New data from an open-label extension study evaluating the long-term safety and efficacy of CIMZIA® (certolizumab pegol) in moderate to severe Crohn's disease patients demonstrate that 82 percent of patients actively treated with CIMZIA - the only PEGylated anti-TNF-alpha (Tumor Necrosis Factor alpha) - remained in long-term remission without dose escalation up to 3.5 years. In a separate analysis, CIMZIA significantly improved patients' symptoms as early as day 8 as reported in a post-hoc responder analysis of PRECiSE 2, the original double-blind placebo controlled study. These data from PRECiSE 2 and the open-label extension PRECiSE 3 studies are being presented this week at the American College of Gastroenterology (ACG) Annual Meeting in San Diego, Calif.
CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
"These data further demonstrate that treatment with a stable dose of CIMZIA enables patients with Crohn's disease to have sustained symptom relief," said study investigator Gary R. Lichtenstein, M.D., Director, Inflammatory Bowel Disease Program, University of Pennsylvania in Philadelphia. "Long-term relief and control of symptoms are vital to helping Crohn's patients manage their disease."
At the start of the open-label extension study, PRECiSE 3, 75 percent of CIMZIA-treated patients (105 out of 141 patients who continued in PRECiSE 3) were in clinical remission. Eighty-two percent of patients who continued in the long-term extension trial on active treatment maintained remission for up to 3.5 years based upon responder analysis. Disease activity was measured by the Harvey-Bradshaw Index (HBI), which tallies the incidence of five clinical items, including general well-being, abdominal pain and number of liquid stools per day, during the previous 24 hours before the assessment. Each item is scored from 0 to 3 and total scores of less than or equal to 4 signify remission. Most reported adverse events were of mild to moderate intensity. The most serious adverse events (some leading to death) reported were exacerbation of Crohn's disease, serious infections (3 of which were tuberculosis) and malignancies. (Abstract #P716)
In the original PRECiSE 2 trial, moderate to severe Crohn's patients who responded to CIMZIA after an open-label induction phase were randomized to receive CIMZIA or placebo and evaluated for maintenance of clinical response by week 26, of which a significant majority (62 percent) of CIMZIA treated patients maintained their overall clinical response compared to placebo (34 percent, p<0.001). In the separate post-hoc analysis of the PRECiSE 2 trial, three patient-reported Crohn's Disease Activity Index (CDAI) components (number of loose/liquid stools, abdominal pain, and general well-being) were examined from baseline (day 0) to day 8 to 14, comparing week 6 responders and nonresponders to CIMZIA treatment. The CDAI is a patient/physician questionnaire which incorporates eight CD-related variables. Patients completed a diary card daily for 7 days prior to each clinic visit. Scores of <150 indicate remission and scores of >450 indicate severe illness along the 600 point scale. There was a 31 percent (95% CI: -1.7, -1.2) reduction of mean number of loose/liquid stools among responders versus a 14 percent (95% CI: -1.0, -0.3) reduction for nonresponders by day 8. Twenty percent of CIMZIA responders reported no abdominal pain by day 8 versus 16 percent of nonresponders>
"These data further underscore the value of CIMZIA as a therapeutic option for those living with this devastating and debilitating disease. The long-term efficacy data solidify CIMZIA's potential to help many patients throughout the course of their disease," said David Robinson, vice president and general manager of UCB's Immunology Business Unit.
Earlier this year, UCB announced that CIMZIA is available to moderate to severe Crohn's patients in a pre-filled syringe, developed in partnership with OXO Good Grips®( )for subcutaneous self-administration once every four weeks after initial dosing. CIMZIA, manufactured by UCB, was approved by the U.S. Food and Drug Administration on April 22, 2008 for reducing signs and symptoms of moderate to severe Crohn's disease and maintaining clinical response in adult patients who have had an inadequate response to conventional therapy.