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"These data are encouraging because we see that REMICADE is an effectivetreatment option for patients with active ulcerative colitis, whether recentlydiagnosed or struggling with the condition for many years," said Dr. BruceSands, Associate Professor of Medicine at Harvard Medical School, and studyinvestigator. "Regardless of disease duration, patients receiving REMICADEshowed significant improvements in clinical response, remission and mucosalhealing, all goals of therapy in the treatment of ulcerative colitis."
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In the analysis of 728 patients from ACT 1 and ACT 2, 254 patients had UCfor less than three years and 474 patients had UC for at least three years.Clinical response, clinical remission and mucosal healing rates at week 8 forthe combined REMICADE treatment group (5 mg/kg and 10 mg/kg) were allsignificantly higher than the placebo group (P < 0.01) regardless of diseaseduration; clinical response: 62 percent versus 33 percent for subjects withdisease duration less than three years, and 68 percent versus 34 percent forsubjects with disease duration of at least three years; clinical remission: 28percent versus 8 percent and 35 percent versus 12 percent, respectively;mucosal healing: 56 percent versus 29 percent and 63 percent versus 35percent, respectively.
At week 30, clinical response, clinical remission and mucosal healingrates for the combined REMICADE treatment group (5 mg/kg and 10 mg/kg) werealso significantly higher than the placebo group (P < 0.01) regardless ofdisease duration; clinical response: 49 percent versus 19 percent for subjectswith disease duration less than three years, and 54 percent versus 34 percentfor subjects with disease duration of at least three years; clinicalremission: 28 percent versus 10 percent, and 35 percent versus 15 percent,respectively; mucosal healing: 47 percent versus 20 percent ,and 52 percentversus 32 percent, respectively. A Cochran-Mantel-Haenszel test stratified bybaseline corticosteroid refractory status was used to compare REMICADE withplacebo within each disease duration subgroup.
Ulcerative colitis is a chronic inflammatory disease of the colon andlarge intestine that affects approximately half a million Americans and canlead to frequent hospitalizations, surgery and loss of work productivity.Both UC and Crohn's disease are known collectively as inflammatory boweldiseases, or IBD. Approved in 1998 by the U.S. Food and Drug Administrationas the first anti-tumor necrosis factor (TNF)-alpha therapy, REMICADE receivedits initial approval for the treatment of Crohn's disease and has since becomethe first and only anti-TNF-alpha therapy approved for the treatment of UC andpediatric Crohn's disease. A Phase 3 study evaluating the efficacy and safetyof REMICADE for the treatment of pediatric UC is currently ongoing.
Impact of Anti-TNF Therapies on Absence from Work Among Employees with IBD
Also presented today were findings from a separate retrospective analysisusing the Human Capital Management Services Research Reference Database.Containing claims from large employers in the U.S. between January 1,
