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- ACCENT, A Crohn’s disease Clinical trial Evaluating infliximab in a New long-term Treatment regimen
- CHARM, Crohn’s Trial of the Fully Human Antibody Adalimumab
- CLASSIC, CLinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn’s
- GAIN, Gauging Adalimumab efficacy in Infliximab Nonresponders
- GETAID, Groupe d’Etudes Therapeutiques des Affections Inflammatoires Digestives
- PRECISE, PEGylated antibody fRagment Evaluation in. Crohn’s disease: Safety and Efficacy
- SONIC, SONIC (Study Of biologic and Immunomodulator Naive patients in Crohn’s disease
- TNF, tumour necrosis factor
With the development and introduction of anti-cytokine therapies as biological agents, our therapeutic approach to Crohn disease and inflammatory diseases in general has dramatically expanded within the past few years. Biological agents technically mean a molecule that is the product of a biological system and functionally that is an agent that targets a specific biological molecule. Gastroenterologists are facing a remarkable wave of new biological therapies for inflammatory bowel diseases (IBD), including anti-tumour necrosis factor (TNF) antibodies (infliximab, adalimumab, certolizumab pegol), an anti-CD3 antibody (visilizumab), an anti-integrin antibody (natalizumab), and an anti-IL-12p40 and anti-IL6 receptor antibody (tocilizumab). Several biological therapies have also proven to be ineffective in large clinical trials, despite good initial promise, such as antibodies against soluble TNF receptors (etanercept, onercept), interleukin-10 and granulocyte–macrophage colony-stimulating factor (sargramostim).
Infliximab, an intravenously administered chimeric monoclonal antibody to TNF, has been for some years the only biological molecule approved for the treatment of Crohn disease, and more recently ulcerative colitis. Currently, two new subcutaneously administered anti-TNF molecules are in the process of being incorporated into the therapeutic armamentarium, including a fully human antibody (adalimumab) and a humanised pegylated Fab fragment (certolizumab pegol). The efficacy of adalimumab for induction of remission in patients with active Crohn disease not previously exposed to anti-TNF therapy was assessed in the CLASSIC (CLinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn’s) I trial,1 showing that remission rates at week 4 in patients receiving two injections of 160 mg and 80 mg of adalimumab (the highest dose tested) at weeks 0 and 2 were significantly higher than in placebo-treated patients (36 vs. 9%). The CLASSIC II study, reported in this issue of Gut (see page 1232),2 is a continuation trial assessing the efficacy and safety of adalimumab 40 mg …
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