BACKGROUND AND AIMS: There is a need to evaluate the benefit-risk ratio of current therapies in inflammatory bowel disease (IBD) patients to provide the best quality of care. The primary objective of I-CARE (IBD Cancer and serious infections in Europe) was to assess prospectively safety concerns in IBD, with specific focus on the risk of cancer/lymphoma and serious infections in patients treated with anti-tumor necrosis factor and other biologic monotherapy as well as in combination with immunomodulators. METHODS: I-CARE was designed as a European prospective longitudinal observational multicenter cohort study to include patients with a diagnosis of Crohn's disease, ulcerative colitis, or IBD unclas-sified established at least 3 months prior to enrollment. RESULTS: A total of 10,206 patients were enrolled between March 2016 and April 2019, including 6169 (60.4%) patients with Crohn's disease, 3853 (37.8%) with ulcerative colitis, and 184 (1.8%) with a diagnosis of IBD unclassified. Thirty-two percent of patients were receiving azathio-prine/thiopurines, 4.6% 6-mercaptopurine, and 3.2% methotrexate at study entry. At inclusion, 47.3% of patients were treated with an anti-tumor necrosis factor agent, 8.8% with vedolizu-mab, and 3.4% with ustekinumab. Roughly one-quarter of patients (26.8%) underwent prior IBD-related surgery. Sixty-six percent of patients had been previously treated with systemic steroids. Three percent of patients had a medical history of cancer prior to inclusion and 1.1% had a history of colonic, esophageal, or uterine cervix high-grade dysplasia. CONCLUSIONS: I-CARE is an ongoing investigator-initiated observational European prospective cohort study that will provide unique information on the long-term benefits and risks of biological therapies in IBD patients. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).

I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease / L. Peyrin-Biroulet, J.-. Rahier, J. Kirchgesner, V. Abitbol, S. Shaji, A. Armuzzi, K. Karmiris, J.P. Gisbert, P. Bossuyt, U. Helwig, J. Burisch, H. Yanai, G.A. Doherty, F. Magro, T. Molnar, M. Lowenberg, J. Halfvarson, E. Zagorowicz, H. Rousseau, C. Baumann, F. Baert, L. Beaugerie, J.-. Gornet, J.-. Reimund, X. Hebuterne, A. Amiot, F. Armelao, P. Blanc, C. Papi, G.P. De Chambrun, X. Roblin, Chu, S. Shariq, N. Viazis, J. Limdi, P. Eder H, G. Michalopoulos, A. Bell, L. Biancone, M. Dewitte, Z. Mazhar, D. Franchimont, S. Nancey, G. Macaigne, M.B. Principi, M. Fumery, G. Parkes, J.-. Valats, G. Doherty, G. Bouguen, H. Tsai, M. Gangi, N. Pedersen, F. Heluwaert, R. Shenderey, S. Zeissig, J. Butterworth, F. Castiglione, L. Corless, C. Zallot, S. Singh, S. Sonwalkar, E. Clayton, D. Vani, G. Bellaiche, M. De Vos, U. Kopylov, T. Lobaton, C. Locher, G. Mantzaris, G. Abouda, K. Smith, M. Sprakes, A. Theodoropoulou, E. Wesley, J. Bonnet, D. Elphick, C. Gilletta, J. Gordon, D. Laharie, A. Nakad, A. Orlando, P. Dubois, P. Hasselblatt, C. Michiels, C. Preston, A. Staicu, L. Vuitton, M. Kaassis, A. Speight, D. Ghosh, N. Mathieu, A.-. Pelletier, A. Phillips, R. Altwegg, I. Avni, Biron, J. Landy, M. Nachury, A. Shenoy, C. Trang, G. Bamias, K. Farkas, C. Maaser, A. Shitrit, B. Siegmund, J. Filippi, C. O'Morain, L. Costes, D. Hobday, Z. Szepes, E. Calabrese, H. Dallal, M. Fung, A. Ramadas, B. Baburajan, K. Koss, C. Barberis, A. Buisson, M. Amil, P. Balestrieri, M. Johnson, M. Tzouvala, S. Viennot, F. Nagy, N. Thompson, L. Alric, S. Samuel, A. Bourrier, E. Chanteloup, E. Del Tedesco, M. Harbord, A. Lobo, S. Myers, R. Pollok, T. Ahmad, R. Chaudhary, C. Karakoidas, A. Soliman, C. Stefanescu, G. Theocharis, S.V. Branden, B. Beltran, Y. Bouhnik, A. Bourreille, J. Branco, B. Colleypriest, R. Eliakim, P. Knight, A. O'Toole, V. Robles, K. Triantafyllou, M.M. Bosca, G. Lambrecht, L.M. Mosquera, S. Panter, A. Pappa, M. Simon, G. Sivaji, C. Bellanger, A. Belle, N. Borruel, L. Egan, H. Peeters, D. Sharpstone, R. Arasaradnam, J.M. Benitez, J.F. Dahlerup, O. Giouleme, M. Minguez, E. Tsironi, A. Variola, P. Allen, L. Boivineau, A. Cole, N. Dib, F. Gomollon, R. Johnston, K. Katsanos, N. Kennedy, M. Kiszka-Kanowitz, I. Marin-Jimenez, P. Miheller, P. Nos, O. Saraj, L. Vinter-Jensen, E. Zittan, C. Baudry, X. Calvet, M.-. Cazelles-Boudier, J.-. Coenegrachts, G. Cullen, M. Daperno, A. Dhar, R. Gerard, N. Jensen, N. Maharshak, M. Mcalindon, S. Mcloughlin, M. Parkes, K. Patel, A. Peixoto, D. Polymeros, F. Portela, R. Rocca, P. Seksik, S. Subramanian, R. Tennenbaum, R. Atreya, O. Bachmann, A. Berger, R. Bor, M. Buckley, D. Carpio, M. Chaparro, F. Costa, E. Domenech, M. Esteve, S. Foley, J. Guardiola, I. Koutroubakis, T. Kuehbacher, C. Landman, A. Lavagna, N. Mancenido, M. Manosa, M.D. Martin-Arranz, L. Plastaras, M.L. Scribano, S. Sengupta, N. Teich, M.-. Tran-Minh, E. Zampeli, L. Amininejad, T. Arroyo, A. Attar, A.-. Backman, A. Balint, J. Beckly, S. Ben Horin, S. Bernardo, L. Caillo, B. Caron, M. Shanika de Silva, A. Fabian, G. Fiorino, A. Gutierrez, A. Lahat, M. Masmoudi, M. Mendolaro, V. Muls, F. Poullenot, C. Probert, C. Reenaers, M. Rutka, Z. Sarwari, J. Sayer, B. Sicilia, H. Sousa, C. van Kemseke, Y. Zabana, M. Astegiano, P. Banim, D. Bettenworth, M. Boualit, J.B. Brodersen, A. Christidou, R. Cooney, J.C. Pinto, P.M. Cravo, A. Cremer, S. Danese, A. di Sabatino, J. Fallingborg, A. Ferronato, E.G. Planella, S. Gupta, E. Israeli, S. Kestenbaum, L. Larsen, E. Macken, N. Mathou, A. Milassin, J. Pofelski, C. Ricci, F. Rodriguez-Moranta, M. Schmidt-Lauber, I. Shaw, M. Soares, H. Soliman, C. Triantos, K. Zografos, A. Agrawal, A. Aubourg, M.B.-. Acosta, J. Barrio, D. Bergemalm, F. Bermejo, G. Bodini, J. Bohr, D. Christodoulou, C. Claessens, P. Collins, R. de Francisco, S. Garcia, S. Georgopoulos, F. Goutorbe, C. Kalantzis, A. Kourikou, V. Mace, G. Malamut, P. Ministro, I.N. Larmurier, E. Ricart, M. Serrero, J. Sheridan, P. Weimers, V. Andersen, B. Arroja, B. Bokemeyer, L. Bujanda, T. Degand, C. Eriksson, C. Garceau, H. Glerup, I. Goren, L. Jackson, S. Koch, F. Mesonero, I. Ordas, P. Riviere, S. Saibeni, J. Soares, N. Tavernier, K. Theede, B. Ungar, E. Bastlein, A. Gasbarrini, A. Protopapas, W. Reindl, F. Bossa, A. Hart, F.-. Heil, A. O'Connor, B. Oldenburg, L. Pastorelli, P. Stephen, S. Ramakrishnan, J. de Caestecker, A. Echarri, D. Kevans, J. Buning, R. Coelho, J. Jansen, B. Koslowski, C. Wells, D. Ceballos, I. Konig, H. Padmanabhan, T. Patani, R. Qureshi, M. Allez, E. Archavlis, D. Bonnet, L. Guidi, D. Mcnamara, P. Vernia, M. Weidenhiller, L. Alon, T. Boysen, C. Delattre, R. Farrell, R.-. Kruger, T. Paupard, I. Vind, F. Caprioli, V. Gancho, V. Quentin, B. Avidan, G. D'Haens, J. Mccarthy, J. Snook, K. Soufleris, F. Zerbib, D. Carter, A. Depla, T. Eisenbach, W. Fries, N. Grammatikos, S. Ilegems, A. Lopez-Sanroman, J. Moreau, G. Riegler, S. Rietdijk, M. Rocha, I. Rosa, B. Ryan, Y. Yeremenko, A. Boruchowicz, F. Damiao, F. Laoudi, A. Lugering, G. Macarri, K. Thomopoulos, L. Barros, T. Blixt, A. Garros, S. Khorrami, H. Sokol, A. Sturm, D. Livovsky, J. Maul, H. Miks, V. Papadopoulos, C. Schmidt, Y. Snir, L. Svenningsen, W. Ahmed, Y. Broitman, E. Cuillerier, P. Kant, J. Leyden, L. Lichtenstein, S. Lopes, C. Martineau, H. Mulcahy, A. Schweitzer, F. Van Schaik, H. Banai, P. Danion, C. Dulery, H. Fidder, C. Gay, H. Hagege, F. Harnois, S.P. Jorgensen, J. Muller-Ziehm, M. Oikonomou, C. Palmela, J. Schulze/roske, M. Smith, T. Thurm, F. Bresso, H. Brixi, J. Jones, P. Macmathuna, C. Painchart, Y. Ron, M. Vester-Andersen, G. Alexandrino, N. Borner, M. Cardoso, C. Chagas, A. Dignass, I. Dotan, C. Hedin, P. Karatzas, P. Kasapidis, K. Palatka, G. Sakizlis, A. Wilson, N. Bosanko, P. Caldeira, C. Gagniere, L. Libier, C. Meunier, G. Moog, A. Pasquion, R. Pica, A. Akbar, N. Arab, G. Cadiot, J. Carvalho, C. Charpignon, L. Fellermann, S. Fishman, G. Fraser, N. Gluck, M. Hoesl, J. Kierkus, M. Klopocka, E.M. Arranz, L. Menchen, S. Nikolaus, A. Petrache, C. Ponsioen, S. Riestra, P. Robledo, C. Rodriguez, M. Samer, M. Tischer, J. Wypych, J. Baudon, C. Bezzio, G. Boschetti, T. Creed, M.G. Demarzo, S. Festa, A. Figueroa, M. Julsgaard, P. Navarro, P. Perez-Galindo, C. Rouillon, E. Sablich, J. Tosca, M. Vidon, M. Vidon, R.-. Vitte, A. Wampach, I.C. Urmes, M. Borie, M. Uzzan, K. Chatten, R. Peter, I. Tariq, M. Cossignani, F. Canete, T. Holvoet, S. Krasz, S. Dias, H. Abalia, A. Abaza, G. Abramovich, I. Ackzell, C. Adams, C. Addleton, E. Alfambra, A. Algaba, C. Allcock, J. Allison, K. Amouriaux, J. Anderson, E. Anderson, S. Appelmans, L. Armstrong, S. Atkins, M. Attaran-Bandarabadi, Y. Bailey, S. Bardot, N. Beck, L. Bennett, J.P. Bergfeld, R. Berkane, H. Boey, L. Bowlas, J. Bradley-Potts, T. Brear, N. Bretlander-Peters, E. Brown, J. Brown, E. Buckingham, K. Buellens, R. Bull, M. Burke, L. Burns, J. Burton, A. Bwalya, K. Cabanas, M. Callaghan, O. Camou, D. Campbell, E. Capoferro, M. Carnahan, C. Carnio, A. Carter, C.C. Clack, L. Chedouba, B. Cipriano, S. Claeys, M. Closset, D. Coban, S. Cococcia, C. Coe, H. Cole, E. Collet, K. Collins, I. Combes, E. Connor, K. Constantin, S. Cooke, N. Cornet, E. Corrihons, P. Corsino, R. Cortaville, D. Cotterill, A. Cowton, H. Cox, V. Cripps, A. Crowder, T. Cukier, A. Daniel, C. Dawe, J. de Haan, R.D.L. Croix, E. Dejonckheere, J.D. Villanegro, G. Delaval, M. Delliponti, A. Delommez, E. Detry, M. Dhanaratne, L.D. Galan, M. Dodel, E. Dooks, J. Du Cheyron, L. Duane, J.D. Vulgo Cochran, S. Dyer, H. Dymond, C. Ekblad, K. Elliott, I. Emmerson, I. Eugene-Jolchine, L. Fleming, E. Fletcher, S. Ford, G. Forshaw, A. Foulds, C. Francois, N. Fuge, G. Gafni, M. Ganon, O.G. Nunez, L.G. Ramirez, S. Gelder, R. Gettkowski, D. Gilardi, P. Giuffrida, V. Gobert, J. Godden, N. Godwin, K. Goulden, S. Graham, C. Green, M. Green, A. Gueye, T. Guler, I. Gustavsson, H. Hadjisavvas, F. Hammonds, C. Hantzi, M. Hauke, J. Haydock, O. Hayes, L.H. Nislev, J. Hochstodter, A. Hogg, M. Holbing, M. Holland, M. Holsbergen, L. Howard, A. Hoyda, R. Hull, J. Irish, W. Jackson, W. Janssen, L. Jeffrey, S. Jourdan, I. Jutrowska, C. Kaniel, T. Karezos, N. Kelly, J. Kelly, M. Kennedy, U. Kennedy, J. Kibaru, G. Kirkman, J. Klaproth, C. Kneese, A. Koch, K. Kokke, M. Koppelow, S. Krause, S. Krauspe, P. Kwakkenbos, N. Labarile, H. Lang, M. Lassailly, M. Leconte, L. Lepczynski, E. Levell, N. Levhar, K. Lindhort, J. Lisle, B.L. Cauce, G. Lorenz, A. Lovati, T. Lowry, M. Lund, A.L. Vorderbrugge, S. Maansson, V. Madapathage, M. Cheviakoff, A. Magness, O. Manley, C. Manyoni, I. Marg, A. Marra, C. Martins, A. Massella, A. Mathias, D. Mervyn, C. Minsart, S. Mitchell, K. Monks, M. Montero, A. Moore, M. Moser, A. Moss, A. Mullen, M.F. Murciano, D. Naylor, A. Nehus, A. Nicholson, S. Noding, S. Nolan, J. Norenberg, C. Northcott, J. O'Connell, A. O'Kelly, N. Orbach-Zingboim, J. Orobitg, C. Otieno, C. Owen, S. Patch, M. Pauker, R. Pauli, H. Pearson, F. Peggy, S. Petit, C. Petrissans, S. Piergallini, L. Pippard, L. Pitt, G. Pocsik, Y. Poher, C. Pomes, L. Pritchard, L. Puchades, S. Quaid, A. Rana, D. Raynard, M. Reilly, S. Reinert, M. Reinknecht, B. Renner, R. Reynolds, G. Rizzuto, M. Robinson, J. Robrechts, E.M. Rodriguez, E. Rosenblum, T. Russel, I. Sadare, N. Salama, T. Schakel, A. Schauer, E. Schiavoni, C. Shaw, S. Shelton, V. Sicart, E. Siouville, O. Smith, T. Soude, S. Stephenson, E. Stephenson, M. Steppe, A. Sterkx, J. Stickley, K. Sugrue, N. Swietec, C. Tasiaux, B. Thamu, S. Thomas, O. Tobi, K. Touabi, S. Tovi, J. Tregonning, L. Turchini, J. Unkhoff, O. Unruh, N. Uzun, F. Van Aert, S.V. Bergh, L. Vandenbroucke, L. Vansteenkiste, S. Vardit, V. Vergriete, E. Walker, E. Warner, O. Watchorn, E. Watson, M.-. Wauthier, B.M. Weetman, M. Weston, W. West-Petroschka, S. Wienecke, K. Wierling, M. Wiestler, R. Wilcox, E. Wilhelmsen, A. Williams, G. Williamson, D. Wilson, K. Wistance, N. Wortmann, S. Wurie, K. Yadgar, G. Young, M. Young, J. Aucouturier, M.-. Bertin, H. Bougrine, M. Coisnon, A. Defrance, K. Gutierrez, A. Harouz, L. Jerber, A. Khlifi, A. Kirati, N. Liworo, M. Logoltat, C. Mailhat, C. M'Bayi, Y. Medane, D. Merkhoufa, S.M. Elhad, B. Monthe, F. Moyon, P. Rabiega, J. Sekela, C. Thilloy, N. Hamamouche, F. Partisotti, P. Blandin, H. Mokhtari, L. Coutard. - In: CLINICAL GASTROENTEROLOGY AND HEPATOLOGY. - ISSN 1542-3565. - 21:3(2023 Mar), pp. 771-788.e10. [10.1016/j.cgh.2022.09.018]

I-CARE, a European Prospective Cohort Study Assessing Safety and Effectiveness of Biologics in Inflammatory Bowel Disease

L. Pastorelli;F. Caprioli;
2023

Abstract

BACKGROUND AND AIMS: There is a need to evaluate the benefit-risk ratio of current therapies in inflammatory bowel disease (IBD) patients to provide the best quality of care. The primary objective of I-CARE (IBD Cancer and serious infections in Europe) was to assess prospectively safety concerns in IBD, with specific focus on the risk of cancer/lymphoma and serious infections in patients treated with anti-tumor necrosis factor and other biologic monotherapy as well as in combination with immunomodulators. METHODS: I-CARE was designed as a European prospective longitudinal observational multicenter cohort study to include patients with a diagnosis of Crohn's disease, ulcerative colitis, or IBD unclas-sified established at least 3 months prior to enrollment. RESULTS: A total of 10,206 patients were enrolled between March 2016 and April 2019, including 6169 (60.4%) patients with Crohn's disease, 3853 (37.8%) with ulcerative colitis, and 184 (1.8%) with a diagnosis of IBD unclassified. Thirty-two percent of patients were receiving azathio-prine/thiopurines, 4.6% 6-mercaptopurine, and 3.2% methotrexate at study entry. At inclusion, 47.3% of patients were treated with an anti-tumor necrosis factor agent, 8.8% with vedolizu-mab, and 3.4% with ustekinumab. Roughly one-quarter of patients (26.8%) underwent prior IBD-related surgery. Sixty-six percent of patients had been previously treated with systemic steroids. Three percent of patients had a medical history of cancer prior to inclusion and 1.1% had a history of colonic, esophageal, or uterine cervix high-grade dysplasia. CONCLUSIONS: I-CARE is an ongoing investigator-initiated observational European prospective cohort study that will provide unique information on the long-term benefits and risks of biological therapies in IBD patients. (EudraCT, Number: 2014-004728-23; ClinicalTrials.gov, Number: NCT02377258).
Biologics; Cancer; Efficacy; I-CARE; Inflammatory Bowel Disease; Lymphoma; Safety
Settore MED/12 - Gastroenterologia
mar-2023
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