2023
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Strober B, Coates L, Lebwohl M, Deodhar A, Leibowitz E, Rowland K, Kollmeier A, Miller M, Wang Y, Li S, Chakravarty S, Chan D, Shawi M, Yang Y, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Safety 2023, 47: 39-57. PMID: 37906417, PMCID: PMC10764399, DOI: 10.1007/s40264-023-01361-w.Peer-Reviewed Original ResearchConceptsGuselkumab-treated patientsPlacebo-controlled periodBody mass indexPrior biologic usePsoriatic diseaseAE ratesSerious AEsBiologic usePsoriatic arthritisOpportunistic infectionsSerious infectionsPsoriasis studiesWeeks 0Clinical studiesWeek 4Phase II/III studyPhase II/III clinical studiesMajor adverse cardiovascular eventsLong-term safety profileBenefit/risk profileFavorable AE profilePlacebo-treated patientsAdverse cardiovascular eventsActive psoriatic arthritisSubgroup of patients
2019
Long‐term safety of adalimumab in adult patients with plaque psoriasis
Leonardi C, Papp K, Strober B, Thaçi D, Warren R, Tyring S, Arikan D, Karunaratne M, Valdecantos W. Long‐term safety of adalimumab in adult patients with plaque psoriasis. British Journal Of Dermatology 2019, 180: e13-e13. DOI: 10.1111/bjd.17366.Peer-Reviewed Original ResearchNon-melanoma skin cancerPatient yearsLong-term safetyIncidence of NMSCTumor necrosis factor alphaMost common AEsNew safety signalsUpper respiratory infectionIncidence of malignancyAnalysis of patientsNumber of patientsNecrosis factor alphaDifferent clinical trialsCommon AEsPlaque psoriasisAdult patientsAdverse eventsRespiratory infectionsOpportunistic infectionsSerious infectionsClinical trialsIncidence rateSafety signalsFactor alphaAdalimumab
2018
Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries
Strober B, Crowley J, Langley R, Gordon K, Menter A, Leonardi C, Arikan D, Valdecantos W. Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries. Journal Of The European Academy Of Dermatology And Venereology 2018, 32: 2126-2133. PMID: 30067882, DOI: 10.1111/jdv.15203.Peer-Reviewed Original ResearchConceptsMajor cardiac eventsAdverse eventsPsoriasis RegistryReal-world evidenceAdalimumab safetySerious AEsAdult patientsCardiac eventsClinical studiesSafety dataLong-term safety profileCardiovascular-related eventsSerious adverse eventsSerious cardiovascular eventsReal-world safetyLong-term safetyRate of infectionEnglish language manuscriptsCardiovascular eventsSafety profileSerious infectionsAdalimumabClinical practiceEligible papersRegistry
2017
Infections from seven clinical trials of ixekizumab, an anti‐interleukin‐17A monoclonal antibody, in patients with moderate‐to‐severe psoriasis
Papp K, Bachelez H, Blauvelt A, Winthrop K, Romiti R, Ohtsuki M, Acharya N, Braun D, Mallbris L, Zhao F, Xu W, Walls C, Strober B. Infections from seven clinical trials of ixekizumab, an anti‐interleukin‐17A monoclonal antibody, in patients with moderate‐to‐severe psoriasis. British Journal Of Dermatology 2017, 177: 1537-1551. PMID: 28600810, DOI: 10.1111/bjd.15723.Peer-Reviewed Original ResearchConceptsIncidence rateTreatment groupsInfection rateSpecific infection rateSevere psoriasisSerious infectionsExposure-adjusted incidence ratesIRs of infectionsMonoclonal antibodiesWeeks of treatmentOverall infection rateIncidence of infectionOesophageal candidiasisBiological therapyPsoriasis trialsAntifungal therapyClinical trialsIxekizumabCandida infectionsPatientsLong-term exposureInfectionPsoriasisIncidenceTrials
2013
Long‐term safety of ustekinumab in patients with moderate‐to‐severe psoriasis: final results from 5 years of follow‐up
Papp K, Griffiths C, Gordon K, Lebwohl M, Szapary P, Wasfi Y, Chan D, Hsu M, Ho V, Ghislain P, Strober B, Reich K, 1 P. Long‐term safety of ustekinumab in patients with moderate‐to‐severe psoriasis: final results from 5 years of follow‐up. British Journal Of Dermatology 2013, 168: 844-854. PMID: 23301632, DOI: 10.1111/bjd.12214.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedCardiovascular DiseasesClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDermatologic AgentsDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansInfectionsMaleMiddle AgedNeoplasmsPsoriasisRandomized Controlled Trials as TopicUstekinumabConceptsAdverse eventsSevere psoriasisGeneral U.S. populationSerious AEsOverall mortalityRate of AEsOverall adverse eventsSerious adverse eventsAEs of interestU.S. populationLong-term safetyLong-term safety evaluationPatient management decisionsUstekinumab doseUstekinumab exposureDose groupMore dosesPsoriasis trialsSerious infectionsSafety dataCumulative toxicityCumulative exposurePsoriasisPatientsEvent rates
2012
PSOLAR: design, utility, and preliminary results of a prospective, international, disease-based registry of patients with psoriasis who are receiving, or are candidates for, conventional systemic treatments or biologic agents.
Papp K, Strober B, Augustin M, Calabro S, Londhe A, Chevrier M. PSOLAR: design, utility, and preliminary results of a prospective, international, disease-based registry of patients with psoriasis who are receiving, or are candidates for, conventional systemic treatments or biologic agents. Journal Of Drugs In Dermatology 2012, 11: 1210-7. PMID: 23134986.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedArthritis, PsoriaticBody Mass IndexBody Surface AreaCardiovascular DiseasesData Interpretation, StatisticalFemaleHumansImmunologic FactorsInfliximabMaleMiddle AgedObesityPhototherapyProduct Surveillance, PostmarketingProspective StudiesPsoriasisRegistriesUstekinumabConceptsDisease-based registryBiologic agentsObservational studyMajor adverse cardiovascular eventsConventional systemic treatmentsGeneral psoriasis populationPsoriasis Longitudinal AssessmentAdverse cardiovascular eventsOverweight/obeseLong-term observational studyBody surface areaPsoriasis populationCardiovascular eventsCause mortalityAdverse eventsPsoriatic arthritisRegistry studySystemic agentsSystemic therapySystemic treatmentMedication historyDisease characteristicsSerious infectionsMean durationEfficacy data