Ahmad Albshesh1, Joshua Taylor2, Edoardo V Savarino3, Marie Truyens4, Alessandro Armuzzi5, Davide G Ribaldone6, Ariella Bar-Gil Shitrit7, Morine Fibelman8, Pauliina Molander9, Claire Liefferinckx10, Stephane Nancey11,12, Mohamed Korani13,14, Mariann Rutka15, Manuel Barreiro-de Acosta16, Viktor Domislovic17, Gerard Suris18, Carl Eriksson19, Catarina Alves20, Afroditi Mpitouli21, Caroline di Jiang22, Katja Tepeš23, Marina Coletta24, Kalliopi Foteinogiannopoulou25, Javier P Gisbert26, Hadar Amir-Barak27, Mohamed Attauabi28, Jakob Seidelin29, Waqqas Afif2, Carla Marinelli3, Triana Lobaton4, Daniela Pugliese5, Nitsan Maharshak8, Anneline Cremer10, Jimmy K Limdi13,14, Tamás Molnár15, Borja Otero-Alvarin16, Zeljko Krznaric17, Fernando Magro20, Konstantinos Karmiris21, Tim Raine22, David Drobne23, Ioannis Koutroubakis25, Maria Chaparro26, Henit Yanai27, Johan Burisch28, Uri Kopylov1. 1. Sheba Medical Center, Tel Hashomer, Israel, Department of Gastroenterology, Sackler School of Medicine, Tel-Aviv University, Tel-Aviv 52621, Israel. 2. Department of Gastroenterology, Montreal General Hospital, Montreal, QC 1650, Canada. 3. Division of Gastroenterology, Department of Surgery, Oncology and Gastroenterology, University of Padua, 35128 Padua, Italy. 4. IBD Unit, Department of Gastroenterology, Ghent University Hospital, 9000 Ghent, Belgium. 5. IBD Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, 00168 Rome, Italy. 6. Division of Gastroenterology, Department of Medical Sciences, University of Turin, 10126 Turin, Italy. 7. Shaare Zedek Medical Center, Faculty of Medicine, Digestive Diseases Institute, Hebrew University of Jerusalem, Jerusalem 9372212, Israel. 8. Tel Aviv Medical Center, Department of Gastroenterology and Liver Diseases, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv 6423906, Israel. 9. Abdominal Center, Department of Gastroenterology, Helsinki University Hospital, 00101 Helsinki, Finland. 10. Department of Gastroenterology, Erasme University Hopital, 1070 Brussels, Belgium. 11. Department of Gastroenterology, Hospices Civils de Lyon, University Claude Bernard Lyon, 69495 Lyon, France. 12. INSERM, U1111, CIRI, 69007 Lyon, France. 13. Division of Gastroenterology, The Pennine Acute Hospitals NHS Trust, Manchester M8 6RB, UK. 14. Manchester Academic Health Sciences, University of Manchester, Manchester BL97TD, UK. 15. First Department of Medicine, University of Szeged, H-6720 Szeged, Hungary. 16. IBD Unit, Gastroenterology Department, University Hospital of Santiago de Compostela, 15706 Santiago, Spain. 17. Department of Gastroenterology, Hepatology, and Nutrition, University Hospital Centre Zagreb, 10000 Zagreb, Croatia. 18. Digestive System Service, Bellvitge University Hospital, Catalan Institute of Health, 08907 Barcelona, Spain. 19. Department of Gastroenterology, Faculty of Medicine and Health, Örebro University, SE-70182 Örebro, Sweden. 20. Department of Gastroenterology, Centro Hospitalar São João, 4200319 Porto, Portugal. 21. Department of Gastroenterology, Venizeleion General Hospital, Heraklion, 71409 Crete, Greece. 22. Department of Gastroenterology, Addenbrooke's Hospital, Cambridge University Hospitals, Cambridge CB2 0QQ, UK. 23. University Medical Centre Ljubljana, Department of Gastroenterology, Medical Faculty, University of Ljubljana, 1231 Ljubljana, Slovenia. 24. Department of Hepatology and Clinical Gastroenterology, ASST Santi Paolo e Carlo-Ospedale San Polo Universitario Milano Mariabeatrice, 20142 Milan, Italy. 25. Department of Gastroenterology, University Hospital of Heraklion, 71500 Crete, Greece. 26. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, 28001 Madrid, Spain. 27. IBD Center, Division of Gastroenterology, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel and the Sackler School of Medicine, Tel-Aviv University, Tel-Aviv 49100, Israel. 28. Copenhagen Center for Inflammatory Bowel Disease in Children, Adolescents and Adults, Hvidovre Hospital, University of Copenhagen, 2650 Copenhagen, Denmark. 29. Department of Gastroenterology, Herlev University Hospital, 3400 Copenhagen, Denmark.
Abstract
BACKGROUND: Multiple studies have described the effectiveness of ustekinumab (UST) and vedolizumab (VDZ) in patients with Crohn's disease (CD) failing anti- Tumor necrosis factors (TNFs); however, the effectiveness of VDZ or UST as a third-class biologic has not yet been described. AIMS AND METHODS: In this retrospective multicenter cohort study, we aimed to investigate the effectiveness of VDZ and UST as a third-class biologic in patients with CD. RESULTS: Two-hundred and four patients were included; 156/204 (76%) patients received VDZ as a second- and UST as a third-class therapy (group A); the remaining 48/204 (24%) patients received UST as a second- and VDZ as a third-class therapy (group B). At week 16-22, 87/156 (55.5%) patients and 27/48 (56.2%) in groups A and B, respectively, responded to treatment (p = 0.9); 41/156 (26.2%) and 15/48 (31.2%) were in clinical remission (p = 0.5). At week 52; 89/103 (86%) patients and 25/29 (86.2%) of the patients with available data had responded to third-class treatment in groups A and B, respectively (p = 0.9); 31/103 (30%) and 47/29 (24.1%) were in clinical remission (p = 0.5). CONCLUSION: Third-class biological therapy was effective in more than half of the patients with CD. No differences in effectiveness were detected between the use of VDZ and UST as a third-class agent.
BACKGROUND: Multiple studies have described the effectiveness of ustekinumab (UST) and vedolizumab (VDZ) in patients with Crohn's disease (CD) failing anti- Tumor necrosis factors (TNFs); however, the effectiveness of VDZ or UST as a third-class biologic has not yet been described. AIMS AND METHODS: In this retrospective multicenter cohort study, we aimed to investigate the effectiveness of VDZ and UST as a third-class biologic in patients with CD. RESULTS: Two-hundred and four patients were included; 156/204 (76%) patients received VDZ as a second- and UST as a third-class therapy (group A); the remaining 48/204 (24%) patients received UST as a second- and VDZ as a third-class therapy (group B). At week 16-22, 87/156 (55.5%) patients and 27/48 (56.2%) in groups A and B, respectively, responded to treatment (p = 0.9); 41/156 (26.2%) and 15/48 (31.2%) were in clinical remission (p = 0.5). At week 52; 89/103 (86%) patients and 25/29 (86.2%) of the patients with available data had responded to third-class treatment in groups A and B, respectively (p = 0.9); 31/103 (30%) and 47/29 (24.1%) were in clinical remission (p = 0.5). CONCLUSION: Third-class biological therapy was effective in more than half of the patients with CD. No differences in effectiveness were detected between the use of VDZ and UST as a third-class agent.