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The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-TNF therapy or were directly switched to abatacept: the ARRIVE trial
  1. Michael H Schiff (lmschiff{at}aol.com)
  1. University of Colorado, Denver, CO, United States
    1. Charles Pritchard
    1. Rheumatology Specialty Center, Willow Grove, PA, United States
      1. J.Eugene Huffstutter
      1. Arthritis Associates, Hixson, TN, United States
        1. Vincente Rodriguez-Valverde
        1. Hospital Universitario Marques De Valdecilla, Universidad de Cantabria, Santander, Spain
          1. Patrick Durez
          1. Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium
            1. Xianhuang Zhou
            1. Bristol-Myers Squibb, Princeton, NJ, United States
              1. Tracy Li
              1. Bristol-Myers Squibb, Princeton, NJ, United States
                1. Kenneth Bahrt
                1. Bristol-Myers Squibb, Princeton, NJ, United States
                  1. Sheila Kelly
                  1. Bristol-Myers Squibb, Princeton, NJ, United States
                    1. Manuela Le Bars
                    1. Bristol-Myers Squibb, Rueil-Malmaison, France
                      1. Mark C Genovese
                      1. Stanford University, Palo Alto, CA, United States

                        Abstract

                        Objective: To assess the safety, tolerability and efficacy of abatacept in patients with rheumatoid arthritis (RA) who had failed anti-tumour necrosis factor (TNF) therapy and were switched to abatacept directly or after completing washout.

                        Methods: In this international, 6-month, open-label trial, patients had active RA, an inadequate response to anti-TNF therapy for ≥3 months and a DAS28 (CRP) of ≥5.1. 'Washout' patients discontinued anti-TNF therapy ≥2 months pre-screening; 'direct-switch' patients began abatacept (~10 mg/kg) at their next scheduled anti-TNF therapy dose.

                        Results: In total, 1046 patients were treated (449 washout, 597 direct-switch; baseline characteristics were similar between groups). At 6 months, adverse events ([AEs] 78.0 vs 79.2%), serious AEs (SAEs; 11.1 vs 9.9%) and discontinuations due to AEs (3.8 vs 4.0%) and SAEs (2.0 vs 1.3%) were comparable in washout versus direct-switch patients. There were no opportunistic infections. At 6 months, in washout versus direct-switch patients, similar clinically meaningful improvements were seen in DAS28 (CRP) (≥1.2 unit improvement, 59.5 vs 53.6%, respectively; LDAS, 22.5 vs 22.3%; DAS28-defined remission,12.0 vs 13.7%), physical function (HAQ-DI ≥0.22 improvement; 46.3 vs 47.1%) and health-related QoL (mean change in SF-36 scores; PCS, 5.5 vs 6.1; MCS, 4.8 vs 5.4).

                        Conclusion: Abatacept demonstrated acceptable safety and tolerability, and clinically meaningful efficacy over 6 months in patients with an inadequate response to anti-TNF therapy. Results were comparable regardless of whether there was a washout or not, supporting direct-switching from anti-TNF therapy to abatacept as an option in clinical practice.

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