Interferon β-1b, a stable analog of human interferon-βproduced by recombinant DNA technique, is the first biotechnology product to be licensed under the FDA's accelerated approval regulation. It is the first drug available for the treatment of relapsing remitting multiple sclerosis (MS). The mechanism of action of interferon β-1b in MS remains unknown. It has shown immunoregulatory properties including its ability to decrease T-cell proliferation, to block the synthesis of interferonγthat may be involved in MS, to inhibit release of other cytokines that damage oligodendrocytes, and to increase T suppresser-cell activity. Interferonβ-1b has also demonstrated potential in melanoma, renal cell carcinoma, genital warts, hepatitis, rhinovirus, and several types of malignant tumors.
Interferon beta-1b, Betaseron, is a protein that is expressedin a recombinant E. coli. It is equivalent in type to the interferonthat is expressed by human fibroblasts. In addition to its antiviralactivity, interferon beta-1b possesses immunomodulatingactivity.Interferon beta-1b is administered SC to decrease the frequencyof clinical exacerbation in ambulatory patients withrelapsing–remitting multiple sclerosis (RRMS). RRMS ischaracterized by unpredictable attacks resulting in neurologicaldeficits, separated by variable periods of remission.Although it is not possible to delineate the mechanismsby which interferon beta-1b exerts its activity in MS, it isknown that the interferon binds to specific receptors on cellsurfaces and induces the expression of several interferoninducedgene products, such as 2',5'-oligoadenylate synthetaseand protein kinase. Additionally, interferon beta-1bblocks the synthesis of INF-γ, which is believed to be involvedin MS attacks.
