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Clinical efficacy and safety of abatacept in methotrexate-naïve patients with early rheumatoid arthritis and poor prognostic factors
  1. Rene Westhovens (rene.westhovens{at}uz.kuleuven.ac.be)
  1. UZ Gasthuisberg, Belgium
    1. Manuel Robles (manuelrsr{at}hotmail.com)
    1. Centro Médico Toluca, Mexico
      1. Antonio Carlos Ximenes (aximenes{at}terra.com.br)
      1. Hospital Geral de Goiânia, Brazil
        1. Savithree Nayiager (drnayiagers{at}ispace.co.za)
        1. St Augustine's Hospital, South Africa
          1. Jurgen Wollenhaupt (wollenhaupt{at}rheumatologikum.de)
          1. Klinikum Eilbek, Germany
            1. Patrick Durez (patrick.durez{at}ruma.ucl.ac.be)
            1. Cliniques Universitaires Saint-Luc, Belgium
              1. Juan Gomez-Reino (juan.jesus.gomez-reino.carnota{at}sergas.es)
              1. 7Hospital Clinico Universidad De Santiago, Spain
                1. Walter Grassi (walter.grassi{at}univpm.it)
                1. Clinica Reumatologica, Italy
                  1. Boulous Haraoui (bharaoui{at}videotron.ca)
                  1. Institut de Rheumatologie de Montréal, Canada
                    1. William Shergy (dshergy{at}hiwaay.net)
                    1. University of Alabama, United States
                      1. Sung-Hwan Park (rapark{at}catholic.ac.kr)
                      1. The Catholic University of Korea, Korea, Republic of
                        1. Harry Genant (hkgenant{at}aol.com)
                        1. University of California, United States
                          1. Charles Peterfy (charles.peterfy{at}synarc.com)
                          1. Synarc, Inc., United States
                            1. Jean-Claude Becker (jeanclaude.becker{at}bms.com)
                            1. Bristol-Myers Squibb, United States
                              1. Allison Covucci (allison.covucci{at}bms.com)
                              1. Bristol-Myers Squibb, United States
                                1. Roy Helfrick (roy.helfrick{at}bms.com)
                                1. Bristol-Myers Squibb, United States
                                  1. Joan Bathon (jbathon{at}jhmi.edu)
                                  1. John Hopkins University, United States

                                    Abstract

                                    Objectives: To assess the efficacy and safety of abatacept in methotrexate (MTX)-naïve patients with early rheumatoid arthritis (RA) and poor prognostic factors.

                                    Methods: In this double-blind, Phase IIIb study, patients with RA ≤2 years were randomized 1:1 to receive abatacept (~10 mg/kg) plus MTX, or placebo plus MTX. Patients were MTX-naïve and seropositive for rheumatoid factor (RF), anti-cyclic citrullinated protein (CCP) 2 or both, and had radiographic evidence of joint erosions. The co-primary endpoints were the proportion of patients achieving Disease Activity Score (DAS) 28-defined remission (C-reactive protein) and joint damage progression (Genant-modified Sharp total score [TS]) at Year 1. Safety was monitored throughout.

                                    Results: At baseline, patients had a mean DAS28 of 6.3, a mean TS of 7.1 and mean disease duration of 6.5 months; 96.5 and 89.0% of patients were RF or anti-CCP2 seropositive, respectively. At Year 1, a significantly greater proportion of abatacept plus MTX-treated patients achieved remission (41.4 vs 23.3%; p<0.001), and there was significantly less radiographic progression (mean change in TS; 0.63 vs 1.06; p=0.040), versus MTX alone. Over 1 year, the frequency of adverse events (AEs; 84.8 vs 83.4%), serious AEs (7.8 vs 7.9%), serious infections (2.0 vs 2.0%), autoimmune disorders (2.3 vs 2.0%) and malignancies (0.4 vs 0%) was comparable for abatacept plus MTX versus MTX alone.

                                    Conclusions: In a MTX-naïve population with early RA and poor prognostic factors, the combination of abatacept and MTX provided significantly better clinical and radiographic efficacy compared with MTX alone, and had a comparable, favorable safety profile.

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