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Journal Articles Digestive and Liver Disease Year : 2023

Efficacy and safety of combination targeted therapies in immune-mediated inflammatory disease: the COMBIO study

1 Hôpital Nord [CHU - APHM]
2 APHM - Assistance Publique - Hôpitaux de Marseille
3 Service de rhumatologie [CHU Cochin]
4 Service d'Hépato-gastro-entérologie [APHP Kremlin-Bicêtre]
5 INFINITE - Institute for Translational Research in Inflammation - U 1286
6 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
7 CIC - Centre d'Investigation Clinique [Rennes]
8 NuMeCan - Nutrition, Métabolismes et Cancer
9 3IHP - Infection Inflammation et Interaction Hôtes Pathogènes [CHU Clermont-Ferrand]
10 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
11 CHU Amiens-Picardie
12 PERITOX - Périnatalité et Risques Toxiques - UMR INERIS_I 1 UPJV
13 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
14 CHU Nice - Centre Hospitalier Universitaire de Nice
15 Hôpital Haut-Lévêque [CHU Bordeaux]
16 Centre Hospitalier Victor Dupouy
17 LBTO - Biologie Intégrative du Tissu Osseux
18 CIRI - Centre International de Recherche en Infectiologie
19 AP-HP - Hôpital Bichat - Claude Bernard [Paris]
20 VIEFRA - EA 3797 - Vieillissement, Fragilité
21 ADEN - Nutrition, Inflammation et axe Microbiote-Intestin-Cerveau
22 IRIB - Institute for Research and Innovation in Biomedicine
23 UNIROUEN - Université de Rouen Normandie
24 Service d'Hépato-Gastroentérologie [CHU Rouen]
25 Service de Gastroentérologie [Hôpital Beaujon]
26 CHU Reims - Hôpital universitaire Robert Debré [Reims]
27 ImmunoConcept - Immunology from Concept and Experiments to Translation = Immunologie Conceptuelle, Expérimentale et Translationnelle
28 NGERE - Nutrition-Génétique et Exposition aux Risques Environnementaux
29 Service d'Hépato-gastro-entérologie [CHRU Nancy]
30 CRSA - Centre de Recherche Saint-Antoine
Jérôme Avouac
Hubert Marotte
Philippe Ah-Soune
  • Function : Author
Nadia Arab
  • Function : Author
Laurent Beaugerie
  • Function : Author
Loïs Bolko
  • Function : Author
Joelle Bonnet
  • Function : Author
Yoram Bouhnik
Anne Bourrier
  • Function : Author
Franck Brazier
  • Function : Author
  • PersonId : 1151134
  • IdRef : 060264497
Franck Carbonnel
Maeva Charkaoui
  • Function : Author
Isabelle Charlot-Lambrecht
  • Function : Author
Antoine Chupin
  • Function : Author
Alice Combier
  • Function : Author
Marion Couderc
  • Function : Author
Fabienne Coury-Lucas
  • Function : Author
Ariadne Desjeux
  • Function : Author
Nicolas Duveau
  • Function : Author
Anne Grasland
  • Function : Author
Jean-Charles Grimaud
  • Function : Author
Xavier Guennoc
  • Function : Author
Cécilia Landman
  • Function : Author
Isabelle Nion-Larmurier
  • Function : Author
Catherien Leberre
  • Function : Author
Romain Leenhardt
  • Function : Author
Aude Le Goffic
  • Function : Author
Henri Montaudie
  • Function : Author
Jacques Morel
  • Function : Author
Thierry Passeron
Jeanne-Marie Perotin Collard
  • Function : Author
Elodie Poisnel
  • Function : Author
Vincent Pradel
  • Function : Author
Martin Soubrier
Harry Sokol
  • Function : Author
Eric Toussirot
  • Function : Author
Caroline Trang
  • Function : Author
My-Linh Trans Minh
  • Function : Author
Sophie Trijau
  • Function : Author
Frank Verhoeven
  • Function : Author
Stéphanie Viennot
  • Function : Author
Daniel Wendling

Abstract

BACKGROUND: Use of a combination of targeted therapies (COMBIO) in patients with refractory/overlapping immune-mediated inflammatory diseases (IMIDs) has increased, but reported data remain scarce. We aimed to assess effectiveness and safety of COMBIO in patients with IMIDs. METHODS: We conducted a French ambispective multicenter cohort study from September 2020 to May 2021, including adults' patients with 1 or 2 IMIDs and treated at least 3-month with COMBIO. RESULTS: Overall, 143 patients were included. The most common IMIDs were Crohn's disease (63.6%), axial spondyloarthritis (37.7%), and ulcerative colitis (14%). Half of patients had only one IMID, of which 60% were Crohn's disease. Mean duration of COMBIO was 274.5±59.3 weeks, and COMBIO persistence at 104 weeks was estimated at 64.1%. The most frequent COMBIOs combined anti-TNF agents with vedolizumab (30%) or ustekinumab (28.7%). Overall, 50% of patients achieved significant and 27% mild-to-moderate improvement in patient-reported outcomes. Extended duration of COMBIO (aOR=1.09; 95% CI: 1.03-1.14; p=0.002) and diagnoses of two IMIDs (aOR=3.46; 95%CI: 1.29-9.26; p=0.013) were associated with significant improvement in patient-reported outcomes. Incidence of serious infection during COMBIO was 4.51 per 100 person-years (95% CI 2.20-8.27) and 5 COMBIOs were discontinued due to adverse events. CONCLUSIONS: COMBIO can be effective and safe in patients with refractory/overlapping IMIDs.

Dates and versions

hal-04167918 , version 1 (21-07-2023)

Identifiers

Cite

Lucas Guillo, Benoit Flachaire, Jérôme Avouac, Catherine Dong, Maria Nachury, et al.. Efficacy and safety of combination targeted therapies in immune-mediated inflammatory disease: the COMBIO study. Digestive and Liver Disease, 2023, 55 (1), pp.61-68. ⟨10.1016/j.dld.2022.07.012⟩. ⟨hal-04167918⟩
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