Comorbidity, not patient age, is associated with impaired safety outcomes in vedolizumab‐ and ustekinumab‐treated patients with inflammatory bowel disease—a prospective multicentre cohort study

Abstract

Summary Background Few data are available on the effects of age and comorbidity on treatment outcomes of vedolizumab and ustekinumab in inflammatory bowel disease (IBD). Aims To evaluate the association between age and comorbidity with safety and effectiveness outcomes of vedolizumab and ustekinumab in IBD. Methods IBD patients initiating vedolizumab or ustekinumab in regular care were enrolled prospectively. Comorbidity prevalence was assessed using the Charlson Comorbidity Index (CCI). Association between age and CCI, both continuously assessed, with safety outcomes (any infection, hospitalisation, adverse events) during treatment, and effectiveness outcomes (clinical response and remission, corticosteroid‐free remission, clinical remission combined with biochemical remission) after 52 weeks of treatment were evaluated. Multivariable logistic regression was used to adjust for confounders. Results We included 203 vedolizumab‐ and 207 ustekinumab‐treated IBD patients, mean age 42.2 (SD 16.0) and 41.6 (SD 14.4). Median treatment duration 54.0 (IQR 19.9‐104.0) and 48.4 (IQR 24.4‐55.1) weeks, median follow‐up time 104.0 (IQR 103.1‐104.0) and 52.0 weeks (IQR 49.3‐100.4). On vedolizumab, CCI associated independently with any infection (OR 1.387, 95% CI 1.022‐1.883, P = 0.036) and hospitalisation (OR 1.586, 95% CI 1.127‐2.231, P = 0.008). On ustekinumab, CCI associated independently with hospitalisation (OR 1.621, 95% CI 1.034‐2.541, P = 0.035). CCI was not associated with effectiveness, and age was not associated with any outcomes. Conclusions Comorbidity ‐ but not age ‐ is associated with an increased risk of hospitalisations on either treatment, and with any infection on vedolizumab. This underlines the importance of comorbidity assessment and safety monitoring of IBD patients.

Obesity Is Not Associated With an Increased Risk of Serious Infections in Biologic-Treated Patients With Inflammatory Bowel Diseases

“…In an open-label extension study of tofacitinib in ulcerative colitis, higher body weight was associated with an increased risk of serious infections ( 17 ). Real-world studies have identified that multimorbidity is independently associated with an increased risk of serious infection; however, they have not examined the impact of obesity on the risk of infections ( 18 , 19 ).…”

Editorial: is age just a number when it comes to treatment of inflammatory bowel disease? Authors' reply

“…We would like to thank Dr Ma and colleagues for their editorial 1 in response to our paper in which we assessed the presence of comorbidity prior to initiating vedolizumab or ustekinumab in patients with inflammatory bowel diseases (IBD) 2 . In our study, we found that comorbidity, and not patient age, was associated with negative health outcomes (hospitalisations and infections) after the start of second‐line biologic therapy.…”

Editorial: is age just a number when it comes to treatment of inflammatory bowel disease?

“…Managing older IBD patients poses unique challenges for clinicians, who must balance the benefits of chronic immunosuppression with a higher burden of patient comorbidity and risks of treatment‐ and disease‐related adverse events (AEs) 2 . Asscher et al recently reported results from the prospective Dutch Initiative on Crohn's Colitis (ICC), comparing the effect of comorbidity and age on impaired safety outcomes in IBD patients treated with second generation biologics 3 . Among 203 vedolizumab‐ and 207 ustekinumab‐exposed patients, comorbidity burden was independently associated with negative safety outcomes, particularly hospitalisations, whereas age was not.…”