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Anti-Cardiolipin Antibodies Induced by Infliximab and Etanercept Are Associated With Poor Clinical Outcome for Rheumatoid Arthritis

Treated with either infliximab or etanercept for rheumatoid arthritis (RA) appears to increase the presence of anti-cardiolipin antibodies (ACLA), and infliximab treatment appears to result in a worse clinical outcome compared to etanercept.

In the general population, ACLA are associated with thromboembolic disease, but the significance of these antibodies in patients with RA has been unclear until now.

To clarify the effects of infliximab and etanercept in RA patients, Thorunn Jonsdottir MD, Department of Rheumatology, Karolinska Hospital, Stockholm, Sweden, and colleagues assessed the frequency of ACLA in infliximab- and etanercept-treated patients and the related clinical outcomes.

Dr. Jonsdottir and his team selected 121 patients from the Stockholm TNF-alpha Follow up Registry (STURE). Sixty-four patients had received 3 mg/kg of infliximab at 0, 2, and 6 weeks and every 8th week thereafter; 90% also received 7.5 to 15 mg of methotrexate weekly. Fifty-seven patients had received 25 mg of subcutaneous etanercept twice weekly, and 50% of those were also treated with methotrexate.

Levels of ACLA, American College of Rheumatology 20% response (ACR20), and the European League Against Rheumatism response (as a disease activity score 28 [DAS-28]) were determined at baseline and at 3, 6 and 12 months.

At 3 months, both treatment groups had increased numbers of ACLA-positive patients -- from 13.5% to 29% for infliximab (P < .05) and from 17% to 27% for etanercept. No further significant increases were seen.

Patients who developed ACLA after infliximab treatment had a 50% response rate by ACR20 criteria, compared to 86.7% response among those who were ACLA-negative (P < .05). No differences in response rates were seen in the etanercept group.

Treatment-limiting infusion reactions occurred more frequently in ACLA-positive patients in both treatment groups when compared with to entire STURE group (17% vs. 5%; P < .05), but there was no significant difference in frequency of thromboembolic events.

"In summary, ACLA are induced in RA patients treated with the TNF-alpha blocking agents infliximab and etanercept, [and] positive ACLA [status] predicts less treatment benefit with infliximab and a higher risk for a treatment limiting infusion reaction," the authors conclude. "Therefore, knowledge of ACLA serology might in principle lead to a change in risk/benefit assessment and might impact the decision-making process regarding selection of antirheumatic treatment."
Ann Rheum Dis 2004 Apr 5 [Epub ahead of print] "Treatment with TNF-{alpha} antagonists in patients with rheumatoid arthritis induces anticardiolipin antibodies (ACLA): ACLA predict worse clinical outcome with infliximab and more frequent treatment limiting infusion reactions"

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