| Description: |
Background Subcutaneous infliximab (IFX-SC) has emerged as an effective and convenient alternative to intravenous infliximab (IFX-IV) for the maintenance treatment of Inflammatory Bowel Disease (IBD). While randomised trials have confirmed comparable efficacy and safety, real-world data on long-term patients switching from stable IV therapy remain limited. This study aimed to evaluate the effectiveness and safety of an elective switch from IFX-IV to IFX-SC in a single-centre cohort of IBD patients in sustained remission in southern Italy. Methods We conducted a prospective observational study including 18 adult IBD patients in clinical and biochemical remission on IFX-IV maintenance (5 mg/kg every 8 weeks). Eligible patients were switched to IFX-SC 120 mg every 2 weeks at the time of their next scheduled infusion. Clinical standardised scores (Harvey–Bradshaw Index for Crohn’s disease (CD), Partial Mayo Score for Ulcerative Colitis (UC)), C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline, and at 1, 3, and 6 months. A questionnaire administered 6 months after the switch assessed satisfaction and adverse events (AEs). Results Eighteen patients were included: 12 with UC and 6 with CD, of whom 2 had a fistulising phenotype. All reported no difficulties handling the device and adhered to the dosing schedule. At baseline, all patients were in clinical and biochemical remission. After 6 months, 16 of 18 patients (88.9%) maintained remission, while one UC patient reverted to IFX-IV due to AEs and another UC patient switched to a different biologic therapy because of loss of response. Median CRP and FC values remained stable at 1, 3, and 6 months (p > 0.05). Mild, self-limited injection-site pain occurred in 4 patients (22.2%). Overall satisfaction was rated as excellent by 16 of 18 patients. Conclusion In this real-world, single-centre experience, an elective switch from long-term IFX-IV to IFX-SC was safe, effective, and well tolerated, with high rates of maintained ... |