P0576Impact of elderly age on long-term outcomes (> 5 years) of patients with IBD receiving vedolizumab – the LONG-LIVE study from the Italian Group for the study of inflammatory bowel disease (IG-IBD)

Background Long-term real-world data on vedolizumab (VDZ) remain limited. We evaluated long-term outcomes of patients (pts) with inflammatory bowel disease (IBD) treated with VDZ. Methods The LIVE cohort included IBD pts who initiated VDZ between 04/2016-06/2017 at 47 Italian centres and were prospectively followed-up to 06/2019. For this long-term extension (LTE, LONG-LIVE), data on therapy withdrawal and treatment-emergent adverse events (TEAEs, including need for surgery/hospitalizations, deaths, cancer, and adverse events of special interest [AESIs]) were retrospectively collected up to the last available follow-up (fup). Elderly (≥65 years) and non-elderly patients were compared using inverse probability weighting (IPW) to adjust for baseline differences. The primary endpoint was TEAE-free persistence; secondary outcomes included surgery- and hospitalization-free survival, and incidence rates of cancer and AESIs. Kaplan-Meier, unadjusted Cox models, and Poisson regression estimated cumulative probabilities, hazard ratios (HR) with 95% confidence intervals (CI), and incidence rate ratios (IRR) with 95% CI. Results A total of 782 pts (652 non-elderly and 130 elderly) contributed 4325.1 patient-years of observation. After IPW, TEAE-free persistence was significantly higher in non-elderly compared to elderly Crohn’s disease (CD) pts (HR 1.56, 95% CI 1.08–2.25, p=.018), with no difference in ulcerative colitis (UC) (HR 1.15 [0.81–1.63] p=.436) (Figure 1). In the CD cohort, no differences in IBD-related surgeries were observed (HR 1.57 [0.74–3.23] p=.240), while non-elderly pts had a significantly higher probability of remaining free from IBD-related non-surgical hospitalizations (HR 4.15 [2.18–7.90] p<.001). Similarly, in the UC cohort, no differences in IBD-related surgeries were observed (HR 1.50 [0.80–2.79] p=.203), whereas non-elderly patients had higher hospitalization-free survival HR 3.32 [1.58–6.99] p=.002). In CD, no cancers occurred among elderly pts, so the IRR could not be interpreted; AESIs did not differ by age (IRR 0.67, 95% CI 0.14–3.13, p=.609). In UC, no significant differences were observed in the risk of cancer (IRR 1.03 [0.21–5.04] p=.967) or AESIs (IRR 0.83 [0.10–6.64] p=.859). Conclusion Elderly pts with CD had worse TEAE-free survival than non-elderly pts, whereas no age-related differences emerged in UC. Non-surgical hospitalizations were more common in the elderly population of both CD and UC. Safety outcomes were comparable across age groups, supporting the favourable long-term safety profile of VDZ. Conflict of interest: Dr. Privitera, Giuseppe: Consultant fee from Johnson & Johnson Pugliese, Daniela: Consultant/Lectures fees from: AbbVie, Takeda, Johnson, Pfizer, Alfasigma, MSD, Lilly, Celltrion. Armuzzi, Alessandro: Consulting fees from AbbVie, Abivax, Alfa Sigma, Astra Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Enthera, Ferring, Galapagos, Gilead, Giuliani, Janssen, Lionhealth, MSD, Nestlé, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sanofi, Sandoz, Takeda, Teva Pharmaceuticals, Tillots Pharma Speaker’s fees from AbbVie, Abivax, AG Pharma, Alfa Sigma, Biogen, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, Lionhealth, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Teva Pharmaceuticals Research support from Biogen, MSD, Takeda, and Pfizer Non-financial support from Abbvie, Janssen, MSD, Pfizer, Takeda