2023
Deucravacitinib 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 signalsSafety 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
Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*
Blauvelt A, Kimball A, Augustin M, Okubo Y, Witte M, Capriles C, Sontag A, Arora V, Osuntokun O, Strober B. Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*. British Journal Of Dermatology 2022, 187: 866-877. PMID: 35791755, PMCID: PMC10087045, DOI: 10.1111/bjd.21743.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisWeek 16Week 52PASI 100Secondary endpointsAdult patientsSafety profileLarge phase III trialsStatic Physician's Global AssessmentGlobal assessmentPhase II clinical trialInterleukin-23 inhibitorsKey secondary endpointNew safety signalsPhysician global assessmentSerious adverse eventsPatient-reported qualityPhase III trialsFavorable safety profilePathogenesis of psoriasisPASI 90PASI 75Coprimary endpointsIII trialsOne-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
Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2*
Reich K, Gordon K, Strober B, Armstrong A, Miller M, Shen Y, You Y, Han C, Yang Y, Foley P, Griffiths C. Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2*. British Journal Of Dermatology 2021, 185: 1146-1159. PMID: 34105767, DOI: 10.1111/bjd.20568.Peer-Reviewed Original ResearchConceptsVOYAGE 2Health-related qualityPatient-reported outcomesWeek 252VOYAGE 1Clinical responseSevere psoriasisWeek 52Open-label guselkumabNew safety signalsProportion of patientsMental component scoreShort Form-36Long-term therapyGuselkumab 100Guselkumab groupHRQOL endpointsWeek 264Week 100Form-36Randomized withdrawalWeek 28Week 16Chronic diseasesLife endpoints
2019
Long‐term safety of adalimumab in adult patients with plaque psoriasis
Leonardi C, Papp K, Strober B, Thaçi D, Warren R, Tyring S, Arikan D, Karunaratne M, Valdecantos W. Long‐term safety of adalimumab in adult patients with plaque psoriasis. British Journal Of Dermatology 2019, 180: e13-e13. DOI: 10.1111/bjd.17366.Peer-Reviewed Original ResearchNon-melanoma skin cancerPatient yearsLong-term safetyIncidence of NMSCTumor necrosis factor alphaMost common AEsNew safety signalsUpper respiratory infectionIncidence of malignancyAnalysis of patientsNumber of patientsNecrosis factor alphaDifferent clinical trialsCommon AEsPlaque psoriasisAdult patientsAdverse eventsRespiratory infectionsOpportunistic infectionsSerious infectionsClinical trialsIncidence rateSafety signalsFactor alphaAdalimumab
2018
Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis
Leonardi C, Papp K, Strober B, Thaçi D, Warren R, Tyring S, Arikan D, Karunaratne M, Valdecantos W. Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2018, 180: 76-85. PMID: 30169904, DOI: 10.1111/bjd.17084.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdultAnti-Inflammatory AgentsClinical Trials as TopicDatasets as TopicFemaleHeadacheHumansIncidenceInjections, SubcutaneousLong-Term CareMaleMiddle AgedNasopharyngitisNeoplasmsOpportunistic InfectionsPsoriasisSeverity of Illness IndexTime FactorsTuberculosisTumor Necrosis Factor-alphaConceptsNonmelanoma skin cancerStandardized incidence ratiosStandardized mortality ratioAdverse eventsLong-term safetyPlaque psoriasisClinical trialsIncidence rateIncidence of NMSCSevere chronic plaque psoriasisTreatment-emergent adverse eventsAE incidence ratesChronic plaque psoriasisCommon adverse eventsSevere plaque psoriasisNew safety signalsUpper respiratory infectionIncidence of malignancyAnalysis of patientsTumor necrosis factorHuman monoclonal antibodyAdalimumab doseAdalimumab exposureLast doseAdult patients
2017
Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2017, 177: 1562-1574. PMID: 28755394, DOI: 10.1111/bjd.15857.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisBody surface areaABP 501Week 16Adverse eventsAntidrug antibodiesPlaque psoriasisBiosimilar ABP 501New safety signalsPercentage of patientsPhase III trialsSimilar clinical efficacySeverity Index scorePercentage body surface areaLong-term resultsEuropean Medicines AgencyPASI 50PASI improvementWeek 52III trialsPsoriasis AreaAdalimumab patientsImmunogenicity profileClinical efficacyPatient population