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Ann Rheum Dis 2004;63:508-516 doi:10.1136/ard.2003.013052
  • Extended report

Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed

  1. L B A van de Putte1,
  2. C Atkins2,
  3. M Malaise3,
  4. J Sany4,
  5. A S Russell5,
  6. P L C M van Riel1,
  7. L Settas6,
  8. J W Bijlsma7,
  9. S Todesco8,
  10. M Dougados9,
  11. P Nash10,
  12. P Emery11,
  13. N Walter12,
  14. M Kaul12,
  15. S Fischkoff13,
  16. H Kupper12
  1. 1University of Nijmegen, The Netherlands
  2. 2Victoria, British Columbia, Canada
  3. 3Service de Rhumatologie, Liege, Belgium
  4. 4Hôpital Lapeyronie, Montpellier, France
  5. 5University of Alberta Hospital, Edmonton, Alberta, Canada
  6. 6AHEPA Hospital, Thessaloniki, Greece
  7. 7UMC Utrecht, Utrecht, The Netherlands
  8. 8Cattedra e Divisione di Reumatologia, Università di Padova, Padova, Italy
  9. 9Service de Rhumatologie, Hôpital Cochin, Paris, France
  10. 10Sixth Avenue Specialist Centre, Maroochydore, Australia
  11. 11University of Leeds, Leeds, UK
  12. 12Abbott GmbH & Co KG, Ludwigshafen, Germany
  13. 13Abbott Laboratories, Parsippany, New Jersey, USA
  1. Correspondence to:
    Professor L B A van de Putte
    University Medical Centre Nijmegen, Department of Rheumatology, PO Box 9101, 6500 HB Nijmegen, The Netherlands; annrheumdis.edoffworldonline.nl
  • Accepted 12 January 2004

Abstract

Objective: To evaluate the efficacy and safety of monotherapy with adalimumab in patients with RA for whom previous DMARD treatment has failed.

Methods: In a 26 week, double blind, placebo controlled, phase III trial, 544 patients with RA were randomised to monotherapy with adalimumab 20 mg every other week, 20 mg weekly, 40 mg every other week, 40 mg weekly, or placebo. The primary efficacy end point was ≥20% improvement in the ACR core criteria (ACR20 response). Secondary efficacy end points included ACR50, ACR70, EULAR responses, and the Disability Index of the Health Assessment Questionnaire (HAQ DI).

Results: After 26 weeks, patients treated with adalimumab 20 mg every other week, 20 mg weekly, 40 mg every other week, and 40 mg weekly had significantly better response rates than those treated with placebo: ACR20 (35.8%, 39.3%, 46.0%, 53.4%, respectively v 19.1%; p≤0.01); ACR50 (18.9%, 20.5%, 22.1%, 35.0% v 8.2%; p≤0.05); ACR70 (8.5%, 9.8%, 12.4%, 18.4% v 1.8%; p≤0.05). Moderate EULAR response rates were significantly greater with adalimumab than with placebo (41.5%, 48.2%, 55.8%, 63.1% v 26.4%; p≤0.05). Patients treated with adalimumab achieved better improvements in mean HAQ DI than those receiving placebo (−0.29, −0.39, −0.38, −0.49 v −0.07; p≤0.01). No significant differences were found between adalimumab and placebo treated patients for serious adverse events, serious infections, or malignancies. Injection site reaction occurred in 10.6% and 0.9% of adalimumab and placebo treated patients, respectively (p≤0.05).

Conclusion: Among patients with RA for whom previous DMARD treatment had failed, adalimumab monotherapy achieved significant, rapid, and sustained improvements in disease activity and improved physical function and was safe and well tolerated.

Footnotes

  • F A Wollheim was the editor for this paper.

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