Etanercept for the Treatment of Lupus Nephritis

Exclusion Criteria

• •Moderately severe anemia
• •Neutropenia
• •Thrombocytopenia
• •Blood creatinine levels greater than 3.0 mg/dl
• •Positive PPD without ongoing treatment for at least 30 days prior to study entry
• •Pulmonary fibrotic changes
• •Active infections (e.g., HIV, hepatitis B virus \[HBV\], hepatitis C virus \[HCV\]) and/or serologic evidence of prior exposure to hepatitis B
• •Received a live vaccine within 3 months prior to study entry
• •Doubled serum creatinine levels within the 3 months prior to study entry OR end-stage kidney disease
• •Dialysis-dependent end-stage kidney disease or membranous nephritis
• •History of cancer. Individuals with a history of cervical carcinoma in situ and resected basal and squamous cell carcinomas of the skin are not excluded.
• •Receiving prednisone greater than 20 mg/day or equivalent corticosteroid treatment
• •Pulse intravenous methylprednisolone within 30 days prior to study entry
• •Receiving immunosuppressive agents other than prednisone, MMF, Mycophenolic Acid, AZA, or hydroxychloroquine
• •Oral or intravenous cyclosporine, leflunomide IVIG, or plasmapheresis within 3 months prior to study entry
• •Current or previous cyclophosphamide treatment
• •Use of other experimental agent within 90 days prior to study entry
• •Severe, progressive, or uncontrolled kidney, liver, blood, stomach, lung, heart, or brain disease. Individuals with any of these conditions that are related to active SLE are not excluded.
• •Previous use of rituximab within 12 months prior to study entry
• •Previous or current exposure to any of the following: etanercept (Enbrel), adalimumab (Humira), infliximab (Remicade), or anakinra (Kineret)
• •Meets New York Heart Association classification of congestive heart failure (CHF) Class III or greater
• •History of myocardial infarction or ischemia
• •Current or history of substance abuse
• •Known hypersensitivity to any component of the study drug
• •Poorly controlled or advanced diabetes mellitus
• •History of multiple sclerosis, transverse myelitis, optic neuritis, or epilepsy
• •History of noncompliance with other therapies
• •Pregnancy or breastfeeding