January 04, 2013
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Abatacept effectively, safely treated RA patients who failed anti-TNF, rituximab treatment

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Abatacept was safe and effective therapy for patients with severe rheumatoid arthritis who had failed to respond to anti-tumor necrosis factor therapy and rituximab in a recent study.

Researchers in Canada studied 23 patients with severe rheumatoid arthritis (RA; mean age, 56 years; 16 women) who were resistant to treatment after failing multiple disease-modifying antirheumatic drugs (DMARD) and tumor necrosis factor (TNF) inhibitors. Patients had a Disease Activity Score 28 (DAS28) of more than 5.1.

Abatacept was assigned at standard dosing protocols. Patients also received methotrexate or an alternative DMARD if they were methotrexate intolerant. Researchers calculated changes in DAS28, European League Against Rheumatism (EULAR) responses, remission rates (DAS28<2.6) and Health Assessment Questionnaire-Disability Index (HAQ-DI). At 3 months, patients could continue treatment if their DAS28 score improved by 1.2 or greater and their HAQ-DI by 0.22 or more.

Seven patients previously had been treated with rituximab (RTX), of which five had B-cells available, and B-cells were depleted in three patients. Patients who were RTX-naive or RTX-experienced had similar baseline characteristics.

At a mean assessment of 9.6 months, significant improvement was shown in median DAS28 scores (change: –2.4; P<.001) and median HAQ-DI (change: –0.8; P<.001). Eighteen patients (78%) experienced a EULAR good/moderate response, with nine (39%) showing a good response. Eight of those patients gained good/moderate response within 3 months. Seven patients (30%) achieved remission; RTX-naive and RTX-experienced subgroups displayed similar responses.

No serious infections or adverse events occurred; six patients developed nine minor infections during 31.4 patient-years of follow-up.

“Although our safety data are limited to short-term follow-up, our observations suggest that abatacept is safe to use in patients who have failed to respond to anti-TNF therapy and RTX, including a small number of patients who were B-cell depleted at the initiation of abatacept,” the researchers concluded.