May 22, 2019
Keio University Hospital
Keio University School of Medicine
Based on the "Clinical Trial of Tocilizumab for Adult-Onset Still's Disease," an investigator-initiated, multicenter clinical trial led by a group including Associate Professor Yuko Kaneko, Head of the Division of Rheumatology, Department of Internal Medicine at Keio University Hospital, and Professor Tsutomu Takeuchi, a regulatory application was submitted by Chugai Pharmaceutical Co., Ltd., the manufacturer and distributor of tocilizumab (brand name: Actemra). Subsequently, the Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval for an additional indication of the humanized anti-human IL-6 receptor monoclonal antibody "Actemra® for Intravenous Infusion 80 mg, 200 mg, and 400 mg" for the treatment of adult-onset Still's disease.
Adult-onset Still's disease is designated as an intractable disease by the Japanese government, and the development of new drugs for refractory cases has been a challenge. However, as it is a rare disease, clinical trials had not been conducted due to difficulties such as securing a sufficient number of patients. This study was the world's first placebo-controlled, randomized, double-blind trial for adult-onset Still's disease. It was conducted jointly by eight institutions nationwide, with Keio University Hospital as the lead site, and was primarily funded by public funds, ultimately leading to this regulatory approval. This is expected to significantly expand the treatment options for refractory cases of adult-onset Still's disease.
The results of this study were published in December 2018 in "Annals of the Rheumatic Diseases," a top journal in the field of rheumatology.
Please see below for the full press release.