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Efficacy and safety of rituximab in moderately‐to‐severely active systemic lupus erythematosus: The randomized, double‐blind, phase ii/iii systemic lupus erythematosus evaluation of rituximab trial

Arthritis & Rheumatism · 2009 · Vol. 62(1) · pp. 222–233

Joan T. Merrill✉(Oklahoma Medical Research Foundation)C. Michael Neuwelt(Alameda Health System)Daniel J. Wallace(Cedars-Sinai Medical Center)Joseph C. Shanahan(Duke University)Kevin Latinis(University of Kansas Medical Center)Jim C. Oates(Medical University of South Carolina)Tammy O. Utset(University of Chicago)Caroline Gordon(University of Birmingham)David Isenberg(University College London)Hsin‐Ju HsiehDavid ZhangPaul Brunetta

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Abstract

The EXPLORER trial enrolled patients with moderately-to-severely active SLE and used aggressive background treatment and sensitive cutoffs for nonresponse. No differences were noted between placebo and rituximab in the primary and secondary end points. Further evaluation of patient subsets, biomarkers, and exploratory outcome models may improve the design of future SLE clinical trials.

Systemic Lupus Erythematosus Research T-cell and B-cell Immunology Monoclonal and Polyclonal Antibodies ResearchRituximabMedicineAzathioprineInternal medicinePlaceboTolerabilityPrednisoneClinical endpointSystemic lupus erythematosusAdverse effect

MeSH terms

RituximabAdultAntibodies, MonoclonalB-LymphocytesDouble-Blind MethodFemaleHumansImmunologic FactorsLupus Erythematosus, SystemicMaleQuality of LifeSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Murine-Derived

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