P262 Effectiveness and safety of ustekinumab in elderly patients: Real world evidence from ENEIDA registry

Abstract

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.

Ustekinumab and Vedolizumab Are Equally Safe and Effective in Elderly Crohn’s Disease Patients

“…In a previous cohort study of 103 vedolizumab-treated patients, 17% of patients developed a serious infection (13.8% in our cohort) [ 17 ]. In a Spanish cohort of 212 ustekinumab-treated elderly patients, a serious infection rate of 7% was reported [ 20 ] which is similar to our cohort. The magnitude of risk also appears broadly comparable to that reported for anti-TNF agents among elderly patients.…”

“…For instance, a single-centre cohort study from the USA reported response rates in excess of 90% in an elderly cohort of 39 patients but importantly remission was only achieved in 28% of patients [ 19 ]. Similarly, in the recently published Spanish cohort of 212 elderly patients, the week 54 response rate was 70% [ 20 ]. These differences are likely explained by differences in patient populations—for instance, in our cohort we had a lower proportion of patients with penetrating phenotype (13% vs 44% in the US study) and a greater proportion of smokers.…”

“…A further recent study included 39 elderly (> 65 years) Crohn’s disease patients treated with ustekinumab and reported a similar safety profile but lower efficacy compared to younger patients [ 19 ]. To the contrary, a recently published Spanish cohort in abstract form showed similar efficacy and serious infection rates among elderly compared to a standard adult IBD cohort but with a higher rate of de novo neoplasms among the elderly [ 20 ]. A pooled analysis of data from clinical trials across all indications showed comparable efficacy and safety among elderly patients compared to a standard cohort [ 21 ], but it is important to note the limitations of clinical trial data due to restricted inclusion of patients with significant co-morbidities.…”

Real-World Evidence of the Effectiveness and Safety of Ustekinumab for the Treatment of Crohn’s Disease: Systematic Review and Meta-Analysis of Observational Studies

“…A total of 63 studies (including 8529 patients) met the inclusion criteria and were finally included in the systematic review and meta-analysis ( Figure 1 ) [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , ...…”

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“…Ustekinumab, a humanized monoclonal antibody, was shown by a study that it achieved clinical response in almost threequarters of elderly patients, with the same rate of infections and other adverse effects, with the exception of de novo neoplasms [14].…”