Trial reportUnited European gastroenterology journal2021
The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies.
Trial report in United European gastroenterology journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 21 papers, 3 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 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
Who cites it
21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- The impact of ustekinumab and tumor necrosis factor antagonists on extraintestinal manifestations of Crohn's disease: a systematic review and meta-analysis.Frontiers in pharmacology · 2026Pooled it
- Saudi consensus guidance for the diagnosis and management of inflammatory bowel disease in children and adolescents.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association · 2025Guideline
- Beyond the Gut: A Systematic Review and Meta-analysis of Advanced Therapies for Inflammatory Bowel Disease-associated Extraintestinal Manifestations.Journal of Crohn's & colitis · 2024Pooled it
- Ustekinumab Persistence in Biologic-Experienced Crohn's Disease Patients: A Single-Center Retrospective Cohort Study.Medicina (Kaunas, Lithuania) · 2026Article
- IBD and Immune-Mediated Inflammatory Diseases: What Is the Optimal Management?Journal of clinical medicine · 2026Review
- Emerging therapeutic targets in non-infectious uveitis and scleritis.Frontiers in medicine · 2026Review
- IBD 2024: Charting a New Course in IBD Proceedings of the Takeda Symposium 22-23 November 2024 W Hotel, Brisbane, Queensland, Australia.Journal of gastroenterology and hepatology · 2025Article
- Ustekinumab in the Treatment of Crohn's Disease-A Narrative Review on Clinical Efficacy and Safety Profile.Pharmacy (Basel, Switzerland) · 2025Review
- Metabolic musculoskeletal disorders in patients with inflammatory bowel disease.The Korean journal of internal medicine · 2025Review
- Extraintestinal Manifestations in Inflammatory Bowel Disease: From Pathophysiology to Treatment.Biomedicines · 2024Review
- IBD Patients with Primary or Secondary Nonresponse to Ustekinumab Benefit from Dose Escalation or Reinduction.Journal of clinical medicine · 2024Review
- Role of Biologic Therapies in the Rheumatic Manifestations of Inflammatory Bowel Disease: A Systematic Analysis.Cureus · 2023Review
- Cytokines in Spondyloarthritis and Inflammatory Bowel Diseases: From Pathogenesis to Therapeutic Implications.International journal of molecular sciences · 2023Review
- Subcutaneous Sweet Syndrome Successfully Treated With Ustekinumab in a Patient With Ulcerative Colitis.ACG case reports journal · 2022Article
- UEG week and UEG journal: A strong scientific liaison.United European gastroenterology journal · 2022Article
- Ustekinumab in Crohn's Disease: New Data for Positioning in Treatment Algorithm.Journal of Crohn's & colitis · 2022Review
- Is There a Best First Line Biological/Small Molecule in IBD: Are We Ready for Sequencing?Biomedicines · 2022Review
- Joint Disease Activity in Inflammatory Bowel Disease-associated Peripheral Spondyloarthritis Stratifies Therapeutic Response.Gastro hep advances · 2022Article
- Increased Demand for Therapeutic Drugs in Pediatric Ulcerative Colitis Patients With Extraintestinal Manifestations.Frontiers in pediatrics · 2022Article
- UEGWeek: The modern School of Athens.United European gastroenterology journal · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This post hoc analysis of the UNITI studies found ustekinumab (UST) did not significantly improve overall extraintestinal manifestations (EIMs) of Crohn's disease compared to placebo-treated patients at weeks 6 and 52. BACKGROUND AND
aimsThe UNITI trials demonstrated that UST was effective in inducing and maintaining clinical remission in Crohn's disease (CD). However, limited data exists regarding its effectiveness for treatment of EIMs. This post hoc analysis evaluated the efficacy of UST in treatment of EIMs.
methodsData from UNITI-1/2 and IM-UNITI (NCT01369329, NCT01369342, NCT01369355) were obtained from the Yale Open Data Access Project (2019-4104). Nine hundred and fourty-one patients eligible for UST induction and 263 patients eligible for maintenance UST were included. The primary outcome of interest was EIM resolution at Week 6 in UST and placebo-treated patients using the chi-square test. EIM resolution at Week 52 was also assessed. McNemar's test was used to compare the proportion of patients who reported active EIMs at weeks 6 and 52 versus baseline.
resultsFrom 941 UST-treated patients in UNITI-1/2, 504 had 527 EIMs at baseline. Overall, there was no significant difference in EIM resolution observed in UST-treated patients (186/504, 36.9%) compared to placebo (90/230, 39.1%; p = 0.564) at Week 6. Patients treated with continuous UST (91/119, 76.4%) had no significant difference in overall EIMs resolved at Week 52 compared to placebo (72/90, 80.0%; p = 0.542). Although many EIMs demonstrated reduction in prevalence compared to baseline at initiation of UST, only erythema nodosum was more likely to improve at Week 52 on treatment versus placebo.
conclusionOverall, UST did not lead to significant resolution of EIMs for CD compared to placebo at weeks 6 and 52.
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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.