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The Careram-MTX combination trial was a 52 week trial conducted in rheumatoid arthritis patients who did not achieve satisfactory benefit with MTX alone. The trial was conducted in two phases: a double-blinded phase that evaluated the efficacy and safety of Careram in combination with MTX compared to MTX in combination with placebo; and a continuation period that evaluated the long-term safety of Careram-MTX in all patients. In the study’s primary end point of ACR20 (see 5 for further details) response rate at Week 24, patients treated with Careram demonstrated a 69.5% (114/164 patients) improvement as compared to a 30.7% (27/88 patients) improvement amongst those patients administered placebo, with the Careram arm showing a significant improvement in ACR20 response rate over the placebo arm (p<0.001). At Week 24, the rate of adverse drug reactions was 51.8% (85/164 patients) and 33.0% (29/88 patients) in the Careram and placebo arms, respectively, and 65.2% (107/ 164 patients) in the Careram arm at Week 52.

Rheumatoid arthritis is a disease that leads to the inflammation of multiple joints throughout the body, causing joint swelling and pain. With joint destruction progressing right from the early stages of the disease, rheumatoid arthritis causes joint deformities and functional impairment over the long term. Rheumatoid arthritis is an autoimmune disease in which synovial cells, which line the inner surface of the joint cavity, proliferate due to an unknown cause. The number of blood vessels in joints also increases, resulting in the migration of lymphocytes, macrophages and other white blood cells from inside blood vessels to the synovial tissue of joints. An immune reaction in localized joints causes an inflammatory reaction and the progression of cartilage and bone destruction due to the effects of cytokines produced by lymphocytes and macrophages. In Japan, rheumatoid arthritis is said to affect an estimated 700,000 to 800,000 patients.

DMARDs (Disease Modifying Anti-Rheumatic Drugs) are a category of drugs that work to control the underlying processes of rheumatoid arthritis. They are expected to control the immune abnormalities that are thought to cause inflammation in the disease.

ACR20 is a criterion developed by the American College of Rheumatology that measures improvement in clinical symptoms of rheumatoid arthritis. It expresses the percentage of patients who demonstrated a 20% or greater improvement in tender and swollen joint counts and at least three of the following five disease activity variables: patient assessment of pain; patient assessment of global disease activity; physician assessment of global disease activity; patient assessment of physical function; and chronic response protein (CRP) or erythrocyte sedimentation rate (ESR) concentrations.

In Japan, Eisai currently markets the fully human anti-TNF-α monoclonal antibody Humira® (adalimumab) under a one brand, one channel, two promotion scheme with Abbott Japan Co., Ltd.. Humira, the world’s first fully human anti-TNFα monoclonal antibody, exerts its effects by neutralizing TNF-α (tumor neurosis factor-alpha), a protein that plays a central role in inflammatory responses in diseases such as rheumatoid arthritis. Humira was approved for the additional indications of juvenile idiopathic arthritis (juvenile rheumatoid arthritis) and inhibition of structural damage of joints in patients with rheumatoid arthritis in July 2011 and August 2012, respectively. Eisai has also established the treatment support program, “myHUMIRA,” for rheumatoid arthritis patients receiving treatment with Humira, through which it provides patients with information on the disease, treatment and issues pertaining to daily life. By providing the newly-launched Careram as a new option for the pharmacological treatment of rheumatoid arthritis, Eisai believes that it can make further contributions to address the diversified needs of rheumatoid arthritis patients and to increase their quality of life.