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New long-term data suggests Abatacept treatment

June 22, 2006

Better inhibition of radiographic progression in RA patients

New data from the long-term extension of the AIM (Abatacept in Inadequate responders to Methotrexte) trial, announced today at the Annual European Congress of Rheumatology, suggests the selective T-cell co-stimulation modulator abatacept sustains inhibition of radiographic progression over 2 years in rheumatoid arthritis patients with an inadequate response to methotrexate.

Abatacept (a disease modifying agent which blocks the signal of blood that is necessary for T-cells to damage joints in arthritis) has previously demonstrated significant reductions in radiographic progression (a measure showing the extent of actual damage to joints) in rheumatoid arthritis patients with an inadequate response to methotrexate (an antimetabolite drug which inhibits the synthesis of DNA, RNA and protein) during the double-blind phase of the AIM trial1. As such the extension arm aimed to investigate long term impact.

433 vs. 219 patients were randomized and treated with abatacept vs. placebo, with 385 (88.9%) vs. 162 (74.0%) completing the double blind phase. 539 patients were treated with Abatacept in the long-term extension arm of the study.

Data shows that 2 years of abatacept treatment slowed progression of structural damage in RA patients with an inadequate response to methotrexate, with the effect seen at year 2 significantly better than those in year 1.

In patients treated with abatacept for 2 years, minimal radiographic progression was observed during the second year of treatment. Using a linear mixed model analysis to compare the slope of radiographic progression over the 2-year period, abatacept was found to be significantly better than 1 year of placebo followed by 1 year of abatacept. Radiographic progression in the abatacept group slowed during year 2 vs. year 1.

"The long term extension of the AIM study shows that 2 yrs of abatacept treatment slowed progression of structural damage in rheumatoid arthritis patients, potentially providing a valuable treatment option for those patients with an inadequate response to methotrexate" explained Harry K. Genant, study lead and Professor Emeritus, University of California San Francisco and Chairman Emeritus Synarc, San Francisco, United States. "It is especially interesting to note that the effect seen at year two was significantly better than that seen at year one, suggesting progressive improvement and sustained reduction of damage which could equate to increased patient quality of life measures such as mobility and independence" he continued.

European League Against Rheumatism