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

Goessens L, Colombel JF, Outtier A, Ferrante M, Sabino J, Judge C, Saeidi R, Rabbitt L, Armuzzi A, Domenech E, Michalopoulos G, Cremer A, García-Alonso FJ, Molnar T, Karmiris K, Gecse K, Van Oostrom J, Löwenberg M, Farkas K, Atreya R, Ribaldone DG, Selinger C, Hoentjen F, Bihin B, Sebastian S, Rahier JF, Baert F, Horin SB, Bossuyt P, Mas EB, Buckley M, Byron C, Coe C, Doherty GA, Dragoni G, Fernandes S, Gaya DP, Gleeson S, Keogh A, Levine A, Ortega TL, Lobo AJ, 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 MT, Vicente GT, Truyens M, Viola A, Yanai H, Zulquernain SA (2021)

Publication Type: Journal article

Publication year: 2021

Journal

DOI: 10.1002/ueg2.12170

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%.

Authors with CRIS profile

Involved external institutions

CHU Dinant Godinne UCL Namur Belgium (BE) Icahn School of Medicine at Mount Sinai United States (USA) (US) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven Belgium (BE) Mercy University Hospital Ireland (IE) St Vincent's University Hospital Ireland (IE) University Hospital Galway Ireland (IE) Fondazione Policlinico Universitario Agostino Gemelli IRCCS Italy (IT) Health Sciences Research Institute of the “Germans Trias i Pujol” Foundation (IGTP) Spain (ES) Tzaneio General Hospital of Piraeus Greece (GR) Hôpital Erasme Belgium (BE) Hospital Universitario Rio Hortega Spain (ES) University of Szeged / József Attila Tudományegyetem Szeged Hungary (HU) Venizeleio General Hospital Greece (GR) Amsterdam University Medical Centers (Amsterdam UMC) / Amsterdam Universitair Medische Centra Netherlands (NL) University of Turin / Università degli Studi di Torino (UNITO) Italy (IT) Leeds Teaching Hospitals NHS Trust United Kingdom (GB) Radboud University Nijmegen Medical Centre / Radboudumc of voluit Radboud Universitair Medisch Centrum (UMC) Netherlands (NL) Hull University Teaching Hospitals NHS Trust United Kingdom (GB)

How to cite

APA:

Goessens, L., Colombel, J.F., Outtier, A., Ferrante, M., Sabino, J., Judge, C.,... Zulquernain, S.A. (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. https://doi.org/10.1002/ueg2.12170

MLA:

Goessens, Laurent, et al. "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 (2021).

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