ArticleTherapeutic advances in gastroenterology2020
Ustekinumab dose escalation improves clinical responses in refractory Crohn's disease.
Article in Therapeutic advances in gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06520397 (Evaluation of the Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease Patients With an Insufficient Response to Standard-dose Ustekinumab), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.
What it found
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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.
Evaluation of the Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohn's Disease Patients With an Insufficient Response to Standard-dose Ustekinumab: A Randomized Controlled Trial
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- Dose Escalation Patterns of Advanced Therapies in Crohn's Disease and Ulcerative Colitis: A Systematic Literature Review.Advances in therapy · 2023Pooled it
- Effectiveness of Reinduction and/or Dose Escalation of Ustekinumab in Crohn's Disease: A Systematic Review and Meta-analysis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022Pooled it
- Ustekinumab trough concentration affects clinical and endoscopic outcomes in patients with refractory Crohn's disease: a Chinese real-world study.BMC gastroenterology · 2021Trial
- Ustekinumab infusion to subcutaneous transition: Coordinating care and identifying potential gaps.Journal of managed care & specialty pharmacy · 2025Article
- Assessing the role of ustekinumab dose escalation in Crohn's disease patients with loss of response: an observational study.Journal of the Canadian Association of Gastroenterology · 2025Article
- Ustekinumab is safe and effective in pediatric patients with Crohn's disease.Journal of pediatric gastroenterology and nutrition · 2025Article
- IBD Patients with Primary or Secondary Nonresponse to Ustekinumab Benefit from Dose Escalation or Reinduction.Journal of clinical medicine · 2024Review
- Approach to loss of response to advanced therapies in inflammatory bowel disease.World journal of gastroenterology · 2024Review
- Crohn's disease management: translating STRIDE-II for UK clinical practice.Therapeutic advances in gastroenterology · 2024Review
- Review
- Systematic Review and Meta-Analysis of Observational Studies on the Effectiveness and Safety of Ustekinumab among Patients with Inflammatory Bowel Disease in Eastern and Western Countries.Journal of clinical medicine · 2023Review
- Korean clinical practice guidelines on biologics for moderate to severe Crohn's disease.Intestinal research · 2023Review
- Saudi Arabia consensus guidance for the diagnosis and management of adults with inflammatory bowel disease.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2022Article
- Exacerbation of Atopic Dermatitis Associated with Ustekinumab Treatment in Crohn's Disease.Cureus · 2022Article
- Long-term effectiveness and safety of ustekinumab in bio-naïve and bio-experienced anti-tumor necrosis factor patients with Crohn's disease: a real-world multicenter Brazilian study.BMC gastroenterology · 2022Article
- Effectiveness of ustekinumab in patients with refractory Crohn's disease: a multicentre real-life study in Italy.Therapeutic advances in gastroenterology · 2022Article
- Optimizing biologic therapy in inflammatory bowel disease: a Delphi consensus in the United Arab Emirates.Therapeutic advances in gastroenterology · 2021Article
- How to Optimize Treatment With Ustekinumab in Inflammatory Bowel Disease: Lessons Learned From Clinical Trials and Real-World Data.Frontiers in medicine · 2021Review
Corrections and comments
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Authors and funding
20 authors at 1 institution in 1 country.
Funding
Abstract
backgroundClinicians often utilize off-label dose escalation of ustekinumab (UST) in Crohn's disease (CD) patients with disease refractory to standard dosing. Previous studies report mixed results with dose escalation of UST.
methodsA retrospective observational study of 143 adult patients with CD receiving UST over a 33-month time period was conducted. Patients receiving UST at standard dosage for a minimum of 16 weeks were included in the analysis. Primary outcomes collected were clinical response [Physician Global Assessment Score (PGA) by >1] and remission (PGA = 0). Changes in clinical parameters were calculated for dose-escalated patients beginning with the time of dose switch (~42 weeks) and compared with a group of patients who were classified as "failing" standard dosing at 42 weeks who were not dose escalated.
resultsDose escalation improved PGA by 0.47 ± 0.19 compared with patients remaining on every 8 weeks dosing (Q8 week), who worsened by 0.23 ± 0.23 (
conclusionOur results support UST Q4 week dose escalation for selected CD patients who fail to achieve remission on standard Q8 week dosing. Dose escalation improves clinical outcomes, prevents worsening disease severity, and positively impacts CRP and albumin levels. Together these data indicate that clinicians should attempt Q4 week UST dosing in refractory CD patients before switching to an alternative class of biologic therapy.
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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.