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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 Burmester1,
  2. Xavier Mariette2,
  3. Carlomaurizio Montecucco3,
  4. Indalecio Monteagudo-Sáez4,
  5. Michel Malaise5,
  6. Athanasios G Tzioufas6,
  7. Johannes W J Bijlsma7,
  8. Kristina Unnebrink8,
  9. Sonja Kary8,
  10. Hartmut Kupper8,
  11. on behalf of the Research in Active Rheumatoid Arthritis Trial study group
  1. 1Charité – University Medicine Berlin, Berlin, Germany
  2. 2Hôpital Bicêtre, Assistance Publique-Hôpitaux de Paris, Université Paris-Sud 11, Le Kremlin Bicêtre, France
  3. 3University of Pavia, IRCCS Policlinico San Matteo, Pavia, Italy
  4. 4HGU Gregorio Marañón, Madrid, Spain
  5. 5CHU Liège, Liège, Belgium
  6. 6Department of Pathophysiology, School of Medicine, University of Athens, Athens, Greece
  7. 7University Medical Center Utrecht, Utrecht, The Netherlands
  8. 8Abbott GmbH & Co KG, Ludwigshafen, Germany
  1. Correspondence to:
    Dr Burmester
    Department of Rheumatology and Clinical Immunology, Charité – University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany; gerd.burmester{at}


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 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 with 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 (5.5/100 PYs, including active tuberculosis, 0.5/100 PYs). 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 to 1.01). The standardised mortality ratio was 1.07 (95% CI 0.75 to 1.49). At week 12, 69% of patients achieved an ACR20 response, 83% a moderate, and 33% 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 clinical practice.

  • ACR, American College of Rheumatology
  • AE, adverse event
  • AM, antimalarials
  • AZA, azathioprine
  • CsA, ciclosporin
  • DAS, Disease Activity Score
  • DMARD, disease-modifying antirheumatic drug
  • EULAR, European League Against Rheumatism
  • HAQ DI, Health Assessment Questionnaire Disability Index
  • LEF, leflunomide
  • MTX, methotrexate
  • PY, patient-year
  • RA, rheumatoid arthritis
  • SAE, serious adverse event
  • SEER, Surveillance, Epidemiology, and End Results
  • SIR, standardised incidence ratio
  • SSZ, sulfasalazine
  • TB, tuberculosis
  • TNF, tumour necrosis factor
  • adalimumab
  • rheumatoid arthritis
  • tumour necrosis factor
  • monoclonal antibody
  • antirheumatic agents
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  • Published Online First 28 February 2007

  • Competing interests: Abbott Laboratories sponsored the trial and was responsible for data collection and analysis. The authors and the sponsor designed the study, interpreted the data, prepared the manuscript, and decided to publish.

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