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Open label study to assess infliximab safety and timing of onset of clinical benefit among patients with rheumatoid arthritis.

Publication ,  Journal Article
Shergy, WJ; Isern, RA; Cooley, DA; Harshbarger, JL; Huffstutter, JE; Hughes, GM; Spencer-Smith, EA; Goldman, AL; Roth, SH; Toder, JS; Warner, D ...
Published in: J Rheumatol
April 2002

OBJECTIVE: To assess the timing of onset of clinical benefit following the initial infusion of infliximab and to obtain additional safety experience of infliximab when given in an office setting to patients with rheumatoid arthritis (RA). In addition, the safety of reducing the infusion time from 2 hours to 1 hour was evaluated. METHODS: Patients (n = 553) with active RA despite receiving methotrexate (MTX) were treated with infliximab 3 mg/kg given over 2 h at baseline (Week 0), and Weeks 2, 6, and 14 in this multicenter open-label trial. Patients continued to receive a stable dose of MTX (> or = 7.5 mg/wk). At selected sites, patients tolerating the first 4 infusions were eligible to receive 2 additional infusions at twice the usual infusion rate (given over 1 h). Patients returned for efficacy assessments at 48 h following the initial infusion and several times throughout study participation. RESULTS: By 48 h following the first infusion, significant (p < 0.001) improvements were observed in duration of morning stiffness (34% mean improvement), physician's global disease assessment scores (30%), patient's global disease assessment scores (25%), and patient's pain assessment scores (30%). By Week 16, 52 to 63% mean improvements in these efficacy variables were observed (p < 0.001), the significant improvement was maintained through the end of study participation in the subset of patients who received the additional 1 h infliximab infusions. Through 16 weeks, 10% (54/553) of patients reported an adverse event associated with at least 1 of the 4 infusion procedures; the majority were mild and transient in nature. In the subset of 197 patients who received 2 additional infusions over 1 h, no increase in the frequency or severity of infusion-related adverse events was observed compared to the 2 h infusion. CONCLUSION: Infliximab administered to patients with RA in an outpatient setting resulted in significant clinical improvement within 48 h that was sustained with additional infusions. Approximately 10% of patients experienced an infusion reaction, highlighting the need for direct supervision over patient treatment. Patients who tolerated infliximab infusions given over 2 h also tolerated a 1 h infusion.

Duke Scholars

Published In

J Rheumatol

ISSN

0315-162X

Publication Date

April 2002

Volume

29

Issue

4

Start / End Page

667 / 677

Location

Canada

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Severity of Illness Index
  • Pain
  • Outpatients
  • Middle Aged
  • Methotrexate
  • Male
  • Joints
  • Infusions, Intravenous
 

Citation

APA
Chicago
ICMJE
MLA
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Shergy, W. J., Isern, R. A., Cooley, D. A., Harshbarger, J. L., Huffstutter, J. E., Hughes, G. M., … PROMPT Study Group. Profiling Remicade Onset with MTX in a Prospective Trial, . (2002). Open label study to assess infliximab safety and timing of onset of clinical benefit among patients with rheumatoid arthritis. J Rheumatol, 29(4), 667–677.
Shergy, William J., Reuben A. Isern, David A. Cooley, John L. Harshbarger, J Eugene Huffstutter, Gordon M. Hughes, Elizabeth A. Spencer-Smith, et al. “Open label study to assess infliximab safety and timing of onset of clinical benefit among patients with rheumatoid arthritis.J Rheumatol 29, no. 4 (April 2002): 667–77.
Shergy WJ, Isern RA, Cooley DA, Harshbarger JL, Huffstutter JE, Hughes GM, et al. Open label study to assess infliximab safety and timing of onset of clinical benefit among patients with rheumatoid arthritis. J Rheumatol. 2002 Apr;29(4):667–77.
Shergy, William J., et al. “Open label study to assess infliximab safety and timing of onset of clinical benefit among patients with rheumatoid arthritis.J Rheumatol, vol. 29, no. 4, Apr. 2002, pp. 667–77.
Shergy WJ, Isern RA, Cooley DA, Harshbarger JL, Huffstutter JE, Hughes GM, Spencer-Smith EA, Goldman AL, Roth SH, Toder JS, Warner D, Quinn A, Keenan GF, Schaible TF, PROMPT Study Group. Profiling Remicade Onset with MTX in a Prospective Trial. Open label study to assess infliximab safety and timing of onset of clinical benefit among patients with rheumatoid arthritis. J Rheumatol. 2002 Apr;29(4):667–677.

Published In

J Rheumatol

ISSN

0315-162X

Publication Date

April 2002

Volume

29

Issue

4

Start / End Page

667 / 677

Location

Canada

Related Subject Headings

  • Treatment Outcome
  • Time Factors
  • Severity of Illness Index
  • Pain
  • Outpatients
  • Middle Aged
  • Methotrexate
  • Male
  • Joints
  • Infusions, Intravenous