Trial reportJournal of Crohn's & colitis2024
Efficacy and Safety of Filgotinib for the Treatment of Perianal Fistulising Crohn's Disease [DIVERGENCE 2]: A Phase 2, Randomised, Placebo-controlled Trial.
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 trial NCT03077412 (A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease), which is not on this map. Cited by 20 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 Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Who cites it
20 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Safety and efficacy of different JAK inhibitors in the treatment of inflammatory bowel disease: a network meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Histologic and combined histologic-endoscopic outcomes with mirikizumab in Crohn's disease: VIVID-1 trial results.Journal of Crohn's & colitis · 2026Trial
- Effects of filgotinib on semen parameters and sex hormones in male patients with inflammatory diseases: results from the phase 2, randomised, double-blind, placebo-controlled MANTA and MANTA-RAy studies.Annals of the rheumatic diseases · 2023Trial
- Observational
- Medical Therapies Beyond Infliximab for Perianal Fistulizing Crohn's Disease: Current Evidence and Future Perspectives.Journal of clinical medicine · 2026Review
- Clinical Trial Endpoints for Perianal Fistulizing Crohn's Disease.The American journal of gastroenterology · 2026Review
- Advanced Medical Therapies for Perianal Fistulizing Crohn's Disease: A Systematic Review of Clinical, Radiological, Surgical, and Composite Outcomes.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Comparative effectiveness of ustekinumab versus infliximab in the management of perianal fistulizing Crohn's disease: a retrospective study in China.Intestinal research · 2026Article
- Filgotinib in Moderate-to-Severe Crohn's Disease: A Network Meta-Analysis of Efficacy and Adverse Events.Healthcare (Basel, Switzerland) · 2025Review
- Review
- Time to classify: a narrative and scoping review of the old and the new classifications of perianal Crohn's disease.Techniques in coloproctology · 2025Article
- Fistula in Crohn's disease: classification, pathogenesis, and treatment options.Tissue barriers · 2025Review
- Refractory Crohn's Disease: Perspectives, Unmet Needs and Innovations.Clinical and experimental gastroenterology · 2024Review
- Advancing therapeutic frontiers: a pipeline of novel drugs for luminal and perianal Crohn's disease management.Therapeutic advances in gastroenterology · 2024Review
- Where Are We and Where to Next?-The Future of Perianal Crohn's Disease Management.Journal of clinical medicine · 2023Review
- Authors' Reply to Unraveling the Place of Small Molecules in the Treatment of Fistulizing Crohn's Disease-A Systematic Review and Network Meta-analysis.Crohn's & colitis 360 · 2023Article
- Horizon scanning: new and future therapies in the management of inflammatory bowel disease.eGastroenterology · 2023Review
- Landscape of new drugs and targets in inflammatory bowel disease.United European gastroenterology journal · 2022Review
- The Optimal Management of Fistulizing Crohn's Disease: Evidence beyond Randomized Clinical Trials.Journal of clinical medicine · 2022Review
- Is There a Best First Line Biological/Small Molecule in IBD: Are We Ready for Sequencing?Biomedicines · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
BACKGROUND AND
aimsThere is an unmet need in the treatment of perianal fistulising Crohn's disease [PFCD]. This study evaluated the efficacy and safety of the Janus kinase 1 preferential inhibitor, filgotinib, for the treatment of PFCD.
methodsThis phase 2, double-blind, multicentre trial enrolled adults with PFCD and prior treatment failure. Participants were randomised [2:2:1] to receive filgotinib 200 mg, filgotinib 100 mg, or placebo, once daily orally for up to 24 weeks. The primary endpoint was combined fistula response (reduction from baseline of at least one draining external opening determined by physical assessment, and no fluid collections >1 cm on pelvic magnetic resonance imaging [MRI]) at Week 24.
resultsBetween April 2017 and July 2020, 106 individuals were screened and 57 were randomised. Discontinuations were lowest in the filgotinib 200 mg group (3/17 [17.6%] versus 13/25 [52.0%] for filgotinib 100 mg and 9/15 [60.0%] for placebo). The proportion of participants who achieved a combined fistula response at Week 24 was 47.1% (8/17; 90% confidence interval [CI] 26.0, 68.9%) in the filgotinib 200 mg group, 29.2% [7/24; 90% CI 14.6, 47.9%] in the filgotinib 100 mg group, and 25.0% [3/12; 90% CI 7.2, 52.7%] in the placebo group. Serious adverse events occurred more frequently with filgotinib 200 mg (5/17 [29.4%]) than with placebo (1/15 [6.7%]). There were no treatment-related serious adverse events or deaths.
conclusionsFilgotinib 200 mg was associated with numerical reductions in the number of draining perianal fistulas based on combined clinical and MRI findings compared with placebo, and was generally well tolerated [NCT03077412].
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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.