CIMZIA(TM) Effective in Reducing Signs and Symptoms of Rheumatoid Arthritis

New data presented at EULAR confirms efficacy with either every two weeks or monthly dosing

BARCELONA, Spain | June 14, 2007 |
New pivotal data (RAPID 1 and RAPID 2) presented at the Annual European Congress of Rheumatology (EULAR) show that CIMZIATM (certolizumab pegol), the first PEGylated, Fc-free anti-TNF, combined with methotrexate therapy has a rapid and significant effect in reducing the signs and symptoms of active rheumatoid arthritis (RA) compared with methotrexate alone. Data from a third study, the 011 trial, presented at the conference also showed that CIMZIATM given every four weeks as monotherapy is significantly more efficacious than placebo in the treatment of patients with active RA who had previously failed disease-modifying anti-rheumatic drug (DMARD) therapy.

In both pivotal Phase III studies, RAPID 1 and RAPID 2, the primary endpoint, ACR20[a] response at 24 weeks, was significantly higher in both CIMZIATM treated arms (400 mg at week zero, week two and week four followed by 200 mg every two weeks plus methotrexate; or 400 mg every two weeks plus methotrexate) compared with the placebo plus methotrexate-treated arm (p<0.001). In both studies there was no significant difference between response levels in either of the CIMZIATM treatment arms. ACR50 and ACR70 responses were also achieved rapidly and with statistical significance in both studies in the CIMZIATM treated arms.

RAPID 1 and RAPID 2 demonstrated that effective results in the treatment of RA can be achieved with a 200 mg every other week dose of CIMZIATM -- the higher dose is not necessary. CIMZIATM was also shown to have a rapid onset of action: in RAPID 1, a 25.4% ACR50 response rate was observed at week 8 in both treatment groups.

"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 - and it is this region that has often been associated with cellular cytotoxicity," commented Professor Edward Keystone, Professor of Medicine, University of Toronto, Canada. "The consistency of the RAPID data confirm that certolizumab pegol may provide a valuable new treatment option for patients with this condition."

The safety and tolerability profile of CIMZIATM in both RAPID studies was consistent with that expected of an anti-TNF agent.

In another study presented at the meeting, the 011 trial, the efficacy of CIMZIATM 400 mg every four weeks as monotherapy was compared with that of placebo in treating the signs and symptoms of RA in patients who had previously failed on one or more courses of a DMARD. The primary endpoint, ACR20 response at 24 weeks, was significantly higher in the CIMZIATM treated arm than in the placebo treated arm (45.5% vs 9.3%: p<0.001). ACR50 and ACR70 responses were also both achieved with statistical significance. CIMZIATM was also significantly superior to placebo in terms of median time to first ACR20 response (2.0 vs 19.9 weeks, p<0.001), with 80.6% of ACR20 responders having achieved response by week 1.

"These data show the potential of certolizumab pegol to safely and effectively treat patients who have previously failed disease modifying antirheumatic drug treatments," added Prof. Josef Smolen, Chairman of the Department of Rheumatology, Medical University of Vienna, Austria. "In addition, certolizumab pegol could provide a valuable option in patients who are unable to take or cannot tolerate methotrexate."

Preparation for a regulatory submission for CIMZIATM in the treatment of RA is ongoing, with filing planned by the end of 2007.


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