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MGFA News: Medical/Scientific Advisory Board issues statement on CellCept Study
Members of the MSAB have released the following statement to address concerns regarding the recent announcement that Aspreva no longer intends to continue any further development of CellCept for the treatment of MG.
Mycophenolate Mofetil (Cellcept) Clinical Trial Update
Introduction: Mycophenolate mofetil (Cellcept) is an immunosuppressive drug that is currently in widespread use for the treatment of autoimmune MG. Members of the MGFA MSAB are reviewing the results of two recently completed clinical trials of Cellcept in the treatment of MG. While there is no current consensus regarding the optimal role of Cellcept in treating MG patients, the results of these studies will help guide our usage of the drug. Additionally the results of these studies will likely have an impact on the design of future clinical trails of Cellcept and other drugs therapies in MG.
Clinical trials and results: In both studies patients were randomly assigned to receive either Cellcept or a placebo and were evaluated by blinded investigators. Patients in these studies were also treated with prednisone and pyridostigmine (Mestinon) and some had previously undergone thymectomy. One study lasted 3 months and the other lasted 9 months. The two studies showed similar results in that patients treated with Cellcept (along with prednisone and Mestinon) had an outcome similar to those patients who did not receive Cellcept. While the two studies did not demonstrate a benefit from Cellcept it is important to look carefully at all of the data, consider the type of patients studied, the design of the studies, the impact of prednisone and Mestinon, duration of treatment, and many other factors that could influence the results.
What does this information mean to practicing physicians and their patients? In current clinical practice there are differing views on the use of Cellcept and other immunosuppressive drug options for treatment of MG. Patients with questions about their own use of Cellcept are advised to discuss their management with their individual physician. Many clinicians feel strongly that Cellcept is an excellent drug for the treatment of myasthenia gravis even though these two studies did not demonstrate a benefit. Patients should also keep in mind that since these studies have just recently been completed their physicians may have limited information regarding the specifics of the results. Most physicians wish to have all available information prior to making significant decisions about treatment options in for MG patients.
The next steps? The MSAB of the MGFA has formed an ad hoc committee charged with further exploration of the results of these studies as well as the development of new trials that might better clarify the role of Cellcept in the treatment of MG. This MSAB “Cellcept Study Group” will provide periodic updates to the MGFA membership.
重症肌无力病友之家 → 老外也无力 → CellCept的临床试验近况(新药)
发表时间：2007-04-12 10:16:00 
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