Trial reportJournal of Crohn's & colitis2024
Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis.
Trial report in Journal of Crohn's & colitis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 25 papers, 2 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.
A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ustekinumab Therapy in Subjects With Moderately to Severely Active Crohn's Disease Previously Treated With TNF Antagonist Therapy
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy (UNITI-1)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects With Moderately to Severely Active Crohn's Disease (UNITI-2)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- Hepatitis B Virus Reactivation Risk With IL-17, IL-23/IL-12, or JAK Inhibitors: A Systematic Review and Meta-Analysis.Liver international : official journal of the International Association for the Study of the Liver · 2026Pooled it
- Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.The Cochrane database of systematic reviews · 2025Pooled it
- Towards Precision Medicine in Inflammatory Bowel Diseases: Pharmacogenetic Predictors of Ustekinumab Effectiveness and Persistence.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Prescribing Biologic Immune-Modifying Therapies for Patients with a History of Cancer: A Cross-Specialty Review.Current oncology (Toronto, Ont.) · 2026Review
- Article
- Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative.Clinical pharmacology and therapeutics · 2026Article
- Ulcerative colitis: signaling pathways, therapeutic targets and interventional strategies.Signal transduction and targeted therapy · 2026Review
- A rare case of ulcerative colitis relapse in a diverted colon after rectal cancer surgery: efficacy of carotegrast methyl.Clinical journal of gastroenterology · 2026Article
- From Inflammation to Thrombosis: The Prothrombotic State and Cardiovascular Risk in Inflammatory Bowel Disease.Medicina (Kaunas, Lithuania) · 2026Review
- Successful and Risk-Minimizing Treatment of Ulcerative Colitis by Positive Switch from JAK Inhibitors to Ustekinumab.Biologics : targets & therapy · 2026Article
- GB20-5A8-31, an anti-TL1A antibody for treating inflammatory bowel disease.Frontiers in immunology · 2026Article
- Enteric opportunistic infections in patients with inflammatory bowel disease receiving biologic therapies: a retrospective cohort study.Gut pathogens · 2025Article
- Review
- The Cardiovascular Effects of Inflammatory Bowel Disease Therapy with Biologics and Small Molecules: A Comprehensive Review.Journal of clinical medicine · 2025Review
- Long-term efficacy of therapeutic drug monitoring-guided optimization of ustekinumab maintenance therapy for Crohn's disease patients.Scientific reports · 2025Observational
- Ustekinumab in the Treatment of Crohn's Disease-A Narrative Review on Clinical Efficacy and Safety Profile.Pharmacy (Basel, Switzerland) · 2025Review
- Advanced Therapies for Inflammatory Bowel Disease and Risk of Skin Cancer: What's New?Cancers · 2025Review
- New Interleukin-23 Antagonists' Use in Crohn's Disease.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Consensus Statements on Assessments and Vaccinations Prior to Commencement of Advanced Therapies for the Treatment of Inflammatory Bowel Diseases.Alimentary pharmacology & therapeutics · 2025Article
- [Application of advanced treatment in chronic inflammatory bowel diseases].Innere Medizin (Heidelberg, Germany) · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 9 institutions in 4 countries.
Funding
Abstract
BACKGROUND AND
aimsPreviously published long-term safety data reported a favourable ustekinumab safety profile for the treatment of inflammatory bowel disease [IBD]. We present the final cumulative safety data from pooled ustekinumab IBD phase 2/3 clinical studies through 5 years in Crohn's disease [CD] and 4 years in ulcerative colitis [UC].
methodsIn phase 3 studies, patients received a single intravenous placebo or ustekinumab [130 mg or ~6 mg/kg] induction dose followed by subcutaneous maintenance doses of placebo or ustekinumab [90 mg q8w or q12w]. Analyses included all patients who received one dose of study treatment and included patients who were biologic-naïve and patients with a history of biologic failure. Safety outcomes are summarized and presented using number of events per 100 patient-years of follow-up and corresponding 95% confidence intervals.
resultsIn this final pooled safety analysis, 2575 patients were treated with ustekinumab with 4826 patient-years of follow-up. Rates of key safety events, including major adverse cardiac events and malignancies, were similar between placebo and ustekinumab or not higher for ustekinumab. Opportunistic infections, including tuberculosis, and malignancies were reported infrequently. Rates of key safety events in the IBD group were no higher in the ustekinumab group than in the placebo group for both patients who were biologic-naïve or who had a history of biologic failure. No lymphomas or cases of posterior reversible encephalopathy syndrome [formerly known as reversible posterior leukoencephalopathy syndrome] were reported.
conclusionThe final cumulative ustekinumab safety data through 5 years in CD and 4 years in UC demonstrated favourable safety compared to placebo and continue to support the well-established safety profile across all approved indications. CLINICAL TRIALS.GOV NUMBERS: NCT00265122, NCT00771667, NCT01369329, NCT01369342, NCT01369355, NCT02407236.
Indexed as
Identifiers
What OpenQuestion holds
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.