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Improved outcomes for fistula closures observed in PRECiSE 2 trial under maintenance therapy with stable dosing of CIMZIA(R) every four weeks
HOLLYWOOD, Fla., Dec. 5 /PRNewswire-FirstCall/ -- 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(R) (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(R) stayed closed with a majority of patients achieving clinical remission.
CIMZIA(R) 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(R). In PRECiSE 2, patients received an open-label induction with subcutaneous CIMZIA(R) 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
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