Anti-tumor necrosis factor therapy in patients with inflammatory bowel disease; comorbidity, not patient age, is a predi

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ORIGINAL ARTICLE

Anti-tumor necrosis factor therapy in patients with inflammatory bowel disease; comorbidity, not patient age, is a predictor of severe adverse events Vera E. R. Asscher 1 & Quirine van der Vliet 2 & Karen van der Aalst 2 & Anniek van der Aalst 3 & Eelco C. Brand 2 & Andrea E. van der Meulen-de Jong 1 & Bas Oldenburg 2 & Marieke J. Pierik 3 & Bas van Tuyl 4 & Nofel Mahmmod 5 & P. W. Jeroen Maljaars 1 & Herma H. Fidder 2 & On behalf of the Dutch ICC Accepted: 14 August 2020 # The Author(s) 2020

Abstract Purpose To assess safety and effectiveness of anti-tumor necrosis factor (anti-TNF) therapy in IBD patients ≥ 60 years. Methods Ninety IBD patients ≥ 60 years at initiation of anti-TNF therapy, 145 IBD patients ≥ 60 years without anti-TNF therapy and 257 IBD patients < 60 years at initiation of anti-TNF therapy were retrospectively included in this multicentre study. Primary outcome was the occurrence of severe adverse events (SAEs), serious infections and malignancies. Secondary outcome was effectiveness of therapy. Cox regression analyses were used to assess differences in safety and effectiveness. In safety analyses, first older patients with and without anti-TNF therapy and then older and younger patients with anti-TNF therapy were assessed. Results In older IBD patients, the use of anti-TNF therapy was associated with serious infections (aHR 3.920, 95% CI 1.185– 12.973, p = .025). In anti-TNF-exposed patients, cardiovascular disease associated with serious infections (aHR 3.279, 95% CI 1.098–9.790, p = .033) and the presence of multiple comorbidities (aHR 9.138 (1.248–66.935), p = .029) with malignancies, while patient age did not associate with safety outcomes. Effectiveness of therapy was not affected by age or comorbidity. Conclusion Older patients receiving anti-TNF therapy have a higher risk of serious infections compared with older IBD patients without anti-TNF therapy, but not compared with younger patients receiving anti-TNF therapy. However, in anti-TNF-exposed patients, comorbidity was found to be an indicator with regards to SAEs. Effectiveness was comparable between older and younger patients. Keywords Crohn’s disease . Ulcerative colitis . Biologicals . Elderly . Co-morbidity

Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00384-020-03716-6) contains supplementary material, which is available to authorized users. * Vera E. R. Asscher [email protected] 1

Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Albinusdreef 2, 2333 ZA Leiden, the Netherlands

2

Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, the Netherlands

3

Department of Gastroenterology and Hepatology, Maastricht University Medical Centre, Maastricht, the Netherlands

4

Department of Gastroenterology and Hepatology, Diakonessenhuis Utrecht, Utrecht, the Netherlands

5

Department of Gastroenterology and Hepatology, Sint Antonius Hospital Nieuwegein, Nieuwegein, the Netherlands

Introduction A