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Cited by 1,757

The DOI matches its Crossref record; 2 of the 2 references it cites were found in a registry or an index.

Adalimumab, a fully human anti–tumor necrosis factor α monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: The ARMADA trial

Weinblatt, Michael E., Keystone, Edward C., Furst, Daniel E., Moreland, Larry W., Weisman, Michael H., Birbara, Charles A., Teoh, Leah A., Fischkoff, Steven A., Chartash, Elliot K.·2003·Arthritis & Rheumatism
DOI 10.1002/art.10697
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Abstract

Objective: To evaluate the efficacy and safety of adalimumab (D2E7), a fully human monoclonal tumor necrosis factor α antibody, in combination with methotrexate (MTX) in patients with active rheumatoid arthritis (RA) despite treatment with MTX. Methods: In a 24‐week, randomized, double‐blind, placebo‐controlled study, 271 patients with active RA were randomly assigned to receive injections of adalimumab (20 mg, 40 mg, or 80 mg subcutaneously) or placebo every other week while continuing to take their long‐term stable dosage of MTX. The primary efficacy end point was the American College of Rheumatology criteria for 20% improvement (ACR20) at 24 weeks. Results: An ACR20 response at week 24 was achieved by a significantly greater proportion of patients in the 20‐mg, 40‐mg, and 80‐mg adalimumab plus MTX groups (47.8%, 67.2%, and 65.8%, respectively) than in the placebo plus MTX group (14.5%) (P < 0.001). ACR50 response rates with the 20‐mg, 40‐mg, and 80‐mg adalimumab dosages (31.9%, 55.2%, and 42.5%, respectively) were significantly greater than that with placebo (8.1%) (P = 0.003, P < 0.001, and P < 0.001, respectively). The 40‐mg and 80‐mg doses of adalimumab were associated with an ACR70 response (26.9% and 19.2%, respectively) that was statistically significantly greater than that with placebo (4.8%) (P < 0.001 and P = 0.020). Responses were rapid, with the greatest proportion of adalimumab‐treated patients achieving an ACR20 response at the first scheduled visit (week 1). Adalimumab was safe and well tolerated; comparable numbers of adalimumab‐treated patients and placebo‐treated patients reported adverse events. Conclusion: The addition of adalimumab at a dosage of 20 mg, 40 mg, or 80 mg administered subcutaneously every other week to long‐term MTX therapy in patients with active RA provided significant, rapid, and sustained improvement in disease activity over 24 weeks compared with MTX plus placebo.

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Metadata

Authors
Weinblatt, M. E., Keystone, E. C., Furst, D. E., Moreland, L. W., Weisman, M. H., Birbara, C. A., Teoh, L. A., Fischkoff, S. A., & Chartash, E. K.
Venue
Arthritis & Rheumatism
Publisher
Wiley
Published
2003-01
Volume
48
Issue
1
Pages
35-45
ISSN
  • 0004-3591 (ISSN-L)
  • 1529-0131
DOI
10.1002/art.10697
OpenAlex
W1979364075
Cited by
1,757
References
2
FWCI
79.37
Type
journal article
Language
en
Open access
closed

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