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 language | English |
|---|---|
| Pages (from-to) | 241-251 |
| Number of pages | 11 |
| Journal | Journal of Gastroenterology |
| Volume | 51 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - 2016 Mar 1 |
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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 journal › Article
}
TY - JOUR
T1 - 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
AU - Kobayashi, Taku
AU - Suzuki, Yasuo
AU - Motoya, Satoshi
AU - Hirai, Fumihito
AU - Ogata, Haruhiko
AU - Ito, Hiroaki
AU - Sato, Noriko
AU - Ozaki, Kunihiko
AU - Watanabe, Mamoru
AU - Hibi, Toshifumi
PY - 2016/3/1
Y1 - 2016/3/1
N2 - 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
AB - 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
KW - Infliximab
KW - Mucosal healing
KW - Primary response
KW - Therapeutic drug monitoring
KW - Ulcerative colitis
UR - http://www.scopus.com/inward/record.url?scp=84975709025&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84975709025&partnerID=8YFLogxK
U2 - 10.1007/s00535-015-1102-z
DO - 10.1007/s00535-015-1102-z
M3 - Article
VL - 51
SP - 241
EP - 251
JO - Journal of Gastroenterology
JF - Journal of Gastroenterology
SN - 0944-1174
IS - 3
ER -