Rituxan is offered for lupus nephritis after failing other therapies. Rituxan has been acccepted for treatment of lupus nephritis based on anecdotal data and small prospective studies but a recent study showed that it is ineffective. The trial was conducted by two biotechnology companies, Genentech and Biogen. They annonced the following results in April of 2008.
The trial involved 257 patients, who received either Rituxan or a placebo. Rituxan did not outperform the placebo on seven effectiveness measures used in the trial. A Phase III study of Rituxan® (rituximab) plus mycophenolate mofetil (MMF) and corticosteroids in patients with lupus nephritis did not meet its primary endpoint of significantly reducing disease activity at 52 weeks.
On Dec.18.2006, the U.S. Food and Drug Administration has issued a new warning for Rituxan after the death of two patients with systemic lupus erythematosus (SLE) who were being treated with Rituxan. The cause of death was a brain infection known as progressive multifocal leukoencephalopathy or PML, which had previously been associated with Rituxan in people who were immunosuppressed. Immunosuppression, a condition of decreased immune function, is seen in people with acquired immune deficiency syndrome (AIDS) and in people being treated with immunosuppressant drugs such as methotrexate.
John N. Boletis , Smaragde Marinaki , Chryssanthe Skalioti , Sofia S. Lionaki , Aliki Iniotaki , and Petros P. Sfikakis
Rituximab and mycophenolate mofetil for relapsing proliferative lupus nephritis: a long-term prospective study
NDT Advance Access published on July 1, 2009, DOI 10.1093/ndt/gfp002.
Nephrol. Dial. Transplant. 24: 2157-2160.
D E Furst, E C Keystone, R Fleischmann, P Mease, F C Breedveld, J S Smolen, J R Kalden, J Braun, B Bresnihan, G R Burmester, et al.
Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2009
Ann Rheum Dis, January 1, 2010; 69(Suppl_1): i2 – i29.