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Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group.

Publication ,  Journal Article
Maini, R; St Clair, EW; Breedveld, F; Furst, D; Kalden, J; Weisman, M; Smolen, J; Emery, P; Harriman, G; Feldmann, M; Lipsky, P
Published in: Lancet
December 4, 1999

BACKGROUND: Not all patients with rheumatoid arthritis can tolerate or respond to methotrexate, a standard treatment for this disease. There is evidence that antitumour necrosis factor alpha (TNFalpha) is efficacious in relief of signs and symptoms. We therefore investigated whether infliximab, a chimeric human-mouse anti-TNFalpha monoclonal antibody would provide additional clinical benefit to patients who had active rheumatoid arthritis despite receiving methotrexate. METHODS: In an international double-blind placebo-controlled phase III clinical trial, 428 patients who had active rheumatoid arthritis, who had received continuous methotrexate for at least 3 months and at a stable dose for at least 4 weeks, were randomised to placebo (n=88) or one of four regimens of infliximab at weeks 0, 2, and 6. Additional infusions of the same dose were given every 4 or 8 weeks thereafter on a background of a stable dose of methotrexate (median 15 mg/week for > or =6 months, range 10-35 mg/wk). Patients were assessed every 4 weeks for 30 weeks. FINDINGS: At 30 weeks, the American College of Rheumatology (20) response criteria, representing a 20% improvement from baseline, were achieved in 53, 50, 58, and 52% of patients receiving 3 mg/kg every 4 or 8 weeks or 10 mg/kg every 4 or 8 weeks, respectively, compared with 20% of patients receiving placebo plus methotrexate (p<0.001 for each of the four infliximab regimens vs placebo). A 50% improvement was achieved in 29, 27, 26, and 31% of infliximab plus methotrexate in the same treatment groups, compared with 5% of patients on placebo plus methotrexate (p<0.001). Infliximab was well-tolerated; withdrawals for adverse events as well as the occurrence of serious adverse events or serious infections did not exceed those in the placebo group. INTERPRETATION: During 30 weeks, treatment with infliximab plus methotrexate was more efficacious than methotrexate alone in patients with active rheumatoid arthritis not previously responding to methotrexate.

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Published In

Lancet

DOI

ISSN

0140-6736

Publication Date

December 4, 1999

Volume

354

Issue

9194

Start / End Page

1932 / 1939

Location

England

Related Subject Headings

  • Tumor Necrosis Factor-alpha
  • Sensitivity and Specificity
  • Remission Induction
  • Placebos
  • Middle Aged
  • Methotrexate
  • Male
  • Infusions, Intravenous
  • Infliximab
  • Humans
 

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Maini, R., St Clair, E. W., Breedveld, F., Furst, D., Kalden, J., Weisman, M., … Lipsky, P. (1999). Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet, 354(9194), 1932–1939. https://doi.org/10.1016/s0140-6736(99)05246-0
Maini, R., E. W. St Clair, F. Breedveld, D. Furst, J. Kalden, M. Weisman, J. Smolen, et al. “Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group.Lancet 354, no. 9194 (December 4, 1999): 1932–39. https://doi.org/10.1016/s0140-6736(99)05246-0.
Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, Smolen J, Emery P, Harriman G, Feldmann M, Lipsky P. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet. 1999 Dec 4;354(9194):1932–1939.
Journal cover image

Published In

Lancet

DOI

ISSN

0140-6736

Publication Date

December 4, 1999

Volume

354

Issue

9194

Start / End Page

1932 / 1939

Location

England

Related Subject Headings

  • Tumor Necrosis Factor-alpha
  • Sensitivity and Specificity
  • Remission Induction
  • Placebos
  • Middle Aged
  • Methotrexate
  • Male
  • Infusions, Intravenous
  • Infliximab
  • Humans