Trial reportGut2013
A randomised phase I study of etrolizumab (rhuMAb β7) in moderate to severe ulcerative colitis.
Trial report in Gut, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 61 papers, 7 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
61 citing papers in PubMed, 7 syntheses or guidelines pooled it, 150 citations in OpenAlex.
- What is the optimal biological therapy for moderate to severe ulcerative colitis: a systematic review and network meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Efficacy and safety of etrolizumab in the treatment of inflammatory bowel disease: a meta-analysis.PeerJ · 2024Pooled it
- Anti-Drug Antibody Formation Against Biologic Agents in Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Pooled it
- Placebo response and remission rates in randomised trials of induction and maintenance therapy for ulcerative colitis.The Cochrane database of systematic reviews · 2017Pooled it
- Systematic Review and Meta-analysis: Placebo Rates in Induction and Maintenance Trials of Ulcerative Colitis.Journal of Crohn's & colitis · 2016Pooled it
- Etrolizumab for induction of remission in ulcerative colitis.The Cochrane database of systematic reviews · 2015Pooled it
- Efficacy and safety of antiintegrin antibody for inflammatory bowel disease: a systematic review and meta-analysis.Medicine · 2015Pooled it
- Population Pharmacokinetics and Exposure-Response Relationships of Etrolizumab in Patients with Moderately-to-Severely Active Crohn's Disease.Journal of clinical pharmacology · 2025Trial
- Pharmacokinetics, Pharmacodynamics, and Safety of Etrolizumab in Children With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease: Results from a Phase 1 Randomized Trial.Inflammatory bowel diseases · 2022Trial
- Pharmacokinetic and Pharmacodynamic Modeling of Serum Etrolizumab and Circulating β7 Receptor Occupancy in Patients With Ulcerative Colitis.Journal of clinical pharmacology · 2018Trial
- Assessment of Disease-Related Therapeutic Protein Drug-Drug Interaction for Etrolizumab in Patients With Moderately to Severely Active Ulcerative Colitis.Journal of clinical pharmacology · 2016Trial
- Therapeutic Applications of Immunobiologics in Autoimmune and Inflammatory Diseases.Pharmaceutics · 2026Review
- Molecular exaptation by the integrin αI domain.Science advances · 2025Article
- Efficacy and safety of etrolizumab in treatment of moderate to severe ulcerative colitis: A systematic review and meta-analysis.Health science reports · 2024Article
- Article
- Meta-analysis of etrolizumabTherapeutic advances in gastroenterology · 2024Article
- A Narrative Review of Cytokine Networks: Pathophysiological and Therapeutic Implications for Inflammatory Bowel Disease Pathogenesis.Biomedicines · 2023Review
- Understanding the molecular mechanisms of anti-trafficking therapies and their clinical relevance in inflammatory bowel disease.Mucosal immunology · 2023Review
- Emerging Therapies for Ulcerative Colitis: Updates from Recent Clinical Trials.Clinical and experimental gastroenterology · 2023Review
- Population pharmacokinetic analysis of etrolizumab in patients with moderately-to-severely active ulcerative colitis.CPT: pharmacometrics & systems pharmacology · 2022Article
1 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
17 authors at 7 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveEtrolizumab (rhuMAb β7, anti-β7, PRO145223) is a humanised monoclonal antibody targeting the β7 subunit of the heterodimeric integrins α4β7 and αEβ7, which are implicated in leucocyte migration and retention in ulcerative colitis (UC). This randomised phase I study evaluated the safety and pharmacology of etrolizumab in patients with moderate to severe UC.
designIn the single ascending dose (SAD) stage, etrolizumab (0.3, 1.0, 3.0, 10 mg/kg intravenous, 3.0 mg/kg subcutaneous (SC) or placebo) was administered 4:1 (n=25) in each cohort. In the multiple dose (MD) stage, new patients received monthly etrolizumab (0.5 mg/kg SC (n=4), 1.5 mg/kg SC (n=5), 3.0 mg/kg SC (n=4), 4.0 mg/kg intravenous (n=5)) or placebo (n=5). The pharmacokinetics was studied and Mayo Clinic Score evaluated at baseline, day 29 (SAD), and days 43 and 71 (MD).
resultsIn the SAD stage, there were no dose limiting toxicities, infusion or injection site reactions. Two impaired wound healing serious adverse events occurred in two patients receiving etrolizumab. In the MD stage, there were no dose limiting toxicities, and no infusion or injection site reactions. Headache was the most common adverse event, occurring more often in etrolizumab patients. Antietrolizumab antibodies were detected in two subjects. The duration of β7 receptor full occupancy was dose related. A clinical response was observed in 12/18 patients, and clinical remission in 3/18 patients treated with etrolizumab in the MD stage, compared with 4/5 and 1/5 placebo patients, respectively.
conclusionEtrolizumab is well tolerated in moderate to severe UC. Further investigation is warranted.
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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.