Eisai Co., Ltd. is planning to launch the anti-rheumatic agent Careram (iguratimod) in Japan on September 12 for the treatment of rheumatoid arthritis. Careram, jointly developed in Japan by Eisai and Toyama Chemical Co., Ltd. from the phase III clinical development stage, was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in June 2012 and was subsequently listed on the National Health Insurance Drug Price List on August 28.
Careram is a novel disease-modifying anti-rheumatic drug (DMARD) that exhibits anti-rheumatic effects by primarily suppressing the production of immunoglobin and inflammatory cytokines. In a phase III clinical study of Careram administered as a monotherapy in patients with rheumatoid arthritis, Careram demonstrated superiority over placebo as well as non-inferiority compared to an existing DMARD (salazosulfapyridine). It is also the only oral anti-rheumatic agent currently approved in Japan to demonstrate efficacy in domestic clinical trials as an add-on therapy to methotrexate (MTX), the standard of care, in rheumatoid arthritis patients who did not achieve satisfactory benefit with MTX alone.
In a trial of Careram in combination with MTX conducted in patients who were administered a combination of the two agents demonstrated favorable tolerability as well as significant improvements compared to those treated with placebo (MTX-only arm) in the study's primary endpoint of ACR20 response rate at Week 24.
In Japan, rheumatoid arthritis is said to affect an estimated 700,000 to 800,000 patients. Eisai, which currently markets the rheumatoid arthritis treatment Humira and the analgesic/anti-inflammatory agent Infree, has extensive data and experience in the field of rheumatoid arthritis. By providing 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 increase their quality of life. Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered Careram until a pre-determined number of patients has been reached in accordance with an approval condition imposed by the MHLW. After confirming the safety of Careram through the all case surveillance, Eisai will strive to provide information on proper use of the agent in hope that more patients will use it.
Careram-MTX Combination Trial is co-promoted with Abbott Japan Co., Ltd. under a one brand, one channel, two promotion scheme. 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 per cent (114/164 patients) improvement as compared to a 30.7 per cent (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 per cent (85/164 patients) and 33 per cent (29/88 patients) in the Careram and placebo arms, respectively, and 65.2 per cent (107/ 164 patients) in the Careram arm at Week 52.
In Japan, Eisai currently markets the fully human anti-TNF-a 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-TNFa monoclonal antibody, exerts its effects by neutralizing TNF-a (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, believes that it can make further contributions to address the diversified needs of rheumatoid arthritis patients and to increase their quality of life.