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FRI0242 Time to achieve remission and sustained remission for mtx-naïve patients with early ra treated with abatacept plus mtx versus mtx alone in the agree trial
  1. J. S. Smolen1,
  2. J. Wollenhaupt2,
  3. P. Durez3,
  4. J. Gomez-Reino4,
  5. W. Grassi5,
  6. M. Le Bars6,
  7. C. Gaillez6,
  8. C. Poncet7,
  9. R. Westhovens8
  1. 1Medical University of Vienna and Hietzing Hospital, Vienna, Austria
  2. 2Schoen Klinikum Eilbek, Hamburg, Germany
  3. 3Université Catholique de Louvain and Cliniques Universitaires Saint-Luc, Brussels, Belgium
  4. 4Universidad De Santiago, A Coruna, Spain
  5. 5Università Politecnica delle Marche, Ancona, Italy
  6. 6Bristol-Myers Squibb, Paris
  7. 7Docs International, Sèvres, France
  8. 8UZ Gasthuisberg, Leuven, Belgium


Background Achieving remission from disease activity, and subsequently maintaining the remission state, is the goal of biologic treatment for early aggressive RA.1

Objectives To evaluate the time to achieve first remission or low disease activity (LDA) and time to achieve first sustained remission or LDA for MTX-naïve patients (pts) with early RA (≤2 years) treated with abatacept (ABA)+MTX vs MTX alone in a post hoc, observed-case analysis.

Methods In AGREE, MTX-naïve pts with early RA and poor prognostic factors were randomized to ABA+MTX or MTX alone for 12 months.2 Cumulative probability of time to achieve first remission/LDA and sustained remission/LDA (defined as maintained at all subsequent visits up to Month 12) according to DAS28 ([CRP] <2.6), SDAI (≤3.3) and CDAI (≤2.8) was evaluated based on Kaplan–Meier estimation with corresponding 95% CI. Pts who lost remission status were censored at the time of remission loss. All analyses were performed for pts with SDAI, CDAI and DAS28 data available at baseline, Month 6 and 12.

Results Overall, 419/509 (82.3%) pts had data available at baseline, Month 6 and 12 and were included (ABA+MTX n=210; MTX alone n=209). Cumulative probabilities of achieving DAS28, SDAI or CDAI-defined remission and LDA within the first 6 months, and overall in the 12-month, DB period are shown in the table. Median (95% CI) days to reach first LDA defined by DAS28, SDAI and CDAI were 139 (113, 169) vs 225 (169, 279), 140 (113, 148) vs 197 (169, 252), and 140 (113, 167) vs 199 (169, 252) for ABA+MTX vs MTX alone, respectively.

Conclusions In AGREE, pts with early RA treated with ABA+MTX were more likely to achieve first remission/LDA up to Months 6 and 12, and first sustained remission/LDA up to Month 12, than pts receiving MTX alone, regardless of the criteria used to define remission and disease activity. These data support the use of abatacept as a first-line biologic in combination with DMARDs in DMARD-naïve (including MTX) pts with early RA, particularly those with poor prognostic factors.


  1. Smolen JS, et al. Ann Rheum Dis 2010;69:964-75;

  2. Westhovens R, et al. Ann Rheum Dis 2009;68:1870-7

Disclosure of Interest: J. Smolen Grant/research support from: Abbott, Bristol-Myers Squibb, Hoffmann-La Roche, Schering-Plough, UCB, Pfizer, Consultant for: Abbott, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Eli-Lilly, Merck, Novo Nordisk, Roche, sanofi-aventis, UCB, J. Wollenhaupt Consultant for: Bristol-Myers Squibb, Chugai, Roche, Speakers bureau: Chugai, Roche, P. Durez Speakers bureau: Bristol-Myers Squibb, J. Gomez-Reino Grant/research support from: Roche, Schering-Plough, Wyeth Pharmaceuticals, UCB, Consultant for: Hoffmann-La Roche, Roche, Schering-Plough, UCB, Pfizer, Bristol-Myers Squibb, Speakers bureau: Bristol-Myers Squibb, Roche, UCB, MSD, Pfizer, Abbott, W. Grassi Grant/research support from: Abbott, Bristol-Myers Squibb, Esaote, General Electric, Menarini, Merck Sharp & Dohme, Pfizer, Roche, Schering-Plough, UCB, Consultant for: Abbott, Bristol-Myers Squibb, Esaote, General Electric, Menarini, Merck Sharp & Dohme, Pfizer, Roche, Schering-Plough, UCB, M. Le Bars Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, C. Gaillez Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, C. Poncet Consultant for: Bristol-Myers Squibb, R. Westhovens Grant/research support from: Roche, UCB, Consultant for: Bristol-Myers Squibb, Galapagos, Janssen, Speakers bureau: Bristol-Myers Squibb

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