Real-world retention, effectiveness, and tolerability of Ustekinumab in Crohn’s disease: a Saudi single-centre cohort

Real-world data on ustekinumab in Crohn’s disease (CD) from Saudi Arabia and the Middle East and North Africa (MENA) region are scarce. We report one of the larger single-centre MENA cohorts, with treatment retention as the primary, objectively ascertained outcome. We retrospectively reviewed 109 patients aged 14–80 years with CD treated with ustekinumab at a Riyadh tertiary centre (January 2016–October 2025; follow-up to 30 November 2025), following the STROBE statement. The primary outcome was Kaplan–Meier treatment retention; secondary outcomes were CRP, faecal calprotectin, investigator-assessed radiological and endoscopic activity, surgery, and discontinuation. Symptom-based measures were exploratory. Median follow-up was 28.8 months (IQR 18.3–42.0); 23.9% of patients were biologic-naive and 43.1% had perianal disease. Retention was 98.1% at 12 months, 91.1% (95% CI 84.3–98.5) at 36 months, and 88.4% (95% CI 80.2–97.5) at 48 months; seven patients (6.4%) discontinued, all because of loss of response. Median CRP fell from 20.0 to 5.0 mg/L and median faecal calprotectin from 294.0 to 140.0 µg/g at 6 months (both p < 0.001). Among patients assessed at both time points, investigator-assessed inactive disease rose from 7.0% to 52.3% on imaging ( n = 86) and from 8.6% to 62.9% on endoscopy ( n = 35; follow-up endoscopy result available in 37/109) (both p < 0.001). Concomitant corticosteroids ( p = 0.010) and more prior biologics ( p = 0.042) were associated with discontinuation. Ustekinumab showed high retention and consistent biochemical, radiological, and endoscopic improvement in this largely refractory Saudi cohort. These single-centre observational findings require confirmation in multicentre studies using validated disease-activity indices.