2024
683 - Risk of major adverse cardiovascular events in patients with moderate-to-severe atopic dermatitis: a United States population-based study
Bunick C, Grada A, Del Rosso J, Armstrong A, Yue E, Krueger W. 683 - Risk of major adverse cardiovascular events in patients with moderate-to-severe atopic dermatitis: a United States population-based study. British Journal Of Dermatology 2024, 191: ljae266.057. DOI: 10.1093/bjd/ljae266.057.Peer-Reviewed Original ResearchRisk of MACEModerate-to-severe diseaseIncidence of MACEMACE riskAdverse cardiovascular eventsAtopic dermatitisMatched controlsRheumatoid arthritisCardiovascular diseaseCardiovascular eventsModerate-to-severe atopic dermatitisAssociated with increased MACE riskRelative risk of MACEMultivariate Cox proportional hazards modelRelative riskCohort entry dateModerate-to-severe ADHistory of cardiovascular diseaseAssociated with multiple comorbiditiesIncreased MACE riskHistory of smokingChronic systemic inflammationFollow-up periodCox proportional hazards modelsUS administrative claims data734 - 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 disease681 - Risk of malignancy excluding nonmelanoma skin cancer in patients with moderate-to-severe atopic dermatitis in the United States: a population-based study using claims data
Vleugels R, Grada A, Yue E, Bunick C, Galimberti F, Krueger W. 681 - Risk of malignancy excluding nonmelanoma skin cancer in patients with moderate-to-severe atopic dermatitis in the United States: a population-based study using claims data. British Journal Of Dermatology 2024, 191: ljae266.055. DOI: 10.1093/bjd/ljae266.055.Peer-Reviewed Original ResearchNon-melanoma skin cancerRisk of malignancyModerate-to-severe diseaseCohort entry dateAtopic dermatitisRheumatoid arthritisFollow-upModerate-to-severe atopic dermatitisSkin cancerNon-AD cohortIncidence of malignancyNonmelanoma skin cancerSubgroup of patientsNon-AD controlsFollow-up periodCox proportional hazards modelsChronic liver diseaseEffect of disease activityInternational Classification of Diseases (ICD)-9Population-based studyProportional hazards modelClinformatics Data MartSystemic therapyClaims-based studyOptum Clinformatics Data Mart696 - Sustained improvements over 140 weeks in signs, symptoms, and quality of life with upadacitinib in adolescents and adults with moderate-to-severe atopic dermatitis: integrated results from the phase 3 Measure Up 1 and Measure Up 2 studies
Prajapati V, Bunick C, Eyerich K, Gold L, Galimberti F, Calimlim B, Teixeira H, Hu X, Yang Y, Sancho C, Grada A, Irvine A. 696 - Sustained improvements over 140 weeks in signs, symptoms, and quality of life with upadacitinib in adolescents and adults with moderate-to-severe atopic dermatitis: integrated results from the phase 3 Measure Up 1 and Measure Up 2 studies. British Journal Of Dermatology 2024, 191: ljae266.070. DOI: 10.1093/bjd/ljae266.070.Peer-Reviewed Original ResearchSkin symptom severityPatient-reported outcomesAtopic dermatitisSkin painClinically meaningful improvementsUpadacitinib monotherapyPatients treated with upadacitinibPatients randomized to placeboSkin symptomsMeaningful improvementsQuality of lifeTreating moderate-to-severe ADModerate-to-severe ADPhase 3 studyDoses of upadacitinibMinimal clinically important differenceSustained improvementJanus kinase inhibitorsClinically important differenceEvaluate long-term benefitsReduced quality of lifeEczema AreaDLQI 0/1Symptom severityKinase inhibitors640 - 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. 640 - 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, 191: ljae266.021. DOI: 10.1093/bjd/ljae266.021.Peer-Reviewed Original ResearchPhase 3 trialLocal tolerancePatient treatment adherenceAdverse eventsAtopic dermatitisSeborrheic dermatitisPenetration enhancersRoflumilast-treated patientsRate of adverse eventsTreatment adherencePatient-rated assessmentsApplication siteTopical medicationsIntertriginous areasRoflumilast creamDay 1Water-based creamRoflumilastInvestigational productPatientsInvestigator-PsoriasisDermatitisPrescription productsTrials697 - Risk of non-melanoma skin cancer in patients with moderate-to-severe atopic dermatitis: a United States population-based study using claims data
Lebwohl M, Yue E, Krueger W, Berman B, Bunick C, Schlesinger T, Grada A. 697 - Risk of non-melanoma skin cancer in patients with moderate-to-severe atopic dermatitis: a United States population-based study using claims data. British Journal Of Dermatology 2024, 191: ljae266.071. DOI: 10.1093/bjd/ljae266.071.Peer-Reviewed Original ResearchNon-melanoma skin cancerRisk of non-melanoma skin cancerModerate-to-severe diseaseAtopic dermatitisNon-AD cohortRheumatoid arthritisControl cohortNon-melanoma skin cancer riskModerate-to-severe atopic dermatitisNon-melanoma skin cancer incidenceMultivariate Cox proportional hazards modelSkin cancerModerate-to-severe ADCohort entry dateSquamous cell carcinomaMatched control cohortIntermittent sun exposureFollow-up timeNon-AD controlsRetrospective observational studyCox proportional hazards modelsEffect of disease activityPopulation-based studyProportional hazards modelClinformatics Data Mart706 - Real-world patient experience of upadacitinib-treated adults with atopic dermatitis: results from the SCALE-UP study
Silverberg J, Calimlim B, Fuxench Z, Altman K, Bensimon A, Liu J, Bunick C. 706 - Real-world patient experience of upadacitinib-treated adults with atopic dermatitis: results from the SCALE-UP study. British Journal Of Dermatology 2024, 191: ljae266.080. DOI: 10.1093/bjd/ljae266.080.Peer-Reviewed Original ResearchPatient support programAtopic dermatitisItch improvementSkin clearanceOral Janus kinase inhibitorPatient experiencePhase 3 clinical trialsTreating moderate-to-severe ADEffect of upadacitinibMultiple phase 3 clinical trialsModerate-to-severe ADJanus kinase inhibitorsClinical trial resultsPatient-reported experiencesDecreased quality of lifeEvaluate patient experiencePatient-reported outcomesTopical corticosteroidsPatient ageCross-sectional analysisQuality of lifeUpadacitinib dosesKinase inhibitorsUpadacitinibTreatment duration699 - Prevalence and incidence of atopic dermatitis in patients with alopecia areata in the United States: a population-based study
Mostaghimi A, Armstrong A, Grada A, Soliman A, Li C, C Bristow C, Lipiszko D, Silverberg J, Issa N, Bunick C. 699 - Prevalence and incidence of atopic dermatitis in patients with alopecia areata in the United States: a population-based study. British Journal Of Dermatology 2024, 191: ljae266.073. DOI: 10.1093/bjd/ljae266.073.Peer-Reviewed Original ResearchPost-index dateCharlson Comorbidity IndexModerate-to-severe ADMild AAModerate-to-severe AASevere AAModerate-to-severeAlopecia areataAtopic dermatitisMarketScan Commercial ClaimsTopical corticosteroidsAlopecia totalisReal-world prevalenceIndex dateAlopecia universalisHigh-potency topical corticosteroidsMonths post-index dateAA disease severityIncidence of atopic dermatitisHighest prevalencePotency topical corticosteroidsUS administrative claims databasePrevalence of AACox proportional hazards modelsAD comorbidityEarly 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 disease504 - 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 productsTrialsClinic533 - 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 safetyInvestigator- 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