engleski

Biological agents in Croatia

Biological agents have been designed so as to inhibit or stimulate specific components of the immune system. The progress in molecular biology has helped identify numerous new therapeutic targets: cytokines, cytokine receptors, and other cytokine-type molecules. The progress in biotechnology, on the other hand, has facilitated production of high quality chimeric (mouse-human) or fully human monoclonal antibodies. In Croatia, biological agents as therapeutic options for rheumatoid arthritis (RA) and seronegative spondyolarthritis (SpA) were approved by the health insurance fund in 2006 and in 2007, and applied in line with the recommendations of the Croatian Rheumatology Society. Rheumatoid arthritis (RA) is a chronic, progressive, systemic inflammatory rheumatic disease, with symptoms of synovitis, pain and edema of joints, stiffness and impairment of joints. It frequently leads to general and work disabilities, causing at the same time huge direct and indirect costs. RA affects 1-2% of the population. It is well known that 50% of patients with RA already manifested during their active work life, end employment 10 years from onset of the disease. Early diagnosis and very early start of treatment are preconditions for better prognosis. A key role in the pathogenesis of RA is played by proinflammatory cytokines, especially TNF-alpha (tumor necrosis factor alpha), which is released first, stimulating release of other proinflammatory cytokines. Apart from cytokines /TNF-α , IL-1, IL-6, etc./, there are numerous cells involved in the inflammatory process at the joints of RA patients: T, B and APC (antigen-presenting cells). Advances in the understanding of the role of proinflammatory cytokines and the cells in the pathogenesis of RA, along with the development of biological agents and evidence of their clinical efficiency, represent a significant progress in the treatment of and for achieving remission of RA patients. In Croatia, three biological agents (anti-TNF-alpha inhibitors) have been approved for the treatment of RA: adalimumab (Humira), a human monoclonal antibody ; infliximab (Remicade), a chimeric, mouse-human antibody ; and etanercept (Enbrel), a fusion protein. Another biological agent has been approved but is not yet on the health insurance fund list: rituximab (Mabthera), a chimeric, mouse-human monoclonal antibody to CD20 antigen, expressed on the surface of B lymphocytes (pre-B cells, immature B cells, activated B cells, and memory cells). The number of biological agents available for RA therapy is growing, and these target not only TNF-alpha cytokine but also other cytokines, cytokine receptors (IL-1, IL-1R, IL-6R) and cells (T, B, APC) involved in the pathogenesis of RA. In rheumatology, besides patients with RA and SpA, biological agents have been applied in the treatment of patients with systemic lupus erythematosus, especially for lupus nephritis, and individually in other autoimmune diseases. In allergology, a biological agent omalizumab has been applied in the treatment of patients with severe forms of asthma because of the key role of type E immunoglobulins with increased expression of high-affinity IgE receptors. Omalizumab is a human monoclonal anti-IgE antibody. In the treatment of inadequately controlled severe allergic asthma it significantly reduces the frequency of clinically important exacerbations, visits to emergency departments, and a need for higher doses of glucocorticoids. Consequently, omalizumab is indicated for patients with uncontrolled severe permanent allergic asthma, and has been introduced as such in the guidelines for asthma treatment – GINA 2006.

biological agents; Croatia

nije evidentirano