2024
Switching from Dupilumab to Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab: Efficacy and Safety Results from the Phase 3b/4 LEVEL UP Study
Bunick C, Magnolo N, Moore A, Xinghua G, Lynde C, Ibrahim N, Grada A, Levy G, Calimlim B, Wu X, Armendariz Y, Eyerich K. Switching from Dupilumab to Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab: Efficacy and Safety Results from the Phase 3b/4 LEVEL UP Study. SKIN The Journal Of Cutaneous Medicine 2024, 8: s451. DOI: 10.25251/skin.8.supp.451.Peer-Reviewed Original ResearchAtopic dermatitisSafety resultsInadequate responseEczema Area and Severity IndexWeeks post-switchEczematous skin lesionsOral Janus kinaseEffective treatment strategiesClinically meaningful improvementsClinically meaningful outcomesJanus kinaseChronic skin diseaseOptimal treatment targetsClinical responseMonotherapy studiesSkin clearanceSafety profileDupilumabTreatment strategiesInterleukin-13Interleukin-4UpadacitinibSafety signalsSwitch groupInterleukin-13 signalingEfficacy 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 disease533 - Long-term 5-year safety of upadacitinib in moderate-to-severe atopic dermatitis: an integrated analysis including over 7000 patient-years of exposure
Bunick C, Chovatiya R, Guttman E, Shahriari M, Boguniewicz M, Gao X, Greiwe J, Blauvelt A, Schuttelaar M, Irvine A, Levy G, Platt A, Dilley D, Teixeira H, Altman K, Grada A, Silverberg J. 533 - Long-term 5-year safety of upadacitinib in moderate-to-severe atopic dermatitis: an integrated analysis including over 7000 patient-years of exposure. British Journal Of Dermatology 2024, 190: ii35-ii36. DOI: 10.1093/bjd/ljad498.037.Peer-Reviewed Original ResearchNon-melanoma skin cancerMajor adverse cardiovascular eventsVenous thromboembolic eventsAtopic dermatitisAdverse eventsAdjudicated major adverse cardiovascular eventsOral Janus kinase 1Rate of serious infectionTreatment-emergent adverse eventsLong-term safety dataDuration of follow-upConcomitant topical corticosteroidsEfficacy of upadacitinibDouble-blind periodRate of adverse eventsPhase 3 studyDoses of upadacitinibEczematous skin lesionsExposure-adjusted ratesMATERIALS & METHODSYear of treatmentAdverse cardiovascular eventsBenefit-risk profileInflammatory skin diseaseLong-term safety
2023
427 Long-term 4-year safety of upadacitinib in moderate-to-severe atopic dermatitis: results of an integrated analysis of phase 3 studies
Silverberg J, Bunick C, Lio P, Guttman-Yassky E, Boguniewicz M, Blauvelt A, Bieber T, Thyssen J, Suravaram S, Khan N, Dilley D, Teixeira H, Vigna N, Gamelli A, Grada A, Irvine A. 427 Long-term 4-year safety of upadacitinib in moderate-to-severe atopic dermatitis: results of an integrated analysis of phase 3 studies. British Journal Of Dermatology 2023, 188: ljad162.047. DOI: 10.1093/bjd/ljad162.047.Peer-Reviewed Original ResearchAbstract Atopic dermatitisNonmelanoma skin cancerMajor adverse cardiovascular eventsVenous thromboembolic eventsPhase 3 studyUpadacitinib 15Adverse eventsAtopic dermatitisSerious infectionsAdjudicated major adverse cardiovascular eventOral Janus kinase 1 inhibitorTreatment-emergent adverse eventsLong-term safety dataFavorable benefit-risk profilePivotal phase 3 studiesConcomitant topical corticosteroidsDouble-blinded periodEczematous skin lesionsEfficacy of upadacitinibPivotal phase 3Rapid itch reliefAdverse cardiovascular eventsSevere atopic dermatitisTreatment of adultsExposure-adjusted rates