2020
High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia
Gyurkocza B, Nath R, Choe H, Seropian S, Stiff P, Abhyankar S, Agura E, Litzow M, Tomlinson B, Chen G, Hari P, Orozco J, Al-Kadhimi Z, Abboud C, Van Besien K, Sabloff M, Magalhaes-Silverman M, Foran J, Schuster M, Kebriaei P, Levy M, Lazarus H, Giralt S, Liang Q, Berger M, Reddy V, Pagel J. High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia. Blood 2020, 136: 30-31. DOI: 10.1182/blood-2020-134624.Peer-Reviewed Original ResearchHematopoietic cell transplantationAcute myeloid leukemiaCurrent equity holderR AMLFebrile neutropeniaTherapeutic doseGI tractBone marrowConventional careOlder patientsMyeloid leukemiaRefractory (R/R) AMLHigh-risk acute myeloid leukemiaLow-dose total body irradiationHigh dosesRadiation doseMyeloablative hematopoietic cell transplantationRefractory acute myeloid leukemiaAllogeneic hematopoietic cell transplantationAdvisory CommitteeAEs of interestIncidence of mucositisRate of mucositisInitiation of therapyMedian radiation dose
2013
SAT0287 Long-Term Safety Of Ustekinumab: 5 Years of Follow-Up from the Psoriasis Clinical Development Program Including Patients with Psoriatic Arthritis
Papp K, Griffiths C, Gordon K, Lebwohl M, Szapary P, Wasfi Y, Chan D, Shen Y, Ho V, Ghislain P, Strober B, Reich K. SAT0287 Long-Term Safety Of Ustekinumab: 5 Years of Follow-Up from the Psoriasis Clinical Development Program Including Patients with Psoriatic Arthritis. Annals Of The Rheumatic Diseases 2013, 72: a680. DOI: 10.1136/annrheumdis-2013-eular.2012.Peer-Reviewed Original ResearchGrant/research supportLong-term safetyAEs of interestOverall populationJanssen ResearchSafety endpointEvent ratesOpen-label long-term extensionLong-term safety experienceLow potency topical steroidsPooled safety dataOverall study populationPhase 3 developmentMajority of ptsClinical development programLong-term extensionHistory of PsAAbsence of PSAPsO patientsSevere PsOTopical steroidsPASI scorePsoriatic arthritisBiologic agentsMedian ageLong‐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
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