2013
Topical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides
Lessin S, Duvic M, Guitart J, Pandya A, Strober B, Olsen E, Hull C, Knobler E, Rook A, Kim E, Naylor M, Adelson D, Kimball A, Wood G, Sundram U, Wu H, Kim Y. Topical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides. JAMA Dermatology 2013, 149: 25-32. PMID: 23069814, PMCID: PMC3662469, DOI: 10.1001/2013.jamadermatol.541.Peer-Reviewed Original ResearchConceptsIndex Lesion SeverityClinical end pointsMycosis fungoidesResponse rateMechlorethamine gelAdverse eventsMulticenter trialTreatment armsLesion severityDrug-related serious adverse eventsSeverity-Weighted Assessment ToolPrimary clinical end pointCutaneous T-cell lymphomaEnd pointSecondary clinical end pointsIIA mycosis fungoidesSerious adverse eventsSubset of patientsTreatment of patientsSerum drug levelsT-cell lymphomaComposite assessmentCarmustine therapyStudy medicationTopical mechlorethamine
2012
Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open‐label extension trial of the interleukin‐12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis
Langley R, Papp K, Gottlieb A, Krueger G, Gordon K, Williams D, Valdes J, Setze C, Strober B. Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open‐label extension trial of the interleukin‐12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis. Journal Of The European Academy Of Dermatology And Venereology 2012, 27: 1252-1261. PMID: 23157612, DOI: 10.1111/j.1468-3083.2012.04705.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Basal CellCarcinoma, Squamous CellCardiovascular DiseasesClinical Trials as TopicFemaleHumansInterleukin-12Interleukin-23MaleMiddle AgedPrevalencePsoriasisRandomized Controlled Trials as TopicSeverity of Illness IndexSkin Diseases, InfectiousSkin NeoplasmsTreatment OutcomeConceptsOpen-label extension studyMajor adverse cardiovascular eventsPotential safety signalsSevere psoriasisAdverse eventsParent studyClinical trialsSafety signalsSafety resultsAnti-IL-12/23 treatmentInterleukin-12/23 monoclonal antibodyOpen-label extension trialPhase IIAdverse cardiovascular eventsCardiovascular risk factorsBaseline blood pressureBody mass indexRate of infectionCardiovascular eventsFirst doseSafety findingsBlood pressureIL-12/23Mass indexExtension trial