A new study entitled “Long-Term Safety and Efficacy of Olokizumab in Patients with Moderate-to-Severe Rheumatoid Arthritis Who Have Previously Failed Anti-TNF Treatment” will be presented during the 2015 American College of Reumatology/ARHP Annual Meeting on November 9 in San Francisco, California. The trial evaluated the use of Olokizumab as a moderate-to-severe rheumatoid arthritis (RA) therapy.
Cytokine-targeted therapy has generated a paradigm change in the treatment of various immune-mediated diseases. Interleukin-6 (IL-6) is a typical cytokine with broad range of biological effects on several types of cells, including on immune cells such as B and T cells, and essential for the regulation of immune responses, hematopoiesis, and inflammation. This cytokine is readily produced and exerts its protective role in the context of infection and tissue injury. However, when produced in excess during these conditions, IL-6 may induce potentially fatal complications, such as systemic inflammatory response syndrome (SIRS). Furthermore, when constantly produced it can lead to the development of several chronic immune-mediated diseases. Therefore, clinical trials worldwide have been evaluating IL-6 inhibition using tocilizumab, a humanized anti-IL-6 receptor monoclonal antibody for the treatment of inflammatory diseases, such as rheumatoid arthritis, revealing excellent levels of efficacy.
The data is based on two 12-week randomized controlled trials (RCTs), (NCT01242488) and (NCT01463059), that evaluated the long-term safety and efficacy of Olokizumab (OKZ), a humanized anti-interleukin-6 monoclonal antibody under development for moderate-to-severe rheumatoid arthritis (RA) therapy. This study enrolled Western and Asian RA patients with an unsuccessful response to anti-TNF therapy. Clinical results showed that OKZ considerably reduced disease activity when compared to placebo (PBO). In the open-label extension (OLE) studies of both RCTs, efficacy measures of OKZ continued to improve, most notably in placebo patients who switched treatment to OKZ.
Overall, this study showed that Olokizumab was well-tolerated as expected for this type of agent, with patients showing a decrease in disease activity up to week 48 of treatment. These findings, the researchers concluded, support the development of OKZ as a therapy for moderate-to-severe rheumatoid arthritis in Western and Asian patients.