Two drugs better than one for RA
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For adults with early, aggressive rheumatoid arthritis (RA), treatment with a combination of Humira (adalimumab) and methotrexate appears to be more effective than treatment with either agent alone, according to results of the PREMIER study.
Humira is a human antibody designed to block a protein known as tumor necrosis factor, which plays a key role in inflammation. So-called TNF-blockers such as Humira have brought relief to many people with inflammatory conditions such as RA or the intestinal disorder Crohn’s disease.
In the PREMIER study, 799 patients with early, aggressive RA who had never been treated with methotrexate were randomly assigned to Humira injections plus oral methotrexate, or to Humira or methotrexate alone.
Dr. Ferdinand C. Breedveld, from Leiden University Medical Center in the Netherlands, and colleagues report in the journal Arthritis and Rheumatism that combination therapy with Humira plus methotrexate was “significantly superior” to either methotrexate alone or Humira alone in improving signs and symptoms of disease, inhibiting RA progression, and effecting clinical remission.
At the end of 1 year, 62 percent of those in the combination group achieved an “ACR50” response—that is a decrease of at least 50 percent in the number of both tender and swollen joints—compared with only 41 percent of those in the Humira group and 46 percent of patients in the methotrexate group. This pattern was sustained at 2 years.
Patients in the combination arm also experienced less joint damage compared with patients on monotherapy.
At the end of 2 years, clinical remission was achieved by 43 percent in the combination group, 23 percent in the Humira group, and 21 percent in the methotrexate group.
There were no significant differences among groups in the incidence of serious adverse events or in the number of subjects who withdrew because of adverse events. Withdrawal because of a lack of efficacy was less frequent in the combination therapy group (4.9 percent versus 19.0 percent and 17.9 percent).
The PREMIER study was sponsored by Humira manufacturer Abbott Laboratories.
SOURCE: Arthritis and Rheumatism January 2006.
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