2017
Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Narbutt J, Philipp S, Spelman L, Weglowska J, Zhang N, Strober B. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study. Journal Of The American Academy Of Dermatology 2017, 76: 1093-1102. PMID: 28291552, DOI: 10.1016/j.jaad.2016.12.014.Peer-Reviewed Original ResearchConceptsABP 501Week 16Psoriasis AreaClinical similaritiesBiosimilar ABP 501Biosimilars of adalimumabSevere plaque psoriasisDouble-blind studySeverity Index scoreTreatment of patientsAntibody incidencePlaque psoriasisSevere psoriasisAdalimumabIndex scoreEquivalence marginPatientsImmunogenicityConfidence intervalsTreatment differencesPercent improvementPsoriasisSame treatmentBaselineMore improvement
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