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    Research Digest

    A new drug being tested for use in treating rheumatoid arthritis takes a new approach to this autoimmune disorder, in which the body's own immune system turns against it and attacks tissues, including the lining of joints.

    Most drugs used to treat RA suppress the entire immune system, which can cause severe side effects. The new drug, created by Alexion, and so far called C51.1, targets just one process in the immune system.

    Our blood has substances called complement proteins that don't do anything most of the time. When they're activated by the presence of foreign substances, such as bacteria or viruses or by the inflammation caused by illness, these proteins split into active byproducts. This process is called the complementary cascade, and that's what the new drug aims at.

    Specifically, C51.1 targets just one of these proteins, called-surprisingly enough-C5. When C5 splits, it tends to cause harmful inflammation. Basically, the new drug binds to C5 and keeps it from splitting into active components.

    Alexion has completed initial studies in humans, using C51.1 to treat RA. In a study of 42 patients who each received one dose of the drug, C51.1 was safe; well-tolerated; and caused a reduction in blood levels of C-reactive protein, whose presence is an important part of the diagnosis of RA.

    The researchers presented their results recently at the annual meeting of the American College of Rheumatology this week. They report that half of the patients, all of whom had mild to moderate RA, showed significant clinical improvement after one dose of C51.1, compared to one-tenth of those receiving placebo. This included fewer tender, swollen joints, less pain, and better functioning.

    Alexion is now recruiting 200 patients for a Phase II clinical trial that will be randomized and double-blind. The new study will look at safety and effectiveness when RA patients get multiple doses of C51.1 over time.

    The researchers hope that because of its targeted approach, C51.1 will prove to be more effective and have fewer side effects than many of the drugs in current use.


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