Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

The 2009 ACR/ARHP Annual Scientific Meeting
Philadelphia October 16-21, 2009.


Reduced Radiographic Progression in Patients with Early Rheumatoid Arthritis (RA) Treated with Abatacept Methotrexate Compared to Methotrexate Alone: 24 Month Outcomes

Bathon1,  J., Genant2,  H., Nayiager3,  S., Wollenhaupt4,  J., Durez5,  P., Gomez-Reino6,  J., Grassi7,  W.

Johns Hopkins Univ Sch of Med, Baltimore, MD
Kangnam St Mary's Hosp, Seoul, South Korea
Centrol Medico Toluca, Mentpec, Mexico
SYNARC, Inc, San Francisco, CA
Bristol-Myers Squibb, Princeton, NJ
UZ Gasthuisberg, KU Leuven, Leuven, Belgium
University of California, San Francisco, CA
St Augustine's Hospital, Durban, South Africa
Klinikum Eilbek, Hamburg, Germany
Univ Catholique de Louvain, Brussels, Belgium
Hospital Clinico Univ De Santiago, A Coruna, Spain
Univ Politecnica delle Marche, Ancona, Italy
Institut de Rhumatolgie de Montreal, Montreal, QC
Univ of Alabama, Huntsville, AL

Purpose:

Radiographic progression early in the course of RA disease may translate into long term detrimental outcomes. Here we report the 24 month radiographic outcomes in methotrexate (MTX)-naïve patients with early, erosive RA and poor prognostic factors who are treated early with abatacept (ABA) + MTX compared to MTX alone.

Method:

The AGREE trial was a 24-month study, with a 12-month double-blind (DB) and a 12-month open-label (OL) period, in adult MTX-naïve patients with early, erosive RA and poor prognostic factors. During the DB, patients were randomized to ABA (~10 mg/kg dose based on weight range) + MTX (dosed up to 20 mg) or placebo (PLA) + MTX. All pts received ABA + MTX during the OL. Radiographic outcomes were assessed using Genant-modified Sharp scores. Changes in erosions [ES], joint space narrowing [JSN] and total score [TS] are reported. A change in TS <= 0 defined nonprogressors.

Results:

Of the 459 pts completing DB and entering OL, 94.3% completed the study. Changes in radiographic outcomes from baseline to year 1 and year 1 to year 2 are presented in the table. From baseline through 24 months, patients originally randomized to the ABA + MTX arm experienced less progression of structural damage as measured by change in TS (0.84 vs 1.75) and a greater proportion of nonprogressors (56.8% vs 43.8%) compared to those originally randomized to MTX monotherapy. Moreover, among patients originally randomized to ABA + MTX arm, there was an increasing degree of inhibition of progression seen in year 2 compared to year 1 (TS = 0.18 vs 0.66, respectively, P<0.0001), with 91.1% of year 1 nonprogressors remaining nonprogressors in year 2 compared to patients initiated on MTX alone.

Table. Radiographic Outcomes*

 ABA + MTX (N=213)MTX Alone (DB) ® ABA + MTX (OL) (N=192)
Mean change Genant-modified Sharp ScoreBaseline to Yr 1Yr 1 to Yr 2Baseline to Yr 1Yr 1 to Yr 2
ES0.500.091.260.13
JSN0.160.090.220.12
TS0.650.181.480.25
* Data are reported as observed for all treated subjects in open label

Conclusion:

Early use of combination therapy with ABA and MTX results in greater long-term sustainable radiographic benefit in MTX-naïve early RA patients than MTX alone and supports the use of abatacept earlier in the RA disease process.

To cite this abstract, please use the following information:
Bathon, J., Genant, H., Nayiager, S., Wollenhaupt, J., Durez, P., Gomez-Reino, J., et al; Reduced Radiographic Progression in Patients with Early Rheumatoid Arthritis (RA) Treated with Abatacept Methotrexate Compared to Methotrexate Alone: 24 Month Outcomes [abstract]. Arthritis Rheum 2009;60 Suppl 10 :639
DOI: 10.1002/art.25719

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