2024
Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary
Papp K, Gordon K, Strober B, Zhuo J, Becker B, Zhong Y, Beaumont J, Pham T, Kisa R, Napoli A, Banerjee S, Armstrong A. Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary. JAMA Dermatology 2024, 160: 204-209. PMID: 38117487, PMCID: PMC10733845, DOI: 10.1001/jamadermatol.2023.5058.Peer-Reviewed Original ResearchSevere plaque psoriasisPatient Global ImpressionClinical trialsPsoriasis symptomsScore changeSigns DiaryPlaque psoriasisGlobal ImpressionWeek 16MAIN OUTCOMEPatient-reported end pointsPlacebo-controlled phase 3 clinical trialPhase 3 clinical trialsPatient-reported assessmentsPhase 3 programMeaningful change thresholdCategory improvementDisease burdenMeaningful score changesSelective TYK2 inhibitorsPatient changeBaseline scoresPsoriasisPatientsEnd point
2022
Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial
Armstrong A, Gooderham M, Warren R, Papp K, Strober B, Thaçi D, Morita A, Szepietowski J, Imafuku S, Colston E, Throup J, Kundu S, Schoenfeld S, Linaberry M, Banerjee S, Blauvelt A. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. Journal Of The American Academy Of Dermatology 2022, 88: 29-39. PMID: 35820547, DOI: 10.1016/j.jaad.2022.07.002.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisGlobal assessment scorePlaque psoriasisWeek 16Static Physician's Global Assessment scoreResponse ratePhysician Global Assessment scoreCoprimary end pointsAdverse event ratesOne-year durationPASI 75Psoriasis AreaWeek 52Psoriasis treatmentPlaceboSafety resultsDeucravacitinibApremilastEnd pointEvent ratesAssessment scoresPsoriasisSeverity IndexKinase 2 inhibitorTyrosine kinase 2 inhibitor
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 points
2018
Benefit–risk profile of tofacitinib in patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis across six clinical trials
Strober B, Gottlieb A, Kerkhof P, Puig L, Bachelez H, Chouela E, Imafuku S, Thaçi D, Tan H, Valdez H, Gupta P, Kaur M, Frajzyngier V, Wolk R. Benefit–risk profile of tofacitinib in patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis across six clinical trials. British Journal Of Dermatology 2018, 180: 67-75. PMID: 30188571, PMCID: PMC7379291, DOI: 10.1111/bjd.17149.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdolescentAdultAgedAged, 80 and overChronic DiseaseDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedPiperidinesProtein Kinase InhibitorsPsoriasisPyrimidinesPyrrolesQuality of LifeRandomized Controlled Trials as TopicRisk AssessmentSeverity of Illness IndexYoung AdultConceptsSevere chronic plaque psoriasisChronic plaque psoriasisEfficacy end pointBenefit-risk profileSevere psoriasisPlaque psoriasisWeek 16Dermatology Life Quality Index scoresLong-term extension studyOral Janus kinase inhibitorGlobal assessmentLife Quality Index scoresEnd pointDepression Scale depression scorePhysician global assessmentImproved patients' qualitySystemic psoriasis therapiesJanus kinase inhibitorQuality Index scoresTofacitinib 5Tofacitinib exposurePsoriasis AreaSystemic treatmentTofacitinib treatmentPatients' quality
2016
Clinical meaningfulness of complete skin clearance in psoriasis
Strober B, Papp KA, Lebwohl M, Reich K, Paul C, Blauvelt A, Gordon KB, Milmont CE, Viswanathan HN, Li J, Pinto L, Harrison DJ, Kricorian G, Nirula A, Klekotka P. Clinical meaningfulness of complete skin clearance in psoriasis. Journal Of The American Academy Of Dermatology 2016, 75: 77-82.e7. PMID: 27206759, DOI: 10.1016/j.jaad.2016.03.026.Peer-Reviewed Original ResearchConceptsComplete skin clearanceSkin clearancePASI 100Score 0Dermatology Life Quality IndexNew psoriasis therapiesPsoriasis Symptom InventoryTotal skin clearancePercentage of patientsPhase III trialsHealth-related qualityLife Quality IndexMeaningful end pointsPASI 75PASI 90Psoriasis symptomsPsoriasis therapyTreatment responsePatient's perspectiveInsufficient evidenceClinical meaningfulnessPatientsEnd pointSymptom InventoryClearance
2013
Topical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides
Lessin S, Duvic M, Guitart J, Pandya A, Strober B, Olsen E, Hull C, Knobler E, Rook A, Kim E, Naylor M, Adelson D, Kimball A, Wood G, Sundram U, Wu H, Kim Y. Topical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides. JAMA Dermatology 2013, 149: 25-32. PMID: 23069814, PMCID: PMC3662469, DOI: 10.1001/2013.jamadermatol.541.Peer-Reviewed Original ResearchConceptsIndex Lesion SeverityClinical end pointsMycosis fungoidesResponse rateMechlorethamine gelAdverse eventsMulticenter trialTreatment armsLesion severityDrug-related serious adverse eventsSeverity-Weighted Assessment ToolPrimary clinical end pointCutaneous T-cell lymphomaEnd pointSecondary clinical end pointsIIA mycosis fungoidesSerious adverse eventsSubset of patientsTreatment of patientsSerum drug levelsT-cell lymphomaComposite assessmentCarmustine therapyStudy medicationTopical mechlorethamine
2010
Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis
Griffiths C, Strober B, van de Kerkhof P, Ho V, Fidelus-Gort R, Yeilding N, Guzzo C, Xia Y, Zhou B, Li S, Dooley L, Goldstein N, Menter A. Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis. New England Journal Of Medicine 2010, 362: 118-128. PMID: 20071701, DOI: 10.1056/nejmoa0810652.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedEtanerceptFemaleHumansImmunoglobulin GImmunologic FactorsImmunosuppressive AgentsInterleukin-12Interleukin-23MaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorSeverity of Illness IndexTumor Necrosis Factor-alphaUstekinumabConceptsHigh-dose etanerceptPhysician global assessmentWeek 12Global assessmentSevere psoriasisAdverse eventsBiologic agentsMinimal diseaseRelative benefit-risk profilesEnd pointMore adverse eventsPrimary end pointSecondary end pointsProportion of patientsSerious adverse eventsTreatment of psoriasisBenefit-risk profileNew therapeutic optionsPsoriasis AreaTherapeutic optionsSuch therapySubcutaneous injectionUstekinumabEtanerceptPatients