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Adalimumab alone and in combination with disease- modifying antirheumatic drugs for the treatment of rheumatoid arthritis in clinical practice: The Research in Active Rheumatoid Arthritis (ReAct) trial
  1. Gerd R Burmester (gerd.burmester{at}
  1. Charite University Hospital, Germany
    1. Xavier Mariette
    1. Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, France
      1. Carlomaurizio Montecucco
      1. University of Pavia, Italy
        1. Indalecio Monteagudo-Sáez
        1. H.G.U. Gregorio Marañón, Spain
          1. Michel Malaise
          1. CHU Liège, Belgium
            1. Athanasios G. Tzioufas
            1. Department of Pathophysiology, School of Medicine, University of Athens, Greece
              1. Johannes W.J. Bijlsma
              1. University Medical Center Utrecht, Netherlands
                1. Kristina Unnebrink
                1. Abbott GmbH & Co. KG, Germany
                  1. Sonja Kary
                  1. Abbott GmbH & Co. KG, Germany
                    1. Hartmut Kupper
                    1. Abbott GmbH & Co. KG, Germany


                      Objective: To evaluate the safety and effectiveness of adalimumab alone or in combination with standard disease-modifying antirheumatic drugs (DMARDs) for the treatment of rheumatoid arthritis (RA).

                      Methods: Patients with active RA despite treatment with DMARDs or prior treatment with a tumour necrosis factor (TNF) antagonist participated in a multicentre, open-label clinical study of adalimumab 40 mg every other week for 12 weeks with an optional extension phase. Patients were allowed to continue pre- existing traditional DMARDs. Long-term safety results are reported for all patients (4210 patient-years [PYs] of adalimumab exposure). The observed effectiveness results at Week 12 are reported using American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) response criteria.

                      Results: Among the 6610 treated patients, adalimumab was generally well-tolerated. Serious infections occurred in 3.1% of patients (5.5/100PYs, including active tuberculosis, 0.5/100PYs). Demyelinating disease (0.06%)and systemic lupus erythematosus (0.03%) were rare serious adverse events. The standardised incidence ratio of malignancy was 0.71 (95% CI, 0.49-1.01). The standardised mortality ratio was 1.07 (95% CI, 0.75-1.49). At Week 12, 69% of patients achieved an ACR20 response, 87% a moderate, and 37% a good EULAR response. Adalimumab was effective in combination with a variety of DMARDs. The addition of adalimumab to antimalarials was comparably effective to the combination of adalimumab and methotrexate.

                      Conclusions: Considering the limitations of an open-label study, adalimumab alone or in combination with standard DMARDs appeared to be well-tolerated and effective in 6610 difficult-to-treat patients with active RA treated in a clinical practice setting.

                      • adalimumab
                      • antirheumatic agents
                      • monoclonal antibody
                      • rheumatoid arthritis
                      • tumour necrosis factor

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