2023
Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co‐Expression Patterns: A Double‐Blind, Randomized, Placebo‐Controlled, Phase 2 Trial
Merrill J, Guthridge J, Smith M, June J, Koumpouras F, Machua W, Askanase A, Khosroshahi A, Sheikh S, Rathi G, Burington B, Foster P, Matijevic M, Arora S, Wang X, Gao M, Wax S, James J, Zack D. Obexelimab in Systemic Lupus Erythematosus With Exploration of Response Based on Gene Pathway Co‐Expression Patterns: A Double‐Blind, Randomized, Placebo‐Controlled, Phase 2 Trial. Arthritis & Rheumatology 2023, 75: 2185-2194. PMID: 37459248, DOI: 10.1002/art.42652.Peer-Reviewed Original ResearchConceptsSystemic lupus erythematosusLoss of improvementPrimary endpointLupus erythematosusWeek 32B cellsEfficacy-evaluable populationImproved disease activityPhase 2 trialProportion of patientsTreatment-related toxicityTreatment of patientsPlacebo-ControlledCorticosteroid injectionDisease activityInfusion reactionsTrough concentrationsPatient subsetsPlasma cellsPatientsSecondary analysisMonoclonal antibodiesStatistical significanceEndpointPlacebo
2015
Randomized, Double‐Blind, Placebo‐Controlled Trial of the Effect of Vitamin D3 on the Interferon Signature in Patients With Systemic Lupus Erythematosus
Aranow C, Kamen DL, Dall'Era M, Massarotti EM, Mackay MC, Koumpouras F, Coca A, Chatham WW, Clowse ME, Criscione-Schreiber LG, Callahan S, Goldmuntz EA, Keyes-Elstein L, Oswald M, Gregersen PK, Diamond B. Randomized, Double‐Blind, Placebo‐Controlled Trial of the Effect of Vitamin D3 on the Interferon Signature in Patients With Systemic Lupus Erythematosus. Arthritis & Rheumatology 2015, 67: 1848-1857. PMID: 25777546, PMCID: PMC4732716, DOI: 10.1002/art.39108.Peer-Reviewed Original ResearchMeSH KeywordsAdaptor Proteins, Signal TransducingAdultAntibodies, Anti-IdiotypicAntigensCarrier ProteinsCholecalciferolCytoskeletal ProteinsDietary SupplementsDNADose-Response Relationship, DrugDouble-Blind MethodFemaleGene Expression RegulationHumansLupus Erythematosus, SystemicMaleMicroarray AnalysisMiddle AgedMyxovirus Resistance ProteinsProspective StudiesRNA-Binding ProteinsVitamin DConceptsPercentage of patientsVitamin D3Vitamin DIFN signatureTreatment groupsSLE patientsInterferon signatureSystemic lupus erythematosus seraDNA antibody levelsVitamin D repletionPlacebo-controlled trialVitamin D deficientVitamin D supplementationVitamin D3 supplementationSubset of patientsSystemic lupus erythematosusD supplementationD deficientD3 supplementationDisease activityImmunologic outcomesInactive diseaseAdverse eventsBaseline characteristicsLupus erythematosus