Background and Aims Clinical trials and real-life studies with ustekinumab in Crohn's disease (CD) have shown a good efficacy and safety profile. However, these data are scarcely available in elderly patients. Therefore, we aim to assess the effectiveness and safety of ustekinumab in elderly patients with CD. Methods Elderly patients (>60 years old) from the prospectively maintained ENEIDA registry treated with ustekinumab due to CD were included. Every patient was matched with two controls under 60 years of age, according to anti-TNF use and smoking habit. Values for the Harvey-Bradshaw Index (HBI), endoscopic activity, C-reactive protein (CRP), and faecal calprotectin (FC) were recorded at baseline and at weeks 16, 32 and 54. Results 648 patients were included, 212 elderlies. Effectiveness was similar between young and elderly patients during the follow-up. Steroid-free remision was similar at week 16 (54.6 vs 51.4%, p=0.20), 32 (53.0% vs 54.5%, p=0.26) and 54 (57.8% vs 51.1%, p=0.21). Persistence of ustekinumab as maintenance therapy was similar in both age groups (log-rank test; p=0.91). There was no difference in the rate of adverse effects (14.2% vs 11.2%, p=0.350), including severe infections (7.1% vs 7.3%, p=1.00), except for the occurrence of de novo neoplasms, which was higher in older patients (0.7% vs 4.3%, p= 0.003). Conclusions Ustekinumab is as effective in elderly patients with CD, as it is in non-elderly. Safety profile seems to be also similar but for a higher rate of de novo neoplasms, probably related to the age of the elderly patients.

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Background Clinical trials and real-life studies with Ustekinumab in Crohn’s disease show its good efficacy and safety profile. However, there are hardly any data on elderly patients, who are excluded from these clinical trials. Our aim is to evaluate these variables in real-life practice. Methods Retrospective analysis of patients from the prospectively maintained ENEIDA registry treated with Ustekinumab for Crohn’s disease. Elderly patients were selected as those over 60 years old at the start of treatment. They were compared with 2 randomised controls from the same centre, aged less than 60 years, matched for smoking habit. The degree of comorbidity was assessed using the Charlson’s index. Clinical and biochemical activity and effectiveness were defined based on Harvey-Bradshaw index and calprotectin and CRP levels at weeks 16, 32 and 54, when available. Results A total of 648 patients were analysed, 212 elderly (mean age 67 [63.6;72.8] years) and 436 young (mean age 41.6 [32.6;50.0] years). No differences were observed between both groups in baseline variables except for the degree of comorbidity, higher in elderly patients (1.00 [0.00;2.00] vs 0.00 [0.00;0.00], p<0.001) and previous anti-TNF use, lower in the elderly (3.44% vs 15.2%, p<0.001). Baseline clinical and biochemical activity was similar in both groups. Clinical response rate was similar in both groups at week 16 (70.5% vs 76.6%, p=0.199), week 32 (67.6% vs 70.2% p=0.104) and week 54 (74% vs 74.9%, p=0.326). Steroid-free remission and biochemical response also showed no differences throughout follow-up. The rate of adverse effects was similar in both groups (14.2% vs 11.2%, p=0.350) except for the occurrence of de novo neoplasms, which was higher in the elderly group (0.69% vs 4.25%, p=0.003). The rate of severe infections (7.08 vs 7.34, p=1.000), the need for surgery (16.5% vs 20.0%, p=0.345) and the need for hospital admission (21.7% vs 19.0%, p=0.489) did not differ. Persistence of UST treatment was similar in both groups (log Rank test p=0.91). Conclusion Ustekinumab achieved clinical response in almost three-quarters of elderly patients, similar to the younger population, with no increase in the rate of infections or other adverse effects, with the exception of de novo neoplasms.

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