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Ann Rheum Dis 65:753-759 doi:10.1136/ard.2005.044404
  • Extended report

Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study

  1. M E Weinblatt1,
  2. E C Keystone2,
  3. D E Furst3,
  4. A F Kavanaugh4,
  5. E K Chartash5,
  6. O G Segurado6
  1. 1Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, Boston, MA, USA
  2. 2The Rebecca MacDonald Centre for Arthritis and Autoimmunity, Mount Sinai Hospital, University of Toronto, Toronto, Canada
  3. 3Rheumatology Division, Geffen School of Medicine at the University of California–Los Angeles (UCLA), Los Angeles, CA, USA
  4. 4Center for Innovative Therapy, University of California–San Diego, Division of Rheumatology, Allergy and Immunology, La Jolla, CA, USA
  5. 5Immunology, Abbott Laboratories, Parsippany, NJ, USA
  6. 6Immunology, Abbott Laboratories, Abbott Park, IL, USA
  1. Correspondence to:
    Dr M E Weinblatt
    Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, 75 Francis St., Boston, MA, USA; mweinblatt{at}partners.org
  • Accepted 19 November 2005
  • Published Online First 24 November 2005

Abstract

Objective: To evaluate the efficacy and safety of adalimumab plus methotrexate (MTX) given for up to 4 years in patients with active, longstanding rheumatoid arthritis.

Methods: Patients responding inadequately to MTX were entered into a 24 week, controlled study (ARMADA) with adalimumab plus MTX or placebo plus MTX, and some were enrolled in a subsequent open label extension. The efficacy and safety of treatment were evaluated. Additional analyses were made for those patients whose corticosteroid and/or MTX dosages were adjusted during the extension.

Results: Of 271 patients in the original ARMADA trial, 262 received at least one dose of adalimumab and were evaluated. At the time of analysis, 162/262 (62%) patients had remained in the study and received treatment for a mean of 3.4 years. Withdrawals were for lack of efficacy (8%), adverse events (12%), and other reasons (18%). In 147 patients who completed 4 years’ treatment, efficacy achieved at 6 months was maintained. At 4 years, 78%, 57%, and 31% had achieved ACR20/50/70; 43% achieved clinical remission (DAS28 <2.6); and 22% had no physical function abnormalities (HAQ = 0). Results were similar for 196 patients who received treatment for 2–4 years. Efficacy was maintained in many patients when dosages were decreased (corticosteroids (51/81 (63%) patients), MTX (92/217 (42%)), or both (25/217 (12%))). Serious adverse events were comparable during open label treatment and the controlled phase. Serious infections occurring during open label treatment and the blinded period were similar (2.03 v 2.30 events per 100 patient-years, respectively).

Conclusions: Adalimumab plus MTX sustained clinical response and remission in patients with RA during 4 years. The safety profile during the first 6 months was similar to that after 4 years’ follow up. Reduction of corticosteroid and/or MTX dosages did not adversely affect long term efficacy.

Footnotes

  • Published Online First 1 December 2005

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