Combination Treatment as Effective as Biologic Therapy in People with Rheumatoid Arthritis

Initial use of methotrexate combined with sulfasalazine and hydroxychloroquine better controls rheumatoid arthritis at six months.

Press Release - American College of Rheumatology

Initial use of methotrexate combined with sulfasalazine and hydroxychloroquine is a successful way of controlling rheumatoid arthritis, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Philadelphia, Pa.

Rheumatoid arthritis is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected by RA, inflammation can develop in other organs as well. An estimated 1.3 million Americans have RA, and the disease typically affects women twice as often as men.

Disease-modifying antirheumatic drugs, or DMARDS as they are commonly called, are often the therapy of choice for patients with RA as they not only reduce inflammation and pain, but can slow the overall progression of the disease.

TNF-antagonists (also called biologics or anti-TNF therapy) are a class of drugs that have been used since 1998; overall, they have been given to more than 600,000 people worldwide. These drugs are given by injection and lessen inflammation by interfering with biologic substances that cause or worsen the inflammatory process.

In a recent investigator-initiated study, researchers looked at the benefit of taking either a combination of three oral disease modifying anti-rheumatic drugs (methotrexate, sulfasalazine, and hydroxychloroquine) or a combination of one DMARD (methotrexate) and an anti-TNF (etanercept) in people with RA. They also looked at the benefit of starting with combination therapy compared to “step-up” therapy, in which additional drugs were added to methotrexate when the clinical response was incomplete.

For two years, researchers followed 755 participants (who were mostly Caucasian women, with an average age of 49). The patients studied had early rheumatoid arthritis, with an average of less than four months from diagnosis, and had not yet received DMARD therapy. Patients were divided into four treatment groups: two began with combination therapy, either with methotrexate, sulfasalazine and hydroxychloroquine or methotrexate and etanercept, while two began with methotrexate then had sulfasalazine and hydroxychloroquine or etanercept added — only if they had persistent disease activity at six months.

This was a double-blind study, in which neither the patients nor their physicians knew which regimen they were receiving.

Researchers found that at six months, either combination therapy approach led to better responses than initial treatment with methotrexate alone. However, during the second year of this trial, they found no differences in the average levels of DAS28, a composite measurement of disease activity, between patients randomized to etanercept or triple DMARD therapy, regardless of whether they received immediate combination treatment or initial therapy with methotrexate with a step-up.

"Data from this investigator-initiated study provides critical information for researchers to perform additional research on the effectiveness of other treatment strategies for patients with rheumatoid arthritis,” explains Larry W. Moreland, MD; chief of rheumatology at the University of Pittsburgh, Pittsburgh, Pa., and lead investigator in the study. “Much more work is needed in order for physicians to be able to better prescribe the most effective therapies for individual patients."

The ACR is an organization of and for physicians, health professionals, and scientists that advances rheumatology through programs of education, research, advocacy and practice support that foster excellence in the care of people with or at risk for arthritis and rheumatic and musculoskeletal diseases. For more information on the ACR’s annual meeting, see www.rheumatology.org/annual.

Editor’s Notes: Dr. Moreland will present this research during the ACR Annual Scientific Meeting at the Pennsylvania Convention Center at 11:45 AM on Tuesday, October 20 in Ballroom AB. Dr. Moreland will be available for media questions and briefing at 1:30 PM on Sunday, October 18 in the on-site press conference room, 109 A.

Source: American College of Rheumatology