Lupus and cellcept
The drug CellCept works in controlling lupus symptoms, yet with few short-term side effects, research shows. CellCept is approved for preventing organ transplant rejection and is known to work for patients who have kidney damage from lupus. However, a new study shows it holds great promise in relieving lupus symptoms for the broader numbers of patients without kidney problems. Lupus is an immune system disease that causes fevers, joint pain, excessive fatigue, and in severe cases, major organ damage, especially to the kidneys. There is no cure for lupus. Like many lupus drugs that work by suppressing the immune system, CellCept increases the risk of infection and the possible development of lymphoma, a cancer of the lymph nodes. A group of researchers at the Mayo Clinic performed a six-month study involving 17 patients with lupus. At the study's end, 11 patients had a significant improvement in lupus symptoms, four had a partial improvement in lupus symptoms, and two had no improvement in lupus symptoms, reports lead researcher Kevin G. Moder, MD, a rheumatologist with the Mayo Clinic. Those who responded with an improvement in lupus symptoms were also able to decrease their dose of prednisone, an immune-suppressing drug commonly used to treat lupus symptoms. Three patients withdrew from the study because of side effects from CellCept, one with a rash and two with nausea. Moder presented his findings at the American College of Rheumatology Annual Scientific Meeting in San Antonio. "This would be considered a nice addition to medications we can use for these patients -- an alternative and widely applicable to many patients," says Moder in a news release. "It's a significant step if the medication is effective but has fewer side effects" than current medications for lupus symptoms. CellCept is the leading immunosuppressant in transplantation. In over a decade of clinical experience CellCept has demonstrated that it provides potent immunosuppression, preventing organ rejection without the long-term toxic effects associated with other therapies. Organ rejection is an immune reaction with many parallels to autoimmune disease. CellCept’s unique mode of action and positive efficacy and safety data in the transplant market suggest it could also benefit many autoimmune disease patients. For several years physicians have been increasingly interested in investigating the use of CellCept in a variety of autoimmune diseases. Some of the most promising results so far have been seen in lupus (a disease causing chronic skin rash and affecting other body systems), myasthenia gravis (a disorder characterized by weakening of the muscles and fatigue, notably affecting the muscles of the mouth and throat), pemphigus vulgaris (a skin disease characterized by blisters that heal poorly) and autoimmune hepatitis. Through the new collaboration, Aspreva will now build upon this evidence base by undertaking a global clinical program that will form the basis of formal regulatory submissions for CellCept in autoimmune diseases. This enables Roche to maintain focus on CellCept’s core market, transplantation, while extending the potential benefits of CellCept to a broader patient population. Under the terms of the deal Aspreva Pharmaceuticals has obtained exclusive worldwide rights (excluding Japan) to develop and market CellCept in autoimmune disease applications. Roche will register and invoice such sales as may result and will share the proceeds with Aspreva. “By bringing together the complimentary expertise of our two organizations, we are better able to enhance the value of this key Roche brand. Roche will stay focused on serving the needs of transplant patients, and Aspreva will undertake the specialized development necessary to expand the use of CellCept into autoimmune disease,” said William M. Burns, Head of Roche’s Pharmaceuticals Division. Richard Glickman, Chairman and CEO of Aspreva Pharmaceuticals said: “Roche is an ideal partner for Aspreva. We share the same philosophy of providing high quality evidence based medicine that can help address the needs of underserved patient populations.” New data on CellCept in autoimmune diseases will be presented at the meeting of the American College of Rheumatology, Orlando, USA 25 - 28th October 2003. This will include a plenary session describing the potential role of CellCept in lupus nephritis, the most serious complication of systemic lupus erythematosus. CellCept was first approved in 1995 for renal transplant, and the indications for CellCept now also include heart, liver and pediatric kidney transplants. In the USA CellCept is the leading branded transplant medicine for the prevention of rejection, and it has been used to treat approximately 593,000 transplant patients worldwide. In over a decade of clinical experience CellCept has demonstrated that it provides potent immunosuppression, preventing organ rejection without the long-term toxic effects associated with other therapies. CellCept prevents immune reactions through a unique mode of action which is highly relevant for many autoimmune disease patients. Autoimmune diseases occur when the immune system attacks the body’s own cells rather than invading microorganisms. There are more than 80 clinically distinct autoimmune diseases, each affecting the body in different ways. Presentation of these diseases can also vary from patient to patient with the same condition. For example, in lupus many parts of the body are affected, especially the skin, joints, blood, and kidneys. But the extent to which each is affected can vary from patient to patient. lupus nephritis – damage to the kidneys caused by autoantibodies - is the most serious complication of systemic lupus erythematosus. It can lead to kidney failure requiring dialysis or transplant.
Corticosteroids are still the mainstay of treatment for many autoimmune diseases and physicians have to constantly balance the requirement for best possible disease control with the drug related morbidities associated with long term steroid exposure. For example, no treatments have been approved for lupus in over for 30 years, and the current standard of care, the cancer drug cyclophosphamide, is associated with significant drug related morbidity.
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