Archive Page 2
Interesting Extracts and Books
Phase III Trials for Antegren. NACC News has further information on the development of natalizumab, one of a class of drugs called human monoclonal antibodies aimed at treating Crohn's Disease. Natalizumab has now completed phase III trials and Elan Corporation Plc and Biogen Idec, who are marketing the drug under the name Antegren, have submitted an application to the European Medicines Agency for the drug to be approved for the treatment of Crohn's.
"Natalizumab is an interesting new antibody therepy for Crohn's Disease," says Miles Parkes, Medical Editor. "It has been used in clinical trials for a number of years and the emerging data indicates a particular role in the maintenance of remission for Crohn's, including allowing patients to come off steroid therepy. It also appears to be safe and relatively free of side effects. As such, it is of course to be welcomed. As with many treatments, a better feel for its role will have to await more widespread use in larger number of patients." Extract taken from NACCNEWS Winter 2004/5.
New drug stimulates cells in the immune system. While many drugs for Crohn's are aimed at suppressing the immume system, sargramostim works by stimulating particular cells of the innate immune system. In the US, scientists tested sargramostim on patients with moderately to severely active Crohn's Disease to find out whether it had a positive response on the disease symptoms. Over a period of 56 days 124 patients were treated with either sargramostim or placebo. The scientists found that significantly more of the patients who received sargramostim as opposed to a placebo demonstrated a positive response to their Crohn's and also experienced clinical remission. Those treated with sargramostim also experienced remission more quickly than those treated with a placebo. In addition, the sargramostim treatment had a healing effect on the mucosa, the intestinal lining, of petients.
The scientists conclude that the drug was generally well-tolerated and resulted in improvements in disease severity, mucosal healing and quality of life in patients with active Crohn's Disease. Miles Parkes, Medical Editor, comments; " It suggests that stimulation of selected cells of the immune system known as granulocytes and macrophages (G and M0 with sargramostim (GM-CSF) can produce both symptomatic improvements in active Crohn's Disease and also healing of the ulceration in the bowel lining". Extract taken from NACCNEWS Winter 2004/5.
Reducing the production of infliximab antibodies. Scientists in Belgium and the US have been working hard to find a way of reducing the risk of patients treated with infliximab developing antibodies to the drug. Infliximab is used to treat some patients with severe Crohn's for whom conventional drugs don't work. However, while it can be very effective, up to 61% of patients develop antibodies to infliximab, and this inhibits it's effectiveness and increases the risk of infusion reactions. While it is known that treatment with immunosuppressant drugs can reduce the risk of these antibodies forming, it is unclear which ones work best. Noman et al tested patients receiving inflixmab with two types of immunosuppressants: methotrexate (MTX) and azathioprine (Aza). In a group of 174 patients, 50 were treated with combined MTX and infliximab, 65 with combined Aza and infliximab, and 59 with infliximab without immunosuppressants. The scientists detected antibodies in 55% of all patients, but in those treated with immunosuppressants alongside infliximab, there was lower incidence of antibodies . The results were similar for Aza and for MTX.
Miles Parkes, Medical Editor, comments: "A number of studies have produced similar findings and it does seem to be an important effect - mainly because the production of antibodies as part of an immune response to the infliximab drug strongly correlates with loss of efficacy of the medication and development of infusion reactions. Thus, patients who are also on Aza/MTX are less prone to producing antibodies to infliximab and thus both less likely to have an adverse reaction to the infusion and more likely to have a more long lasting response to it - as well as the posibility that the Aza/MTX will themselves continue to damp down the Crohn's inflammation. Extract taken from NACCNEWS Winter 2004/5.
