2025
Deucravacitinib in Moderate to Severe Plaque Psoriasis: 5-year, Long-term Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Warren R, Strober B, Blauvelt A, Tada Y, Passeron T, Thaçi D, Daamen C, Li J, Popmihajlov Z, Vaile J, Scotto J, Lebwohl M. Deucravacitinib in Moderate to Severe Plaque Psoriasis: 5-year, Long-term Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2025, 9: s532. DOI: 10.25251/skin.10.supp.532.Peer-Reviewed Original ResearchLong-term extensionLong-term extension trialsSevere plaque psoriasisPlaque psoriasisLong-term safetyTyrosine kinase 2Moderate to severe plaque psoriasisSafety signalsExposure-adjusted incidence ratesModified nonresponder imputationClinical response rateClinical efficacy rateParent trialYears of continuous treatmentLong-term efficacyYear of treatmentAssess adverse eventsTreatment of adultsOral placeboSystemic therapyNonresponder imputationEfficacy rateTargeted therapySafety profileEfficacy profileDeucravacitinib in plaque psoriasis: Four‐year safety and efficacy results from the Phase 3 POETYK PSO‐1, PSO‐2 and long‐term extension trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Paul C, Papp K, Colombo M, Scotto J, Vaile J, Zhuo J, Vritzali E, Berger V, Schroeder G, Banerjee S, Thaçi D, Strober B. Deucravacitinib in plaque psoriasis: Four‐year safety and efficacy results from the Phase 3 POETYK PSO‐1, PSO‐2 and long‐term extension trials. Journal Of The European Academy Of Dermatology And Venereology 2025, 39: 1336-1351. PMID: 40045918, PMCID: PMC12188513, DOI: 10.1111/jdv.20553.Peer-Reviewed Original ResearchLong-term extension trialsLong-term extensionModerate to severe plaque psoriasisSevere plaque psoriasisPlaque psoriasisAdverse eventsTyrosine kinase 2Person yearsData cut-offYear of treatmentAdverse cardiovascular eventsTreatment of adultsPatient-reported outcomesSystemic therapyHerpes zosterSafety profileVenous thromboembolismDeucravacitinibCardiovascular eventsEfficacy resultsPatientsPsoriasisOutcome ratesExtension trialParent trialNatural Product Use for Chronic Pain: A New Survey of Patterns of Use, Beliefs, Concerns, and Disclosure to Providers
Seal K, Feinberg T, Moore L, Woodruff N, Purcell N, Bertenthal D, McCamish N, Becker W. Natural Product Use for Chronic Pain: A New Survey of Patterns of Use, Beliefs, Concerns, and Disclosure to Providers. Global Advances In Integrative Medicine And Health 2025, 14: 27536130251320101. PMID: 40026674, PMCID: PMC11869316, DOI: 10.1177/27536130251320101.Peer-Reviewed Original ResearchVeterans Health AdministrationChronic painPrimary carePain medicationPragmatic trialVA primary careVeteran focus groupsRespondents' mean ageNon-opioid pain medicationsPain management approachesNatural product useHealth AdministrationFocus groupsNP useParent trialPrescribed medicationsHispanic/Latinx ethnicityPrescribed opioidsDisabling painMedication substitutionProvidersVeteransMean ageClinical dataPain
2024
Deucravacitinib in Plaque Psoriasis: 4-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Colombo M, Vaile J, Vritzali E, Hoyt K, Daamen C, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 4-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s423. DOI: 10.25251/skin.8.supp.423.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateParent trialAdverse cardiovascular eventsTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsCardiovascular eventsSafety signalsPatientsResponse rateIncidence ratePsoriasisPromoting Race and Ethnic Diversity in a Hospital-Based Randomized Clinical Trial to Address Untreated Alcohol Use Disorder: Initial Lessons Learned
Edelman E, Frankforter T, Rojas-Perez O, Ablondi K, Castro C, Corvino J, Garcia I, Gordon D, Jaramillo Y, Johnson N, Jordan A, Nich C, Paris M, Pagano D, Weimer M, Williams E, Kiluk B. Promoting Race and Ethnic Diversity in a Hospital-Based Randomized Clinical Trial to Address Untreated Alcohol Use Disorder: Initial Lessons Learned. Journal Of Addiction Medicine 2024, 19: 334-337. PMID: 39514895, PMCID: PMC12178687, DOI: 10.1097/adm.0000000000001400.Peer-Reviewed Original ResearchAlcohol use disorderBrief Negotiation InterviewUntreated Alcohol Use DisorderUse disorderSocial determinants of healthCognitive behavioral therapyElectronic medical record dataDeterminants of healthEthnically diverse sampleMedical record dataMonths of recruitmentBehavioral therapyModifications-EnhancedReporting AdaptationsTreatment engagementEffectiveness of strategiesSocial determinantsInitiation of medicationRecruitment approachesDiverse samplePost-hospitalizationAlcohol useResearch staffParent trialRecord dataReliability of Uroflowmetry Pattern Interpretation in Adult Women
Rickey L, Mueller E, Newman D, Markland A, Falke C, Rudser K, Smith A, Mueller M, Lowder J, Lukacz E, Consortium P. Reliability of Uroflowmetry Pattern Interpretation in Adult Women. Neurourology And Urodynamics 2024, 43: 2084-2092. PMID: 39264028, PMCID: PMC12006900, DOI: 10.1002/nau.25584.Peer-Reviewed Original ResearchInterrater reliabilityIntrarater reliabilityModerate interrater reliabilityNon-Hispanic ethnicityAge of participantsHealth instrumentsObservational cohort studyFemale LUTSUroflowmetry studiesParent trialVoiding dysfunctionCohort studyUroflowmetry dataScreening toolRe-reviewedUroflow curvesUroflowmetryAge categoriesAdult womenVoiding timeIntraraterUroflowmetry tracingsRatersWomenVoid volumeDeucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Colombo M, Vaile J, Vritzali E, Hoyt K, Daamen C, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s406. DOI: 10.25251/skin.8.supp.406.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsSafety signalsPatientsContinuous treatmentResponse rateIncidence rateParent trialPsoriasisAllosteric TYK2 inhibitorDeucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Strober B, Imafuku S, Paul C, Gooderham M, Spelman L, Seo S, Passeron T, Hoyt K, Colombo M, Banerjee S, Augustin M, Stein Gold L, Alexis A, Thaci D, Lebwohl M, Issa N, Cameron M. Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s407. DOI: 10.25251/skin.8.supp.407.Peer-Reviewed Original ResearchLong-term extensionModerate to severe plaque psoriasisSevere plaque psoriasisPlaque psoriasisLong-term extension trialsResponse rateModified nonresponder imputationMaintenance of responseYears of continuous treatmentPhase 3 trialLong-term efficacyNonresponder imputationPrimary endpointPsoriasis AreaResponse assessmentClinical efficacyDeucravacitinibPASISafety signalsTreatment durabilityPatientsContinuous treatmentPsoriasisLong-term effectsParent trialDeucravacitinib in Plaque Psoriasis: 3-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1 and PSO-2 Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 3-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s366. DOI: 10.25251/skin.8.supp.366.Peer-Reviewed Original ResearchModified nonresponder imputationPlaque psoriasisModerate to severe plaque psoriasisDiscontinuations due to AEsExposure-adjusted incidence ratesSevere plaque psoriasisParent trialAdverse cardiovascular eventsLong-term extensionTreatment of adultsSystemic therapyNonresponder imputationEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismDeucravacitinibCardiovascular eventsEfficacy resultsPatientsResponse rateIncidence ratePsoriasisAllosteric TYK2 inhibitorEfficacy
2023
Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials
Sofen H, Strober B, Imafuku S, Paul C, Gooderham M, Spelman L, Seo S, Passeron T, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Augustin M, Stein Gold L, Alexis A, Thaçi D, Blauvelt A, Lebwohl M. Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s241. DOI: 10.25251/skin.7.supp.241.Peer-Reviewed Original ResearchPASI 75 respondersSevere plaque psoriasisPASI 75PASI 90Week 148Plaque psoriasisWeek 52Week 16Week 24Parent trialClinical efficacyDay 1Response rateLong-term extension trialsNew safety signalsPhase 3 trialSubset of patientsMaintenance of responseLong-term efficacyLong-term effectivenessNonresponder imputationOral placeboPsoriasis AreaExtension trialSafety signalsDeucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s240. DOI: 10.25251/skin.7.supp.240.Peer-Reviewed Original ResearchSevere plaque psoriasisPlaque psoriasisParent trialDay 1Exposure-adjusted incidence ratesLong-term extension trialsMajor adverse cardiovascular eventsAdverse cardiovascular eventsConsistent safety profileTreatment of adultsNonresponder imputationOral placeboSerious AEsWeek 148Cardiovascular eventsEfficacy outcomesVenous thromboembolismWeek 52Herpes zosterSystemic therapyDurable efficacySafety profileExtension trialIncidence rateEfficacy results
2022
Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial
Pashchenko O, Bromberg D, Dumchev K, LaMonaca K, Pykalo I, Filippovych M, Esserman D, Polonsky M, de Leon S, Morozova O, Dvoriak S, Altice F. Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial. PLOS Global Public Health 2022, 2: e0000344. PMID: 36962514, PMCID: PMC10021202, DOI: 10.1371/journal.pgph.0000344.Peer-Reviewed Original ResearchPrimary care clinicsOpioid use disorderOpioid agonist therapyPrimary careComplete self-reported dataPatient medical record dataMedical record dataComprehensive health outcomesAddiction treatment clinicsAdult PWIDAgonist therapySecondary outcomesParent trialPrimary outcomeRandomized participantsCare clinicsTreatment clinicsIntervention sitesUse disordersHealth outcomesAddiction treatmentRecord dataSelf-reported dataHealth indicatorsClinic
2020
Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Houndé District, Burkina Faso and Bougouni District, Mali
Cairns M, Sagara I, Zongo I, Kuepfer I, Thera I, Nikiema F, Diarra M, Yerbanga S, Barry A, Tapily A, Coumare S, Milligan P, Tinto H, Ouédraogo J, Chandramohan D, Greenwood B, Djimde A, Dicko A. Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Houndé District, Burkina Faso and Bougouni District, Mali. PLOS Medicine 2020, 17: e1003214. PMID: 32822362, PMCID: PMC7442230, DOI: 10.1371/journal.pmed.1003214.Peer-Reviewed Original ResearchConceptsSeasonal malaria chemopreventionMalaria chemopreventionUncomplicated malariaTransmission seasonIntense seasonal malaria transmissionDay 28 PCRParasitological response rateUncomplicated clinical malariaPlacebo-controlled trialIncidence of hospitalisationSeasonal malaria transmissionIncidence rate ratiosBurden of malariaRapid diagnostic testsBougouni DistrictAsymptomatic malariaClinical malariaPlacebo groupStudy drugMalaria parasitaemiaAge range 3Parent trialAmodiaquine resistancePrevalence ratiosProtective efficacyAssessment of Patient and Caregiver Attitudes and Approaches to Decision-Making Regarding Bone Marrow Transplant for Sickle Cell Disease
Bakshi N, Katoch D, Sinha C, Ross D, Quarmyne M, Loewenstein G, Krishnamurti L. Assessment of Patient and Caregiver Attitudes and Approaches to Decision-Making Regarding Bone Marrow Transplant for Sickle Cell Disease. JAMA Network Open 2020, 3: e206742. PMID: 32469414, PMCID: PMC7260617, DOI: 10.1001/jamanetworkopen.2020.6742.Peer-Reviewed Original ResearchConceptsBone marrow transplantCaregivers of patientsSickle cell diseasePatient decision aidMarrow transplantMedian ageCurative treatmentCell diseaseGroup 2Group 1Caregiver attitudesNovel disease-modifying therapiesDisease-modifying therapiesSickle cell clinicAssessment of patientsFuture prospective studiesRandomized clinical trialsParent trialProspective studyTreatment optionsClinical trialsNeeds assessment phaseMAIN OUTCOMECell clinicPatientsLong-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer
Agin-Liebes G, Malone T, Yalch M, Mennenga S, Ponté K, Guss J, Bossis A, Grigsby J, Fischer S, Ross S. Long-term follow-up of psilocybin-assisted psychotherapy for psychiatric and existential distress in patients with life-threatening cancer. Journal Of Psychopharmacology 2020, 34: 155-166. PMID: 31916890, DOI: 10.1177/0269881119897615.Peer-Reviewed Original ResearchConceptsPsilocybin-assisted psychotherapyLife-threatening cancerAnxiolytic responseExistential distressPsychiatric distressLong-term reliefQuality of lifeGroup effect sizesSubset of participantsSelf-reported symptomatologyParent trialPresent studySecond followPsilocybin administrationParent studyCrossover designPositive life changesTherapy experiencePatientsSpiritual wellDistressTherapyCancerEffect sizeLife changes
2016
Is mode of delivery associated with the risk of necrotizing enterocolitis?
Son M, Grobman WA, Miller ES. Is mode of delivery associated with the risk of necrotizing enterocolitis? American Journal Of Obstetrics And Gynecology 2016, 215: 389.e1-389.e4. PMID: 27173084, DOI: 10.1016/j.ajog.2016.04.058.Peer-Reviewed Original ResearchConceptsMode of deliveryCesarean deliveryGestational agePreterm deliveryVaginal deliveryBivariable analysisPotential confoundersExtreme preterm deliveryMother-neonate pairsNeonates of womenWeeks gestational ageWeeks of gestationCohort of womenImminent riskSingleton gestationsParent trialCerebral palsyMultivariable analysisMinimum relative riskRelative riskEnterocolitisNeonatesSecondary analysisWomenMagnesium sulfate
2014
Effect of Optional Home Initiation of HIV Care Following HIV Self-testing on Antiretroviral Therapy Initiation Among Adults in Malawi: A Randomized Clinical Trial
MacPherson P, Lalloo D, Webb E, Maheswaran H, Choko A, Makombe S, Butterworth A, van Oosterhout J, Desmond N, Thindwa D, Squire S, Hayes R, Corbett E. Effect of Optional Home Initiation of HIV Care Following HIV Self-testing on Antiretroviral Therapy Initiation Among Adults in Malawi: A Randomized Clinical Trial. JAMA 2014, 312: 372-379. PMID: 25038356, PMCID: PMC4118051, DOI: 10.1001/jama.2014.6493.Peer-Reviewed Original ResearchConceptsHIV self-test resultsAntiretroviral therapy initiationSelf-test resultsHIV careHome initiationTherapy initiationART initiatorsHome groupAdult residentsSelf-testing groupStandard HIV careUptake of HIVFacility-based careFacility-based servicesHIV self-testingProportion of adultsART initiationHome HIVSecondary outcomesHIV infectionParent trialPrimary outcomeMalawian adultsClinical trialsEarly diagnosis
2006
Multicenter Open-label Extension Trial of Long-term Treatment with Gefitinib (IRESSA®)
Nakagawa K, Ranson M, Yano S, Tamura T, Saka H, Imamura F, Yokoyama A, Matsui K, Jiang H, Herbst R. Multicenter Open-label Extension Trial of Long-term Treatment with Gefitinib (IRESSA®). Haigan 2006, 46: 345. DOI: 10.2482/haigan.46.345.Peer-Reviewed Original ResearchProgression-free survivalLong-term treatmentNew safety issuesExtension trialOpen-label extension trialSkin-related adverse eventsMedian overall survivalMajority of patientsLong-term safetyGefitinib monotherapyAdvanced NSCLCAdverse eventsOverall survivalParent trialClinical benefitGefitinib treatmentSafety profileClinical trialsClinical studiesPatientsGefitinibIdeal 1TrialsSafety issuesSurvival
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