Trial reportGut2019
Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II).
Trial report in Gut, 2019. 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 103 papers, 1 of them a synthesis 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 Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)
A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)
Who cites it
103 citing papers in PubMed, 1 synthesis or guideline pooled it, 175 citations in OpenAlex.
- Model-Based Meta-Analysis on the Efficacy of Biologics and Small Targeted Molecules for Crohn's Disease.Frontiers in immunology · 2022Pooled it
- Safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of olamkicept: Results from randomized, placebo-controlled, first-in-human phase I trials.Clinical and translational science · 2024Trial
- Refining therapeutic targeting of interleukin-6 by signalling mode selectivity.Nature reviews. Drug discovery · 2026Review
- Pharmacogenetic Risk Factors for Thiopurine-Induced Leukopenia in Patients with Inflammatory Bowel Disease.Yonsei medical journal · 2026Article
- Spatial transcriptomics atlas of inflammatory bowel disease to guide implementation in research consortiums and clinical trials.Nature communications · 2026Article
- Development of New Molecularly Targeted Agents in Inflammatory Bowel Disease.Internal medicine (Tokyo, Japan) · 2026Review
- A human intestinal epithelial-mesenchyme-immune triple culture system for disease modelling.Frontiers in cell and developmental biology · 2026Article
- Mechanisms of Inflammation in Post-Operative Recurrence of Crohn's Disease.Journal of inflammation research · 2026Review
- Intestinal barrier in chronic gut and liver diseases: Pathogenesis and therapeutic targets.Acta pharmaceutica Sinica. B · 2025Review
- ZnO@Cu5.4O Nanoparticle Alleviates Inflammatory Responses of Intestinal Epithelial Cells by Inhibiting the Expression of GSDMB.ACS omega · 2025Article
- Fibroblasts in immune responses, inflammatory diseases and therapeutic implications.Nature reviews. Rheumatology · 2025Review
- A Pelvic Mass in a Young Patient With Crohn's Disease.ACG case reports journal · 2025Article
- Immunohistochemistry Analysis in Inflammatory Bowel Disease-Should We Bring to Light Interleukin-10?Biomedicines · 2025Article
- Assessment of IL-6 Pathway Inhibition in Gastrointestinal Behçet's Disease from Immunological and Clinical Perspectives.Biomedicines · 2025Review
- Assessment of the Utility of Selected Inflammatory Markers in Correlation with Magnetic Resonance Enterography (MRE) Findings in the Diagnosis of Crohn's Disease.Biomolecules · 2025Article
- Deciphering the immunocellular regulatory network in inflammatory bowel disease: from susceptibility genes to cellular effectors and toward precision therapies.Frontiers in immunology · 2025Review
- Identification of potential hub genes and drugs in septic kidney injury: a bioinformatic analysis with preliminary experimental validation.Frontiers in medicine · 2025Article
- Helminths in alternative therapeutics of inflammatory bowel disease.Intestinal research · 2025Review
- (-)-Fenchone Ameliorates TNBS-Induced Colitis in Rats via Antioxidant, Immunomodulatory, and Cytoprotective Mechanisms.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Key Interleukins in Inflammatory Bowel Disease-A Review of Recent Studies.International journal of molecular sciences · 2024Review
43 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 10 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveNeutralising pro-inflammatory interleukin-6 (IL-6) may effectively treat Crohn's disease (CD). Effects of PF-04236921, an anti-IL-6 antibody, in adults with CD are reported.
designParallel-group, dose-ranging, double-blind trial with 4-week screening and 12-week treatment periods. After induction, patients entered 28-week follow-up or 48-week open-label extension (OLE) with 28-week follow-up. Adults with confirmed CD and inadequate response to anti-tumour necrosis factor (TNF) therapy were included.
results247 patients were randomised and received treatment in the induction study. The 200 mg dose was discontinued due to safety findings in another study (NCT01405196) and was not included in the primary efficacy analysis. Crohn's Disease Activity Index (CDAI)-70 response rates with PF-04236921 50 mg were significantly greater than placebo at weeks 8 (49.3% vs 30.6%, P<0.05) and 12 (47.4% vs 28.6%, P<0.05) and met the primary end point. Week 12 CDAI remission rates with PF-04236921 50 mg and placebo were 27.4% and 10.9%, respectively (16.5% difference; P<0.05). 191 subjects received treatment in the OLE. Common treatment-emergent and serious adverse events in both studies included worsening CD, abdominal pain and nasopharyngitis.
conclusionsPF-04236921 50 mg induced clinical response and remission in refractory patients with moderate-to-severe CD following failure of anti-TNF therapy. GI abscess and perforation were observed, a specific focus of attention during future clinical development. TRIAL REGISTRATION NUMBER: NCT01287897 and NCT01345318.
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.