Safety and effectiveness of ustekinumab in elderly Crohn’s disease patients

Abstract

Objective Anti-tumour necrosis factor (TNF) agents are associated with increased infection risk among elderly IBD patients, but little is known about non anti-TNF biologics in this cohort. We examined the safety and effectiveness of ustekinumab in elderly Crohn’s patients. Methods This retrospective multi-centre cohort study included Crohn’s patients ≥60-years old who commenced ustekinumab. We recorded Harvey-Bradshaw index (HBI), concomitant steroid therapy, treatment persistence and new infections or malignancies. Primary outcome was serious infections requiring hospitalisation. Results Seventy patients were included, with median age of 68 years. 43 (61.4%) had prior anti-TNF exposure, and 15 (21.4%) vedolizumab. Median treatment duration was 12 months, totalling 84 patient-years. Nine serious infections were reported, incidence 106.7/1000 patient-years. Systemic steroids were associated with increased risk of serious infections [odds ratio (OR) 7.83, 95% confidence interval (CI): 1.44–44.32, P = 0.02]. There were 27 “non-serious” infections; 321.4/1000 patient-years. Charlson co-morbidity index (OR 1.49, 95% CI: 1.05–2.12, P = 0.03) and steroid exposure (OR 44.10, 95% CI: 1.75–1112.10, P = 0.02) increased non-serious infection risk (P < 0.05). Mean HBI improved from 8.13 to 4.64 at 6 months and 4.10 at last follow up (P < 0.0001). 12-month treatment persistence was 55.7% (N = 39); 34 (48.6%) were steroid-free. Conclusion Ustekinumab was safe and effective in a cohort of elderly Crohn’s disease patients. Infections were mostly mild, not resulting in therapy discontinuation. Serious infection risk was comparable to previously reported rates with anti-TNF agents. Steroid exposure was associated with an increased serious infection risk.

Meta‐analysis: Persistence of advanced therapies in the treatment of inflammatory bowel disease

“…Among the 63 publications, 10‐72 58 were journal articles and 5 were international conference abstracts. Two conference abstracts 71,72 were replaced by subsequent published articles found in our search.…”

Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn’s disease

“…However, a proportion of patients still show poor responses on the already q8w and q4w drug intervals, which calls for intravenous reinduction as a rescue treatment. To date, published studies evaluating the efficacy and safety of extra weight-based intravenous doses of UST are scarce ( 24 , 25 ). A recent study including 65 patients has demonstrated that 31% of patients achieved clinical remission off corticosteroids after UST intravenous reinduction ( 26 ).…”

Efficacy and Safety of Biological Therapies and JAK Inhibitors in Older Patients with Inflammatory Bowel Disease

“…Data are expressed as percentages according to different outcomes. SFR = steroid-free remission, SFP = steroid-free persistence, FU = follow-up, MH = mucosal healing, naïve: Patients without prior biologic treatment, studies including a younger control group of patients treated with the same biologic drug are represented with parallel bars, studies comparing different therapeutic drugs are allocated to the respective column, Ref [ 36 ] was excluded because only treatment failure was calculated [ 30 , 31 , 32 , 33 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 ].…”

“…Effectiveness : In the first report on 70 elderly CD with a mean CCI of 4.14, USTE showed a good effectiveness and safety profile with a median treatment of 16 months. More than half of these patients were anti-TNF and/or VEDO experienced [ 45 ]. Another study comparing a small cohort of older CD patients compared with younger patients found a lower probability of achieving steroid-free remission in patients ≥65-years-old [ 46 ].…”