2018
Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1
Emu B, Fessel J, Schrader S, Kumar P, Richmond G, Win S, Weinheimer S, Marsolais C, Lewis S. Phase 3 Study of Ibalizumab for Multidrug-Resistant HIV-1. New England Journal Of Medicine 2018, 379: 645-654. PMID: 30110589, DOI: 10.1056/nejmoa1711460.Peer-Reviewed Original ResearchConceptsPhase 3 studyHIV-1 infectionViral loadBackground regimenVirologic failureAdverse eventsWeek 25Multidrug-resistant HIV-1 infectionMDR HIV-1 infectionMean baseline viral loadMultidrug-resistant HIV-1Human immunodeficiency virus type 1Immunodeficiency virus type 1Control periodMultiple antiretroviral therapiesViral load decreaseCommon adverse eventsMean CD4 countPrimary end pointSerious adverse eventsBaseline viral loadProportion of patientsHIV-1 RNALimited treatment optionsVirus type 1
2012
Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial
Emu B, Luca D, Offutt C, Grogan JL, Rojkovich B, Williams MB, Tang MT, Xiao J, Lee JH, Davis JC. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial. Arthritis Research & Therapy 2012, 14: r6. PMID: 22225620, PMCID: PMC3392792, DOI: 10.1186/ar3554.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArea Under CurveArthritis, RheumatoidChemokine CXCL13DiarrheaDose-Response Relationship, DrugDouble-Blind MethodFemaleHeadacheHumansInjections, IntravenousInjections, SubcutaneousLymphotoxin-alphaMaleMetabolic Clearance RateMiddle AgedSignal TransductionTreatment OutcomeYoung AdultConceptsRA patientsAdverse eventsDose phaseClinical activityBiologic activityMedian Disease Activity ScoreMajority of AEsLymphotoxin αACR70 response ratesActive RA patientsRA disease activityDisease Activity ScorePlacebo-controlled trialSerious adverse eventsRheumatoid arthritis (RA) pathogenesisC-reactive proteinNovel monoclonal antibodyDisease activityPlacebo groupArthritis pathogenesisSerum CXCL13Activity scoreClinical effectsMultiple dosesT cells