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Chugai Announces Japanese Phase III Trial Data Demonstrates Efficacy of 'Actemra(R),' a Humanized Anti-Human IL-6 Receptor Monoclonal Antibody, on Rheumatoid Arthritis Patients.

Tokyo, Japan, Apr 26, 2006 - (JCN Newswire) - Chugai Pharmaceutical Co., Ltd. (TSE: 4519) and F. Hoffmann-La Roche Ltd. (hereinafter "Roche") announced today that the humanized anti-human IL-6 (interleukin-6) receptor monoclonal antibody, Actemra(R) (generic name: tocilizumab (genetical recombination) injection), globally co-developed by Chugai and Roche, has shown efficacy as a monotherapy in rheumatoid arthritis patients in a double-blinded phase III trial conducted in Japan. The results were presented today at The Japan College of Rheumatology (JCR) Annual Scientific Meeting held in Nagasaki, Japan.

Trial Objective, Design and Results

Objective: To ascertain Actemra's clinical efficacy and safety for rheumatoid arthritis patients with inadequate response to methotrexate (MTX) treatment.

Method: This is a double-blinded trial evaluating 125 patients. 61 patients were allocated to receive Actemra 8mg/kg with MTX placebo (Actemra group) and 64 patients were allocated to receive Actemra placebo with MTX 8mg (placebo group). Actemra was administered every four weeks for total of six times, and MTX was administered every week for a total of 24 weeks.

Results: ACR response rates were used to determine the anti-rheumatic efficacy, and at the end of the 24 weeks (or at the last observation), Actemra group achieved statistically significantly higher response rates.
--------------------------------------------------------------------------
 Actemra group placebo group p value
 (Actemra + (Actemra placebo
 MTX placebo) +MTX)
--------------------------------------------------------------------------
 N=61 N=64 Actemra vs.
 placebo group
--------------------------------------------------------------------------
20% ACR response 80.3 25.0 p<0.001
50% ACR response 49.2 10.9 p<0.001
70% ACR response 29.5 6.3 p<0.001
--------------------------------------------------------------------------


Safety: The incidence of adverse events were observed in 56 cases out of 61 (91.8%) for the Actemra group, and 46 cases out of 64 (71.9%) for the placebo group. Serious adverse events were 4 and 3 cases, for Actemra and placebo group, respectively.

Actemra(R) is currently marketed in Japan under the trade name "ACTEMRA(R) 200 for Intravenous Infusion'' after approval as a therapy for Castleman's disease in April 2005, and is now in preparation for filing additional indication of rheumatoid arthritis. Outside of Japan, phase III trials in rheumatoid arthritis are going on in 41 countries worldwide including co-development between Chugai and Roche.

** Reference

Interleukin-6 (IL-6)

IL-6 was identified as an agent that can induce the differentiation of B cells in immune systems from cells producing antibodies. Later research revealed that IL-6 has diverse physiologic activation properties. They include proliferating and differentiating hematopoietic cells and nerve cells, as well as inflammatory reactions. IL-6 also relates to the pathologies of various immune abnormalities and inflammatory diseases, such as rheumatoid arthritis, Castleman's disease, Crohn's disease and multiple myeloma.

Actemra(R) (humanized anti-human IL-6 receptor monoclonal antibody)

Actemra(R) is a humanized antibody to the human IL-6 receptor, and was created using genome engineering technology. It controls IL-6 molecules by stopping IL-6 from binding with IL-6 receptors. Actemra may have applications in the treatment of diseases whose pathologies apparently relate closely to IL-6.

ACR response

The ACR-20 response was developed as one of the measures of improvement in the treatment of rheumatoid arthritis by the American College of Rheumatology, with standards for a 20% response, 50% response and 70% response. An ACR-20 response is defined as a reduction in each patient of at least 20% in criteria (1) and (2) listed below, plus an improvement of at least 20% in at least three of the others.

Disease Activity Measure

(1) Tender joint count

(2) Swollen joint count

(3) Patient's assessment of pain

(4) Patient's global assessment of disease

(5) Physician's global assessment of disease activity

(6) Patient's assessment of physical function

(7) Acute-phase reactant value

About Chugai Pharmaceutical Co., Ltd.

Chugai Pharmaceutical Co., Ltd. is one of Japan's leading research-based pharmaceutical companies with strengths in biotechnology products and in the therapeutic fields of oncology, renal diseases, cardiovascular diseases, bone/joint diseases and transplantation/infection/immunity. As a most important member of the Roche group, we aim to become a top Japanese pharmaceutical company by providing a continuous flow of innovative new medicines domestically and internationally.

Source: Chugai Pharmaceutical Co., Ltd.

Contact:
Mamoru Togashi
General Manager,
Corporate Communications Dept.
Tel:+81-3-3273-0881


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Publication:JCN Newswires
Geographic Code:9JAPA
Date:Apr 26, 2006
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