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Immunosuppressive and other Effects of Mycophenolic Acid and an Ester Prodrug, Mycophenolate Mofetil

The advantages and limitations of currently used immunosuppressive drugs are well known. Each drug has specific side effects: for example, cyclophosphamide can produce hemorrhagic cystitis (Levine & Jarrad 1993); cyclosporin can cause nephrotoxicity and hypertension (Bennett & Pulliam 1983); and methotrexate may lead to liver damage, pneumonitis and bone marrow suppression (Jolivet et al. 1983). In addition, there are short-term and long-term effects common to many immunosuppressive drugs. In the short term, immunosuppressive drugs can increase susceptibility to herpesvirus and other infections; it is desirable that when treatment is terminated immune function is rapidly restored, so that recovery from infections is facilitated. A long-term risk of immunosuppressive therapy is the development of lymphomas. This is well known in organ graft recipients (Penn 1988), but is observed also in patients with rheumatoid arthritis (Baker et al. 1987). As discussed more fully below, two factors predispose to lymphoma development. One is inhibition of T-cell-mediated surveillance against outgrowth of Epsten-Barr virus-transformed B lymphocytes (Rickinson et al. 1984). The second is chromosomal translocations, which can convert polyclonal B-cell proliferation into frank malignancy (Klein & Klein 1989). Mutagenic effects of immunosuppressive drugs are obviously undesirable. Cyclosporin inhibits surveillance against EBV-transformed lymphocytes (Rickinson et al. 1984). Cyclophosphamide and azathioprine have several active metabolites and mechanisms of action (Clarke & Waxman 1989. Elion 1989). Metabolites of cyclophosphamide are alkylating agents, and their effects on lymphocytes are not rapidly reversible. Cyclophosphamide is mutagenic and carcinogenic (De Neve et al. 1989). Azathio-