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,Marieke J Pierik,Eelco C Brand,Herma H Fidder,Quirine Van Der Vliet,Andrea E Van Der Meulen-De Jong,Karen Van Der Aalst,Nofel Mahmmod,Anniek Van Der Aalst,Bas Oldenburg,Bas Van Tuyl,P W Jeroen Maljaars

doi:10.1007/s00384-020-03716-6

Abstract

PurposeTo assess safety and effectiveness of anti-tumor necrosis factor (anti-TNF) therapy in IBD patients ≥ 60 years.MethodsNinety 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.ResultsIn 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.ConclusionOlder 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.

Highlights

Safety and effectiveness of medication may differ between older and younger patients, as a consequence of comorbidity, polypharmacy, senescence of the immune system or altered clearance of drugs. [5, 6] Results from clinical trials cannot be extrapolated to the older patient population with inflammatory bowel diseases (IBD) because these patients are generally excluded from trial participation and available data from observational studies on the occurrence of severe adverse events (SAEs) in older IBD patients exposed to anti-tumor necrosis factor (TNF) therapy are inconsistent. [7,8,9,10] Besides
We identified 347 IBD patients currently using antiTNF therapy, of whom 90 were 60 years or older at initiation of anti-TNF therapy and of whom 257 patients were younger than 60 years at the start of anti-TNF therapy
An additional 145 anti-TNF naive IBD patients of 60 years or older served as controls

Summary

Introduction

As a consequence of the aging population and the rising prevalence of inflammatory bowel diseases (IBD), the group of older patients with Crohn’s disease (CD) or ulcerative colitis (UC) is enlarging. [1] Currently, approximately 10–30% of IBD patients is > 60 years old and about 10–15% of new IBD cases is diagnosed in patients > 60 years of age. [2,3,4]Safety and effectiveness of medication may differ between older and younger patients, as a consequence of comorbidity, polypharmacy, senescence of the immune system or altered clearance of drugs. [5, 6] Results from clinical trials cannot be extrapolated to the older patient population with IBD because these patients are generally excluded from trial participation and available data from observational studies on the occurrence of severe adverse events (SAEs) in older IBD patients exposed to anti-TNF therapy are inconsistent. [7,8,9,10] BesidesInt J Colorectal Dis (2020) 35:2331–2338 this, previous literature has been focussing on patient age, rather than comorbidity as a predictor of safety and effectiveness in patients with IBD receiving anti-tumor necrosis factor (TNF) therapy.The aim of the present study is to assess safety and effectiveness of anti-TNF therapy in patients with IBD aged 60 years and older while accounting for the presence of comorbidities. As a consequence of the aging population and the rising prevalence of inflammatory bowel diseases (IBD), the group of older patients with Crohn’s disease (CD) or ulcerative colitis (UC) is enlarging. [1] Currently, approximately 10–30% of IBD patients is > 60 years old and about 10–15% of new IBD cases is diagnosed in patients > 60 years of age. [5, 6] Results from clinical trials cannot be extrapolated to the older patient population with IBD because these patients are generally excluded from trial participation and available data from observational studies on the occurrence of severe adverse events (SAEs) in older IBD patients exposed to anti-TNF therapy are inconsistent.

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Conclusion