In the news release, Clinical Studies Show REMICADE Reduces Incidence ofBowel Surgeries in Ulcerative Colitis Patients, issued earlier today byCentocor, Inc. over PR Newswire, we are advised by a representative of thecompany that the first paragraph, second sentence should read "there is a 41percent reduction in the incidence of colectomy" rather than "43 percent" and"compared to those receiving placebo (p=0.015)" rather than "(p=0.012)" asoriginally issued inadvertently.
Clinical Studies Show REMICADE Reduces Incidence of Bowel Surgeries in Ulcerative Colitis Patients
Separate Analysis Reveals Colectomy Increases Healthcare Utilization and Costs
PHILADELPHIA, Oct. 15 /PRNewswire/ -- Clinical data presented today at theannual meeting of the American College of Gastroenterology (ACG) show thatREMICADE significantly reduces the incidence of colectomy surgeries forpatients with moderately to severely active ulcerative colitis (UC).According to a primary analysis of long-term extension data from the ActiveUlcerative Colitis 1 and 2 trials (ACT trials), there is a 43 percentreduction in the incidence of colectomy, the surgical removal of the colon, inpatients receiving REMICADE through 54 weeks, compared to those receivingplacebo (p=0.012). REMICADE is the first and only biologic approved for thetreatment of ulcerative colitis.
The analysis of the ACT extension trials included 728 patients from theinitial ACT 1 and 2 trials, of whom 630 (86 percent) had complete follow-upthrough 54 weeks to ascertain whether they underwent colectomy surgery.
"These data illustrate that treatment with REMICADE significantly reducesthe need for life-altering colectomy in patients with refractory ulcerativecolitis," said Paul Rutgeerts, M.D., Ph.D., University Hospital Gasthuisberg,University of Leuven; Leuven, Belgium. "REMICADE may offer patients who failother therapies the possibility of avoiding costly surgeries andhospitalizations while managing the symptoms of this debilitating diseaselong-term."
Separate data also presented at ACG today show the significant impact ofcolectomy on ulcerative colitis patients' use of healthcare services,including inpatient and outpatient hospital procedures, emergency room andphysician visits, and laboratory and drug costs. A retrospective analysis of411 patients, identified from the U.S. PharMetrics database as having UC and acolectomy between January 1, 2000, and June 30, 2005, found that totalutilization of healthcare services increased significantly in the 12 monthsfollowing colectomy, including inpatient and outpatient procedures (P < 0.05).
"These diseases are devastating to patients and their loved ones and weare excited to see more and better therapies become available to ease theirsuffering," said Richard J. Geswell, President, Crohn's & Colitis Foundationof America.
About the ACT Long-Term Extension
Patients with moderate to severe UC, defined as a baseline Mayo scoregreater then or equal to 6 and less then or equal to 12, who were unresponsiveto or intolerant to at least one standard therapy, including corticosteroids,immunosuppressants or 5ASAs, were enrolled in ACT 1 (n=364) or ACT 2 (n=364).The 728 patients were randomized to receive REMICADE 5 mg/kg, REMICADE 10mg/kg or placebo at weeks 0, 2, 6 and every subsequent 8 weeks through week 22(ACT 2) or week 46 (ACT 1). Patients were allowed to continue to receiveconventional therapy.
Patients who completed treatment through the final infusion visit and who,in the opinion of the investigator, could benefit from continued treatmentwith REMICADE could enroll in the extension trials. Across multiple sites,one hundred and eighteen (118) patients were entered into the ACT 1 extensionand 111 patients were entered into the ACT 2 extension.
During the extension, patients continu