TITLE

A randomised, controlled, double blind, escalating dose study of alicaforsen enema in active ulcerative colitis

AUTHOR(S)
van Deventer, S. J. H.; Tami, J. A.; Wedel, M. K.
PUB. DATE
December 2004
SOURCE
Gut;Dec2004, Vol. 53 Issue 12, p1646
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
Objective: To evaluate the safely and efficacy of an enema formulation of alicaforsen, an antisense inhibitor of intercellular adhesion molecule, after 1, 3, and 6 months. Methods: This was a randomised, placebo controlled, double blind, escalating dose multicentre study in 40 patients with mild to moderately active distal ulcerative colitis (disease activity index (DAI) 4-10). Patients were assigned to four dosing cohorts of 10 patients each (eight active, two placebo). Each patient received 60 ml of alicaforsen enema (0.1, 0.5, 2, or 4 mg/ml or placebo) once daily for 28 consecutive days. Safety and efficacy (DAI and clinical activity index) scores were evaluated up to six months alter initiation of dosing. Results: At day 29, alicaforsen enema resulted in dose dependent improvement in DAI (overall p = 0.003). Alicaforsen 4 mg/ml improved DAI by 70% compared with the placebo response of 28% (p = 0.004). Alicaforsen 2 and 4 mg/ml improved DAI status by 72% and 68% compared with a placebo response of 11.5% at month 3 (p = 0.016 and 0.021, respectively). Specifically, DAI improved from 5.6 to 1.6 and from 6.3 to 2.5 in the 2 and 4 mg/ml groups compared with placebo (7.5 to 6.1). None of the patients in the 4 mg/ml group compared with 4/8 placebo patients required additional medical or surgical intervention over baseline during the six month period after starting the enema treatment. The safety profile was favourable. Conclusions: Alicaforsen enema showed promising acute and long term benefit in patients with mild to moderate descending ulcerative colitis. Alicaforsen enemas had a favourable safely profile. These findings require verification in larger randomised controlled clinical trials.
ACCESSION #
18384795

 

Related Articles

  • Meta-Analysis of the Placebo Response in Ulcerative Colitis. Sagar Garud; Alphonso Brown; Adam Cheifetz; Emily Levitan; Ciaran Kelly // Digestive Diseases & Sciences;Apr2008, Vol. 53 Issue 4, p875 

    Abstract   Purpose The placebo response rate in randomized controlled trials (RCTs) in ulcerative colitis (UC) varies from 0 to 76%. The aims of this study were to quantify the pooled placebo response rate and identify the factors affecting it. Methods We performed a...

  • Abnormalities in colonic mucin may contribute to the persistence of colonic mucosal inflammation.  // Journal of Gastroenterology;2000, Vol. 35 Issue 1, p71 

    Editorial. Deals with the possible contribution of the abnormalities in colonic mucin to the persistence of colonic mucosal inflammation. Percentage of ulcerative colitis patients with circulating antibodies to colonocytes; Number of reported mucin genes; Description of MUC2 mucin; Candidate...

  • Infliximab: the evidence for its place in therapy in ulcerative colitis. Assche, Gert Van; Vermeire, Séverine; Rutgeerts, Paul // Core Evidence;2007, Vol. 2 Issue 3, p151 

    Introduction: Refractory ulcerative colitis has a high, unmet medical need for avoiding steroid dependency and avoiding colectomy. Controlled trials with biologic agents have recently been reported. Aims: We aimed to review the current evidence supporting the use of the monoclonal antitumor...

  • Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Sfremmel, W.; Merle, U.; Zahn, A.; Autschbach, F.; Hinz, U.; Ehehalt, R. // Gut;Jul2005, Vol. 54 Issue 7, p966 

    Background and aims: We examined the hypothesis of an anti-inflammatory effect of phosphatidylcholine in ulcerative colitis. Methods: A phase IIA, double blind, randomised, placebo controlled study was performed in 60 patients with chronic active, non steroid dependent, ulcerative colitis, with...

  • Colon capsule endoscopy versus standard colonoscopy in assessing disease activity of ulcerative colitis: a prospective trial. Meister, T.; Heinzow, H. S.; Domagk, D.; Dortgolz, A.; Lenze, F.; Ross, M.; Domschke, W.; Lügering, A. // Techniques in Coloproctology;Dec2013, Vol. 17 Issue 6, p641 

    Background: The aim of our study was to compare colon capsule endoscopy (CCE) with standard colonoscopy (SC) in the assessment of mucosal disease activity and localization of inflammatory colonic mucosa in patients with known ulcerative colitis (UC). Methods: Thirteen symptomatic patients (8...

  • Safety and Efficacy of a New 3.3 g b.i.d. Tablet Formulation in Patients With Mild-to-Moderately-Active Ulcerative Colitis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study. Scherl, Ellen J.; Pruitt, Ronald; Gordon, Glenn L.; Lamet, Mark; Shaw, Audrey; Huang, Shirley; Mareya, Shadreck; Forbes, William P. // American Journal of Gastroenterology;Jun2009, Vol. 104 Issue 6, p1452 

    OBJECTIVES:To evaluate the safety and efficacy of a new twice-daily balsalazide disodium 1.1 g tablet dosing regimen (6.6 g/day, three tablets twice daily) for the treatment of mild-to-moderately-active ulcerative colitis (UC).METHODS:In a double-blind, multicenter study patients with symptoms...

  • Confirmation of Multiple Crohn's Disease Susceptibility Loci in a Large Dutch—Belgian Cohort. Weersma, Rinse K.; Stokkers, Pieter C. F.; Cleynen, Isabelle; Wolfkamp, Simone C. S.; Henckaerts, Liesbet; Schreiber, Stefan; Dijkstra, Gerard; Franke, Andre; Nolte, Ilja M.; Rutgeerts, Paul; Wijmenga, Cisca; Vermeire, Séverine // American Journal of Gastroenterology;Mar2009, Vol. 104 Issue 3, p630 

    OBJECTIVES:Inflammatory bowel diseases (IBD)—Crohn's disease (CD) and ulcerative colitis (UC)—are chronic gastrointestinal inflammatory disorders with a complex genetic background. A genome-wide association scan by the Wellcome Trust Case Control Consortium (WTCCC) recently...

  • Adverse events in clinical trials with azathioprine and mesalamine for prevention of postoperative recurrence of Crohn's disease. Herfarth, H.; Tjaden, C.; Lukas, M.; Obermeier, F.; Dilger, K.; Müller, R.; Schölmerich, J. // Gut;Oct2006, Vol. 55 Issue 10, p1525 

    The article presents a letter entitled "Adverse events in clinical trials with azathioprine and mesalamine for prevention of postoperative recurrence of Crohn's disease," by H. Herfarth, C. Tjaden and M. Lukas published within the issue. The authors comment on the study about the efficacy and...

  • Treatment of Ulcerative Colitis with a Humanized Antibody to the α4β7 Integrin. Feagan, Brian G.; Greenberg, Gordon R.; Wild, Gary; Fedorak, Richard N.; Paré, Pierre; McDonald, John W.D.; Dubé, Rejean; Cohen, Albert; Steinhart, A. Hillary; Landau, Steven; Aguzzi, Rasha A.; Fox, Irving H.; Vandervoort, Margaret K. // New England Journal of Medicine;6/16/2005, Vol. 352 Issue 24, p2499 

    Background: Selective blockade of interactions between leukocytes and vascular endothelium in the gut is a promising strategy for the treatment of inflammatory bowel diseases. Methods: We conducted a multicenter, double-blind, placebo-controlled trial of MLN02, a humanized antibody to the...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics