An enema formulation of alicaforsen, an antisense inhibitor of intercellular adhesion molecule‐1, in the treatment of chronic, unremitting pouchitis

Miner, Philip B.; Wedel, Michael; Bane, Barbara L.; Bradley, J. Andrew

doi:10.1111/j.1365-2036.2004.01863.x

Cited by 128 publications

(83 citation statements)

References 8 publications

(13 reference statements)

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“…A randomized trial of ciprofloxacin and metronidazole showed that patients treated with ciprofloxacin experience significantly greater reductions in the PDAI scores and fewer adverse effects than those treated with metronidazole [67] . Other agents have been reported in open-labeled trials including tetracycline, clarithromycin, amoxicillin/clavulanic acid, doxycycline, rifaximin, and budesonide enemas [68] , alicaforsen enemas, an anti-sense inhibitor of intercellular adhesion molecule-1 [69] , and AST-120, a highly adsorptive, porous, carbon microspheres [70] .…”

Section: Treatmentmentioning

confidence: 99%

Pouchitis

Yu¹,

Shao²,

Shen³

2007

WJG

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While restorative proctocolectomy with ileal pouch-anal anastomosis has significantly improved the quality of life in patients with underlying ulcerative colitis who require surgery, complications can occur. Pouchitis as the most common long-term complication represents a spectrum of disease processes ranging from acute, antibioticresponsive type to chronic antibiotic-refractory entity. Accurate diagnosis using a combined assessment of symptoms, endoscopy and histology and the stratification of clinical phenotypes is important for treatment and prognosis the disease. The majority of patients respond favorably to antibiotic therapy. However, management of chronic antibiotic-refractory pouchitis remains a challenge.

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Section: Treatmentmentioning

confidence: 99%

Pouchitis

Yu¹,

Shao²,

Shen³

2007

WJG

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“…Alicaforsen (ISIS 2302) administered in enema form may be useful in the management of left UC and antibiotic-resistant chronic pouchitis (95,96). A double-blind, placebo-controlled phase-2 study was recently reported where 120 patients with left active UC received alicafors-en enemas at various doses.…”

Section: Anti-leukocyte Adhesion Therapiesmentioning

confidence: 99%

Biologic therapies for chronic inflammatory bowel disease

Martínez-Montiel

Muñoz-Yagüe

2006

Rev. esp. enferm. dig.

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Crohn's disease (CD) and ulcerative colitis (UC) make up the so-called chronic inflammatory bowel disease (IBD). Advances in the understanding of IBD pathophysiologic mechanisms in the last few years have allowed the development of novel therapies such as biologic therapies, which at least theoretically represent a more specific management of this disease with fewer side effects. Currently, the only effective and widely accepted biologic therapy for the treatment of intraluminal, fistulizing CD, both for remission induction and maintenance, is infliximab. The role of other monoclonal antibodies such as adalimumab is not clearly established. It could be deemed an alternative for patients with allergic reactions to infliximab, and for those with lost response because of anti-infliximab antibody development. However, relevant issues such as dosage and administration regimen remain to be established. Antiintegrin α4 therapies, despite encouraging results in phase-3 studies, are still unavailable, as their marketing authorization was held back in view of a number of reports regarding progressive multifocal leukoencephalopathy cases. Immunostimulating therapy may be highly relevant in the near future, as it represents a novel strategy against disease with the inclusion of granulocyte-monocyte colony-stimulating factors.Regarding ulcerative colitis, results from the ACT-1 and ACT-2 studies showed that infliximab is also useful for the management of serious UC flare-ups not responding to standard treatment, which will lead to a revision of therapeutic algorithms, where this drug should be given preference before intravenous cyclosporine. In the next few years, the role of anti-CD3 drugs (vilisilizumab), T-cell inhibiting therapies, and epithelial repair and healing stimulating factors will be established.Key words: Inflammatory bowel disease. Crohn's disease. Ulcerative colitis. Therapy. 2006; 98: 265-291. Martínez-Montiel MP, Muñoz-Yagüe MT. Biologic therapies for chronic inflammatory bowel disease. Rev Esp Enferm Dig INTRODUCTIONCrohn's disease (CD) and ulcerative colitis (UC) make up the so-called inflammatory bowel disease (IBD). Advances in the knowledge of this condition's etiopathogenesis have been correlated to the development of novel therapeutic agents. Medical treatment is currently the cornerstone for managing these conditions, and surgery is reserved for complications or treatment refractoriness (1). The available therapeutic armamentarium includes anti-inflammatory drugs (aminosalicylates and steroids), antibiotics, and immune modulators (azathioprine, 6-mercaptopurin, cyclosporin and methotrexate). All these drugs result in a nonspecific suppression of inflammatory processes, and their use during the past few years has determined a relevant advance in BDI control. However, their efficacy is limited and they are not exempt from side effects. Biologic therapies, at least theoretically, would be more therapeutically effective with fewer side effects, and thus would represent more specific means for t...

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“…To our knowledge, this is the only case series investigating the role and potential efficacy of the ICAM-1 antisense oligonucleotide alicaforsen in chronic refractory pouchitis in UC patients after proctocolectomy, besides one open-label study with 12 patients. 13 …”

Section: Introductionmentioning

confidence: 99%

Alicaforsen, an antisense inhibitor of ICAM‐1, as treatment for chronic refractory pouchitis after proctocolectomy: A case series

et al. 2016

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Background and aims:The published data about the efficacy of the intercellular adhesion molecule-1 (ICAM-1) antisense oligonucleotide termed alicaforsen in inflammatory bowel disease (IBD) is rather inconsistent. This case series analyzes its efficacy in chronic refractory pouchitis, after proctocolectomy. Methods: We performed a retrospective analysis on all patients who had received at least one dose of alicaforsen for IBD at three referral centers in Switzerland. We assessed the drug's efficacy in patients treated for chronic refractory pouchitis, by comparing the clinical and/or endoscopic disease activity at baseline with a 2-3-month follow-up visit. Results: We identified 22 patients who had received at least one dose. Among them, 13 patients were being treated for chronic refractory pouchitis. These patients had a median age of 38.0 years (95% CI 21.0-69.0) and five were female (38.5%). The median time since pouch surgery was 102.5 months (95% CI 16.0-288.0), with a median pouchitis duration of 16.0 months (95% CI 4.0-216.0). At 2-3 months after therapy, clinical and endoscopic disease activity was significantly reduced (stool frequency 9.0 versus 6.0, the Pouchitis Disease Activity Index (PDAI) clinical subscore was 4.0 versus 1.0, and the endoscopic disease activity was 4.0 versus 2.0). Clinical improvement was achieved in 11 out of 13 pouchitis patients (84.6%); however, a relapse was observed in nine of these patients (81.8%). The median time from clinical improvement to relapse was 16 weeks (95% CI 9.0-23.0). Conclusions: 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.

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An enema formulation of alicaforsen, an antisense inhibitor of intercellular adhesion molecule‐1, in the treatment of chronic, unremitting pouchitis

Cited by 128 publications

References 8 publications

Pouchitis

Pouchitis

Biologic therapies for chronic inflammatory bowel disease

Alicaforsen, an antisense inhibitor of ICAM‐1, as treatment for chronic refractory pouchitis after proctocolectomy: A case series

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