Evidence map›Paper›PMID 40751824›Full record

SynthesisEuropean journal of clinical pharmacology2025

Dose-dependent efficacy and safety of Filgotinib in moderate to severe Crohn's disease: a grade-assessed systematic review and meta-analysis of randomized controlled trials.

Mohamed S Elgendy, Ahmed Raza, Mohamed Rifai, Wajeeh Ur Rehman, Ahmed Emara, Muhammad Haris Khan, Ayiz Jan, Muhammad Younas, Anum Nawaz, Ubaid Khan

Abstract readSystematic ReviewMeta-Analysis
PubMed Publisher
In one paragraph

Synthesis in European journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Mohamed S ElgendyFaculty of Medicine, Tanta University, Tanta, Egypt.
Ahmed RazaDepartment of Medicine, Services Institute of Medical Sciences, Lahore, Punjab, Pakistan.
Mohamed RifaiFaculty of Medicine, Menoufia University, Shebin El Kom, Egypt.
Wajeeh Ur RehmanDepartment of Medicine, Saidu Medical College, Swat, Pakistan.
Ahmed EmaraFaculty of Medicine Al, Azhar University, Cairo, Egypt.
Muhammad Haris KhanDepartment of Medicine, Saidu Medical College, Swat, Pakistan.
Ayiz JanDepartment of Medicine, Lady Reading Hospital, Peshawar, Pakistan.
Muhammad YounasDepartment of Gastroenterology, Hayatabad Medical Complex, Peshawar, Pakistan.
Anum NawazDepartment of Radiology, Pakistan Atomic Energy Commission Hospital, Islamabad, Pakistan.
Ubaid KhanDepartment of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA. Ubaidkhanafridi@yahoo.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCrohn's disease is a chronic inflammatory condition that can relapse and can impact any part of the digestive tract. Janus kinase (JAK) inhibitors, like Filgotinib, have surfaced as a promising treatment option. This meta-analysis evaluates its dose-dependent effects (100 mg or 200 mg) in moderate-to-severe cases.

methodsA comprehensive search was conducted in PubMed, CENTRAL, Web of Science, Scopus, and EMBASE up to March 2025. Risk ratio (RR) was used for dichotomous outcomes, with 95% confidence intervals (CI). PROSPERO ID: CRD420251032985.

resultsFour RCTs with 1681 patients were included. Filgotinib 200 mg compared to placebo had a higher rate of mucosal remission at 24 to 58 weeks (wk) (14.9% vs 6%, RR = 2.51, 95% CI [1.06:5.95], P = 0.0370), two-item patient'sreported outcome (PRO2) clinical remission at 10 wk (35.7% vs 22.5%, RR = 1.48, 95% CI [1.21:1.81], P = 0.0002), and Crohn's Disease Activity Index (CDAI) clinical remission at 10 wk (33.4% vs 17.8%, RR = 1.77, 95% CI [1.42:2.21], P < 0.0001). However, there was no significant difference between Filgotinib 100 mg and placebo in rates of CDAI clinical remission at 10 wk (P = 0.7490) and mucosal remission at 24 to 58 wk (P = 0.5850). In both doses, there was no significant difference in total treatment adverse events (TEAEs) at 20 to 58 wk (P = 0.4576, P = 0.2354) and serious TEAEs at 20 to 58 wk (P = 0.992, P = 0.2354).

conclusionsFilgotinib 200 mg demonstrated superior short-term clinical benefits and medium-term mucosal remission compared to placebo in moderate-to-severe CD. However, Filgotinib 100 mg showed no significant efficacy. Both doses have acceptable safety profiles, necessitating further long-term multicenter RCTs.

Indexed as

Crohn DiseaseJanus Kinase InhibitorsPyridinesTriazolesDose-Response Relationship, DrugHumansRandomized Controlled Trials as TopicRemission InductionSeverity of Illness IndexTreatment OutcomeGLPG0634Janus Kinase InhibitorsPyridinesTriazolesCrohn’s diseaseFilgotinibJAK1 inhibitorsMeta-analysisMucosal healing

Identifiers

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Registered trials

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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.