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 - European COMBIO study group
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 - 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 - Yanai, Henit
N1 - 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 - 10.1002/ueg2.12170
DO - 10.1002/ueg2.12170
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C2 - 34694746
AN - SCOPUS:85117882145
SN - 2050-6406
VL - 9
SP - 1136
EP - 1147
JO - United European Gastroenterology Journal
JF - United European Gastroenterology Journal
IS - 10
ER -