Filgotinib in Moderate-to-Severe Crohn’s Disease: A Network Meta-Analysis of Efficacy and Adverse Events
Year: 2025
Type: review
Study designs: Systematic Review, Meta-Analysis
Abstract: Background: Filgotinib is an emerging Janus kinase 1 (JAK1) inhibitor being investigated for inflammatory bowel disease. This systematic review and network meta-analysis (NMA) evaluated the efficacy and safety of filgotinib in adult patients with moderate-to-severe crohn’s disease. Methods: We systematically searched PubMed, EMBASE, and Scopus through April 2025. Randomized controlled trials evaluating filgotinib versus placebo in adults with moderate-to-severe Crohn’s disease were included. Primary outcomes were clinical remission and endoscopic response. Study quality was assessed using the Cochrane Risk of Bias 2.0 tool. A network meta-analysis was performed to integrate direct and indirect evidence, reporting risk ratios (RRs) with 95% confidence intervals (CIs). Results: Five randomized controlled trials (from 4 publications) met the inclusion criteria. Filgotinib 200 mg significantly improved clinical remission compared with placebo (RR: 1.75 [1.40–2.19]) and 100 mg (RR: 1.38 [1.11–1.71]), while 100 mg showed no significant difference versus placebo (RR: 1.27 [0.99–1.63]). For endoscopic response, both 200 mg (RR: 1.72 [1.09–2.69]) and 100 mg (RR: 1.65 [1.02–2.69]) demonstrated significant benefit over placebo, though no difference was observed between active doses (RR: 1.04 [0.64–1.68]; I2 = 57%). In the two-item patient-reported outcome, 200 mg showed significant improvement versus placebo (RR: 1.47 [1.20–1.80]) and 100 mg (RR: 1.26 [1.02–1.55]), while 100 mg remained insignificant versus placebo (RR: 1.17 [0.93–1.46]). Neither dose increased the risk of treatment-emergent adverse events, serious adverse events, or infections compared with placebo, with consistent homogeneity across analyses. Conclusions: Filgotinib 200 mg demonstrated superior efficacy across clinical, endoscopic, and patient-reported outcomes compared with 100 mg and placebo, with a favorable safety profile. The 100 mg dose showed limited efficacy and no advantage over placebo. Filgotinib represents a promising oral therapeutic option, particularly for biologic-naïve patients and in maintenance therapy, while also showing potential benefit in perianal fistulising crohn’s disease. Future trials should explore long-term safety and head-to-head comparisons with established biologics.
Source: Healthcare
Authors: Yasser Ali Khoshaim, Yahya Z. Habis, Afnan Ghazi Daqnah, Razan Khalid Alqurashi, Yazeed Shaker Abdulrahim, Abdullah Sakkat, Sultan Ali Alsubhi, Deema Tawfeq Almuwlad, Halah Samer Bukhari, Abdulrhman J. Shogdar, Omar Ashraf Amir, Mohamed Sayed Zaazouee
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,258
OpenAlex ID: W7116083443