2024
Early and Sustained Improvements in Symptoms and Quality of Life with Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: 52-Week Results from Two Phase III Randomized Clinical Trials (Measure Up 1 and Measure Up 2)
Silverberg J, Gooderham M, Paller A, Deleuran M, Bunick C, Gold L, Hijnen D, Calimlim B, Lee W, Teixeira H, Hu X, Zhang S, Yang Y, Grada A, Platt A, Thaçi D. Early and Sustained Improvements in Symptoms and Quality of Life with Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis: 52-Week Results from Two Phase III Randomized Clinical Trials (Measure Up 1 and Measure Up 2). American Journal Of Clinical Dermatology 2024, 25: 485-496. PMID: 38528257, PMCID: PMC11070400, DOI: 10.1007/s40257-024-00853-4.Peer-Reviewed Original ResearchPatient Global ImpressionModerate-to-severe atopic dermatitisPatients treated with upadacitinibPatient-reported outcomesGlobal ImpressionAtopic dermatitisWeek 1Skin symptomsQuality of lifeTreating moderate-to-severe atopic dermatitisPhase III monotherapy trialsPhase III randomized clinical trialsWeek 8Baseline to week 1Pruritus Numerical Rating ScaleScoring Atopic Dermatitis indexEffect of upadacitinibOral selective Janus kinaseAtopic Dermatitis indexAssessed patient-reported outcomesMinimal clinically important differenceNumerical rating scaleDermatology Life Quality IndexPatient-Oriented Eczema MeasureChronic inflammatory 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 safety504 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis
Bunick C, Bhatia N, Del Rosso J, Draelos Z, Eichenfield L, Kircik L, Lebwohl M, Gooderham M, Green L, Hebert A, Vender R, Zirwas M, Simpson E, Gold L, Seal M, Snyder S, Osborne D, Burnett P, Higham R, Chu D, Berk D. 504 - Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis. British Journal Of Dermatology 2024, 190: ii9-ii10. DOI: 10.1093/bjd/ljad498.012.Peer-Reviewed Original ResearchPhase 3 trialLocal tolerancePatient treatment adherenceAdverse eventsPenetration enhancersRoflumilast-treated patientsRate of adverse eventsTreatment adherencePatient-rated assessmentsApplication siteTopical medicationsIntertriginous areasAtopic dermatitisRoflumilast creamDay 1Seborrheic dermatitisWater-based creamRoflumilastInvestigational productPatientsInvestigator-PsoriasisPrescription productsTrialsClinicInvestigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis
Bunick C, Bhatia N, Del Rosso J, Draelos Z, Eichenfield L, Kircik L, Lebwohl M, Gooderham M, Green L, Hebert A, Vender R, Zirwas M, Simpson E, Stein Gold L, Seal M, Snyder S, Osborne D, Burnett P, Higham R, Chu D, Berk D. Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s309. DOI: 10.25251/skin.8.supp.309.Peer-Reviewed Original ResearchPhase 3 trialLocal toleranceAdverse eventsPatient treatment adherencePatients discontinued due to adverse eventsAtopic dermatitisSeborrheic dermatitisPenetration enhancersRoflumilast-treated patientsRate of adverse eventsTreatment adherencePatient-rated assessmentsApplication siteTopical medicationsIntertriginous areasRoflumilast creamDay 1RoflumilastWater-based creamInvestigator-Investigational productPatientsPsoriasisDermatitisPrescription products
2023
Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis
Bunick C, Bhatia N, Del Rosso J, Draelos Z, Eichnfield L, Kircik L, Lebwohl M, Gooderham M, Green L, Hebert A, Vender R, Zirwas M, Simpson E, Stein Gold L, Seal M, Snyder S, Osborne D, Burnett P, Higham R, Chu D, Berk D. Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis. SKIN The Journal Of Cutaneous Medicine 2023, 7: s251. DOI: 10.25251/skin.7.supp.251.Peer-Reviewed Original Research42262 Sustained Improvement Over 52 Weeks in Patient-Reported Itch, Symptoms, and Quality of Life With Upadacitinib in Patients With Atopic Dermatitis: Results From Phase 3 Studies (Measure Up 1, Measure Up 2, and AD Up)
Silverberg J, Deleuran M, Gold L, Bunick C, Hijnen D, Calimlim B, Teixeira H, Platt A, Grada A, Hu X, Gooderham M. 42262 Sustained Improvement Over 52 Weeks in Patient-Reported Itch, Symptoms, and Quality of Life With Upadacitinib in Patients With Atopic Dermatitis: Results From Phase 3 Studies (Measure Up 1, Measure Up 2, and AD Up). Journal Of The American Academy Of Dermatology 2023, 89: ab90. DOI: 10.1016/j.jaad.2023.07.365.Peer-Reviewed Original Research427 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
2022
JAK Inhibitor Safety Compared to Traditional Systemic Immunosuppressive Therapies.
Daniele S, Bunick C. JAK Inhibitor Safety Compared to Traditional Systemic Immunosuppressive Therapies. Journal Of Drugs In Dermatology 2022, 21: 1298-1303. PMID: 36468956, DOI: 10.36849/jdd.7187.Peer-Reviewed Original ResearchConceptsIncidence of adverse eventsAdverse cardiac eventsNon-melanoma skin cancerSystemic therapyAdverse eventsAtopic dermatitisCardiac eventsJAK inhibitorsVenous thromboembolismControl patientsSkin cancerIncidence rateTreatment of atopic dermatitisSystemic immunosuppressive therapyRates of non-melanoma skin cancerTraditional systemic therapiesIncidence of malignancyLong-term clinical trial dataReference control populationAtopic dermatitis treatmentBaseline rateLow incidence rateClinical trial dataImmunosuppressive therapySystemic corticosteroids