A Phase II dose ranging, double‐blind, placebo‐controlled study of alicaforsen enema in subjects with acute exacerbation of mild to moderate left‐sided ulcerative colitis

@article{vanDeventer2006API,
  title={A Phase II dose ranging, double‐blind, placebo‐controlled study of alicaforsen enema in subjects with acute exacerbation of mild to moderate left‐sided ulcerative colitis},
  author={Sander J. H. van Deventer and M K Wedel and Brenda F Baker and Summer Xia and Emil Chuang and Philip B. Miner},
  journal={Alimentary Pharmacology \& Therapeutics},
  year={2006},
  volume={23}
}
Alicaforsen is an antisense oligonucleotide designed to inhibit expression of human intercellular adhesion molecule 1. Previous clinical studies have demonstrated activity of alicaforsen enema in ulcerative colitis and pouchitis. 
Meta‐analysis using individual patient data: efficacy and durability of topical alicaforsen for the treatment of active ulcerative colitis
TLDR
The antisense ICAM‐1 inhibitor alicaforsen has been studied in four phase 2 studies in ulcerative colitis with varied results as to the extent of their colitis and in the severity of disease at entry. Expand
Systematic review with meta‐analysis: high prevalence and cost of continued aminosalicylate use in patients with ulcerative colitis escalated to immunosuppressive and biological therapies
TLDR
Aminosalicylates are the most frequently prescribed treatment for ulcerative colitis but clinicians are uncertain whether to continue aminosalicylate treatment in patients with UC after escalating therapy. Expand
Systematic review with meta‐analysis: endoscopic and histologic placebo rates in induction and maintenance trials of ulcerative colitis
Regulatory requirements for claims of mucosal healing in ulcerative colitis (UC) will require demonstration of both endoscopic and histologic healing. Quantifying these rates is essential for futureExpand
The emerging role of vedolizumab in the treatment of ulcerative colitis
TLDR
The emerging role of vedolizumab, a humanized monoclonal antibody that selectively blocks lymphocyte trafficking to the gut, for the treatment of ulcerative colitis is discussed. Expand
Alicaforsen in the treatment of pouchitis.
TLDR
Given the positive results evolving from one open-label trial and one case series in patients with chronic refractory pouchitis, US FDA has agreed to a rolling submission for a license application for the treatment of pouchitis which has recently initiated. Expand
Advances in therapeutic approaches to ulcerative colitis and crohn’s disease
  • S. Travis
  • Medicine
  • Current gastroenterology reports
  • 2005
TLDR
With the cost and complexity of biotherapy, inflammatory bowel disease is emerging as a specific subspecialty and its management is about more than drug therapy, dose, and timing. Expand
Alicaforsen, an antisense inhibitor of ICAM-1, as treatment for chronic refractory pouchitis after proctocolectomy: A case series
TLDR
Alicaforsen seemed to be efficacious in inducing clinical and/or endoscopic improvement in chronic refractory pouchitis and may be a promising treatment alternative in those patients; however, given the high proportion of relapse, one 6-week course of alicAForsen may not be sufficient. Expand
Safety of biologics in inflammatory bowel disease
TLDR
Two recent trials observed high efficacy of infliximab in inducting and maintaining clinical remission, mucosal healing, and corticosteroid-sparing effects in patients with moderate to severe UC. Expand
Alicaforsen, an Antisense Inhibitor of Intercellular Adhesion Molecule-1, in the Treatment for Left-Sided Ulcerative Colitis and Ulcerative Proctitis
TLDR
A 6-week course of alicaforsen seemed to be safe and efficacious in inducing clinical improvement in patients with left-sided UC and proctitis. Expand
Alicaforsen for the treatment of inflammatory bowel disease
ABSTRACT Introduction: Intracellular adhesion molecule-1 (ICAM-1), is a transmembrane glycoprotein of the immunoglobulin family, constitutively expressed on vascular endothelial cells and upregulatedExpand
...
1
2
3
4
5
...

References

SHOWING 1-10 OF 32 REFERENCES
Safety and efficacy of two dose formulations of alicaforsen enema compared with mesalazine enema for treatment of mild to moderate left‐sided ulcerative colitis: a randomized, double‐blind, active‐controlled trial
Alicaforsen is an antisense oligonucleotide inhibitor of intercellular adhesion molecule 1 protein expression with activity in subjects with ulcerative colitis and pouchitis.
A randomised, controlled, double blind, escalating dose study of alicaforsen enema in active ulcerative colitis
TLDR
Alicaforsen enema showed promising acute and long term benefit in patients with mild to moderate descending ulcerative colitis and had a favourable safety profile, and these findings require verification in larger randomised controlled clinical trials. Expand
An enema formulation of alicaforsen, an antisense inhibitor of intercellular adhesion molecule‐1, in the treatment of chronic, unremitting pouchitis
TLDR
Pouchitis is the major long‐term complication of ileal pouch‐anal anastomosis for ulcerative colitis and one‐quarter of pouchitis patients who recur suffer from chronic, unremitting pouchitis. Expand
Mesalamine capsules for treatment of active ulcerative colitis: results of a controlled trial. Pentasa Study Group.
TLDR
The data suggest that controlled-release mesalamine capsules are a safe and effective monotherapy in doses of 2-4 g daily for treating mild to moderately active ulcerative colitis, as well as for inducing remission, regardless of prior oral steroid or sulfasalazine therapy or extent of disease. Expand
A placebo-controlled trial of ICAM-1 antisense oligonucleotide in the treatment of Crohn's disease.
TLDR
ISIS 2302 seems to be a well-tolerated and promising therapy for steroid-treated Crohn's disease. Expand
5-ASA enemas for refractory distal ulcerative colitis. An open trial.
TLDR
Although the role of 5-ASA enemas in the treatment of refractory distal ulcerative colitis remains to be determined, it appears that the drug appears to be beneficial for only a minority of patients dependent on systemic corticosteroids. Expand
Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study.
TLDR
It is concluded that oral 5-ASA administered in a dosage of 4.8 g per day is effective therapy, at least in the short term, for mildly to moderately active ulcerative colitis. Expand
Distribution of mesalamine enemas in patients with active distal ulcerative colitis.
TLDR
It is concluded that a 60-ml enema, when administered as recommended clinically, routinely flows retrograde as far as the splenic flexure but rarely spreads beyond this point, support the use of intrarectally administered 5-aminosalicylic acid for segmental colitis of the descending colon. Expand
5-Aminosalicylic acid enema in the treatment of distal ulcerative colitis, proctosigmoiditis, and proctitis.
The efficacy and safety of 4-g 5-aminosalicylic acid enemas were assessed in 153 patients with ulcerative colitis involving up to 50 cm of distal colon. Seventy-six patients received activeExpand
Maintaining Remission in Distal Ulcerative Colitis and Ulcerative Proctitis
TLDR
This paper reviews the literature on maintenance therapy for both distal and universal ulcerative colitis and concludes that patients in remission can be safely maintained in remission with sulphasalazine or one of its 5-ASA derivatives. Expand
...
1
2
3
4
...