Impact of trough serum level on radiographic and clinical response to infliximab plus methotrexate in patients with rheumatoid arthritis: Results from the RISING study

Tsutomu Takeuchi, Nobuyuki Miyasaka, Kazuhiko Inoue, Tohru Abe, Takao Koike

Research output: Contribution to journalArticle

79 Citations (Scopus)

Abstract

This study is a prospective, randomized, double-blind study to compare the efficacy and safety of 10 mg/kg infliximab with those of 3 mg/kg infliximab treatment in methotrexate-refractory rheumatoid arthritis patients. After the patients received 3 mg/kg infliximab infusion at weeks 0, 2, and 6, they were randomly assigned to be administered 3, 6 or 10 mg/kg infliximab every 8 weeks from week 14 to 46. Mean American College of Rheumatology improvement (ACR-N) at week 54, the primary endpoint, was 51.3% and 58.3% for the 3 mg/kg and 10 mg/kg groups, respectively, with a statistically significant difference. Treatment with 10 mg/kg was found to be remarkably beneficial in patients who had not responded to three infusions with 3 mg/kg at week 10. The median changes in the modified Sharp score were 0.0 in the two groups. There were no significant differences in the incidences of adverse events between the groups. In patients who achieved better clinical response or greater inhibition of progression of joint damage, trough serum infliximab level was significantly higher than in patients who did not. The magnitudes of both efficacies were correlated with the trough serum infliximab level (ClinicalTrials.gov number: NCT00691028).

Original languageEnglish
Pages (from-to)478-487
Number of pages10
JournalModern rheumatology
Volume19
Issue number5
DOIs
Publication statusPublished - 2009 Jul 23
Externally publishedYes

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Keywords

  • Clinical trial
  • Infliximab
  • Rheumatoid arthritis
  • Serum level
  • Tumor necrosis factor (TNF) antagonist

ASJC Scopus subject areas

  • Rheumatology

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