First trough level of infliximab at week 2 predicts future outcomes of induction therapy in ulcerative colitis—results from a multicenter prospective randomized controlled trial and its post hoc analysis

Taku Kobayashi, Yasuo Suzuki, Satoshi Motoya, Fumihito Hirai, Haruhiko Ogata, Hiroaki Ito, Noriko Sato, Kunihiko Ozaki, Mamoru Watanabe, Toshifumi Hibi

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Background: Infliximab (IFX) is one of the treatments of choice for corticosteroid-refractory and corticosteroid-dependent ulcerative colitis (UC). A high serum trough level of IFX (TL) is reported to be associated with sustained efficacy during maintenance treatment. As part of a phase 3 randomized controlled trial of IFX in UC, we assessed the predictive value of the first TL at week 2 for short- and long-term response. Methods: Patients received intravenous IFX 5 mg/kg or placebo at weeks 0, 2, and 6. Patients with evidence of a response by week 8 continued treatment at weeks 14 and 22. TL was measured by enzyme-linked immunosorbent assay. Post hoc analysis was then performed for TL and clinical outcomes. Results: Clinical response rate at week 8, the primary end point, was significantly higher in the IFX group than placebo (p = 0.005). The incidence of adverse events between groups was similar. Week 2 TL was significantly associated with a 14-week clinical activity index (CAI) remission. In multiple logistic regression analysis, the week 2 TL-to-CAI ratio (TL/CAI, odds ratio 8.07; 95 % confidence interval 2.84–27.07, p 

Original languageEnglish
Pages (from-to)241-251
Number of pages11
JournalJournal of Gastroenterology
Volume51
Issue number3
DOIs
Publication statusPublished - 2016 Mar 1

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Randomized Controlled Trials
Ulcerative Colitis
Adrenal Cortex Hormones
Placebos
Therapeutics
Logistic Models
Enzyme-Linked Immunosorbent Assay
Odds Ratio
Regression Analysis
Infliximab
Confidence Intervals
Incidence
Serum

Keywords

  • Infliximab
  • Mucosal healing
  • Primary response
  • Therapeutic drug monitoring
  • Ulcerative colitis

ASJC Scopus subject areas

  • Gastroenterology

Cite this

First trough level of infliximab at week 2 predicts future outcomes of induction therapy in ulcerative colitis—results from a multicenter prospective randomized controlled trial and its post hoc analysis. / Kobayashi, Taku; Suzuki, Yasuo; Motoya, Satoshi; Hirai, Fumihito; Ogata, Haruhiko; Ito, Hiroaki; Sato, Noriko; Ozaki, Kunihiko; Watanabe, Mamoru; Hibi, Toshifumi.

In: Journal of Gastroenterology, Vol. 51, No. 3, 01.03.2016, p. 241-251.

Research output: Contribution to journalArticle

Kobayashi, Taku ; Suzuki, Yasuo ; Motoya, Satoshi ; Hirai, Fumihito ; Ogata, Haruhiko ; Ito, Hiroaki ; Sato, Noriko ; Ozaki, Kunihiko ; Watanabe, Mamoru ; Hibi, Toshifumi. / First trough level of infliximab at week 2 predicts future outcomes of induction therapy in ulcerative colitis—results from a multicenter prospective randomized controlled trial and its post hoc analysis. In: Journal of Gastroenterology. 2016 ; Vol. 51, No. 3. pp. 241-251.
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