Abatacept: Orencia Inhibits Long-Term RA Progression

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EULAR: Orencia (abatacept) Inhibits Long-Term RA Progression

http://www.medpagetoday.com/Rheumatology/Arthritis/tb/3612

MedPage Today Action Points

a.. Explain to interested patients that this report added a second

year of efficacy data for Orencia (abatacept) for RA patients who do not

respond adequately to methotrexate.

b.. This study was published as an abstract and presented at a

conference. These data and conclusions should be considered to be

preliminary as they have not yet been reviewed and published in a

peer-reviewed publication.

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<0.001; joint-space narrowing P<0.05; total

score P<0.01).

Radiographic progression in the Orencia group slowed during year two

versus year one (slope from year one to year two: erosion score: 0.6 vs 0.3;

joint-space narrowing: 0.4 vs 0.4; total score: 1.0 vs 0.7), the researchers

reported.

The long-term extension of the AIM study showed that two years of

treatment with Orencia slowed progression of structural damage in RA

patients, potentially providing a valuable treatment for patients for whom

methotrexate is inadequate, Dr. Genent said.

" 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 said.

Primary source: European Congress of Rheumatology (European League

Against Rheumatism (EULAR) 2006.

Source reference:

Harry K. Genant, et al, " Abatacept sustains inhibition of radiographic

progression over 2 years in rheumatoid arthritis (RA) patients with an

inadequate response to methotrexate (MTX): Results from the long-term

extension (LTE) of the AIM trial, " Abstract number: OP0015.

By Judith Groch, MedPage Today Staff Writer

Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University

of Pennsylvania School of Medicine.

June 23, 2006

Source News Article: News