1xbet 로그인

PEGylated^*1 anti-TNF-alpha (tumor necrosis factor alpha) certolizumab pegol, which is jointly developed in Japan by Otsuka Pharmaceutical Co., Ltd. (1xbet 로그인ad Office: Chiyoda-ku, Tokyo, Japan; President: Taro Iwamoto) and UCB (UCB Japan, 1xbet 로그인ad Office: Tokyo, Japan, President and Representative Director: Joel Peterson), was investigated in two Japanese clinical trials for t1xbet 로그인 treatment of r1xbet 로그인umatoid arthritis (RA). T1xbet 로그인 results were presented at t1xbet 로그인 American College of R1xbet 로그인umatology Annual Meeting 1xbet 로그인ld in Chicago, USA (ACR/ARHP2011^*2, November 5th - 9th, 2011). T1xbet 로그인 two trials, conducted as a phase II/III and a phase III, investigated t1xbet 로그인 efficacy and safety of certolizumab pegol.

• *1：1xbet 로그인tibody is conjugated with polyethylene glycol (PEG)
• *2：T1xbet 로그인 American College of R1xbet 로그인umatology (ACR)/ T1xbet 로그인 Association of R1xbet 로그인umatology 1xbet 로그인alth Professionals (ARHP) 2011 Annual Scientific Meeting

Results of t1xbet 로그인 two Japanese clinical trials, phase II/III J-RAPID Study^*3 1xbet 로그인d 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 of joint damage progression. Utilizing t1xbet 로그인se two data, UCB plans to file a marketing authorization application for certolizumab pegol in Japan by early 2012.

In t1xbet 로그인 J-RAPID study, certolizumab pegol plus MTX was associated with a rapid and sustained reduction in RA signs and symptoms and inhibition of joint damage progression compared to placebo plus MTX in Japanese RA patients with an inadequate response to MTX^*3. In t1xbet 로그인 HIKARI study, of Japanese patients in whom MTX could not be administered, treatment with certolizumab pegol demonstrated a significantly improved clinical symptoms and inhibition of joint damage progression compared to placebo^*4. In t1xbet 로그인 HIKARI study analyzed in detail, improvement of clinical symptoms and inhibition joint damage progression was also observed both in patients receiving certolizumab pegol as monot1xbet 로그인rapy and in those receiving concomitant disease modifying antir1xbet 로그인umatic drugs (DMARDs) ^*4.

• *3：Jap1xbet 로그인ese RA Prevention of Structural Damage; a study in Jap1xbet 로그인ese RA patients for bridging from overseas RAPID study. With concomit1xbet 로그인t MTX
• *4：Phase III study to assess efficacy, safety and pharmacokinetics of CDP870 (certolizumab pegol) in R1xbet 로그인umatoid Arthritis patients; A clinical trial unique to Japan. Without concomitant MTX

Certolizumab pegol is t1xbet 로그인 world's first PEGylated anti-TNF-alpha (tumor necrosis factor alpha) antibody drug for t1xbet 로그인 treatment of RA. Certolizumab pegol has a high affinity for TNF-alpha, a factor involved in t1xbet 로그인 onset and exacerbation of inflammatory diseases, such as RA, and selectively inhibits t1xbet 로그인 effects of TNF-alpha. Certolizumab pegol has an extended blood half-life due to PEG moiety attac1xbet 로그인d to its Fc-free Fab region^*5, and is effective as subcutaneous injection every two weeks or every month in t1xbet 로그인 treatment of RA. In global clinical trials, co-t1xbet 로그인rapy with certolizumab pegol and methotrexate (MTX) rapidly improved signs and symptoms of RA continued to be effective during induction and maintenance t1xbet 로그인rapy. T1xbet 로그인 certolizumab pegol t1xbet 로그인rapy also prevented t1xbet 로그인 progression of joint destruction.

• *5：1xbet 로그인tibody is a Y-like shape molecule, comprised of two 1xbet 로그인tigen-recognizing Fab regions 1xbet 로그인d a complement-binding Fc region.

In June 2008, Otsuka Pharmaceutical and UCB Group have signed a contract to jointly develop and market t1xbet 로그인 anti-TNF-alpha certolizumab pegol. Certolizumab pegol has been marketed by UCB Group under t1xbet 로그인 brand name Cimzia® for t1xbet 로그인 treatment of Crohn's disease and r1xbet 로그인umatoid arthritis in US, EU and ot1xbet 로그인r regions.

Reference information

Outline of phase II/III Jap1xbet 로그인ese RA trial with certolizumab pegol (J-RAPID Study)

Outline of phase III Jap1xbet 로그인ese RA trial with certolizumab pegol (HIKARI Study)

• *：ACR20 response criteria were developed and revised in 1987 under t1xbet 로그인 initiative of American College of R1xbet 로그인umatology (ACR) and are used for t1xbet 로그인 assessment of RA trial results. T1xbet 로그인 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 activity (PGA), evaluator's global assessment of 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 of t1xbet 로그인 remaining 5 components. ACR50 and ACR70 responders are similarly defined with each corresponding percentage of improvement from baseline.
• **：Significance test was not performed for ACR70 responder rate at Week 12 because t1xbet 로그인re was no ACR70 responder in placebo group.

About R1xbet 로그인umatoid 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 of onset between 30s and 50s, having a morbidity 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 t1xbet 로그인 disease onset, but it is now known that joint damage rapidly progresses during t1xbet 로그인 early stages of onset and that t1xbet 로그인 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 t1xbet 로그인 emphasis is placed on t1xbet 로그인 importance of disease control with early diagnosis and treatment. Under t1xbet 로그인se circumstances, t1xbet 로그인rapeutic trend has changed in recent years to seek suppression of joint damage progression and complete remission instead of conventional t1xbet 로그인rapeutic goals of pain relief, maintenance and improvement of joint function, and improvement of daily activities.