AMSTERDAM ? Two-year data from the extension of a major trial of Orencia (abatacept) suggest that the agent continued to prevent the advance of structural damage in rheumatoid arthritis, researchers reported here.
AMSTERDAM, The Netherlands, June 23 ? Two-year data from the extension of a major trial of Orencia (abatacept) suggest that the agent continued to prevent the advance of structural damage in rheumatoid arthritis, researchers reported here.
Patients treated with Orencia, a selective T-cell co-stimulation modulator, were significantly better at year two than at year one, said Harry Genant, M.D., of the University of California San Francisco, and colleagues, at the at the European League Against Rheumatism (EULAR) meeting.
The data emerged from an extension of the double-blind AIM 1 (Abatacept in Inadequate responders to Methotrexate) trial that demonstrated significant reductions in radiographic progression in RA patients for whom methotrexate was inadequate. The extension arm of the trial was designed to study the drug's long-term impact, said Dr. Genant.
Patients completing the earlier double-blind phase of the AIM trial were eligible to enter the long-term study. All patients were treated with a fixed dose of Orencia (10 mg/kg every four weeks), plus methotrexate. Radiographs of hands and feet were independently scored for erosion score, joint-space narrowing, and total score, using the Genant-modified Sharp score.
Of 539 patients treated with Orencia, radiographic progression was minimal during the second year of treatment, the researchers reported.
Using a linear mixed-model analysis to compare the slope of radiographic progression, two years of Orencia (376 patients) proved significantly better than one year of placebo (160 patients) followed by one year of Orencia (erosion score P