Lupus nephritis is inflammation of the kidney that is caused by systemic lupus erythematous (SLE). Also called lupus, SLE is an autoimmune disease. With lupus, the body's immune system targets its own body tissues. Lupus nephritis happens when lupus involves the kidneys. A preliminary analysis of the safety data did not reveal any new or unexpected safety signals in patients receiving Rituxan. Beta blockers, calcium channel blockers, and other blood pressure medications may also be needed.
The overall prevalence and incidence of SLE ranges from 1.4 to 21.9% and from 7.4 to 159.4 cases per 100,000 people, respectively . SLE can affect several organs and systems, including the joints, skin, brain, heart, lungs, blood vessels, and kidneys. Age-specific and sex-specific prevalence rates obtained from 1976 to 1978 and mortality rates from 1972 to 1978. In December 1978 the prevalence of SLE was 28:100 000. The overall mortality rate was 4.7 per million person-years in 1972-78.
Induction and maintenance therapy, the respective place of mycophenolate mofetil and intravenous cyclophosphamide are balanced, taking into account efficacy, safety and patients' perspective. The authors anticipate that, in a few years, when long-term data on lupus nephritis patients induced with mycophenolate mofetil becomes available, it is probably that intravenous cyclophosphamide, which has been for so long the 'standard of care'.
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven Lupus Nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population. Participants who complete this study through Week 52.