Study: New Rheumatoid Arthritis Drug Shows Promise in Clinical Trials

Isis Pharmaceuticals' new antisense TNF-alpha inhibitor Isis 104838 is showing promise in the middle stages of its clinical testing as a treatment for rheumatoid arthritis, according to the company.

In a Phase 2 clinical trial, 157 rheumatoid arthritis patients received injections of either a placebo or 200 milligrams of ISIS 104838 either every other week, once weekly or twice weekly.

Forty-one percent of the patients receiving the once- and twice- weekly doses achieved a 20 percent decrease in disease activity, compared to 23 percent of the patients receiving the placebo, according to researchers.

The researchers also found that significantly more patients dropped out of the placebo group due to progression of their rheumatoid arthritis than the two highest ISIS 104838 dose groups. No drug-related serious adverse events were reported.

Dr. Jon T. Holmlund, Isis vice president of development, said the patient responses to the drug in the trial were continuing to increase at the conclusion of three months of treatment with Isis 104838.

"Therefore, we believe longer dosing or higher doses of ISIS 104838 may significantly enhance activity," Holmlund said, while noting that the drug appears to offer several important advantages over protein-based drugs, particularly with regard to side effects and cost.

"We are aggressively advancing the development of ISIS 104838 for the treatment of rheumatoid arthritis as an alternative to currently available
drugs," Holmlund said, noting that additional Phase 2 trials will be initiated to further explore dose, schedule and treatment duration of the drug.

Other sources: Isis Pharmaceuticals, Inc.