The missing evidence: Stricturing Crohn’s disease in clinical trials, a systematic review

Abstract Background Stricturing Crohn’s disease (CD) represents a major cause of morbidity, with limited prospective data addressing response to treatment. We performed a systematic review to evaluate the efficacy of biologic and small-molecule therapies in stricturing CD and to assess the role of imaging modalities in diagnosing and monitoring bowel stenoses. Methods We conducted a systematic search of PubMed, Scopus, and Web of Science through August 26, 2025. Prospective studies, including randomized controlled trials and prospective observational cohorts, reporting outcomes in adult patients with stricturing CD treated with biologics or small molecules were included. Risk of bias was assessed using the RoB 2 and ROBINS-I tools. Results Of 22 306 records identified, 7 publications corresponding to 10 prospective studies (6 randomized controlled trials, 4 nonrandomized studies) were included. All studies evaluated biologic therapies, predominantly anti-tumor necrosis factor agents; no prospective trials specifically assessed small-molecule therapies in stricturing CD. Due to methodological heterogeneity, a meta-analysis was not appropriate. Across studies, biologic therapy was associated with clinical improvement and, in selected cohorts, reductions in inflammatory activity and need for surgery. Response appeared to vary according to stricture severity, with lower rates in nonpassable lesions. Intestinal ultrasonography and magnetic resonance were investigated in 4 studies, showing reductions in bowel wall thickness. Conclusions Prospective evidence for medical therapy in stricturing CD is limited and restricted to anti-tumor necrosis factor α agents. Imaging plays an important role in characterization and monitoring but lacks a standardized fibrosis assessment. Dedicated phenotype-specific trials and validated imaging biomarkers are needed to optimize management of stricturing CD.