New Biologic Treatment for Rheumatoid Arthritis Shows Promise

Newswise — Patients who do not respond to methotrexate therapy for the treatment of rheumatoid arthritis may have another option in CNTO 148 (golimumab), according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Diego.

Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. RA affects approximately 2.1 million Americans. Although low-dose weekly methotrexate therapy has resulted in a significant reduction of joint inflammation and structural damage in patients with RA, not all patients with RA respond completely to methotrexate.

Biologic therapies, which specifically target and block the effect of inflammatory mediators such as interleukin-1 and tumor necrosis factor a (TNFa), have offered much hope to patients with RA in recent years. Developing additional drugs in this class, with a range of dosing frequencies, will offer additional options to rheumatologists and their patients. This study of CNTO 148, a fully human anti-TNFa monoclonal antibody, showed that the treatment was effective at reducing the signs and symptoms of RA. In this relatively small study, treatment was generally well tolerated and no unexpected safety concerns occurred.

The double-blind, placebo-controlled study segmented participants into four dosage groups of 34 or 35 patients each, compared to a placebo group. Dosage amounts were: biweekly injections of 100mg and 50mg, or 100 mg or 50mg dosages every 4 weeks. The endpoint was patient assessment using the ACR 20/50/70 scoring criteria, which measures improvement in tender and swollen joint count and improvement in at least three of the following five criteria: pain; level of disability; overall self-assessment; overall physician assessment; acute phase reactant (e.g., C-reactive protein).

Of the 172 subjects who completed the Week 16 visit, a clinical effect of CNTO 148 was apparent in all four dose groups and there was no clear dose-response relationship. Further, a significantly higher proportion of subjects in the combined CNTO 148 group achieved ACR 20 response (i.e., a 20% reduction in signs and symptoms of disease), compared with that of the placebo group (63% vs. 37%, respectively). More encouraging, a significantly higher proportion of subjects in each of the four CNTO 148 groups achieved ACR 50 and ACR 70 responses, compared with that of the placebo group.

"The results of this trial demonstrate the potential of CNTO 148 as another therapy for the treatment of rheumatoid arthritis," said Jonathan Kay, MD, Associate Clinical Professor of Medicine at Harvard Medical School, Director of Clinical Trials in the Rheumatology Unit at Massachusetts General Hospital, and lead author on the study. "Through further investigation, we hope to advance our understanding of the safety and effectiveness of CNTO 148, thereby enhancing our insight into the treatment of this chronic and potentially crippling disease."

The American College of Rheumatology is the professional organization for rheumatologists and health professionals who share a dedication to healing, preventing disability and curing arthritis and related rheumatic and musculoskeletal diseases. For more information on the ACR's annual meeting, see http://www.rheumatology.org/annual.