Press Release

CIMZIA® Data Shows Long-term Improvements in Productivity, Quality of Life and Lessened Fatigue According to Studies Presented at American College of Rheumatology (ACR) Annual Scientific Meeting

San Francisco, October 27, 2008 – 5:00 am PST — UCB announced today results from several Phase III clinical trials evaluating CIMZIA® (certolizumab pegol) – the only PEGylated anti-TNF (Tumor Necrosis Factor) - presented at the American College of Rheumatology (ACR) Annual Scientific Meeting. Results from the open-label extension study to RAPID 1 met both co-primary endpoints (American College of Rheumatology (ACR) 20 responsea scores at Week 24 and change from baseline in modified Total Sharp Scores at Week 52). Results also showed that CIMZIA® together with methotrexate (MTX) provided ACR 20 response as early as Week 1 with sustained long-term benefit in relieving symptoms of rheumatoid arthritis (RA) through 100 weeks.

Another analysis investigating the rapidity of response to CIMZIA® as a monotherapy (FAST 4WARD) and together with MTX (RAPID 1) was presented at the meeting. Both studies met their primary endpoints (ACR20 response rate at Week 24) with clinical and statistical significance. The analysis presented showed that the response to CIMZIA® treatment was rapid in both studies with more than a third (36.7 percent) of patients receiving CIMZIA® as a monotherapy (FAST 4WARD) and nearly a quarter (22.9 percent) of patients receiving CIMZIA together with MTX (RAPID 1) achieving an ACR20 response within one week, both significantly different from placebo. ACR20 response rates peaked at Week 12 in both studies and were sustained until the end of the studies (Week 24 in FAST 4WARD; Week 52 in RAPID 1).

“The data show that treatment with CIMZIA® in clinical trials produced a fast and clinically meaningful effect for RA patients over an extended period of time,” said Michael Schiff, M.D., study investigator and Clinical Professor of Medicine at the University of Colorado School of Medicine.

CIMZIA® had a low occurrence of treatment discontinuation due to adverse events. The most commonly occurring adverse events were headache, nasopharyngitis, and upper respiratory tract infections. Pooled safety data from the two main phase III trials showed there was a low incidence of injection site burning and stinging (n=<3 new cases /100 patient-years) and a low level of discontinuations due to adverse events (AEs). Reported serious adverse reactions were infections (including tuberculosis) and malignancies (including lymphoma).

Additional data presented at ACR showed that patients who withdrew from RAPID 1 and 2 trials because they did not achieve an ACR20 response at Week 12 (confirmed at Week 14) nevertheless showed a slowed progression of structural damage within the joints as measured at Week 16 by analysis of radiographic data.

Additional data presented focused on the effect of treatment with CIMZIA® together with MTX in quality of life measurements. In RAPID 1, nearly three-quarters of patients achieved improvements in physical function when treated with CIMZIA® together with MTX, including 72.4 percent of those initially treated with CIMZIA® 200 mg together with MTX or 70.1 percent of those treated with CIMZIA® 400 mg together with MTX.

On a 10-point improvement on the Patients Assessment of Arthritis Pain (PAAP) scale, the data showed an average improvement of 39.1 and 38.1 points for those on CIMZIA® 200 mg together with MTX and CIMZIA® 400 mg together with MTX, respectively.

“It is exciting to see that these patients are deriving and maintaining improvements on multiple levels with continued CIMZIA® treatment,” noted Philip Mease, M.D., study investigator at the Seattle Rheumatology Associates and Director of Rheumatology Research at Swedish Medical Center. “Reducing pain and discomfort from RA is extremely important, but it is also noteworthy when patients find treatments that lead to a better overall quality of life.”

In RAPID 1, patients treated with CIMZIA® together with MTX reported gains in additional work and household work days per month and productive work and household work days per month as early as week 4. Over 6 months, improvements continued compared to the control group. These improvements were maintained for up to one year.

Additionally, data presented shows Health Reported Quality of Life Measurements (HRQoL) approached population norms in the “vitality” and “mental health” domains. As assessed by the Fatigue Assessment Scale of 1 to 10, patients in the trial also reported a mean reduction in fatigue to 3.1 points at week 100 with CIMZIA® together with MTX treatment.

Further information

Bert Kelly, Communications Manager, UCB
Cell: 404.784.6303, Bert.Kelly@ucb-group.com

Scott Fleming, Global Communications Manager, UCB Group
Tel: +447702777378, Scott.Fleming@ucb-group.com
 

For more information:
http://www.ucb-group.com