease clearanceOne-year safetyFrequent adverse eventsSevere plaque psoriasisNew safety signalsPhase 3 trialRespiratory tract infectionsDurability of responseForms of psoriasisGlobal assessment scoreLong-term safetyEligible patientsTapinarof creamDisease clearanceAdverse eventsTract infectionsMean durationSafety signalsContact dermatitisCream 1
2021
Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis
Lebwohl M, Stein Gold L, Strober B, Papp K, Armstrong A, Bagel J, Kircik L, Ehst B, Hong H, Soung J, Fromowitz J, Guenthner S, Piscitelli S, Rubenstein D, Brown P, Tallman A, Bissonnette R. Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. New England Journal Of Medicine 2021, 385: 2219-2229. PMID: 34879448, DOI: 10.1056/nejmoa2103629.Peer-Reviewed Original ResearchConceptsPrimary end pointPatient-reported outcomesTapinarof creamGlobal assessment scoreBody surface areaPlaque psoriasisWeek 12End pointPGA responseAdverse eventsPGA scoreMean changeSkin barrier protein filaggrinSecondary efficacy end pointsUpper respiratory tract infectionPhysician Global Assessment scoreNumeric rating scale scoreTotal body surface areaTotal scoreEfficacy end pointIdentical phase 3Local adverse eventsSymptom diary scoresProportion of patientsSecondary end pointsPOS1042 EFFICACY AND SAFETY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 (TYK2) INHIBITOR, COMPARED WITH PLACEBO AND APREMILAST IN MODERATE TO SEVERE PLAQUE PSORIASIS: RESULTS FROM THE PHASE 3 POETYK PSO-1 STUDY
Armstrong A, Gooderham M, Warren R, Papp K, Strober B, Thaçi D, Colston E, Throup J, Kundu S, Banerjee S, Blauvelt A. POS1042 EFFICACY AND SAFETY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 (TYK2) INHIBITOR, COMPARED WITH PLACEBO AND APREMILAST IN MODERATE TO SEVERE PLAQUE PSORIASIS: RESULTS FROM THE PHASE 3 POETYK PSO-1 STUDY. Annals Of The Rheumatic Diseases 2021, 80: 795.1-796. DOI: 10.1136/annrheumdis-2021-eular.1002.Peer-Reviewed Original ResearchSevere plaque psoriasisKyowa Hakko KirinGrant/research supportBristol-Myers SquibbCommon adverse eventsCorrona Psoriasis RegistryPlaque psoriasisAdverse eventsSanofi GenzymeWeek 16Merck SeronoLEO PharmaPASI 75Meiji Seika PharmaPersonal feesTyrosine kinase 2Boehringer IngelheimMerck SharpPsoriasis RegistryWeek 24Psoriatic arthritisSpeakers bureauEli LillyJanssen-CilagUpper respiratory tract infection
2017
Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study.
Strober B, Bagel J, Lebwohl M, Stein Gold L, Jackson J, Chen R, Goncalves J, Levi E, Callis Duffin K. Efficacy and Safety of Apremilast in Patients With Moderate Plaque Psoriasis With Lower BSA: Week 16 Results from the UNVEIL Study. Journal Of Drugs In Dermatology 2017, 16: 801-808. PMID: 28809995.Peer-Reviewed Original ResearchConceptsModerate plaque psoriasisSafety of apremilastPlaque psoriasisGlobal assessment scoreStatic Physician's Global Assessment scoreDermatology Life Quality Index scoresUpper respiratory tract infectionPhysician Global Assessment scoreLife Quality Index scoresPercentage changePrior topical therapyMost adverse eventsPrimary efficacy endpointSevere plaque psoriasisTreatment Satisfaction QuestionnaireRespiratory tract infectionsHigh patient satisfactionMean percentage changeQuality Index scoresQuality of lifeGreater percentage changeEfficacy endpointAdverse eventsTopical therapyTract infections