AMERICAN COLLEGE OF RHEUMATOLOGY: More than one-fourth of rheumatoid arthritis patients respond to methotrexate-first strategy

February 1, 2012

Methotrexate alone, with step up to other therapies only if a response is not achieved, is a reasonable starting strategy for treating "poor prognosis" rheumatoid arthritis (RA), said James O'Dell, MD, at the annual scientific meeting of the American College of Rheumatology, Chicago.

Methotrexate alone, with step up to other therapies only if a response is not achieved, is a reasonable starting strategy for treating "poor prognosis" rheumatoid arthritis (RA), said James O'Dell, MD, at the annual scientific meeting of the American College of Rheumatology, Chicago.

More than one-fourth of patients who were started on methotrexate alone achieved clinical remission at week 24, and this remission was dur-able out to 2 years, in a randomized 4-treatment arm study.

In the Treatment of Early Aggressive RA (TEAR) trial, 755 patients were randomly assigned to 1 of 4 treatment arms:

In the primary analysis, at 24 weeks, patients assigned to combination treatment had clinically superior responses on DAS28, but the difference was lost by 36 weeks after monotherapy nonresponders stepped up to double or triple therapy.

Twenty-eight percent of patients on methotrexate alone achieved DAS28 remission at week 24, and these responders maintained a durable response to 2 years.

There was an immediate advantage to using all drugs together when measuring the outcome (DAS28 remission) at 24 weeks, "but if you measure outcome between 1 and 2 years, there is no advantage clinically to doing that," said Dr O'Dell, professor of internal medicine, division of rheumatology, University of Nebraska Medical Center, Omaha.

Radiographic outcomes between the 4 treatment arms from treatment initiation to week 102 were nearly identical. "There was no radiographic penalty for waiting to make the decision clinically [to step up after initial methotrexate therapy]," he said.

In the group assigned to methotrexate monotherapy, 72% had a DAS28 >3.2 and stepped up to either etanercept or sulfasalazine/hydroxychloroquine, while 28% had low disease activity (DAS28 ≤3.2) and remained on methotrexate monotherapy.

Patients that stepped up had significantly more tender and swollen joints and a higher mean DAS28 score than those who did not require step-up therapy.