Safety and efficacy of combining biologics or small molecules for inflammatory bowel disease or immune-mediated inflammatory diseases: A European retrospective observational study.

Goessens, Laurent;Colombel, Jean-Frédéric;Outtier, An;Ferrante, Marc;Rahier, Jean-François;et.al.
(2021) United European Gastroenterology Journal — Vol. 9, n° 10, p. 1136-1147 (2021)

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  • Goessens, LaurentUCLouvain
    Author
  • Colombel, Jean-Frédéric
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  • Outtier, An
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  • Ferrante, Marc
    Author
  • Bihin, BenoîtUCLouvain
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  • Rahier, Jean-Françoisorcid-logoUCLouvain
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Abstract
(en) 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%.
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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., García-Alonso, F. J., Molnar, T., Karmiris, K., Gecse, K., Van Oostrom, J., Löwenberg, M., Farkas, K., et al. (2021). Safety and efficacy of combining biologics or small molecules for inflammatory bowel disease or immune-mediated inflammatory diseases: A European retrospective observational study. United European Gastroenterology Journal, 9(10), 1136-1147. https://doi.org/10.1002/ueg2.12170 (Original work published 2021)