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

• DOI: 10.1007/s00535-015-1102-z
• Publication Date: 2015-07-10T13:20:55Z
• Authors: Taku Kobayashi; Yasuo Suzuki; Satoshi Motoya; Fumihito Hirai; Haruhiko Ogata; Hiroaki Ito; Noriko Sato; Kunihiko Ozaki; Mamoru Watanabe; Toshifumi Hibi
• Keywords: Post-hoc analysis; Clinical endpoint; Discontinuation

Infliximab (IFX) is one of the treatments choice for corticosteroid-refractory and corticosteroid-dependent ulcerative colitis (UC). A high serum trough level IFX (TL) reported to be associated with sustained efficacy during maintenance treatment. As part a phase 3 randomized controlled trial in UC, we assessed predictive value first TL at week 2 short- long-term response. Patients received intravenous 5 mg/kg or placebo weeks 0, 2, 6. evidence response by 8 continued treatment 14 22. was measured enzyme-linked immunosorbent assay. Post hoc analysis then performed clinical outcomes. Clinical rate 8, primary end point, significantly higher group than (p = 0.005). The incidence adverse events between groups similar. Week 14-week activity index (CAI) remission. In multiple logistic regression analysis, TL-to-CAI ratio (TL/CAI, odds 8.07; 95 % confidence interval 2.84–27.07, p < 0.001) an independent factor correlating CAI TL/CAI were also 30-week mucosal healing. confirmed effective safe this population. Our results suggest that combination evaluation, useful predicting both outcomes, allowing earlier decision continuing switching other options.