NEW YORK (Reuters Health) – Adalimumab alone or in combination with disease-modifying antirheumatic drugs (DMARDs) is effective in difficult-to-treat patients with rheumatoid arthritis, according to European researchers.

In the June issue of the Annals of the Rheumatic Diseases, Dr. Gerd R. Burmester of Charite Medical University, Berlin, and colleagues note that tumor necrosis factor (TNF) antagonists are effective against rheumatoid arthritis, but detailed assessment of TNF antagonist therapy in combination with the wide range of DMARDs commonly used to treat patients with rheumatoid arthritis in clinical practice is lacking.

To shed more light on the matter, the researchers conducted an open-label study of 6610 patients from 12 European countries. All had active rheumatoid arthritis despite treatment with DMARDs or prior treatment with a TNF antagonist. They received adalimumab 40 mg every other week for 12 weeks.

Patients were allowed to continue treatment with DMARDs and other agents. Among these were methotrexate, leflunomide, sulfasalazine and chloroquine, as well as glucocorticoids and non-steroidal anti-inflammatory drugs.

At 12 weeks, 69% of patients achieved an American College of Rheumatology improvement of 20%. In addition, 33% showed a good European League Against Rheumatism response. The agent was also well tolerated.

Adalimumab "provided substantial improvement in multiple measures of effectiveness in patients with long-standing active rheumatoid arthritis despite extensive standard treatment," the investigators conclude.

"Although a placebo-controlled trial is necessary to prove the efficacy of a drug," they add, "an open-label study conducted in a large cohort of patients in multiple countries and a variety of clinical practice sites should provide reassurance about the safety and effectiveness of adalimumab in typical practice."