Leading the way to a cure

Lupus Research Update: 2006 Volume 3

Volume 3, 2006 - Online Edition | In This Issue

Meet the Investigator >
Pilot Grant Program >
Research Results - Using Cholesterol Levels to Screen for Worsening Lupus-Related Kidney Disease >
Research Results - New Genetic Findings Linked to Lupus in Mouse Models >
Research Results - Rituximab for Lupus Shows Promise >
Research Results - New Target for Treatment Identified >
Advocacy Update - Senator Charles Schumer Champions Lupus Research >
Beyond the Research - The ALR Walks Nationwide >
Drug Research and Development News >

Research Results - Rituximab for Lupus Shows Promise

Ever since the US Food and Drug Administration approved the drug rituximab (Rituxan) for use in patients with non-Hodgkin lymphoma and rheumatoid arthritis, some rheumatologists prescribe it “off label” for their lupus patients. This genetically engineered monoclonal antibody binds to the CD20 antigen found on the surface of normal and malignant B lymphocytes, allowing for the destruction of peripheral B cells without preventing their regeneration from stem cells. Since B cells are one of the major culprits in SLE, it seems likely that rituximab may have benefits for lupus patients. Several case reports and small trials published in the medical journals attest to its promise.

A study published in the May 2006 issue of the journal Arthritis Research & Therapy finds that not only is the therapy effective in cases of very severe lupus with lupus nephritis, but that its benefits may be related to an effect on T cells as well as B cells.

The study, conducted by researchers from several Mexican universities, was an open label clinical trial of 22 patients with active SLE and lupus-related kidney disease who no longer responded to immunosuppressive therapy. They received two infusions of rituximab along with their existing therapy and were followed for three months. Ninety percent experienced significant improvements in their disease, with 77 percent also experiencing improved kidney function.

However, one patient died from overwhelming infection likely caused by the immunosuppressive effects of rituximab added to several other immune-suppressing drugs, suggesting rituximab should be used with caution in those taking several immunesuppressing drugs at once.

One interesting finding from the study, noted lead author Roberto Gonzàlez-Amaro, MD, of the Department of Immunology at Universidad Autónoma de San Luis Potosí in Mexico, was that rituximab appeared to enhance the function and number of regulatory T cells, which suppress immune system activation, while leading to the death of T lymphocytes, whose dysfunction contributes to lupus.

However, he warns, additional studies are necessary, both to determine the drug’s effects on T cells and to more fully evaluate its usefulness in SLE patients. “It must be kept in mind that we performed an open clinical trial (so patients and their doctors knew they were getting the drug), and that, consequently, our preliminary results must be validated with a double-blind, randomized clinical trial.”

Vigna-Perez M, Hernández-Castro B, Paredes-Saharopulos O, et al. Clinical and immunological effects of Rituximab in patients with lupus nephritis refractory to conventional therapy: a pilot study. Arthritis Research & Therapy. 2006;8(3):R83.1

Just the Facts

What the study showed:
Rituximab (Rituxan) may provide significant benefits for lupus patients with lupus nephritis

What it means:
The possibility of a new, targeted treatment for lupus

What's next:
Larger, double-blind, randomized clinical trials of rituximab Related ALR-funded research: Previous ALR funding in this area included small pilot studies showing Rituximab is well tolerated by SLE patients and may have some effectiveness in treating the disease. Currently, ALR-funded researcher Robert A. Eisenberg, MD, of the University of Pennsylvania, is conducting immunological studies to provide new information on the basic mechanisms of kidney disease in SLE — in particular, the role of B cells and how depletion of B cells in lupus patients might be an effective therapy

ALR funding:
$1.5 million to date

1.5 million

people in the U.S. have Lupus.

172 million

dollars committed to lupus research by the Lupus Research Alliance.

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