TY - JOUR
T1 - 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
AU - Asscher, Vera E. R.
AU - Biemans, Vince B. C.
AU - Pierik, Marieke J.
AU - Dijkstra, Gerard
AU - Lowenberg, Mark
AU - van der Marel, Sander
AU - de Boer, Nanne K. H.
AU - Bodelier, Alexander G. L.
AU - Jansen, Jeroen M.
AU - West, Rachel L.
AU - Haans, Jeoffrey J. L.
AU - van Dop, Willemijn A.
AU - Weersma, Rinse K.
AU - Hoentjen, Frank
AU - Maljaars, P. W. Jeroen
AU - Dutch Initiative Crohn and Colitis
N1 - Funding Information:
No financial support was received for this study. The data were generated as part of routine work of the participating organisations. Declaration of personal interests: Vera E.R. Asscher has no conflicts of interest to declare. Vince B.C. Biemans has no conflicts of interest to declare. Marieke J. Pierik has served on advisory boards, or as speaker or consultant for Abbvie, Janssen-Cilag, MSD, Takeda, Ferring, Dr Falk and Sandoz and has received unrestricted grants from Janssen-Cilag, Abbvie and Takeda outside the submitted work. Gerard Dijkstra received unrestricted research grants from Abbvie and Takeda. Advisory boards for Mundipharma and Pharmacosmos. Received speakers fees from Abbvie, Takeda and Janssen Pharmaceuticals. Mark Löwenberg has served as speaker and/or principal investigator for: Abbvie, Celgene, Covidien, Dr. Falk, Ferring Pharmaceuticals, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck Sharp & Dohme, Pfizer, Protagonist therapeutics, Receptos, Takeda, Tillotts and Tramedico. He has received research grants from AbbVie, Merck Sharp & Dohme, Achmea healthcare and ZonMW. Sander van der Marel has no conflicts of interest to declare. Nanne K.H. de Boer has served as a speaker for AbbVie, Takeda and MSD. He has served as consultant and principal investigator for Takeda and TEVA Pharma B.V. He has received (unrestricted) research grants from Dr. Falk and Takeda. Alexander G.L. Bodelier has served as speaker and/or participant in advisory board for: Abbvie, Merck Sharp & Dohme, Takeda, Vifor Pharma, Mundipharma. Jeroen M. Jansen has served on advisory boards, or as speaker or consultant for Abbvie, Amgen, Ferring, Fresenius, Janssen, MSD, Pfizer, Takeda. Rachel L. West has participated in advisory board and/or received financial compensation from the following companies: Jansen and Abbvie. Jeoffrey J.L. Haans reports personal fees from advisory board for Takeda Nederland B.V., personal fees from advisory board for Lamepro B.V. Willemijn A. van Dop has no conflicts of interest to declare. Rinse K. Weersma received unrestricted research grants from Takeda, Tramedico and Ferring. Frank Hoentjen has served on advisory boards, or as speaker or consultant for Abbvie, Celgene, Janssen-Cilag, MSD, Takeda, Celltrion, Teva, Sandoz and Dr Falk, and has received unrestricted grants from Dr Falk, Janssen-Cilag, Abbvie. P.W. Jeroen Maljaars has served as a speaker and an advisory board member for Abbvie, Takeda and Janssen-Cilag.
Funding Information:
No financial support was received for this study. The data were generated as part of routine work of the participating organisations.
Publisher Copyright:
© 2020 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd
PY - 2020/10
Y1 - 2020/10
N2 - 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.
AB - 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.
KW - MAINTENANCE THERAPY
KW - ELDERLY-PATIENTS
KW - INDUCTION
KW - RISK
U2 - 10.1111/apt.16073
DO - 10.1111/apt.16073
M3 - Article
C2 - 32901983
SN - 0269-2813
VL - 52
SP - 1366
EP - 1376
JO - Alimentary Pharmacology & Therapeutics
JF - Alimentary Pharmacology & Therapeutics
IS - 8
ER -