2024
Brodalumab: Six-Year US Pharmacovigilance Report
Lebwohl M, Koo J, Armstrong A, Strober B, Yoon S, Rawnsley N, Goehring E, Mangin G, Jacobson A. Brodalumab: Six-Year US Pharmacovigilance Report. Dermatology And Therapy 2024, 1-10. PMID: 39589679, DOI: 10.1007/s13555-024-01304-y.Peer-Reviewed Original ResearchAdverse eventsSystemic therapyUS patientsCase of Candida infectionSafety profile of brodalumabSafety of brodalumabMajor adverse cardiovascular eventsInterleukin-17 receptorAdverse cardiovascular eventsLong-term safetyFungal infection rateCandida infectionsPlaque psoriasisSafety profileAdult patientsBrodalumabCardiovascular eventsBox warningPharmacovigilance reportsFungal infectionsClinical trialsPatientsPharmacovigilance dataMedDRA QueriesClinical practiceDeucravacitinib 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: s423. DOI: 10.25251/skin.8.supp.423.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateParent trialAdverse cardiovascular eventsTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsCardiovascular eventsSafety signalsPatientsResponse rateIncidence ratePsoriasisSpesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients switching from conventional systemic treatments: Results from the EFFISAYIL® 2 trial
Merola J, Strober B, Gottlieb A, Mostaghimi A, Hawkes J, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients switching from conventional systemic treatments: Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s488. DOI: 10.25251/skin.8.supp.488.Peer-Reviewed Original ResearchGeneralized pustular psoriasisBody surface areaBody surface area involvementSystemic medicationsConventional systemic treatmentsAverage body surface areaTreating generalized pustular psoriasisLife-threatening skin diseaseSignificant patient burdenYears of ageSystemic therapyDosing regimenSystemic treatmentPediatric patientsPustular psoriasisExtent of involvementSpesolimabWeek 4Skin symptomsPatientsMonoclonal antibodiesLower extremitiesSkin diseasesPatient burdenUpper extremitySpesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients with various lengths of disease history: Results from the EFFISAYIL® 2 trial
Mostaghimi A, Strober B, Merola J, Gottlieb A, Elewski B, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients with various lengths of disease history: Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s489. DOI: 10.25251/skin.8.supp.489.Peer-Reviewed Original ResearchGeneralized pustular psoriasisBody surface areaBody surface area involvementWeek 4Disease historyAverage body surface areaTreating generalized pustular psoriasisYear prior to enrollmentLife-threatening skin diseaseSignificant patient burdenYears of ageDosing regimenPediatric patientsPustular psoriasisExtent of involvementSpesolimabDisease courseSkin symptomsPatientsMonoclonal antibodiesLower extremitiesSkin diseasesPatient burdenUpper extremityTime pointsSpesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial
Gottlieb A, Strober B, Merola J, Mostaghimi A, Farberg A, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s490. DOI: 10.25251/skin.8.supp.490.Peer-Reviewed Original ResearchGeneralized pustular psoriasisPhysician global assessmentSkin symptomsPustular psoriasisGlobal assessmentProportion of patientsPercentage of patientsTreating generalized pustular psoriasisLife-threatening skin diseaseSignificant patient burdenYears of ageDosing regimenPediatric patientsClear skinSpesolimabPatientsContinuous treatmentMonoclonal antibodiesSkin diseasesPatient burdenSymptomsPsoriasisTotal scoreSkinTreatmentSpesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time: Results from the EFFISAYIL® 2 trial
Strober B, Merola J, Gottlieb A, Mostaghimi A, Hsiao J, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time: Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s491. DOI: 10.25251/skin.8.supp.491.Peer-Reviewed Original ResearchGeneralized pustular psoriasisBody surface areaBody surface area involvementTreating generalized pustular psoriasisLife-threatening skin diseaseArea of involvementSignificant patient burdenYears of ageDosing regimenPediatric patientsPustular psoriasisExtent of involvementSpesolimabSkin symptomsContinuous treatmentPatientsMonoclonal antibodiesLower extremitiesSkin diseasesPatient burdenUpper extremityTime pointsTreatmentInvolvementBody regionsMatching-Adjusted Indirect Comparison of Risankizumab Versus Deucravacitinib in Patients with Moderate-to-Severe Plaque Psoriasis
Armstrong A, Soliman A, Gisondi P, Fang S, Patel M, Strober B. Matching-Adjusted Indirect Comparison of Risankizumab Versus Deucravacitinib in Patients with Moderate-to-Severe Plaque Psoriasis. Dermatology And Therapy 2024, 14: 3071-3081. PMID: 39453596, PMCID: PMC11557788, DOI: 10.1007/s13555-024-01293-y.Peer-Reviewed Original ResearchDermatology Life Quality IndexSkin clearanceIndirect comparisonsStatic Physician's Global AssessmentRisankizumab-treated patientsPhysician global assessmentTreatment of psoriasisMatching-adjusted indirect comparisonIndividual patient dataLife Quality IndexPlaque psoriasisPsoriasis AreaRisankizumabDeucravacitinibNew therapiesIntroductionDespite advancesPsO.Global assessmentQuality of lifePsoriasisPatientsPropensity scorePatient dataClearanceHealthcare providers52875 Integrated cardiovascular safety analysis of ritlecitinib in patients with alopecia areata (AA) in the phase 2 and phase 3 ALLEGRO clinical trials, and contextualization with a US cohort of patients with AA
Sicco K, Soung J, Strober B, Irvine A, Wajsbrot D, Gromek K, Wolk R, Barnes D, Takiya L. 52875 Integrated cardiovascular safety analysis of ritlecitinib in patients with alopecia areata (AA) in the phase 2 and phase 3 ALLEGRO clinical trials, and contextualization with a US cohort of patients with AA. Journal Of The American Academy Of Dermatology 2024, 91: ab55. DOI: 10.1016/j.jaad.2024.07.228.Peer-Reviewed Original Research52675 Bimekizumab efficacy across subgroups of patients with moderate to severe plaque psoriasis: Pooled analysis from up to 3 years of treatment in 5 phase 3/3b clinical trials
Strober B, Krueger J, Magnolo N, Vender R, Boehncke W, Hong H, Tilt N, Staelens F, Wiegratz S, Paul C. 52675 Bimekizumab efficacy across subgroups of patients with moderate to severe plaque psoriasis: Pooled analysis from up to 3 years of treatment in 5 phase 3/3b clinical trials. Journal Of The American Academy Of Dermatology 2024, 91: ab142. DOI: 10.1016/j.jaad.2024.07.572.Peer-Reviewed Original ResearchRisk of developing inflammatory arthritis in patients with psoriasis initiating treatment with biologics: A population-based analysis
Strober B, Soliman A, Li C, Patel M, Unigwe I, Gisondi P. Risk of developing inflammatory arthritis in patients with psoriasis initiating treatment with biologics: A population-based analysis. Journal Of The American Academy Of Dermatology 2024, 91: 1143-1149. PMID: 39197499, DOI: 10.1016/j.jaad.2024.06.106.Peer-Reviewed Original ResearchIL-23 inhibitorsDevelopment of inflammatory arthritisIL-23IL-17Inflammatory arthritisPsO patientsTNF inhibitorsMultivariate Cox proportional hazards modelDiagnosis of inflammatory arthritisPatients initiate treatmentCox proportional hazards modelsData Mart DatabaseAdjusted hazard ratiosProportional hazards modelIL-12/23Hazard ratioLow riskPatientsProtopathic biasBaseline diagnosisIncidence rateHazards modelArthritisTNFEffect of biological treatmentSpesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial
Gottlieb A, Strober B, Kokolakis G, Merola J, Zheng M, Langley R, Tang M, Hofmann P, Thoma C, Warren R. Spesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s409. DOI: 10.25251/skin.8.supp.409.Peer-Reviewed Original ResearchGeneralized pustular psoriasisDermatology Life Quality IndexDermatology Life Quality Index scoresGeneralized pustular psoriasis flaresPustular psoriasisVisits up to weekWeek 4Results Baseline characteristicsLength of diseaseLife Quality IndexLife-threatening diseasePlacebo groupHigh-doseSkin pustulesBaseline characteristicsSpesolimabFlare preventionPlaceboDLQI scoreQuality of lifePatientsWeeksPsoriasisScoresDiseaseDeucravacitinib 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 inhibitorDeucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Strober B, Imafuku S, Paul C, Gooderham M, Spelman L, Seo S, Passeron T, Hoyt K, Colombo M, Banerjee S, Augustin M, Stein Gold L, Alexis A, Thaci D, Lebwohl M, Issa N, Cameron M. Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s407. DOI: 10.25251/skin.8.supp.407.Peer-Reviewed Original ResearchLong-term extensionModerate to severe plaque psoriasisSevere plaque psoriasisPlaque psoriasisLong-term extension trialsResponse rateModified nonresponder imputationMaintenance of responseYears of continuous treatmentPhase 3 trialLong-term efficacyNonresponder imputationPrimary endpointPsoriasis AreaResponse assessmentClinical efficacyDeucravacitinibPASISafety signalsTreatment durabilityPatientsContinuous treatmentPsoriasisLong-term effectsParent trialDeucravacitinib onset of action and maintenance of response in phase 3 plaque psoriasis trials
Korman N, Warren R, Bagel J, Armstrong A, Gooderham M, Strober B, Thaçi D, Morita A, Imafuku S, Foley P, Sofen H, Zheng M, Hippeli L, Kisa R, Banerjee S, Blauvelt A. Deucravacitinib onset of action and maintenance of response in phase 3 plaque psoriasis trials. Journal Of Dermatological Treatment 2024, 35: 2371045. PMID: 38945549, DOI: 10.1080/09546634.2024.2371045.Peer-Reviewed Original ResearchConceptsMaintenance of responseModerate to severe plaque psoriasisOnset of actionSevere plaque psoriasisPlaque psoriasisApremilast-treated patientsEfficacy measuresOral placeboClinical responseCoprimary endpointsDeucravacitinibPsoriasis trialsWeek 8PlaceboPASIPatientsWeek 1WeeksEfficacyPsoriasisSPGABaselineSignificant improvementTrialsApremilastP101 Sustained improvement in atopic dermatitis disease control and treatment satisfaction with dupilumab in clinical practice: 4-year follow-up results from the RELIEVE-AD study
Wang Z, Yang M, Chao J, Martins B, Chuang C, Shumel B, Sierka D, Carboni M, Strober B. P101 Sustained improvement in atopic dermatitis disease control and treatment satisfaction with dupilumab in clinical practice: 4-year follow-up results from the RELIEVE-AD study. British Journal Of Dermatology 2024, 191: i63-i64. DOI: 10.1093/bjd/ljae090.128.Peer-Reviewed Original ResearchAtopic dermatitisEpisodes of itchingTreatment satisfactionMonth 1Disease controlClinical practiceProportion of patientsPatient survey studyPercentage of patientsSustained improvementFollow-up resultsPrescribed dupilumabGeneralized estimating equationsQuality of lifePatient support programmeSingle-armDupilumabSkin symptomsBaseline surveyPatientsSupport programmesPatient satisfactionPractice guidelinesStatistical significanceMonthsBrodalumab: 5-Year US Pharmacovigilance Report
Lebwohl M, Koo J, Armstrong A, Strober B, Martin G, Rawnsley N, Goehring E, Jacobson A. Brodalumab: 5-Year US Pharmacovigilance Report. Dermatology And Therapy 2024, 14: 1349-1357. PMID: 38724839, PMCID: PMC11116300, DOI: 10.1007/s13555-024-01162-8.Peer-Reviewed Original ResearchAdverse eventsSystemic therapyInterleukin-17 receptor A antagonistPharmacovigilance dataPsoriasis Longitudinal AssessmentMajor adverse cardiovascular eventsLong-term clinical trialsUS prescribing informationAdverse cardiovascular eventsPlaque psoriasisReported malignanciesSafety profileAdult patientsCardiovascular eventsBrodalumabBox warningUS patientsPharmacovigilance reportsFungal infectionsClinical trialsPrescribing informationSafety signalsSuspected COVID-19 casesPatientsPackage insertsDeucravacitinib 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 inhibitorEfficacyBimekizumab Efficacy through Year 1 in Patients with Moderate to Severe Plaque Psoriasis Who Had Not Achieved a PASI 90 Response by Week 16: A Pooled Analysis from Four Phase 3/3B Trials
Han G, Gottlieb A, Armstrong A, Strober B, Soung J, Herr H, Davis L, Lebwohl M. Bimekizumab Efficacy through Year 1 in Patients with Moderate to Severe Plaque Psoriasis Who Had Not Achieved a PASI 90 Response by Week 16: A Pooled Analysis from Four Phase 3/3B Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s369. DOI: 10.25251/skin.8.supp.369.Peer-Reviewed Original ResearchOpen-label extensionSevere plaque psoriasisPASI responseBaseline PASIPlaque psoriasisSkin clearanceModerate to severe plaque psoriasisInhibits interleukin (IL)-17FLevels of skin clearanceDouble-blind periodPhase 3b trialPhase 3 trialProportion of patientsInterleukin (IL)-17FAssociated with improved quality of lifeMonoclonal IgG1 antibodyHigher PASIMaintenance dosePsoriasis AreaBimekizumabAssociated with improved qualityPooled analysisPASIPatientsQuality of lifeEffect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis
Strober B, Augustin M, Tada Y, Garg A, Jullien D, Gottlieb A, Gudjonsson J, Hu N, Hofmann P, Thoma C, Marzano A. Effect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s371. DOI: 10.25251/skin.8.supp.371.Peer-Reviewed Original ResearchGeneralized pustular psoriasisProportion of patientsGeneralized pustular psoriasis flaresWeek 4Pustular psoriasisGeneralized Pustular Psoriasis Physician Global AssessmentPhysician global assessmentTotal scoreLife-threatening skin diseaseRandomized controlled trialsPlacebo groupMaintenance doseLoading doseSterile pustulesSkin manifestationsSpesolimabApproved treatmentPlaceboTreatment periodGlobal assessmentPatientsMonoclonal antibodiesTreatment groupsSkin diseasesBaseline scoresAssociation of the clinical components in the distal interphalangeal joint synovio-entheseal complex and subsequent response to ixekizumab or adalimumab in psoriatic arthritis
McGonagle D, Kavanaugh A, McInnes I, Kristensen L, Merola J, Strober B, Bolce R, Lisse J, Pustizzi J, Sapin C, Ritchlin C. Association of the clinical components in the distal interphalangeal joint synovio-entheseal complex and subsequent response to ixekizumab or adalimumab in psoriatic arthritis. Rheumatology 2024, 63: 3115-3123. PMID: 38341669, PMCID: PMC11534097, DOI: 10.1093/rheumatology/keae060.Peer-Reviewed Original ResearchNail psoriasisJoint involvementPsoriatic arthritisJoint tendernessTargeting IL-17ADistal interphalangeal joint involvementPost hoc analysisPost-baseline assessmentSPIRIT-H2HInhibitor adalimumabIL-17AAdalimumabStudy cohortTNF-aDrug classesMusculoskeletal outcomesPsoriasisPatientsHoc analysisDistal interphalangealIxekizumabSynovio-entheseal complexWeeksAdjacent nailPSA