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 efficacyClindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.
Lain E, Bhatia N, Kircik L, Gold L, Harper J, Bunick C, Guenin E, Baldwin H, Feldman S, Rosso J. Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis. Journal Of Drugs In Dermatology 2024, 23: 873-881. PMID: 39361705, DOI: 10.36849/jdd.2024.8484.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsModerate-to-severe acneWeeks of once-daily treatmentInflammatory/noninflammatory lesion countsMild to moderate severityTriple-combination treatmentOnce-daily treatmentBaseline to weekPhase 3 studyTreatment success rateQuality-of-life improvementAcne-specific quality of lifePost hoc analysisCutaneous safety/tolerabilityFixed-doseVehicle gelDouble-blindNoninflammatory lesionsFemale acneNo significant differenceImpact of sexEfficacy measuresLesion countsAdverse eventsTreatment success49169 Impact of secukinumab on high-sensitivity C-reactive protein and erythrocyte sedimentation rate: Post hoc analysis of pooled data from the SUNSHINE and SUNRISE Phase 3 randomized trials
van Straalen K, Bunick C, Lobach I, Uhlmann L, Passera A, Alarcon I, Wozniak M, Ravichandran S, Martinez A, da Costa A, Bechara F. 49169 Impact of secukinumab on high-sensitivity C-reactive protein and erythrocyte sedimentation rate: Post hoc analysis of pooled data from the SUNSHINE and SUNRISE Phase 3 randomized trials. Journal Of The American Academy Of Dermatology 2024, 91: ab235. DOI: 10.1016/j.jaad.2024.07.932.Peer-Reviewed Original ResearchTriple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis
Stein Gold L, Gold M, Kircik L, Harper J, Del Rosso J, Bunick C, Bhatia N, Baldwin H, Draelos Z, Callender V, Lain E. Triple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s357. DOI: 10.25251/skin.8.supp.357.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsModerate-to-severe acnePhase 3 studyVehicle gelLeast-squares mean percent changesTreatment successEvaluator's Global Severity ScoreClear/almost clear skinIdentical phase 3Inflammatory/noninflammatory lesion countsTopical acne productsMild-moderate severityGlobal severity scoreReduce antibiotic resistanceNear baseline valuesPost hoc analysisCutaneous safety/tolerabilityDouble-blindModerate acneNoninflammatory lesionsClear skinLesion countsAdverse eventsAcne productsSafety resultsTriple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis
Stein Gold L, Gold M, Kircik L, Harper J, Del Rosso J, Bunick C, Bhatia N, Baldwin H, Draelos Z, Callender V, Lain E. Triple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s339. DOI: 10.25251/skin.8.supp.339.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsModerate-to-severe acnePhase 3 studyVehicle gelLeast-squares mean percent changesTreatment successEvaluator's Global Severity ScoreClear/almost clear skinIdentical phase 3Inflammatory/noninflammatory lesion countsTopical acne productsMild-moderate severityGlobal severity scoreReduce antibiotic resistanceNear baseline valuesPost hoc analysisCutaneous safety/tolerabilityDouble-blindModerate acneNoninflammatory lesionsClear skinLesion countsAdverse eventsAcne productsSafety results