Drs. St.Clair, van der Heijde, Smolen, Maini, Bathon, Emery, Keystone, and Kalden have received consultancies and/or honoraria from Centocor, Inc., totaling less than $10,000 per year. In 2002, Drs. van der Heijde and Maini gave expert testimony to the FDA hearing on inhibition of structural damage and received a fee. The Kennedy Institute of Rheumatology has a patent and a research and licensing agreement from Centocor, Inc., under which it has received royalties for the use of infliximab in rheumatoid arthritis. As a coinventor, Dr. Maini receives a percentage of these royalties under the Kennedy Institute's formula for the division of royalties. Drs. Maini, Wang, DeWoody, Weiss, and Baker own stock in Johnson & Johnson, of which Centocor, Inc., is a subsidiary.
Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: A randomized, controlled trial
Article first published online: 4 NOV 2004
Copyright © 2004 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 50, Issue 11, pages 3432–3443, November 2004
How to Cite
St. Clair, E. W., van der Heijde, D. M. F. M., Smolen, J. S., Maini, R. N., Bathon, J. M., Emery, P., Keystone, E., Schiff, M., Kalden, J. R., Wang, B., DeWoody, K., Weiss, R., Baker, D. and 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 & Rheumatism, 50: 3432–3443. doi: 10.1002/art.20568
- Issue published online: 4 NOV 2004
- Article first published online: 4 NOV 2004
- Manuscript Accepted: 30 JUN 2004
- Manuscript Received: 9 MAR 2004
- Centocor, Inc., a subsidiary of Johnson & Johnson
To compare the benefits of initiating treatment with methotrexate (MTX) and infliximab (anti–tumor necrosis factor α [anti-TNFα] monoclonal antibody) with those of MTX treatment alone in patients with rheumatoid arthritis (RA) of ≤3 years' duration.
RA patients were eligible if they had active disease and no prior treatment with MTX or a TNFα 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.
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.
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.