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      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

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          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.

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          Most cited references20

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          Efficacy and safety of anti-TNF therapy in elderly patients with inflammatory bowel disease.

          The general increased life expectancy is reflected in the age of patients with inflammatory bowel disease (IBD). The knowledge about efficacy and safety of anti-tumour necrosis factor (TNF) therapy in elderly is scarce and conflicting.
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            Comorbidities in inflammatory bowel disease: a call for action

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              Is Open Access

              Ustekinumab for Crohn’s Disease: Results of the ICC Registry , a Nationwide Prospective Observational Cohort Study

              Abstract Background and Aims Ustekinumab is approved for the treatment of Crohn’s disease [CD]. Systematically registered prospective real-world data are scarce. We therefore aimed to study the effectiveness, safety and usage of ustekinumab for CD in everyday practice. Methods We prospectively enrolled CD patients initiating ustekinumab in regular care between December 2016 and January 2019. Clinical (Harvey Bradshaw Index [HBI]), biochemical (C-reactive protein [CRP] and faecal calprotectin [FCP]), extra-intestinal manifestations and, peri-anal fistula activity, ustekinumab dosage, concomitant medication use, and adverse events were documented at weeks 0, 12, 24, and 52. The primary outcome was corticosteroid-free clinical remission. Results In total, 221 CD patients were included (98.6% anti-tumour necrosis factor [TNF] and 46.6% vedolizumab exposed) with a median follow-up of 52.0 weeks [interquartile range 49.3–58.4]. Corticosteroid-free clinical remission rates at weeks 24 and 52 were 38.2% and 37.1%, respectively. An initial dosing schedule of 8 weeks, compared to 12 weeks, correlated with a lower discontinuation rate [20.0% vs 42.6%, p = 0.01], but comparable corticosteroid-free clinical remission at week 52 (46.3% [q8w] vs 34.6% [q12w], p = 0.20). There was no clinical benefit of combination therapy after 52 weeks when compared to ustekinumab monotherapy [combi 40.6% vs mono 36.0%, p = 0.64]. At baseline, 28 patients had active peri-anal fistula, of whom 35.7% showed complete clinical resolution after 24 weeks. During follow-up we encountered six severe infections [3.5 per 100 patient-years], with all patients being on concomitant immunosuppressant therapies. Ustekinumab treatment discontinuation was observed in 75 [33.9%] patients mainly due to lack of response. Conclusion Ustekinumab is a relatively safe and effective treatment option for CD patients with prior failure of anti-TNF and anti-integrin therapies.
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                Author and article information

                Contributors
                v.e.r.asscher@lumc.nl
                Journal
                Aliment Pharmacol Ther
                Aliment Pharmacol Ther
                10.1111/(ISSN)1365-2036
                APT
                Alimentary Pharmacology & Therapeutics
                John Wiley and Sons Inc. (Hoboken )
                0269-2813
                1365-2036
                09 September 2020
                October 2020
                : 52
                : 8 ( doiID: 10.1111/apt.v52.8 )
                : 1366-1376
                Affiliations
                [ 1 ] Leiden the Netherlands
                [ 2 ] Nijmegen the Netherlands
                [ 3 ] Maastricht the Netherlands
                [ 4 ] Groningen the Netherlands
                [ 5 ] Amsterdam the Netherlands
                [ 6 ] The Hague the Netherlands
                [ 7 ] Breda the Netherlands
                [ 8 ] Rotterdam the Netherlands
                Author notes
                [*] [* ] Correspondence

                Vera E. R. Asscher, Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, the Netherlands.

                Email: v.e.r.asscher@ 123456lumc.nl

                Author information
                https://orcid.org/0000-0002-2447-3123
                https://orcid.org/0000-0002-1361-8868
                https://orcid.org/0000-0003-0477-9499
                Article
                APT16073
                10.1111/apt.16073
                7539998
                32901983
                8090a8b0-ace7-4d0c-82a4-acc6090722f2
                © 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 27 March 2020
                : 25 April 2020
                : 15 August 2020
                Page count
                Figures: 0, Tables: 4, Pages: 11, Words: 8139
                Categories
                Original Scientific Paper
                Efficacy and Safety of Biologics for Crohn's Disease
                Custom metadata
                2.0
                October 2020
                Converter:WILEY_ML3GV2_TO_JATSPMC version:5.9.2 mode:remove_FC converted:07.10.2020

                Pharmacology & Pharmaceutical medicine
                Pharmacology & Pharmaceutical medicine

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