The first findings from a major study comparing options for treating severe rheumatoid arthritis, or RA, soon after diagnosis brings reassuring news to patients and doctors. The TEAR – Treatment of Early Aggressive Rheumatoid Arthritis – study found that good disease control appears to be possible whether a patient starts on one drug and has therapies added within the first six months as needed, or if a patient starts immediately on several therapies. It also found that older-drug combinations appear to be equally as effective as the newer biologic drugs.

Previous studies have shown that aggressive treatment of RA with disease-modifying antirheumatic drugs, or DMARDs, soon after diagnosis leads to better control of the disease – which results in less joint damage and better physical function – compared with less intensive treatment. Currently, doctors generally take a “step up” approach to therapy, starting with a DMARD like methotrexate, and adding more drugs as needed if disease activity remains high.

But questions remain: Is immediately starting treatment with more than one drug a better strategy than stepping up, so as not to miss the crucial window of opportunity to keep disease activity to a minimum? How large is the window of opportunity? And which drug combinations work best? The study, published recently online in Arthritis & Rheumatism, aimed to address some of these issues; it is the first set of findings released from the TEAR study.

The researchers looked at two questions. First, are results better if treatment starts with a combination of drugs, or is it just as good to start with methotrexate alone and add drugs only if needed to gain control? Second, which combination of drugs gets better results: methotrexate plus etanercept, or Enbrel – a biologic drug that blocks tumor necrosis factor-alpha, or TNF – or traditional “triple therapy” of methotrexate plus sulfasalazine and hydroxychloroquine? (Both drug combinations are commonly used by rheumatologists when RA disease activity remains high on methotrexate alone.)

To address these questions, the researchers studied 755 patients at 44 different medical centers across the United States for two years. All patients had been recently diagnosed with RA at the time of enrollment. They also had what is considered severe or aggressive RA. Severity is determined by whether the patient tests positive for RA-related antibodies, has signs of joint damage on X-rays, and/or has a high disease activity score as measured by the DAS28, which reflects swollen and tender joints in 28 spots around the body. The average DAS28 score at the start of the study was 5.8.

The patients were randomized into four groups. One group immediately started on the combination of methotrexate and etanercept. Another immediately started on triple therapy. A third and fourth group received methotrexate alone for 24 weeks (six months). At that point, people in these two groups were stepped up to one of the combination therapies if their DAS28 score was 3.2 or greater. The study was double-blinded, meaning neither patient nor doctor knew who received which treatment.