Trial reportGut2003
A randomised placebo controlled trial of pegylated interferon alpha in active ulcerative colitis.
Trial report in Gut, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 3 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
33 citing papers in PubMed, 3 syntheses or guidelines pooled it, 91 citations in OpenAlex.
- Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Type I interferons for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2015Pooled it
- Meta-analysis of the placebo response in ulcerative colitis.Digestive diseases and sciences · 2008Pooled it
- Trial
- Type I interferons in inflammatory bowel diseases: balancing barrier integrity, repair and inflammation in the intestinal epithelium.Frontiers in medicine · 2025Review
- Crosstalk Between Microbiota, Microbial Metabolites, and Interferons in the Inflammatory Bowel Disease Gut.Journal of the Canadian Association of Gastroenterology · 2024Review
- Core indicators of an evaluation and guidance system for quality of care in inflammatory bowel disease centers: A critical review.EClinicalMedicine · 2022Review
- Liver involvement in inflammatory bowel disease: What should the clinician know?World journal of hepatology · 2021Review
- Ulcerative colitis triggered by pegylated interferon alpha-2b in a patient with chronic hepatitis B: A case report and literature review.Liver research (Beijing, China) · 2021Article
- Article
- Secondary causes of inflammatory bowel diseases.World journal of gastroenterology · 2020Review
- Type I and III Interferon in the Gut: Tight Balance between Host Protection and Immunopathology.Frontiers in immunology · 2017Review
- Plasmacytoid dendritic cell-derived IFNα modulates Th17 differentiation during early Bordetella pertussis infection in mice.Mucosal immunology · 2016Article
- Efficacy and safety of treatment of hepatitis C in patients with inflammatory bowel disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2013Article
- TNFR1 determines progression of chronic liver injury in the IKKγ/Nemo genetic model.Cell death and differentiation · 2013Article
- Type I interferons maintain Foxp3 expression and T-regulatory cell functions under inflammatory conditions in mice.Gastroenterology · 2012Article
- Article
- Article
- Recent advances in cytokines: therapeutic implications for inflammatory bowel diseases.World journal of gastroenterology · 2011Review
- Investigational new drugs in the treatment of inflammatory bowel disease: a review.Journal of experimental pharmacology · 2011Review
Corrections and comments
- Commented on by
Authors and funding
16 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPilot studies of interferon alpha (IFN-alpha) suggest a high remission rate in the treatment of active ulcerative colitis. We evaluated the safety of pegylated interferon alpha (PegIFN) and its role in induction of remission in patients with active ulcerative colitis, in a multicentre placebo controlled trial.
methodsSixty patients with a clinical activity score (CAI) of >6 were randomised to receive placebo (n=20), PegIFN 0.5 microg/kg (n=19), or PegIFN 1.0 microg/kg body weight (n=21) once weekly (PegIntron; Schering-Plough, USA) over 12 weeks. Patients receiving 5-aminosalicylates, steroids, and/or azathioprine in stable dosages were included.
resultsSerious adverse events were seen in none of the placebo patients, in 3/19 patients in the PegIFN 0.5 microg/kg group (hospitalisation due to disease flare up n=3), and in 3/21 in the PegIFN 1.0 microg/kg group (hospitalisation due to disease flare up n=1; thrombosis n=1; grand mal seizure n=1). Otherwise, we observed only minor IFN-alpha side effects. Clinical remission rates at week 12 (CAI < or =4) were 7/20 (35%) in the placebo, 9/19 (47%) in the PegIFN 0.5 microg/kg group, and 7/21 (33%) in the PegIFN 1.0 microg/kg group (NS). Early withdrawal from the study was observed in 11/20 placebo patients, in 6/19 in the PegIFN 0.5 microg/kg group, and in 10/21 in the PegIFN 1.0 microg/kg group, mainly due to lack of efficacy. The higher PegIFN dose was associated with a significant decrease in levels of C reactive protein (p=0.003, day 0 v 85).
conclusionsPegIFN is safe but not effective, at the dosages used, in patients with ulcerative colitis.
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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.