TY - JOUR
T1 - Safety and efficacy of combining biologics or small molecules for inflammatory bowel disease or immune-mediated inflammatory diseases
T2 - A European retrospective observational study
AU - Goessens, Laurent
AU - Colombel, Jean-Frédéric
AU - Outtier, An
AU - Ferrante, Marc
AU - Sabino, Joao
AU - Judge, Ciaran
AU - Saeidi, Reza
AU - Rabbitt, Louise
AU - Armuzzi, Alessandro
AU - Domenech, Eugeni
AU - Michalopoulos, George
AU - Cremer, Anneline
AU - García-Alonso, Francisco Javier
AU - Molnar, Tamas
AU - Karmiris, Konstantinos
AU - Gecse, Krisztina
AU - van Oostrom, Joep
AU - Löwenberg, Mark
AU - Farkas, Klaudia
AU - Atreya, Raja
AU - Ribaldone, Davide Giuseppe
AU - Selinger, Christian
AU - Hoentjen, Frank
AU - Bihin, Benoit
AU - Sebastian, Shaji
AU - Rahier, Jean-François
AU - European COMBIO study group
AU - Baert, Filip
AU - Horin, Shomron Ben
AU - Bossuyt, Peter
AU - Mas, Eduard Brunet
AU - Buckley, Martin
AU - Byron, Clodagh
AU - Coe, Carolann
AU - Doherty, Glen A.
AU - Dragoni, Gabriele
AU - Fernandes, Samuel
AU - Gaya, Daniel P.
AU - Gleeson, Sarah
AU - Keogh, Aine
AU - Levine, Arie
AU - Ortega, Triana Lobaton
AU - Lobo, Alan J.
AU - Macken, Elisabeth
AU - McCarthy, Jane
AU - Noor, Nurulamin
AU - O'Toole, Aoibhlinn
AU - Posen, Annelies
AU - Privitera, Giuseppe
AU - Pugliese, Daniele
AU - Raine, Tim
N1 - Funding Information: We warmly thank the BIRD office in helping for all legal and ethical considerations, namely Ms Saskia Appelmans, Ms Caroline Saudoyer, Ms Laura Vansteenkiste and Ms Marjan Steppe (BIRD Office). This work was not supported by any financial contribution. Publisher Copyright: © 2021 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.
PY - 2021/12
Y1 - 2021/12
N2 - 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%.
AB - 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%.
KW - biologics
KW - combination therapy
KW - immune mediated inflammatory disease
KW - inflammatory bowel disease
KW - safety
KW - small molecules
KW - treatment
UR - http://www.scopus.com/inward/record.url?scp=85117882145&partnerID=8YFLogxK
U2 - https://doi.org/10.1002/ueg2.12170
DO - https://doi.org/10.1002/ueg2.12170
M3 - Article
C2 - 34694746
SN - 2050-6406
VL - 9
SP - 1136
EP - 1147
JO - United European gastroenterology journal
JF - United European gastroenterology journal
IS - 10
ER -