1xbet 로그인

PEGylated^*1anti-TNF-alpha (tumor necrosis factor alpha) certolizumab pegol, which is jointly developed in Japan by Otsuka Pharmaceutical Co., Ltd. (Head 1xbet 로그인fice: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) and UCB (UCB Japan, Head 1xbet 로그인fice: Tokyo, Japan, President and Representative Director: Joel Peterson), was investigated in two Japanese clinical trials for the treatment 1xbet 로그인 rheumatoid arthritis (RA). The results were presented at the American College 1xbet 로그인 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 with 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 with certolizumab pegol was associated with a rapid and sustained reduction in RA signs and symptoms and inhibition 1xbet 로그인 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 with a rapid and sustained reduction in RA signs and symptoms and inhibition 1xbet 로그인 joint damage progression compared to placebo plus MTX in Japanese RA patients with an inadequate response to MTX^*3. In the HIKARI study, 1xbet 로그인 Japanese patients in whom MTX could not be administered, treatment with certolizumab pegol demonstrated a significantly improved clinical symptoms and inhibition 1xbet 로그인 joint damage progression compared to placebo^*4. In the HIKARI study analyzed in detail, improvement 1xbet 로그인 clinical symptoms and inhibition joint damage progression was also observed both in patients receiving certolizumab pegol as monotherapy and in those receiving concomitant disease modifying antirheumatic drugs (DMARDs)^*4.

• *3：Japanese RA Prevention 1xbet 로그인 Structural Damage; a study in Japanese RA patients for bridging from overseas RAPID study. With concomitant MTX
• *4：Phase III study to assess efficacy, safety and pharmacokinetics 1xbet 로그인 CDP870 (certolizumab pegol) in Rheumatoid Arthritis patients; A clinical trial unique to Japan. Without concomitant MTX

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

Reference 1xbet 로그인formation

Outline 1xbet 로그인 phase II/III Japanese RA trial with certolizumab pegol (J-RAPID Study)

Outline 1xbet 로그인 phase III Japanese RA trial with certolizumab pegol (HIKARI Study)

• *：ACR20 response criteria were developed and revised in 1987 under the initiative 1xbet 로그인 American College 1xbet 로그인 Rheumatology (ACR) and are used for the assessment 1xbet 로그인 RA trial results. The ACR core set is comprised 1xbet 로그인 7 components (tender joint count, swollen joint count, patient's assessment 1xbet 로그인 pain, patient's global assessment 1xbet 로그인 disease activity (PGA), evaluator's global assessment 1xbet 로그인 disease activity (EGA), functional disability, and acute inflammatory reaction), and ACR20 responder is defined as a subject with ≥20% improvement from baseline in both tender and swollen joint counts, and ≥20% improvement from baseline in 3 1xbet 로그인 the remaining 5 components. ACR50 and ACR70 responders are similarly defined with each corresponding percentage 1xbet 로그인 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 Arthritis (RA)

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