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薬理と治療
- Author: 山中 寿1
Abstract
Interleukin 6(IL-6)is a key cytokine in the pathogenesis of rheumatoid arthritis(RA).Tocilizumab(TCZ)is a humanized, anti-human IL-6 receptor monoclonal antibody that originated in Japan and inhibits IL-6 from binding with the IL-6 receptor. Clinical trials of TCZ in RA patients have demonstrated that TCZ improved signs and symptoms, relieved structural damage, and improved quality of life compared to the control groups. TCZ was first approved in Japan in 2008, in the EU in 2009, and in the US in 2010. Standard treatment regimen with TCZ in Japan is 8 mg/kg intravenously(TCZ-IV)every 4 weeks. A subcutaneous form of TCZ(TCZ-SC)is being developed. The MUSASHI study in Japan showed that the efficacy of TCZ-SC at 162 mg/body per 2 weeks was equivalent to the efficacy of TCZ-IV at 8 mg/kg per every 4 weeks IV. Effectiveness of TCZ has been demonstrated in clinical practice as well in clinical studies conducted prior to launch. Although anti-tumor necrosis factor(anti-TNF)drugs were more effective when combined with methotrexate(MTX)than anti-TNF monotherapy, many clinical studies, including the ACT-RAY study, found the efficacy of TCZ in monotherapy to be nearly equivalent to TCZ+MTX. The safety profile of TCZ has been clarified by clinical studies, including long term extension studies and all case post-marketing surveillance (PMS)conducted in Japan. The most common adverse events(AE)and serious AE were infections. The incidence rate of serious infection was similar to that reported in clinical studies and PMS for anti-TNF drugs.
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