Healthcare Industry News: Methotrexate
News Release - February 23, 2007
Significant Phase III Results with CIMZIA(TM) in Rheumatoid ArthritisRadiographic Data Demonstrated Significant Reduction in Joint Damage
BRUSSELS, BELGIUM--(Healthcare Sales & Marketing Network)--Feb 23, 2007 -- Brussels (Belgium), February 23, 2007 at 7:00 AM CET - UCB today announced key results of a pivotal Phase III study (RAPID 1) involving nearly 1,000 patients on CIMZIA(TM) (certolizumab pegol), the first PEGylated, Fc-free anti-TNF, intended for the treatment of moderate to severe rheumatoid arthritis (RA). RAPID 1's radiographic data showed that CIMZIA(TM) in combination with Methotrexate prevented structural damage of the joints to a significantly greater degree than placebo plus Methotrexate after one year's treatment.
RAPID 1 achieved its co-primary endpoint, the inhibition of progression of structural damage, with a statistically significantly smaller change from baseline in modified Total Sharp Score (mTSS)[a] observed at week 52 in both CIMZIA(TM) treatment arms (400mg at week zero, week two and week four followed by 200mg every two weeks; or 400mg every two weeks) compared with the placebo treated arm (p < 0.001).
The study also showed that in both active treatment arms CIMZIA(TM) improved the signs and symptoms of RA to a clinically statistically significantly greater degree than the placebo arm in patients who had inadequately responded to Methotrexate alone (p < 0.001).
Similar results were observed with a second pivotal Phase III study of CIMZIA(TM) in RA, RAPID 2, using CIMZIA(TM)'s new subcutaneous liquid formulation.
In both RAPID 1 and RAPID 2, the primary endpoint, ACR 20 response[b] at 24 weeks, was significantly higher in both CIMZIA(TM) treated arms than in the placebo treated arm (p < 0.001) . In both studies there was no significant difference between response levels in either of the CIMZIA(TM) treatment arms. ACR 50 and ACR 70 responses were also both achieved with statistical significance in both studies.
RAPID 1 and RAPID 2 demonstrated that effective results in the treatment of RA can be achieved with a 400mg total monthly dose of CIMZIA(TM) -- a higher dose is not necessary.
"These results are significant. They showed, for the first time, that the Fc region present in conventional anti-TNFs is not required for activity in rheumatoid arthritis", commented Professor Edward Keystone, Professor of Medicine, University of Toronto, Canada. "These data confirm that certolizumab pegol may provide a valuable new treatment option for patients with this condition."
CIMZIA(TM) was also shown to have a rapid onset of action: approximately three-quarters of actively-treated patients, who achieved ACR 20 at week 24, actually reached ACR 20 within four weeks.
"The RAPID 1 and 2 studies showed consistent and robust efficacy with both the lyophilized and liquid formulations of certolizumab pegol," added Professor Joseph Smolen, Chairman of the Department of Rheumatology, Medical University of Vienna, Austria. "Interestingly, both studies show that maximal response can be achieved as early as 12 to 16 weeks."
The safety and tolerability profile of CIMZIA(TM) in both studies was consistent with that expected of an anti-TNF agent.
Further data from both RAPID 1 and RAPID 2 will be presented at major international rheumatology congresses later this year. Preparation for a licence submission in the treatment of RA is ongoing, with filing planned in the second half of 2007. [a] The mTSS (modified Total Sharp Score) assesses bone erosion and joint space narrowing measured by X-ray. A smaller change in mTSS reflects less progression of joint damage.
[b] ACR (American College of Rheumatology) response scores measure improvement in the tender and swollen joint count and also include assessment of the following five parameters: patient's global assessment, physician's global assessment, patient's assessment of pain, degree of disability, and level of acute-phase reactant. ACR20 is achieved when there is 20% improvement in the tender and swollen joint count as well as a 20% improvement in at least three of the five parameters. ACR50 & ACR70 are an extension of these criteria corresponding to a 50% and 70% improvement respectively.
. Sharp JT, Lidsky MD, Collins LC, Moreland J. Methods of scoring the progression of radiologic changes in rheumatoid arthritis: Correlation of radiographic, clinical and laboratory abnormalities. Arthritis & Rheumatism , 1971, Vol. 14, No. 6
. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the Management of Rheumatoid Arthritis 2002 update. Arthritis & Rheumatism, 2002 Vol. 46, No. 2
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