Arthritis & Rheumatism, Volume 60,
October 2009 Abstract Supplement

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


A Significant Proportion of Patients with RA Achieve Simplified Disease Activity Index (SDAI)-Defined Low Disease Activity or Remission with Abatacept Vs Placebo, and SDAI Remission Is Associated with Reduced Radiographic Progression

Smolen1,  J. S., Aletaha1,  D., Le Bars2,  M., Poncet3,  C., Schiff4,  M., Kremer5,  J. M., Yazici6,  Y.

Medical Univ Vienna, Vienna, Austria,
Bristol-Myers Squibb, Rueil-Malmaison, France,
Docs International, Issy-les-Moulineaux, France,
Univ of Colorado, Denver, CO,
Albany Medical College, Albany, NY,
NYU Hospital for Joint Diseases, New York, NY,
Univ Leeds, Leeds, United Kingdom,
UZ Gasthuisberg, KU Leuven, Leuven, Belgium,
Hospital Cochin, Descartes Univ, Paris, France

Purpose:

The SDAI composite disease activity index is a stringent measure of remission1, and good correlation between SDAI states and changes in radiographic progression have been reported2. Analyses were performed to assess SDAI disease activity status and to determine the correlation between SDAI status and radiographic progression in patients (pts) with RA and an inadequate response to MTX.

Methods:

Pts who completed the 1-yr, randomized, double-blind period of the AIM (Abatacept in Inadequate Responders to MTX) trial (abatacept ~10 mg/kg or placebo, plus MTX)3 and had radiographs at baseline and Yr 1 were eligible for analysis (post hoc, as observed). SDAI states were assessed at Mths 3 and 12, defined as High Disease Activity (HDA; >26), Moderate Disease Activity (MDA; >11–26), Low Disease Activity (LDA; >3.3–11) or remission (<=3.3). Changes from baseline to Mth 12 in Genant-modifed Sharp total score (TS) were analysed by SDAI status attained at Mth 3.

Results:

366 abatacept and 154 placebo pts were eligible for analysis. Baseline demographics were comparable between treatment groups3. At Mth 3, significantly more abatacept than placebo pts had achieved LDA; at Mth 12, the proportions of abatacept pts in LDA and remission had increased ~twofold and differences between treatment groups were statistically significant for both measures (Figs). The proportion of abatacept pts in HDA was reduced by ~45% from Mth 3 to 12; levels were significantly lower vs placebo at both time points ((Figs). In the radiographic analysis, the smallest change in TS from baseline to Mth 12 was observed in abatacept pts who achieved remission at Mth 3 (change in TS: –0.2 [n=14]); mean changes in TS were 0.63 (72), 1.1 (159) and 1.97 (104) for LDA, MDA and HDA, respectively. For placebo pts mean changes in TS were 0.73 (3), 2.75 (12), 2.26 (50) and 2.9 (81) for remission, LDA, MDA and HDA, respectively. Changes in TS, especially in the remission and LDA groups, were numerically smaller in abatacept vs placebo pts.

Conclusion:

A significant proportion of abatacept pts achieved LDA or remission vs placebo over 1 yr according to the stringent SDAI criteria. SDAI remission and LDA at Mth 3 were associated with low levels of radiographic progression at Mth 12, in particular with abatacept compared with placebo, suggesting that these states are predictive of a reduction in radiographic progression, as observed with other biologics4.

References:

1.Mierau, M, et al. Rheumatology 2007; 46:975–9

2.Smolen, JS, et al. Rheumatology 2003; 42:244–2

3.Kremer, JM, et al. Ann Intern Med 2006; 144:865–76

4.Smolen, JS, et al. Ann Rheum Dis 2009; 68:823–7

To cite this abstract, please use the following information:
Smolen, J. S., Aletaha, D., Le Bars, M., Poncet, C., Schiff, M., Kremer, J. M., et al; A Significant Proportion of Patients with RA Achieve Simplified Disease Activity Index (SDAI)-Defined Low Disease Activity or Remission with Abatacept Vs Placebo, and SDAI Remission Is Associated with Reduced Radiographic Progression [abstract]. Arthritis Rheum 2009;60 Suppl 10 :1691
DOI: 10.1002/art.26765

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