1. Safety and efficacy of combining biologics or small molecules for inflammatory bowel disease or immune-mediated inflammatory diseases
- Author
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Goessens, L., Colombel, J. -F., Outtier, A., Ferrante, M., Sabino, J., Judge, C., Saeidi, R., Rabbitt, L., Armuzzi, A., Domenech, E., Michalopoulos, G., Cremer, A., Garcia-Alonso, F. J., Molnar, T., Karmiris, K., Gecse, K., Van Oostrom, J., Lowenberg, M., Farkas, K., Atreya, R., Ribaldone, D. G., Selinger, C., Hoentjen, F., Bihin, B., Sebastian, S., Rahier, J. -F., Baert, F., Horin, S. B., Bossuyt, P., Mas, E. B., Buckley, M., Byron, C., Coe, C., Doherty, G. A., Dragoni, G., Fernandes, S., Gaya, D. P., Gleeson, S., Keogh, A., Levine, A., Ortega, T. L., Lobo, A. J., Macken, E., Mccarthy, J., Noor, N., O'Toole, A., Posen, A., Privitera, G., Pugliese, D., Raine, T., Reenaers, C., Resal, T., Scarcelli, A., Slattery, E., Strubbe, B., Sugrue, K., Groen, M. T., Vicente, G. T., Truyens, M., Viola, A., Yanai, H., Zulquernain, S. A., Gastroenterology and Hepatology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Graduate School, UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie, UCL - (MGD) Service de gastro-entérologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, and UCL - (MGD) Unité de support scientifique
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Adult ,Male ,safety ,medicine.medical_specialty ,Combination therapy ,Adolescent ,Opportunistic infection ,Inflammatory bowel disease ,combination therapy ,Young Adult ,Interquartile range ,inflammatory bowel disease ,Internal medicine ,Medicine ,Humans ,biologics ,Adverse effect ,Retrospective Studies ,Biological Products ,treatment ,business.industry ,immune mediated inflammatory disease ,Gastroenterology ,Retrospective cohort study ,medicine.disease ,Inflammatory Bowel Diseases ,Europe ,small molecules ,Oncology ,Immune-mediated inflammatory diseases ,Original Article ,Drug Therapy, Combination ,Female ,Skin cancer ,business ,Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5] - Abstract
BACKGROUND AND AIMS: Few data are available regarding the combination of biologics or small molecules in inflammatory bowel disease (IBD) patients. We report safety and efficacy of such combinations through a retrospective multicentre series. METHODS: Combination therapy was defined as the concomitant use of two biologics or one biologic with a small molecule. Patient demographics, disease characteristics and types of combinations were recorded. Safety was evaluated according to the occurrence of serious infection, opportunistic infection, hospitalisation, life-threatening event, worsening of IBD or immune-mediated inflammatory diseases (IMID), cancer and death. Efficacy was evaluated as the physician global assessment of the combination and comparison of clinical/endoscopic scores of IBD/IMID activity prior and during combination. RESULTS: A total of 104 combinations were collected in 98 patients. Concomitant IMID were present in 41 patients. Reasons for starting combination therapy were active IBD (67%), active IMID or extra-intestinal manifestations (EIM) (22%), both (10%) and unclassified in 1. Median duration of combination was 8 months (interquartile range 5-16). During 122 patient-years of follow-up, 42 significant adverse events were observed, mostly related to uncontrolled IBD. There were 10 significant infections, 1 skin cancer and no death. IBD disease activity was clinically improved in 70% and IMID/EIM activity in 81% of the patients. Overall, combination was continued in 55% of the patients. CONCLUSIONS: Combination of biologics and small molecules in patients with IBD and IMID/EIM seems to be a promising therapeutic strategy but is also associated with a risk of opportunistic infections or infections leading to hospitalisation in 10%. ispartof: UNITED EUROPEAN GASTROENTEROLOGY JOURNAL vol:9 issue:10 pages:1136-1147 ispartof: location:England status: published
- Published
- 2021
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