Traditional Therapy as Effective as Newer Biologics in Early Rheumatoid Arthritis

Alice Goodman

October 27, 2009

October 27, 2009 (Philadelphia, Pennsylvania) — Three older disease-modifying anti-rheumatic drugs (DMARDs) were as effective as the biologic agent etanercept (Enbrel) plus methotrexate in patients with early rheumatoid arthritis (RA). Researchers said they were surprised by the results of the 2-year Treatment of Early Aggressive Rheumatoid Arthritis (TEAR) trial, which were announced here at American College of Rheumatology (ACR) 2009.

"Most rheumatologists would have predicted that the biologic therapy [anti-tumor necrosis factor agent] would be better. We still need to see the x-ray results, which will be available in 2010, to see if either treatment [approach] is better," said Larry Moreland, MD, from the University of Pittsburgh in Pennsylvania.

Although these findings raise questions about the value of more expensive therapy with new biologic agents for an overall population of RA patients, Dr. Moreland said that biologic therapy might be better for specific subsets of patients, but exactly which subsets will have preferential benefit is currently unknown.

Investigators with the TEAR trial enrolled 755 patients with early aggressive RA (mean duration from diagnosis, 3.6 months), limited exposure to DMARDs (less than 2 months), and treatment-naïve to biologics used to treat RA. A total of 48% had previous exposure to oral prednisone (≤10 mg/day). The majority were females (72%), and 79.6% were Caucasian. Mean age was 49 years.

The study had 4 treatment groups. Two groups were initiated on drug therapy at the start of the study: 1 group with a triple-drug combination of older drugs (methotrexate, sulfasalazine, and hydroxychloroquine) and 1 group with methotrexate plus the anti-tumor necrosis factor agent etanercept. Two other groups were treated initially with methotrexate and then, at 6 months, if they had evidence of persistent disease activity, they were assigned to either the traditional 3-drug combination or to methotrexate plus etanercept (step-up therapy).

Dr. Moreland and colleagues presented 6-month Disease Activity Score (DAS) 28 findings. No difference between the 2 treatments was observed, either in the immediate-therapy groups or the step-up therapy groups. At 2 years, DAS 28 scores were 3.1 for triple therapy and 3.0 for methotrexate/etanercept in the immediate-therapy groups; for step-up therapy, DAS 28 was 2.8 for both groups.

Patients in both immediate-therapy groups improved more quickly than those in the step-up therapy groups. At 6 months, a much higher percentage of the immediate-therapy groups were improved, according to ACR20, ACR50, and ACR70 (instruments showing 20%, 50%, and 70% improvement, respectively, on the ACR measure). "This study provides exciting news that, for a significant number of patients, the 3-drug combination is as effective as biologic agents," stated Eric Matteson, MD, from the Mayo Clinic in Rochester, Minnesota. "It is compelling that we can do as well in a group of patients with these older drugs."

He also said that the x-ray data will be important. "It is intuitive that x-ray damage follows disease activity. We will know those results down the road."

Biologics might not work in individual patients, and DMARDs might not work in individual patients, he continued. "We are just starting to understand which patients don't respond well to these agents. We hope to be able to tease out these factors and to define which drugs are best in specific subsets of patients."

"This study showed that biologics are not the right approach for every patient, and this has cost implications," he said.

The study was supported by Immunex and Amgen. Dr. Moreland reports having financial ties with Amgen, Barr, Pharmacia, and NIAMS-NIH. Dr. Matteson reports having financial ties with Amgen, Wyeth, UCB, Genentech, and Pfizer.

American College of Rheumatology (ACR) 2009: Abstract 1895. Presented October 20, 2009.

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