Abstract Background The prevalence of Crohn’s disease (CD) in elderly patients is rising and is associated with aging-related challenges. Data on effectiveness and safety of first line biologic treatment (FLBT) in the elderly, are scarce. Our aim was to compare the safety, effectiveness, and drug persistence to FLBT in elderly patients with CD. Methods A retrospective, single tertiary center study, including all patients with CD who initiated their FLBT at age≥60 years, between 1/1/2010 to 31/12/2023. Clinical and demographic data were extracted and adverse events (AEs), treatment response and drug persistence were collected. Results A total of 214 patients with CD ≥60 years of age started FLBT, data were available for 168 (78.5%) patients. Anti-TNFs were initiated in 85 (50.6%) patients, and non anti-TNFs in 83 (49.4%) patients (71-vedolizumab, 12-ustekinumab). Patients starting anti-TNF were younger (67.3±6.1 vs 72.0±7.0 years, p<0.001), with lower Charlson comorbidity index (CCI: 3.6±1.7 vs 4.9±2.2, p<0.001), had higher rates of penetrating (31.8% vs 9.6%, p=0.002) and perianal (40.0% vs 18.1%, p=0.002) disease phenotype, and previous GI resections (37.6% vs 22.9%, p=0.038). Endoscopic disease severity was comparable [Table 1]. Drug persistence was calculated from 2014 (time of vedolizumabs’ approval for clinical use) and was similar between the groups (60 patients on anti-TNF: median 82.0 weeks [IQR 27.5-175.3] vs. 83 patients on non-anti-TNF median 89.7 weeks [IQR 41.0-183.9], p=0.765). Use of corticosteroids (CS) and immunomodulators (IMM) during 14-weeks of induction and 52-weeks of maintenance was comparable (p=NS). At 52-weeks, no difference was observed in clinical response and remission rates, nor in dose escalation and drug discontinuation rates (p=NS). Eighty-three AEs were recorded at 52-weeks: 50 (58.8%) in anti TNF vs. 33 (39.8%) in non-anti-TNF group. Serious infections: 7 (8.2%) patients in the anti-TNF group (3 hospitalized for sepsis: 1 urinary and 2 respiratory, 1 cellulitis, 1 pharyngitis, 1 systemic CMV and 1 clostridium difficile infection (CDI) vs 7 (8.2%) in the non-anti-TNF group (2 intra-abdominal abscess, 1 herpes zoster infection, 1 CDI, 1 cellulitis and 2 bronchitis, p=1). Hospitalization and surgery rates were 25.8% and 12.9% in anti-TNF vs 22.9% and 8.4% in non-anti-TNF groups respectively, (p=NS) [Table 2]. In a multivariate logistic regression analysis adjusted to type of FLBT, age, gender, CCI, dose escalation, and treatment with CS and IMM, no variable was significantly associated with the development of AEs (p=NS). Conclusion Anti-TNFs and vedolizumab/ustekinumab have similar safety and drug persistence as FLBT among elderly patients with CD. Larger prospective studies are needed to fortify our findings.
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