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

• Published in: European journal of gastroenterology & hepatology Vol. 34; no. 11; pp. 1132 - 1139
• Main Authors: Fiske, Joseph, Liu, Eleanor, Limdi, Jimmy K., Conley, Thomas E., Townsend, Tristan, Davies, Mike, Brockwell, Robert, Baig, Daniyal, Abdelbadiee, Sherif, Uney, Anastasia, Liaros, Angela, Gaba, Waqas, Smith, Philip J., Flanagan, Paul K., Subramanian, Sreedhar
• Format: Journal Article
• Language: English
• Published: England Wolters Kluwer Health, Inc. All rights reserved 01-11-2022
• Subjects: Aged; Biological Products - adverse effects; Cohort Studies; Crohn Disease - chemically induced; Crohn Disease - diagnosis; Crohn Disease - drug therapy; Humans; Middle Aged; Remission Induction; Retrospective Studies; Treatment Outcome; Tumor Necrosis Factor-alpha; Ustekinumab - adverse effects
• ISSN: 0954-691X; 1473-5687
• DOI: 10.1097/MEG.0000000000002436

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.
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.
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.
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.