Biological treatment includes antibodies, receptors, inhibitors or parts of nucleic acids which decrease the concentration of pro-inflammatory agents in the organism as well as anti-inflammatory cytokines. Infliximab is the most commonly used. It is a chimeric monoclonic antibody against tumour necrosis factor alpha (TNF-alpha, major proinflammatory cytokine). Infliximab binds TNF molecule, neutralises it and thus increases the activated T lymphocytes apoptosis . Infliximab is indicated in the active severe course of disease which does not respond to other types of treatment; in non-healing fistulae and in extra-intestinal complications (skin, eyes, joints).
Patients with active disease without fistula formation should be administered a single, 2-h intravenous infusion of infliximab at a dose of 5 mg/kg. Patients with concomitant fistulae should get triple intravenous infusion (0, 2,6 weeks) followed by the intravenous injection of 5 mg/kg every 8 weeks to sustain the effects of therapy. Side effects include increased risk for infection, especially of the respiratory tract including the activation of quiescent TB. Treatment should be preceded by chest X-ray, and TB tests .
There are a number of trials on the effectiveness and safety of infliximab treatment. One of the better ones is the prospective ACCENT (a Crohn's disease clinical trial evaluating infliximab in a new long-term treatment regimen). The study included CD patients from North America, Europe and Israel.
In the first phase of the trial, ACCENT I, 335 patients with active CD were enrolled and received the initial dose of infliximab (5 mg/kg/day). The results showed higher remission rates in groups receiving the consequent doses of infliximab at 2, 6 and every 8 weeks (5 mg/kg/day and 10 mg/kg/day respectively), but did not reach statistical significance between study groups. Steroids treatment however could have been stopped in both groups, and the disease-free time and time to surgical intervention was longer in both groups compared to placebo .
The second phase of the trial, ACCENT II, investigated the effects of infliximab in supportive treatment of patients with fistulous CD. Intravenous injections were performed every 8 weeks. After 14 weeks, almost two-thirds of the patients demonstrated significant improvement in fistula healing, and in the 54th week a complete closing of the fistula was demonstrated in 38% of patients receiving infliximab compared to 22% of patients in a control group. Patients of the study group experienced a longer positive effect of treatment lasting 40 weeks, while in the placebo group it was only 14 weeks. The trial also showed that patients undergoing supportive treatment are less likely to be hospitalised and have a lower chance for surgical intervention .
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