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Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial.

Publication ,  Journal Article
St Clair, EW; van der Heijde, DMFM; Smolen, JS; Maini, RN; Bathon, JM; Emery, P; Keystone, E; Schiff, M; Kalden, JR; Wang, B; Dewoody, K ...
Published in: Arthritis Rheum
November 2004

OBJECTIVE: To compare the benefits of initiating treatment with methotrexate (MTX) and infliximab (anti-tumor necrosis factor alpha [anti-TNFalpha] monoclonal antibody) with those of MTX treatment alone in patients with rheumatoid arthritis (RA) of < or =3 years' duration. METHODS: RA patients were eligible if they had active disease and no prior treatment with MTX or a TNFalpha inhibitor. One thousand forty-nine patients were randomly assigned in a 4:5:5 ratio to 3 treatment groups: MTX-placebo, MTX-3 mg/kg infliximab, and MTX-6 mg/kg infliximab. MTX dosages were rapidly escalated to 20 mg/week, and infliximab or placebo infusions were given at weeks 0, 2, and 6, and every 8 weeks thereafter through week 46. RESULTS: At week 54, the median percentage of American College of Rheumatology improvement (ACR-N) was higher for the MTX-3 mg/kg infliximab and MTX-6 mg/kg infliximab groups than for the MTX-placebo group (38.9% and 46.7% versus 26.4%, respectively; P < 0.001 for both comparisons). Patients in the MTX-3 mg/kg infliximab and MTX-6 mg/kg infliximab groups also showed less radiographic progression than those receiving MTX alone (mean +/- SD changes in van der Heijde modification of the total Sharp score at week 54: 0.4 +/- 5.8 and 0.5 +/- 5.6 versus 3.7 +/- 9.6, respectively; P < 0.001 for each comparison). In addition, physical function improved significantly more in the MTX-3 mg/kg infliximab and MTX-6 mg/kg infliximab groups than in the MTX-placebo group. Infliximab therapy was associated with a significantly higher incidence of serious infections, especially pneumonia. CONCLUSION: For patients with active RA in its early stages, combination therapy with MTX and infliximab provides greater clinical, radiographic, and functional benefits than treatment with MTX alone.

Duke Scholars

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Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

November 2004

Volume

50

Issue

11

Start / End Page

3432 / 3443

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Recovery of Function
  • Patient Dropouts
  • Middle Aged
  • Methotrexate
  • Male
  • Infliximab
  • Humans
  • Female
  • Drug Therapy, Combination
 

Citation

APA
Chicago
ICMJE
MLA
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St Clair, E. W., van der Heijde, D. M. F. M., Smolen, J. S., Maini, R. N., Bathon, J. M., Emery, P., … Active-Controlled Study of Patients Receiving Infliximab for the Treatment of  Rheumatoid Arthritis of Early Onset Study Group, . (2004). Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum, 50(11), 3432–3443. https://doi.org/10.1002/art.20568
St Clair, E William, Désirée M. F. M. van der Heijde, Josef S. Smolen, Ravinder N. Maini, Joan M. Bathon, Paul Emery, Edward Keystone, et al. “Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial.Arthritis Rheum 50, no. 11 (November 2004): 3432–43. https://doi.org/10.1002/art.20568.
St Clair EW, van der Heijde DMFM, Smolen JS, Maini RN, Bathon JM, Emery P, et al. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum. 2004 Nov;50(11):3432–43.
St Clair, E. William, et al. “Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial.Arthritis Rheum, vol. 50, no. 11, Nov. 2004, pp. 3432–43. Pubmed, doi:10.1002/art.20568.
St Clair EW, van der Heijde DMFM, Smolen JS, Maini RN, Bathon JM, Emery P, Keystone E, Schiff M, Kalden JR, Wang B, Dewoody K, Weiss R, Baker D, Active-Controlled Study of Patients Receiving Infliximab for the Treatment of  Rheumatoid Arthritis of Early Onset Study Group. Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomized, controlled trial. Arthritis Rheum. 2004 Nov;50(11):3432–3443.
Journal cover image

Published In

Arthritis Rheum

DOI

ISSN

0004-3591

Publication Date

November 2004

Volume

50

Issue

11

Start / End Page

3432 / 3443

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Recovery of Function
  • Patient Dropouts
  • Middle Aged
  • Methotrexate
  • Male
  • Infliximab
  • Humans
  • Female
  • Drug Therapy, Combination