2024
Efficacy and Safety of Upadacitinib vs Dupilumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: Week 16 results of an Open-label, Randomized, Efficacy Assessor-Blinded Head-to-Head Phase 3b/4 Study (Level Up)
Silverberg J, Bunick C, Hong H, Mendes-Bastos P, Gold L, Costanzo A, Ibrahim N, Sancho C, Wu X, Han Y, Levy G, Altman K, Calimlim B, Eyerich K. Efficacy and Safety of Upadacitinib vs Dupilumab in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: Week 16 results of an Open-label, Randomized, Efficacy Assessor-Blinded Head-to-Head Phase 3b/4 Study (Level Up). British Journal Of Dermatology 2024, ljae404. PMID: 39438067, DOI: 10.1093/bjd/ljae404.Peer-Reviewed Original ResearchAtopic dermatitisSecondary endpointsDose escalationOpen-labelClinical responseSafety profile of upadacitinibSafety signalsResponse to systemic therapyPruritus Numerical Rating ScaleSafety of upadacitinibEczematous skin lesionsWeeks of treatmentNumerical rating scaleSeverity Index reductionsChronic skin diseasePost hoc analysisPhase 3b/4Systemic therapyItch responseSystemic treatmentPrimary endpointEczema AreaDupilumabSafety profileSuperior efficacy734 - Efficacy and safety of upadacitinib vs dupliumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (Level Up)
Silverberg J, Bunick C, Hong H, Mendes-Bastos P, Gold L, Costanzo A, Ibrahim N, Sancho C, Wu X, Han Y, Levy G, Altman K, Eyerich K. 734 - Efficacy and safety of upadacitinib vs dupliumab in adults and adolescents with moderate-to-severe atopic dermatitis: results of an open-label, efficacy assessor-blinded head-to-head phase 3b/4 study (Level Up). British Journal Of Dermatology 2024, 191: ljae266.107. DOI: 10.1093/bjd/ljae266.107.Peer-Reviewed Original ResearchSafety of upadacitinibVenous thromboembolic eventsProportion of patientsAdverse eventsAtopic dermatitisDose escalationSystemic therapyOpen-labelSecondary endpointsAdjudicated major adverse cardiac eventsModerate-to-severe atopic dermatitisResponse to systemic therapyTreatment-emergent adverse eventsWeek 4Major adverse cardiac eventsPruritus Numerical Rating ScaleChronic inflammatory skin diseaseDiscontinuation of study treatmentEczematous skin lesionsOral Janus kinaseSevere adverse eventsAdverse cardiac eventsWeeks of treatmentNumerical rating scaleInflammatory skin disease
2023
Topical Isotretinoin (TMB-001) Treatment for 12 Weeks Did Not Result in Clinically Relevant Laboratory Abnormalities in Participants with Congenital Ichthyosis in the Phase 2b CONTROL Study
Marathe K, Teng J, Guenthner S, Bunick C, Kempers S, Eads K, Castelo-Soccio L, Mendelsohn A, Raiz J, Murrell D. Topical Isotretinoin (TMB-001) Treatment for 12 Weeks Did Not Result in Clinically Relevant Laboratory Abnormalities in Participants with Congenital Ichthyosis in the Phase 2b CONTROL Study. Dermatology And Therapy 2023, 13: 1255-1264. PMID: 37170057, PMCID: PMC10264299, DOI: 10.1007/s13555-023-00923-1.Peer-Reviewed Original ResearchSignificant laboratory changesLaboratory changesCongenital ichthyosisLaboratory parameter changesRelevant laboratory abnormalitiesPhase 2b studyWeeks of treatmentYears of ageSingle reportCI subtypesIsotretinoin treatmentStudy discontinuationSystemic isotretinoinUrinalysis abnormalitiesLaboratory abnormalitiesOral retinoidsTreatment cohortsVehicle treatmentDrug withdrawalLaboratory valuesLeukocyte esteraseUrea nitrogenControl studyWeeksNeutropenia