2024
Clindamycin 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 success734 - 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 diseaseTriple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis
Kircik L, Stein Gold L, Gold M, Weiss J, Harper J, Del Rosso J, Bunick C, Bhatia N, Tanghetti E, Eichenfield L, Baldwin H, Draelos Z, Callender V, Han G, Gooderham M, Sadick N, Lupo M, Lain E, Werschler W. Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis. Dermatology And Therapy 2024, 14: 1211-1227. PMID: 38724841, PMCID: PMC11116301, DOI: 10.1007/s13555-024-01155-7.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsModerate-to-severe acneClear/almost clear skinTopical acne productsFixed-doseVehicle gelClear skinAcne productsLeast-squares mean percent changesTreatment successEvaluator's Global Severity ScoreIdentical phase 3Acne lesion countsMild-moderate severityGlobal severity scoreReduce antibiotic resistanceNear baseline valuesCutaneous safety/tolerabilityDouble-blindNoninflammatory lesionsResultsAt weekLesion countsAdverse eventsClinical studiesAcne treatment533 - 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 safetyTriple-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
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