ArticleIntestinal research2019
Efficacy and safety of abrilumab, an α4β7 integrin inhibitor, in Japanese patients with moderate-to-severe ulcerative colitis: a phase II study.
Article in Intestinal research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 2 of them syntheses that pooled it.
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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.
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Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Drug-Induced Progressive Multifocal Leukoencephalopathy (PML): A Systematic Review and Meta-Analysis.Drug safety · 2024Pooled 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
- Development of New Molecularly Targeted Agents in Inflammatory Bowel Disease.Internal medicine (Tokyo, Japan) · 2026Review
- Integrin α4β7: Pathogenic Roles in Metabolic and Inflammatory Diseases and Translational Therapeutics.Journal of inflammation research · 2026Review
- Advancing therapeutic frontiers: a pipeline of novel drugs for UC management.Frontiers in gastroenterology (Lausanne, Switzerland) · 2026Review
- Biosimilars versus biological therapy in inflammatory bowel disease: challenges and targeting strategies using drug delivery systems.Clinical and experimental medicine · 2025Review
- Paradigm Shift in Inflammatory Bowel Disease Management: Precision Medicine, Artificial Intelligence, and Emerging Therapies.Journal of clinical medicine · 2025Review
- Integrin signaling in cancer: bidirectional mechanisms and therapeutic opportunities.Cell communication and signaling : CCS · 2023Review
- Review
- Targeting integrin pathways: mechanisms and advances in therapy.Signal transduction and targeted therapy · 2023Review
- Tackling Inflammatory Bowel Diseases: Targeting Proinflammatory Cytokines and Lymphocyte Homing.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Immunology of Inflammatory Bowel Disease: Molecular Mechanisms and Therapeutics.Journal of inflammation research · 2022Review
- Emerging therapeutic options in inflammatory bowel disease.World journal of gastroenterology · 2021Review
- Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis.Intestinal research · 2021Article
- Targeting Immune Cell Trafficking - Insights From Research Models and Implications for Future IBD Therapy.Frontiers in immunology · 2021Review
- Anti-Integrins for the Treatment of Inflammatory Bowel Disease: Current Evidence and Perspectives.Clinical and experimental gastroenterology · 2021Review
- Is fasting beneficial for hospitalized patients with inflammatory bowel diseases?Intestinal research · 2020Article
- Subcutaneous integrin inhibitors may provide more treatment options for patients with moderate-to-severe ulcerative colitis.Intestinal research · 2019Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
BACKGROUND/
aimsInhibition of α4β7 integrin has been shown to be effective for induction and maintenance therapy in patients with ulcerative colitis (UC). We investigated the effects of varying doses of the α4β7 inhibitor abrilumab in Japanese patients with moderate-to-severe UC despite conventional treatments.
methodsIn this randomized, double-blind, placebocontrolled study, 45 UC patients were randomized to abrilumab 21 mg (n=11), 70 mg (n=12), 210 mg (n=9), or placebo (n=13) via subcutaneous (SC) injection for 12 weeks. The double-blind period was followed by a 36-week open-label period, in which all patients received abrilumab 210 mg SC every 12 weeks, and a 28-week safety follow-up period. The primary efficacy variable was clinical remission at week 8 (total Mayo score ≤2 points with no individual subscore >1 point).
resultsClinical remission at week 8 was 4 out of 31 (12.9%) overall in the abrilumab groups versus 0 out of 13 in the placebo group (abrilumab 21 mg, 1/10 [10.0%]; 70 mg, 2/12 [16.7%]; 210 mg, 1/9 [11.1%]). In both the double-blind and open-label periods, fewer patients in the abrilumab groups experienced ≥1 adverse event compared with those in the placebo group. There were no cases of progressive multifocal leukoencephalopathy and no deaths.
conclusionsAbrilumab 70 mg and 210 mg yielded numerically better results in terms of clinical remission rate at Week 8 than placebo, with the 210 mg dose showing more consistent treatment effects. Abrilumab was well tolerated in Japanese patients with UC.
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