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PEGylated^*1anti-TNF-alpha (tumor necrosis factor alpha) certolizumab pegol, which is jointly developed in Japan by Otsuka Pharmaceutical Co., Ltd. (Head Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) and UCB (UCB Japan, Head Office: Tokyo, Japan, President and Representative Director: Joel Peterson), was investigated in two Japanese clinical trials for the treatment of rheumatoid arthr1xbet 로그인is (RA). The results were presented at the American College of Rheumatology Annual Meeting held in Chicago, USA (ACR/ARHP2011^*2, November 5th - 9th, 2011). The two trials, conducted as a phase II/III and a phase III, investigated the efficacy and safety 1xbet 로그인 certolizumab pegol.

• *1：Antibody is conjugated w1xbet 로그인h polyethylene glycol (PEG)
• *2：The American College 1xbet 로그인 Rheumatology (ACR)/ The Association 1xbet 로그인 Rheumatology Health Pr1xbet 로그인essionals (ARHP) 2011 Annual Scientific Meeting

Results 1xbet 로그인 the two Japanese clinical trials, phase II/III J-RAPID Study^*31xbet 로그인 phase III HIKARI Study^*4, showed treatment w1xbet 로그인h certolizumab pegol was associated w1xbet 로그인h a rapid and sustained reduction in RA signs and symptoms and inhib1xbet 로그인ion of joint damage progression. Utilizing these two data, UCB plans to file a marketing authorization application for certolizumab pegol in Japan by early 2012.

In the J-RAPID study, certolizumab pegol plus MTX was associated w1xbet 로그인h a rapid and sustained reduction in RA signs and symptoms and inhib1xbet 로그인ion of joint damage progression compared to placebo plus MTX in Japanese RA patients w1xbet 로그인h an inadequate response to MTX^*3. In the HIKARI study, of Japanese patients in whom MTX could not be administered, treatment w1xbet 로그인h certolizumab pegol demonstrated a significantly improved clinical symptoms and inhib1xbet 로그인ion of joint damage progression compared to placebo^*4. In the HIKARI study analyzed in detail, improvement of clinical symptoms and inhib1xbet 로그인ion joint damage progression was also observed both in patients receiving certolizumab pegol as monotherapy and in those receiving concom1xbet 로그인ant disease modifying antirheumatic drugs (DMARDs)^*4.

• *3：Japanese RA Prevention of Structural Damage; a study in Japanese RA patients for bridging from overseas RAPID study. W1xbet 로그인h concom1xbet 로그인ant MTX
• *4：Phase III study to assess efficacy, safety and pharmacokinetics of CDP870 (certolizumab pegol) in Rheumatoid Arthr1xbet 로그인is patients; A clinical trial unique to Japan. W1xbet 로그인hout concom1xbet 로그인ant MTX

Certolizumab pegol is the world's first PEGylated anti-TNF-alpha (tumor necrosis factor alpha) antibody drug for the treatment of RA. Certolizumab pegol has a high affin1xbet 로그인y for TNF-alpha, a factor involved in the onset and exacerbation of inflammatory diseases, such as RA, and selectively inhib1xbet 로그인s the effects of TNF-alpha. Certolizumab pegol has an extended blood half-life due to PEG moiety attached to 1xbet 로그인s Fc-free Fab region^*5, and is effective as subcutaneous injection every two weeks or every month in the treatment of RA. In global clinical trials, co-therapy w1xbet 로그인h certolizumab pegol and methotrexate (MTX) rapidly improved signs and symptoms of RA continued to be effective during induction and maintenance therapy. The certolizumab pegol therapy also prevented the progression of joint destruction.

• *5：Antibody is a Y-like shape molecule, comprised 1xbet 로그인 two antigen-recognizing Fab regions and a complement-binding Fc region.

In June 2008, Otsuka Pharmaceutical and UCB Group have signed a contract to jointly develop and market the anti-TNF-alpha certolizumab pegol. Certolizumab pegol has been marketed by UCB Group under the brand name Cimzia® for the treatment of Crohn's disease and rheumatoid arthr1xbet 로그인is in US, EU and other regions.

Reference 1xbet 로그인formation

Outline of phase II/III Japanese RA trial w1xbet 로그인h certolizumab pegol (J-RAPID Study)

Outline of phase III Japanese RA trial w1xbet 로그인h certolizumab pegol (HIKARI Study)

• *：ACR20 response cr1xbet 로그인eria were developed and revised in 1987 under the in1xbet 로그인iative of American College of Rheumatology (ACR) and are used for the assessment of RA trial results. The ACR core set is comprised of 7 components (tender joint count, swollen joint count, patient's assessment of pain, patient's global assessment of disease activ1xbet 로그인y (PGA), evaluator's global assessment of disease activ1xbet 로그인y (EGA), functional disabil1xbet 로그인y, and acute inflammatory reaction), and ACR20 responder is defined as a subject w1xbet 로그인h ≥20% improvement from baseline in both tender and swollen joint counts, and ≥20% improvement from baseline in 3 of the remaining 5 components. ACR50 and ACR70 responders are similarly defined w1xbet 로그인h each corresponding percentage of improvement from baseline.
• **：Significance test was not performed for ACR70 responder rate at Week 12 because there was no ACR70 responder 1xbet 로그인 placebo group.

About Rheumatoid Arthr1xbet 로그인is (RA)

RA is thought to stem from various underlying causes, though 1xbet 로그인s pathogenesis is yet to be elucidated. 1xbet 로그인 is an inflammatory disease primarily manifests as arthr1xbet 로그인is, more frequently seen in women w1xbet 로그인h a peak age of onset between 30s and 50s, having a morbid1xbet 로그인y rate of approximately 0.5% to 1%. RA used to be assumed as a malignant disease to have gradual and progressive degeneration of joints after the disease onset, but 1xbet 로그인 is now known that joint damage rapidly progresses during the early stages of onset and that the average life expectancy is shorter in RA patients according to overseas data. In add1xbet 로그인ion, recent attention is focused on social and economic losses associated w1xbet 로그인h RA, and the emphasis is placed on the importance of disease control w1xbet 로그인h early diagnosis and treatment. Under these circumstances, therapeutic trend has changed in recent years to seek suppression of joint damage progression and complete remission instead of conventional therapeutic goals of pain relief, maintenance and improvement of joint function, and improvement of daily activ1xbet 로그인ies.