Trial reportJournal of gastroenterology2016
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.
Trial report in Journal of gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
57 citing papers in PubMed, 8 syntheses or guidelines pooled it, 115 citations in OpenAlex.
- Meta-Analysis: Intravenous Versus Subcutaneous Infliximab in Inflammatory Bowel Disease.Alimentary pharmacology & therapeutics · 2025Pooled it
- Infliximab for patients with moderate to severely active ulcerative colitis: an updated meta-analysis of randomized controlled trials.BMC gastroenterology · 2025Pooled it
- Comparative Efficacy of Advanced Therapies for Management of Moderate-to-Severe Ulcerative Colitis: 2024 American Gastroenterological Association Evidence Synthesis.Gastroenterology · 2024Pooled it
- AGA Living Clinical Practice Guideline on Pharmacological Management of Moderate-to-Severe Ulcerative Colitis.Gastroenterology · 2024Guideline
- Comparative efficacy of advanced treatments in biologic-naïve or biologic-experienced patients with ulcerative colitis: a systematic review and network meta-analysis.International journal of clinical pharmacy · 2023Pooled it
- Factors predicting clinical and endoscopic remission with placebo therapy in East Asian patients with ulcerative colitis: a systematic review and meta-analysis.European journal of clinical pharmacology · 2022Pooled it
- Predictive value of blood concentration of biologics on endoscopic inactivity in inflammatory bowel disease: A systematic review.World journal of gastroenterology · 2021Pooled it
- Pooled it
- Trial
- Trial
- Infliximab for pediatric patients with ulcerative colitis: a phase 3, open-label, uncontrolled, multicenter trial in Japan.BMC pediatrics · 2019Trial
- Efficacy of Biologic Agents and Small Molecules for Endoscopic Improvement and Mucosal Healing in Patients with Moderate-to-Severe Ulcerative Colitis: Systematic Review and Meta-Analysis.Journal of clinical medicine · 2025Review
- Network Meta-Analysis: Efficacy of Biological Therapies and Small Molecules as Maintenance Therapy in Ulcerative Colitis.Alimentary pharmacology & therapeutics · 2025Article
- Early monitoring of anti-infliximab antibodies by drug-tolerant assay predicts later immunogenicity and drug survival in rheumatic diseases.Rheumatology (Oxford, England) · 2025Observational
- Early change in serum leucine-rich α-2-glycoprotein predicts clinical and endoscopic response in ulcerative colitis.Intestinal research · 2024Article
- Racial Disparities in Infliximab Efficacy for Ulcerative Colitis: Evidence Synthesis and Effect Modification Assessment.Journal of clinical medicine · 2024Review
- Optimising infliximab induction dosing to achieve clinical remission in Chinese patients with Crohn's disease.Frontiers in pharmacology · 2024Article
- Recent Advances in the Optimization of Anti-TNF Treatment in Patients with Inflammatory Bowel Disease.Journal of clinical medicine · 2023Review
- Comparative onset of effect of biologics and small molecules in moderate-to-severe ulcerative colitis: a systematic review and network meta-analysis.EClinicalMedicine · 2023Article
- Guidelines for the management of ulcerative colitis. Recommendations of the Polish Society of Gastroenterology and the Polish National Consultant in Gastroenterology.Przeglad gastroenterologiczny · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundInfliximab (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.
methodsPatients 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.
resultsClinical 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 < 0.001) was an independent factor correlating with 14-week CAI remission. The week 2 TL and TL/CAI were also significantly associated with 30-week mucosal healing.
conclusionsIFX was confirmed to be effective and safe in this population. Our results suggest that the first TL at week 2, in combination with clinical evaluation, is useful for predicting both short- and long-term outcomes, allowing an earlier decision between continuing IFX or switching to other options.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.