CIMZIA Active In Treating Fistulizing Disease
Data presented this week by UCB at Advances in Inflammatory Bowel Diseases 2008, the Crohn's & Colitis Foundation's Clinical & Research Conference, demonstrated more than half (53.6%) of those moderate to severe Crohn's disease patients who had open fistulas at baseline had closure of fistulas by Week 26 following short-term induction therapy with CIMZIA (certolizumab pegol) - the only PEGylated anti-TNFa (Tumor Necrosis Factor alpha). Additionally, the data showed that fistulas in most of these patients treated continuously with CIMZIA stayed closed with a majority of patients achieving clinical remission.
CIMZIA is indicated for reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have had an inadequate response to conventional therapy.
Fistulas are abnormal tunnels or tracts that develop in response to inflammation and ulceration associated with CD. Fistulas may originate from the intestinal tract or rectum and connect to the bladder, vagina, skin or other intestinal areas. If left untreated, fistulas may cause a decrease in absorption of nutrients from food, abnormal drainage of bowel contents into other organs, or a life-threatening infection or abscess.
These results focus on a subpopulation of adult, moderate to severe Crohn's disease patients with fistulizing disease who took part in PRECiSE 2, the Phase III maintenance study of CIMZIA. In PRECiSE 2, patients received an open-label induction with subcutaneous CIMZIA 400 mg at Weeks 0, 2 and 4. Those who responded to treatment (reduction of less than or equal to 100 points from baseline on the Crohn's Disease Activity Index (CDAI)) at Week 6 were randomized to CIMZIA 400 mg or placebo every 4 weeks until Week 24 with final assessment at Week 26. Of the patients in the intent-to-treat population who responded to CIMZIA induction, 13.6% (58 of 425) had open fistulas at baseline: 30 of these patients were randomized to placebo and 28 to CIMZIA 400 mg.
Among patients who had fistula closure (the absence of drainage on gentle compression) during the study, a higher proportion of those treated continuously with CIMZIA 400 mg (73.3%) maintained 50% fistula closure at Week 26 versus patients receiving placebo (38.5%). More than two-thirds (66.7%) of the CIMZIA-treated patients maintained 100% closure of fistulas compared to placebo (30.8%) at Week 26.
Of the adult, moderate to severe Crohn's disease patients with open fistula at baseline, a higher percentage of patients in the CIMZIA versus placebo group achieved CDAI response of 100 points from baseline (71.4% versus 33.3%, respectively) and CDAI remission (53.6% versus 20%, respectively). The CDAI is a patient/physician questionnaire which incorporates eight CD-related variables. Scores of <150 indicate remission, and scores of >450 indicate severe illness along the 600 point scale.
Health-related quality of life measurements was assessed by the 32-question Inflammatory Bowel Disease Questionnaire (IBDQ), which measures social, systemic, emotional and bowel related symptoms on a scale of 32 to 224 points (higher scores denote better well-being). In this study, mean change in IBDQ scores from baseline were greater in CIMZIA (36.7 points) than placebo-treated groups (20.7 points).
There was a higher rate of discontinuation from treatment in the placebo group (50%) compared to the CIMZIA group (14%). In the PRECiSE 2 trial, the most common AEs in the CIMZIA group were headache (7%), nasopharyngitis (6%) and cough (6%). For the placebo group AEs included headache (7%), nasopharyngitis (4%) and cough (<1%). The incidence of injection site pain was lower in the CIMZIA group (<1%) compared to in the placebo group (5%). Serious AEs were broadly similar in both groups (6% CIMZIA versus 7% placebo). Three percent and less than 1% respectively were due to infection or infestation; 2% and 4% respectively were due to gastrointestinal disorder.