Trial reportInflammatory bowel diseases2021
Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies.
Trial report in Inflammatory bowel diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 6 registered trials, which are not on this map. Cited by 59 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
59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 113 citations in OpenAlex.
- Activation of the interleukin-23/Th17 axis in major depression: a systematic review and meta-analysis.European archives of psychiatry and clinical neuroscience · 2025Pooled it
- Comparative efficacy and safety of biologic therapies for moderate-to-severe Crohn's disease: a systematic review and network meta-analysis.The lancet. Gastroenterology & hepatology · 2021Pooled it
- Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis.Journal of Crohn's & colitis · 2024Trial
- The role of antidrug antibodies in ustekinumab therapy and the impact of methotrexate.Rheumatology (Oxford, England) · 2023Trial
- Long-Term Effectiveness and Persistence of Ustekinumab in Crohn's Disease Patients: An Observational Retrospective Study.Journal of clinical medicine · 2026Article
- Article
- Article
- Ulcerative colitis: signaling pathways, therapeutic targets and interventional strategies.Signal transduction and targeted therapy · 2026Review
- Comparative risk ofTherapeutic advances in gastroenterology · 2026Article
- Safety assessment of ustekinumab in inflammatory bowel disease: a real-world analysis based on the FDA adverse event reporting system (FAERS).European journal of medical research · 2025Article
- Australian Real-World Effectiveness and Safety of Ustekinumab for the Treatment of Crohn's Disease: Results of the AURORA Study, Including the ANZIBD Consortium.JGH open : an open access journal of gastroenterology and hepatology · 2025Article
- Review
- From Gut Inflammation to Cardiovascular Conflagration: Mapping IBD's Cardiometabolic Risks.Current atherosclerosis reports · 2025Review
- Review
- Ustekinumab in the Treatment of Crohn's Disease-A Narrative Review on Clinical Efficacy and Safety Profile.Pharmacy (Basel, Switzerland) · 2025Review
- Risk factors for Clostridioides difficile infection among patients diagnosed with inflammatory intestinal and rheumatological diseases in the biologic era.BMC gastroenterology · 2025Article
- Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis.BMJ open gastroenterology · 2025Article
- A Study of Dizziness or Vertigo Cases Associated with Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis) in a Vertigo Outpatient Clinic.Journal of clinical medicine · 2025Article
- Review Article: Green Management of IBD-New Paradigms for an Eco-Friendly Approach.Alimentary pharmacology & therapeutics · 2025Review
- Immunological pathogenesis of inflammatory bowel disease: focus on tissue resident memory T cells.Frontiers in immunology · 2025Review
Corrections and comments
- Erratum issued
Authors and funding
13 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUstekinumab is currently approved globally in Crohn's disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety/efficacy in ulcerative colitis (UC). Crohn's disease and UC phase 3 programs had similar study designs, facilitating integrated safety analyses.
methodsData from 6 ustekinumab phase 2/3 CD and UC studies were pooled, and safety was evaluated through 1 year. Patients received 1 placebo or ustekinumab (generally 130 mg or ~6 mg/kg) intravenous induction, then subcutaneous (90 mg) maintenance every 8/12 weeks. Analyses incorporated all patients who received ≥1 ustekinumab dose. Safety outcomes are presented as percentages of patients (induction) and as number of patients with events per 100 patient-years of follow-up (through 1 year). For key safety events, 95% confidence intervals (CIs) are provided, as appropriate. Hazard ratios with 95% CIs from time-to-event analyses for serious adverse events and serious infections were also performed.
resultsThrough 1 year, 2574 patients received ustekinumab (1733 patient-years of follow-up). The number of patients with adverse events per 100 patient-years (placebo 165.99 [95% CI, 155.81-176.67] vs ustekinumab 118.32 [95% CI, 113.25-123.55]), serious AEs (27.50 [95% CI, 23.45-32.04] vs 21.23 [95% CI, 19.12-23.51]), infections (80.31 [95% CI, 73.28-87.84] vs 64.32 [95% CI, 60.60-68.21]), serious infections (5.53 [95% CI, 3.81-7.77] vs 5.02 [95% CI, 4.02-6.19]), and malignancies excluding nonmelanoma skin cancer (0.17 [95% CI, 0.00-0.93] vs 0.40 [95% CI, 0.16-0.83]) were similar between placebo and ustekinumab.
conclusionsThe safety profile of ustekinumab across the pooled inflammatory bowel disease population through 1 year was favorable and generally comparable to placebo. These data are consistent with the established safety profile of ustekinumab across indications. CLINICALTRIALS.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.