Utilisation and real-world effectiveness of advanced therapies for inflammatory bowel disease in Middle Eastern populations: a systematic review.
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OBJECTIVES: We aimed to systematically review the real-world evidence (RWE) on the effectiveness and utilisation of advanced therapies for inflammatory bowel disease (IBD) in Middle Eastern populations. DESIGN: Systematic review. DATA SOURCES: PubMed/MEDLINE, Embase, Scopus, Web of Science and the Cochrane Central Register of Controlled Trials were searched up to May 2025. ELIGIBILITY CRITERIA: Observational RWE studies investigating biologics or small molecules in Middle Eastern IBD patients (adult and paediatric) were included. Randomised controlled trials and case series with fewer than 10 patients were excluded. No language restrictions were applied. DATA EXTRACTION AND SYNTHESIS: Data were independently extracted by two reviewers. Due to significant heterogeneity in study design, populations and outcome reporting, a narrative synthesis was performed. RESULTS: From 884 records, 23 studies were included, originating primarily from Saudi Arabia (n=8) and Iran (n=4). For anti-tumour necrosis factor (TNF) therapy, a Kuwaiti study of biologic-naive patients found 12-month endoscopic remission rates with infliximab of 56% for ulcerative colitis (UC) and 53% for Crohn's disease (CD), while a Saudi study reported higher odds of treatment failure with adalimumab versus infliximab (OR=26.91). Ustekinumab demonstrated strong efficacy, achieving 76.9% clinical remission at 52 weeks in a Saudi paediatric anti-TNF refractory IBD cohort and showing higher probability of effectiveness than vedolizumab in another Saudi study. In contrast, vedolizumab remission rates in advanced therapy-experienced UC patients were 89.3% with intensified dosing. Newer agents also showed promise; risankizumab induction led to 43.2% clinical remission in an Emirati CD cohort, while tofacitinib achieved clinical remission rates of 56.4% and 61.1% at 52 weeks in Lebanese and Iranian UC cohorts, respectively. CONCLUSIONS: Advanced therapies for IBD appear to be effective in Middle Eastern cohorts; however, the available evidence is methodologically diverse, with substantial heterogeneity in study design, population characteristics and outcome reporting, which limits the ability to draw strong conclusions and highlights the need for further robust evaluation. Prospective, collaborative regional registries are imperative to address these gaps and inform local guidelines. PROSPERO REGISTRATION NUMBER: CRD420251083256.