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Orencia efficacy satisfactory after 1 year, enhanced by concomitant methotrexate in patients with RA
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Orencia demonstrated satisfactory efficacy between 24 and 52 weeks of treatment among patients with rheumatoid arthritis in routine clinical practice, with concomitant methotrexate use observed to have a strong influence on those results, according to recently published trial results.
Researchers studied 231 patients with rheumatoid arthritis (RA) enrolled in a Japanese multicenter registry who were followed for at least 52 weeks after beginning a regimen of intravenous Orencia (abatacept, Bristol-Meyers Squibb) with dosage based on patient weight. Patient data were collected from the Tsurumai Biologics Communication Registry (TBCR) retrospectively between 2003 and 2008 and prospectively between 2008 and October 2013.
Patients’ mean age 64.3 years, and 80.1% were female. Mean disease duration was 12.1 years.
Mean 28-joint Disease Activity Score C-reactive protein (DAS28-CRP) was 4.49, and 48.5% of the patients received methotrexate concomitantly at baseline. Mean CRP was 2.3 mg/dL.
Of the patients, 164 were classified in advanced Steinbrocker stages (III and IV), and disease activity overall was high. Thirty-three patients had pulmonary comorbidities at baseline, including 25 patients with interstitial pneumonia.
By week 4, mean DAS28-CRP decreased to 3.77; mean DAS28-CRP decreased to 3.56 at week 12 and to 3.34 at week 24. By week 52, 28.6% of patients achieved remission. In addition, the proportion of patients with high disease activity was reduced from 59.7% to 22.1%.
Fifty-three patients withdrew from the trial by week 52, with the most frequent reason as lack of response (34 patients, 14.8%). Eight patients discontinued treatment due to adverse events, including facial flushing, purpura and one appendicitis within the first 28 days. At 31 days, one patient presented with methotrexate-related proliferative disorder and one had malignant lymphoma at 39 days. Two developed pneumonia after 90 days and one had palpitations at 193 days.
Univariate logistic analysis revealed the use of methotrexate concomitantly as the highest predictor of categorical improvement in DAS28 at week 52. Patients who did not receive methotrexate were also more likely to have pulmonary involvement.
The efficacy and safety in clinical practice were similar to results from random control trials, according to the researchers. - by Shirley Pulawski
Disclosure: No disclosure information was available at the time of publication.
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