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Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group.

Publication ,  Journal Article
Lipsky, PE; van der Heijde, DM; St Clair, EW; Furst, DE; Breedveld, FC; Kalden, JR; Smolen, JS; Weisman, M; Emery, P; Feldmann, M; Harriman, GR ...
Published in: N Engl J Med
November 30, 2000

BACKGROUND: Neutralization of tumor necrosis factor a (TNF-alpha) for three to six months reduces the symptoms and signs of rheumatoid arthritis. However, the capacity of this approach to effect a more sustained benefit and its effect on joint damage are not known. METHODS: We treated 428 patients who had active rheumatoid arthritis despite methotrexate therapy with placebo or infliximab, a chimeric monoclonal antibody against TNF-alpha, in intravenous doses of 3 or 10 mg per kilogram of body weight every 4 or 8 weeks in combination with oral methotrexate for 54 weeks. We assessed clinical responses with use of the criteria of the American College of Rheumatology, the quality of life with a health-status questionnaire, and the effect on joint damage radiographically. RESULTS: The combination of infliximab and methotrexate was well tolerated and resulted in a sustained reduction in the symptoms and signs of rheumatoid arthritis that was significantly greater than the reduction associated with methotrexate therapy alone (clinical response, 51.8 percent vs. 17.0 percent; P<0.001). The quality of life was also significantly better with infliximab plus methotrexate than with methotrexate alone. Radiographic evidence of joint damage increased in the group given methotrexate, but not in the groups given infliximab and methotrexate (mean change in radiographic score, 7.0 vs. 0.6, P<0.001). Radiographic evidence of progression of joint damage was absent in infliximab-treated patients whether or not they had a clinical response. CONCLUSIONS: In patients with persistently active rheumatoid arthritis despite methotrexate therapy, repeated doses of infliximab in combination with methotrexate provided clinical benefit and halted the progression of joint damage.

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Published In

N Engl J Med

DOI

ISSN

0028-4793

Publication Date

November 30, 2000

Volume

343

Issue

22

Start / End Page

1594 / 1602

Location

United States

Related Subject Headings

  • Tumor Necrosis Factor-alpha
  • Middle Aged
  • Methotrexate
  • Male
  • Joints
  • Injections, Intravenous
  • Infliximab
  • Humans
  • General & Internal Medicine
  • Female
 

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Lipsky, P. E., van der Heijde, D. M., St Clair, E. W., Furst, D. E., Breedveld, F. C., Kalden, J. R., … Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group, . (2000). Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med, 343(22), 1594–1602. https://doi.org/10.1056/NEJM200011303432202
Lipsky, P. E., D. M. van der Heijde, E. W. St Clair, D. E. Furst, F. C. Breedveld, J. R. Kalden, J. S. Smolen, et al. “Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group.N Engl J Med 343, no. 22 (November 30, 2000): 1594–1602. https://doi.org/10.1056/NEJM200011303432202.
Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med. 2000 Nov 30;343(22):1594–602.
Lipsky, P. E., et al. “Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group.N Engl J Med, vol. 343, no. 22, Nov. 2000, pp. 1594–602. Pubmed, doi:10.1056/NEJM200011303432202.
Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, Smolen JS, Weisman M, Emery P, Feldmann M, Harriman GR, Maini RN, Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med. 2000 Nov 30;343(22):1594–1602.
Journal cover image

Published In

N Engl J Med

DOI

ISSN

0028-4793

Publication Date

November 30, 2000

Volume

343

Issue

22

Start / End Page

1594 / 1602

Location

United States

Related Subject Headings

  • Tumor Necrosis Factor-alpha
  • Middle Aged
  • Methotrexate
  • Male
  • Joints
  • Injections, Intravenous
  • Infliximab
  • Humans
  • General & Internal Medicine
  • Female