Background: Data on ustekinumab and vedolizumab in the elderly inflammatory bowel disease (IBD) population are limited. The aim of the current study was to assess the safety and effectiveness of both in an elderly real-life population. Methods: A multicentric retrospective study was performed on IBD patients who started vedolizumab or ustekinumab between 2010 and 2020. Clinical and endoscopic remission rates and (serious) adverse events (AE) were assessed. Results: A total of 911 IBD patients were included, with 171 (19%) aged above 60 (111 VDZ, 60 UST). Elderly patients treated with vedolizumab or ustekinumab had an increased risk for non-IBD hospitalization (10.5% vs. 5.7%, p = 0.021) and malignancy (2.3% vs. 0.5%, p = 0.045) compared to the younger population. Corticosteroid-free clinical (50% vs. 44%; p = 0.201) and endoscopic remission rates (47.9% vs. 31%, p = 0.07) at 1 year were similar. Comparing vedolizumab to ustekinumab in the elderly population, corticosteroid-free (47.9% vs. 31%, p = 0.061) and endoscopic remission rates (66.7% vs. 64.4%, p = 0.981) were similar. Vedolizumab- and ustekinumab-treated patients had comparable infection rates (13.5% vs. 10.0%, p = 0.504), IBD flare-ups (4.5% vs. 5%, p = 1.000), the occurrence of new EIMs (13.5% vs. 10%, p = 0.504), a risk of intestinal surgery (5.4% vs. 6.7%, p = 0.742), malignancy (1.8% vs. 3.3%, p = 0.613), hospitalization (9.9% vs. 11.7%, p = 0.721), and mortality (0.9% vs. 1.7%, p = 1.000). AE risk was associated only with corticosteroid use. Conclusions: Ustekinumab and vedolizumab show comparable effectiveness and safety in the elderly IBD population. Elderly IBD patients have an increased risk for non-IBD hospitalizations and malignancy compared to the younger IBD population, with corticosteroid use as the main risk factor.

Background/Objectives: Ustekinumab (UST) has shown to be effective and safe in patients with moderate-to-severe UC in the UNIFI trials. However, real-life data on its effectiveness, particularly for histological remission, are still limited. To assess the real-world effectiveness and safety of UST in refractory UC patients. Methodology: This multicentric, retrospective cohort study included UC patients treated with UST from September 2020 to June 2023. The primary endpoint was steroid-free clinical remission (partial Mayo score of ≤2 with no subscore > 1) at week 16. Secondary endpoints included clinical, endoscopic, histological response and remission. Results: 120 patients with moderate–severe UC were included across 16 centers. Median disease duration was 11 years (1–74 y), and 81 (68%) patients had previously failed ≥2 biological therapies. At week 16, steroid-free clinical remission was achieved in 34% (41/120) of patients, with endoscopic and histological remission in, respectively, 19% (23/120) and 8% (3/37). By week 52, 44% (38/85) of patients were in steroid-free clinical remission, with endoscopic and histological remission, respectively, in 25% (13/52) and 11% (5/45). Active smoking was a negative predictor for steroid-free remission (OR 0.412, p = 0.011). UST drug persistence by week 52 was 70.8%. Active smoking (aOR 3.058, p = 0.02), prior vedolizumab non-response (OR 2.592, p = 0.03) and a high Nancy baseline score (OR 2.46, p = 0.04) were associated with early UST failure. No new safety signals were observed. Conclusions: In this real-life cohort, UST shows acceptable remission rates and high treatment persistence in refractory UC patients, with a favorable safety profile.