A pilot study on the use of the humanized anti-interleukin-2 receptor antibody daclizumab in active ulcerative colitis

Assche, Gert Van; Dalle, Ignace; Noman, Maja; Aerden, Isolde; Swijsen, Caroline; Asnong, Katrien; Maes, Bart; Ceuppens, Jan; Geboes, Karel; Rutgeerts, Paul

doi:10.1111/j.1572-0241.2003.07239.x

Cited by 58 publications

(20 citation statements)

References 18 publications

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“…As there was no placebo control group it was not possible to determine if the events were attributable to the administration of basiliximab 29 30. In contrast to the results with basiliximab, although an initial open-label study of 10 patients with refractory UC indicated that daclizumab produced some clinical benefit,31 a larger randomised controlled trial in patients with moderate UC showed that those treated with daclizumab were not more likely to be in remission after 8 weeks of treatment compared with patients given placebo 32. Adverse events were few with daclizumab, with the most common being nausea in patients simultaneously treated with azathioprine31 as well as nasopharyngitis and fever 32…”

Section: Targeting the Adaptive Immune Systemmentioning

confidence: 99%

New therapies for inflammatory bowel disease: from the bench to the bedside

Danese

2011

Gut

282

172

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The mechanisms underlying the chronic intestinal inflammation that is a hallmark of inflammatory bowel diseases (IBD) are complex. Components of the pathological response include the adaptive and innate immune systems, as well as the intestinal epithelium and endothelium. Advances in the understanding of the roles of each of these components have resulted in the development of multiple biological agents that all represent an alternative to the use of current therapies in patients with refractory Crohn's disease or ulcerative colitis. This study systematically reviews the mechanisms of action, efficacy and safety of new and emerging therapies that are currently in clinical trials and discusses future directions in the treatment of IBD.

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Section: Targeting the Adaptive Immune Systemmentioning

confidence: 99%

New therapies for inflammatory bowel disease: from the bench to the bedside

Danese

2011

Gut

282

172

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“…This effect was most prominent in patients with elevated baseline concentrations of CRP [36]. An additional phase 2 study of fontolizumab at lower subcutaneous doses of 1.0 mg/kg or 4.0 mg/kg in 196 patients with active CD did not demonstrate efficacy at day 28 [37]. These results indicate that a single dose may not be sufficient to achieve a significant improvement.…”

Section: Fontolizumab (Anti-interferon-γ Antibody)mentioning

confidence: 96%

Current and Future Biological Treatments in Inflammatory Bowel Disease

Yamamoto‐Furusho¹

2011

Gene Therapy Applications

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“…In a little open-label study on 10 steroid-resistant UC patients, Daclizumab (administered in two infusions 4 weeks apart), permitted clinical remission in 80% and clinical response in 50% of patients. Contemporary decrease in CRP serum level and in CD25+ mucosal T cells number, while no effect on mucosal healing were observed [130].…”

Section: Inhibitors Of T Cells Proliferationmentioning

confidence: 96%

Biological Therapies For Inflammatory Bowel Disease: Research DrivesClinics

Danese¹,

Semeraro²,

Armuzzi³

et al. 2006

MRMC

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The better understanding of the mechanisms of inflammatory bowel disease has driven our progress into the development of new biological therapies targeting specific molecules. Anti-TNF-alpha biologic compounds have shown great efficacy particularly in Crohn's disease. Infliximab (an IgG1 mouse/human chimeric monoclonal anti-TNF-alpha antibody fragment) is the most efficacious compound in induction and maintenance therapy of active and fistulizing Crohn's disease, being at present the only biological compound approved for therapy, but with the limit of the immunogenicity; CDP-571 (a humanized anti-TNF-alpha antibody) and CDP-870 (a PEGylated anti-TNF-alpha antibody) are less immunogenic, showed some efficacy in induction therapy in Crohn's disease but a rapid loss of response in maintenance therapy. Etanercept and onercept (soluble human recombinant TNF-alpha receptors fusion proteins) seem not to be efficacious in Crohn's disease demonstrating no class-effect for anti-TNF-alpha compounds. In preliminary study, adalimumab (an IgG1 humanized monoclonal anti-TNF-alpha antibody) offers good perspective of efficacy and safety also in infliximab-resistant or allergic patients. Inhibition of lymphocyte trafficking to the gut, through anti-adhesion molecules specific therapies (natalizumab, MLN-02, alicaforsen), has shown promising results: unfortunately, natalizumab, the most effective drug of this class, has recently been suspected to favour serious neurological complications. Other biologic therapies are under evaluation but at present seem to be less promising than infliximab; they consist of antiinflammatory cytokines, inhibitors of proinflammatory cytokines, hormones and growth factors: anti-IL12-antibody, interferon-alpha, interferon-beta, G-CSF, GM-CSF, EGF, growth hormone, anti-interferon-gamma, anti-IL-18, anti-IL-2-receptor and anti-CD3 antibodies. The evaluation of other biological drugs has been suspended for severe side effects as happened for anti-CD40L antibody causing thromboembolism and anti-CD4 antibody causing ly.mphopenia. Other compounds as IL-10 and IL-11 have been proven to be ineffective even if an oral formulation of IL-11 is under evaluation. Among the MAP kinases inhibitors BIRB-796 and RDP58 showed to be ineffective while CNI-1493 is under evaluation. The effort in identifying specific patients features predicting therapy response and the possible combination of different biological therapies represent undoubtedly a very promising perspective. Aim of this article is to review the biological compounds and their efficacy in IBD.

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A pilot study on the use of the humanized anti-interleukin-2 receptor antibody daclizumab in active ulcerative colitis

Abstract: The anti-IL-2R antibody daclizumab was safe and well tolerated in acute UC. Patients experienced clinical benefit along with signs of endoscopic improvement, but further controlled trials are needed to determine the therapeutic benefit of this compound.

Cited by 58 publications

References 18 publications

New therapies for inflammatory bowel disease: from the bench to the bedside

New therapies for inflammatory bowel disease: from the bench to the bedside

Current and Future Biological Treatments in Inflammatory Bowel Disease

Biological Therapies For Inflammatory Bowel Disease: Research DrivesClinics

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