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Purpose Intensive treatment of patients early in the RA disease process is becoming a standard of care making disease remission, as a treatment goal, more attainable. Here we report the clinical and safety outcomes in methotrexate naïve patients with early erosive RA treated with a combination of abatacept + methotrexate through 24 months.
Method The AGREE trial was a 24 month study with a 12 month double-blind period (DB) and 12 month open label period (OL). During 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 patients completing DB and entering OL received ABA + MTX. Safety was assessed in all pts receiving ≥1 dose of ABA in OL. Clinical outcomes evaluated included DAS28 remission (DAS28 <2.6), low disease activity state (LDAS, DAS28 <= 3.2), and ACR responses.
Results All 459 pts completing DB entered OL; 94.3% completed OL. Remission, LDAS, and ACR responses were sustained or increased from 12 to 24 months in original ABA + MTX arm (Table), with over half (55.2%) in remission at 24 months. Proportion achieving these outcomes in the original MTX alone arm increased after initiating ABA in OL, with 44.5% in remission at 24 months. Rates (per 100 pt yrs) of serious AE (6.42 vs 8.35) and serious infections (1.73 vs 2.04) were similar in the OL vs DB respectively. Autoimmune events occurred at a similar rate in OL as in DB (1.30 vs 2.47, respectively). Two deaths occurred. No malignancies or TB were reported. Clinical Outcomes, (%) Conclusion Sustained disease remission is an achievable goal for many patients with early RA when treatment with combination of ABA + MTX (DB & OL)
(N=232)MTX Alone (DB) →
(N=227)Baseline to Yr 1 Yr 1 to Yr 2 Baseline to Yr 1 Yr 1 to Yr 2 DAS(28) Remission 46.1 55.2 26.9 44.5 LDAS 60.8 71.1 43.2 60.4 ACR 50 64.7 74.1 50.2 67.0 ACR 70 48.3 53.9 31.7 49.8 ACR 90 18.5 22.0 7.5 22.9
Disclosure: R. Westhovens, Bristol-Myers Squibb, 8, Bristol-Myers Squibb, Schering-Plough, Centocor, Roche, 5, UCB , 2 ; M. Robles, None; S. Nayiager, None; J. Wollenhaupt, Bristol-Myers Squibb, 5 ; P. Durez, UCL, 3, Bristol-Myers Squibb, Roche, Centocor, Abbott, Wyeth, 5, UEMS, Royal Belgian Society of Rheumatology, 6, Bristol-Myers Squibb, 8 ; J. Gómez-Reino, Wyeth, Schering-Plough, Bristol-Myers Squibb, Roche, 6, Abbott, Wyeth, Roche, Bristol-Myers Squibb, Schering-Plough ; W. Grassi, Abbott Immunology, Wyeth, 2, Bristtol-Myers Squibb, Abbott Immunology, Schering-Plough, 5, Bristol-Myers Squibb, Abbott Immunology, General Electric, Esaote, Schering-Plough, Roche, Wyeth, Abbott Immunology, Wyeth, 2, Bristtol-Myers Squibb, Abbott Immunology, Schering-Plough, 5, Bristol-Myers Squibb, Abbott Immunology, General Electric, Esaote, Schering-Plough, Roche, Wyeth ; B. Haraoui, Abbott, Amgen, Bristol-Myers Squibb, Roche, Shering-Plough, UCB, Wyeth, 2, Abbott, Amgen, Bristol-Myers Squibb, Roche, Shering-Plough, UCB, Wyeth, 5, Abbott, Amgen, Bristol-Myers Squibb, Roche, Shering-Plough, UCB, Wyeth, 8 ; W. Shergy, Amgen, Wyeth, Abbott, Bristol-Myers Squibb, Centocor, Genentech, Biogen-Idec, 9 ; S. Park, None; H. Genant, Synarc, Inc., 1, Bristol-Myers Squibb, Roche, Genentech, Pfizer, Amgen, Merck, Servier, Biogen-Idec, Lilly, 2, Bristol-Myers Squibb, Roche, Merck, Lilly, Genentech, Amgen, Servier, Synarc, 5 ; C. Peterfy, Synarc, Inc., 1, Synarc, Inc., 3 ; J. -. C. Becker, Bristol-Myers Squibb, 1, Bristol-Myers Squibb, 3 ; A. Covucci, Bristol-Myers Squibb, 3 ; R. Helfrick, Bristol-Myers Squibb, 3 ; J. Bathon, Biogen-Idec, Merck Serono, 2, Crescendo Biosciences, Roche, UCB, 5 .