Study: Adalimumab Safe and Effective for Rheumatoid Arthritis

Data from ongoing phase III trials of the human monoclonal antibody D2E7, one of a new class of injectable antibody drugs designed to block a protein called tumor necrosis factor (TNF) which is involved in inflammation, continue to show the drug safe and effective in the treatment of rheumatoid arthritis, according to the drug's manufacturer.

"(Rheumatoid arthritis) is a progressive disease that can be very debilitating for patients, which is why the research we are conducting with D2E7 is so exciting," said Dr. Michael Schiff of University of Colorado School of Medicine, a lead investigator for D2E7 clinical trials.

The drug's manufacturer, Abbott, reported at the European League Against Rheumatism meeting in Stockholm on results of its phase III STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis) trial.

Safety is a key concern with all therapies for rheumatoid arthritis, with some rheumatologists expressing concern that even the latest Cox-2 inhibitors -- while safer than older anti-inflammatory drugs -- might be linked to heart and kidney problems.

In the STAR trial, 636 rheumatoid arthritis patients randomly were injected with 40 milligrams of D2E7 or a placebo every other week, in addition to their current medication, which included up to four disease-modifying antirheumatic drugs.

After 24 weeks of treatment, D2E7 (adalimumab) showed no significant differences in side effects or infections compared to a placebo when added to patients' current therapies, except for injection site reactions, rash and back pain.

"The phase III data for D2E7 offer patients hope for a potential new option that has demonstrated favorable clinical results with convenient dosing and administration," Schiff said.

Abbott, currently is seeking United States and European approval for the drug (see earlier Arthritis Week story).

Other sources: Abbott Laboratories