Trial reportJournal of Crohn's & colitis2016
Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results.
Trial report in Journal of Crohn's & colitis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 19 papers.
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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.
Clinical Trial to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
Efficacy and Safety of the Adacolumn® Granulocyte and Monocyte/Macrophage Apheresis Device for Cerebral Edema After Acute Anterior Circulation Occlusive Cerebral Infarction: A Prospective, Randomized, Controlled Clinical Trial
Who cites it
19 citing papers in PubMed.
- Bioinspired microcapsule reactor with engineered probiotics for IBD therapy.Nature communications · 2026Article
- Efficacy of Biologics in Patients with Ulcerative Colitis Exhibiting Non-Response or Insufficient Response to Cytapheresis.Journal of clinical medicine · 2025Article
- Review
- Efficacy of cytapheresis in patients with ulcerative colitis showing insufficient or lost response to biologic therapy.World journal of gastroenterology · 2022Review
- Innovative, complementary and alternative therapy in inflammatory bowel diseases: A broad 2020s update.Frontiers in gastroenterology (Lausanne, Switzerland) · 2022Review
- Granulocyte and monocyte/macrophage apheresis in paediatric patients with ulcerative colitis: a case series in Spain.Drugs in context · 2022Article
- Pyoderma gangrenosum with primary sclerosing cholangitis-associated colitis successfully treated with concomitant granulocyte and monocyte adsorption apheresis with corticosteroids.Clinical journal of gastroenterology · 2021Article
- Fecal calprotectin is a useful biomarker for predicting the clinical outcome of granulocyte and monocyte adsorptive apheresis in ulcerative colitis patients: a prospective observation study.BMC gastroenterology · 2021Observational
- Cytapheresis re-induces high-rate steroid-free remission in patients with steroid-dependent and steroid-refractory ulcerative colitis.World journal of gastroenterology · 2021Article
- Clinical Considerations Regarding the Use of Thiopurines in Older Patients with Inflammatory Bowel Disease.Drugs & aging · 2021Review
- Chronic Antibiotic-Refractory Pouchitis: Management Challenges.Clinical and experimental gastroenterology · 2021Review
- Leukocytapheresis in patients with inflammatory bowel diseases.Przeglad gastroenterologiczny · 2021Review
- Selective granulocyte and monocyte apheresis in inflammatory bowel disease: Its past, present and future.World journal of gastrointestinal pathophysiology · 2020Review
- Inflammatory Bowel Disease in Japan-Is It Similar to or Different from Westerns?Journal of the anus, rectum and colon · 2020Review
- Safety and effectiveness of granulocyte and monocyte adsorptive apheresis in patients with inflammatory bowel disease in special situations: a multicentre cohort study.BMC gastroenterology · 2019Article
- Faecal calprotectin level for assessing endoscopic activity and predicting future clinical course in patients with moderately active ulcerative colitis undergoing granulomonocytapheresis: a prospective cohort study.BMC gastroenterology · 2018Article
- A multicenter retrospective study aiming to identify patients who respond well to adsorptive granulomonocytapheresis in moderately to severely active ulcerative colitis.Clinical and translational gastroenterology · 2018Article
- Immunological Mechanisms of Adsorptive Cytapheresis in Inflammatory Bowel Disease.Digestive diseases and sciences · 2017Review
- Efficacy of granulocyte and monocyte apheresis for antibiotic-refractory pouchitis after proctocolectomy for ulcerative colitis: an open-label, prospective, multicentre study.Therapeutic advances in gastroenterology · 2017Article
Corrections and comments
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Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimsPatients with active, steroid-dependent ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologic therapies have limited treatment options. Adacolumn, a granulocyte/monocyte adsorptive apheresis device, has shown clinical benefit in these patients. This study aimed to provide additional clinical data regarding the safety and efficacy of Adacolumn in this patient subgroup.
methodsThis single-arm, open-label, multicentre trial [ART] was conducted at 18 centres across the UK, France, and Germany. Eligible patients were 18-75 years old with moderate-to-severe, steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologics. Patients received ≥ 5 weekly apheresis sessions with Adacolumn. The primary endpoint was clinical remission rate [clinical activity index ≤ 4] at Week 12.
resultsIn all, 86 patients were enrolled. At Week 12, 33/84 [39.3%] of patients in the intention-to-treat population achieved clinical remission, with 47/84 [56.0%] achieving a clinical response [clinical activity index reduction of ≥ 3]. Clinical remission was achieved in 30.0% of patients with previous immunosuppressant and biologic failure; steroid-free clinical remission and response were observed in 22.6% and 35.7% of these patients, respectively. Quality of life [Short Health Scale] significantly improved at Week 12 [p < 0.0001]. The majority of adverse events were of mild/moderate intensity.
conclusionsAt Week 12, Adacolumn provided significant clinical benefit in a large cohort of steroid-dependent ulcerative colitis patients with previous failure to immunosuppressant and/or biologic treatment, with a favourable safety profile. These results are consistent with previous studies and support Adacolumn use in this difficult-to-treat patient subgroup.
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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.