2023
Abrocitinib effect on patient‐reported outcomes 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, Farooqui S, Kerkmann U, Clibborn C. Abrocitinib effect on patient‐reported outcomes 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: 2047-2055. PMID: 37319109, DOI: 10.1111/jdv.19254.Peer-Reviewed Original ResearchConceptsSevere atopic dermatitisPatient-reported outcomesAbrocitinib 200Phase 3 studyAtopic dermatitisWeek 48POEM scoresDermatology Life Quality Index scoresLong-term extension studyLife Quality Index scoresEczema Measure scoreManageable safety profilePatient-reported endpointsMean DLQI scorePatient-reported symptomsProportion of patientsPatient-reported responsesFull treatment periodPhase 3Quality Index scoresDLQI 0/1DLQI scoreWeek 12AD trialsSafety profileAbrocitinib 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 trials
2017
Psoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab
Elewski B, Puig L, Mordin M, Gilloteau I, Sherif B, Fox T, Gnanasakthy A, Papavassilis C, Strober B. Psoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab. Journal Of Dermatological Treatment 2017, 28: 492-499. PMID: 28266243, DOI: 10.1080/09546634.2017.1294727.Peer-Reviewed Original ResearchConceptsQuality of lifeSeverity Index (PASI) 90 responseDLQI 0/1 responsePASI 75Skin clearancePASI 90Psoriasis AreaDermatology Life Quality Index responseGreater health-related qualityPatients' QOLGreater skin clearancePhase 3 studyHealth-related qualityNew biological therapiesRelevant therapeutic goalSevere psoriasisWeek 52Psoriasis patientsBiological therapyWeek 12Therapeutic goalsTrial dataSustained levelsIgA resultsClearance
2016
Secukinumab Provides Clearer Skin and Better Control on Patient-Reported Psoriasis Symptoms of Itching, Pain, and Scaling than Placebo and Etanercept
Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, Stonkus S, Septe M, Elewski B, Gottlieb A, Zhao Y, Herrera V, Mordin M, Odom D, Papavassilis C, Nyirady J, Lebwohl M. Secukinumab Provides Clearer Skin and Better Control on Patient-Reported Psoriasis Symptoms of Itching, Pain, and Scaling than Placebo and Etanercept. Journal Of Psoriasis And Psoriatic Arthritis 2016, 1: 167-174. DOI: 10.1177/247553031600100406.Peer-Reviewed Original ResearchPsoriasis-related itchingSevere plaque psoriasisPhase 3 studyComplete symptom reliefWeeks of treatmentProportion of respondersGreater symptom improvementSymptom respondersPlaque psoriasisPsoriasis symptomsSymptom reliefComplete reliefSustained efficacySymptom improvementPsoriasis treatmentResults SubjectsSecukinumabEtanerceptItchingPainClear skinPlaceboMonoclonal antibodiesTreatment effectsPatientsSecukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials
Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, Stonkus S, Septe M, Elewski BE, Gottlieb AB, Zhao Y, Tran MH, Karpov A, McLeod LD, Mordin M, Papavassilis C, Nyirady J, Lebwohl M. Secukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials. International Journal Of Dermatology 2016, 55: 401-407. PMID: 26866518, DOI: 10.1111/ijd.13236.Peer-Reviewed Original ResearchConceptsWeek 12Multicenter phase 3 studyPlacebo-controlled clinical trialInterleukin-17A antagonistPsoriasis-related itchingPlacebo treatment groupsSevere plaque psoriasisPhase 3 studyWeeks of treatmentProportion of subjectsPlaque psoriasisSevere psoriasisPsoriasis symptomsSystemic therapySymptom diaryClinical trialsSecukinumabTreatment responsePlaceboItchingPainTreatment groupsPhase 3PsoriasisAdults
2015
Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis
Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. New England Journal Of Medicine 2015, 373: 1318-1328. PMID: 26422722, DOI: 10.1056/nejmoa1503824.Peer-Reviewed Original ResearchConceptsPASI 100 response ratesGlobal assessment scoreWeek 12Response rateSevere psoriasisStatic Physician's Global Assessment scorePASI 75 response ratesPhysician Global Assessment scoreRates of neutropeniaSerious infectious episodesPhase 3 studySignificant clinical improvementSeverity Index scoreTreatment of psoriasisEarly clinical studiesAMAGINE-2Brodalumab treatmentSPGA scoreInfectious episodesWeek 52Clinical improvementMaintenance dosePASI scorePsoriasis AreaBrodalumab
2010
Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study.
Leonardi C, Strober B, Gottlieb A, Elewski B, Ortonne J, van de Kerkhof P, Chiou C, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. Journal Of Drugs In Dermatology 2010, 9: 928-37. PMID: 20684143.Peer-Reviewed Original ResearchConceptsLong-term safetyExtension studyOpen-label etanercept treatmentPrevious phase 3 studyOpen-label extension studyEfficacy of etanerceptOpen-label studySevere plaque psoriasisPhase 3 studySymptoms of psoriasisEligible patientsEtanercept treatmentInterrupted therapySubcutaneous etanerceptEtanercept therapyPlaque psoriasisAdverse eventsPsoriatic patientsEtanerceptPatientsSkin diseasesPsoriasisWeeksYears of experiencePredetermined criteria
2006
Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis
Elewski B, Leonardi C, Gottlieb A, Strober B, Simiens M, Dunn M, Jahreis A. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. British Journal Of Dermatology 2006, 156: 138-142. PMID: 17199580, DOI: 10.1111/j.1365-2133.2006.07585.x.Peer-Reviewed Original ResearchConceptsPhase 3 studyWeeks of etanerceptGlobal phase 3 studyExtension study baselineExtension studyPK profilesEfficacy endpointStudy baselinePharmacokinetic profileTumor necrosis factor antagonistsOpen-label extension studyDermatology Life Quality IndexGlobal assessmentMean PASI scoreNew safety findingsNecrosis factor antagonistsPhysician global assessmentSevere plaque psoriasisSubset of patientsLife Quality IndexSet of patientsPlaque psoriasisAdult patientsPASI scorePsoriasis Area