Gene Therapy for Rheumatoid Arthritis Promising in Early Trials

FRANKFURT, Germany (Reuters Health) Jan 21 - Preliminary research into a gene therapy treatment for rheumatoid arthritis has yielded promising results, indicating that it might be possible to develop anti-inflammatory injections that need to be given just once every few months, German researchers report. Dr. Axel Baltzer, of the University Hospital in Dusseldorf, told Reuters Health that phase I clinical trials of the gene therapy confirmed that the treatment has no serious side effects and that this method to treat joint diseases is feasible.

"We can show that this is a method will enable us to give long-term treatment of rheumatoid arthritis with just one injection," he said. The developer of the treatment is Dr. C. H. Evans of Harvard Medical School in Boston, Massachusetts. Dr. Evans and colleagues in the US conducted phase I research on nine patients, while in German phase one research has thus far been done on three patients by Dr. Baltzer and Dr. Peter Wehling, now operating a biotech company in Dusseldorf. Dr. Baltzer said research on the 12 patients, all with advanced rheumatoid arthritis, followed the same basic procedure. Cells were drawn from an arthritic joint, cultured, and transduced to produce the anti-inflammatory protein interleukin-1 receptor antagonist.

After a few weeks of culturing, a solution of treated cells was injected into two joints. In the placebo-controlled study, one additional joint was injected with non-treated cells and one joint injected with a saline solution. In the US, patients participating in the study had already been slated for joint replacements. The injections were given four weeks before replacement surgery, and were producing the desired anti-inflammatory protein effectively for at least 4 weeks, Dr. Baltzer said. In Germany, the injection was shown to be effective for six weeks, until all transduced tissues were resected. In both the US and Germany, the treatment resulted in some patients with pain relief of a few months, he said.

Dr. Baltzer said the researchers will publish study results within the next few months and hope to begin phase II studies this year. "This could be the first step in finding a cure for rheumatoid arthritis," he said. "But right now our goal is to find a way to help people suffering from rheumatoid arthritis for an extended period of time with just one injection." Reuters Health Information 2002. © 2002 Reuters Ltd