Efficacy and safety of combination targeted therapies in immune-mediated inflammatory disease: the COMBIO study. Issue 1 (January 2023)

• Record Type: Journal Article
• Authors: Guillo, Lucas; Flachaire, Benoit; Avouac, Jérôme; Dong, Catherine; Nachury, Maria; Bouguen, Guillaume; Buisson, Anthony; Caillo, Ludovic; Fumery, Mathurin; Gilletta, Cyrielle; Hébuterne, Xavier; Lafforgue, Pierre; Laharie, David; Mahé, Emmanuel; Marotte, Hubert; Nancey, Stéphane; Ottaviani, Sébastien; Salmon, Jean-Hugues; Savoye, Guillaume; Serrero, Mélanie; Uzzan, Mathieu; Viguier, Manuelle; Richez, Christophe; Peyrin-Biroulet, Laurent; Seksik, Philipe; Pham, Thao; Ah-Soune, Philippe; Arab, Nadia; Beaugerie, Laurent; Bolko, Loïs; Bonnet, Joelle; Bouhnik, Yoram; Bourrier, Anne; Brazier, Franck; Carbonnel, Franck; Charkaoui, Maeva; Charlot-Lambrecht, Isabelle; Chupin, Antoine; Combier, Alice; Couderc, Marion; Coury-Lucas, Fabienne; Desjeux, Ariadne; Dong, Catherine; Duveau, Nicolas; Grasland, Anne; Grimaud, Jean-Charles; Guennoc, Xavier; Landman, Cécilia; Nion-Larmurier, Isabelle; Leberre, Catherien; Leenhardt, Romain; Goffic, Aude Le; Montaudie, Henri; Morel, Jacques; Passeron, Thierry; Collard, Jeanne-Marie Perotin; Poisnel, Elodie; Pradel, Vincent; Soubrier, Martin; Sokol, Harry; Toussirot, Eric; Trang, Caroline; Minh, My-Linh Trans; Trijau, Sophie; Verhoeven, Frank; Viennot, Stéphanie; Wendling, Daniel;
• Is Part Of: Digestive and liver disease. Volume 55:Issue 1(2023)
• Page Start: 61
• Page End: 68
• Publication Date: 2023-01
• Subjects: Combination therapy -- Molecular targeted therapy -- Immune-mediated inflammatory diseases; Digestive organs -- Diseases -- Periodicals; Liver -- Diseases -- Periodicals; 616.33005
• DOI: 10.1016/j.dld.2022.07.012
• Languages: English
• ISSNs: 1590-8658

Abstract

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.