학술논문
Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study.
Document Type
Academic Journal
Author
Tursi A; Territorial Gastroenterology Service, ASL BAT, Andria, Italy.; Department of Medical and Surgical Sciences, Post-graduate School of Digestive Diseases, Catholic University, Rome, Italy.; Mocci G; Division of Gastroenterology, 'Brotzu' Hospital, Cagliari, Italy.; Allegretta L; Division of Gastroenterology, 'Santa Caterina Novella' Hospital, Galatina (LE), Italy.; Aragona G; Division of Gastroenterology, 'Guglielmo da Saliceto' Hospital, Piacenza, Italy.; Bianco MA; Division of Gastroenterology, 'T. Maresca' Hospital, Torre del Greco (NA), Italy.; Colucci R; Digestive Endoscopy Unit, 'San Matteo degli Infermi' Hospital, Spoleto (PG), Italy.; Cuomo A; Division of Gastroenterology, 'Umberto I' Hospital, Nocera Inferiore (SA), Italy.; Della Valle N; Division of Gastroenterology, 'Ospedali Riuniti' Hospital, Foggia, Italy.; Ferronato A; Digestive Endoscopy Unit, ULSS7 Pedemontana, Santorso (VI), Italy.; Forti G; Digestive Endoscopy Unit, 'S. Maria Goretti' Hospital, Latina, Italy.; Gaiani F; Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy.; Giorgetti G; Digestive Endoscopy and Nutritional Unit, 'S. Eugenio' Hospital, Rome, Italy.; Graziani MG; Division of Gastroenterology, 'S. Giovanni - Addolorata' Hospital, Rome, Italy.; Lofano K; Division of Gastroenterology, 'S. Paolo' Hospital, Bari, Italy.; Lorenzetti R; Division of Gastroenterology, 'Nuovo Regina Margherita' Territorial Hospital, Rome, Italy.; Larussa T; Department of Health Science, University of Catanzaro, Catanzaro, Italy.; Penna A; Territorial Gastroenterology Service, ASL BA, Bari, Italy.; Pica R; Division of Gastroenterology, IBD Unit, 'S. Pertini' Hospital, Rome, Italy.; Pranzo G; Ambulatory for IBD Treatment, 'Valle D'Itria' Hospital, Martina Franca (TA), Italy.; Rodino' S; Division of Gastroenterology, 'Ciaccio-Pugliese' Hospital, Catanzaro, Italy.; Scarcelli A; Division of Gastroenterology, 'San Salvatore' Hospital, Pesaro, Italy.; Zampaletta C; Division of Gastroenterology, 'Belcolle' Hospital, Viterbo, Italy.; Bassotti G; Gastroenterology & Hepatology Section, Department of Medicine & Surgery, University of Perugia, Perugia, Italy.; Cazzato AI; Division of Gastroenterology, 'Santa Caterina Novella' Hospital, Galatina (LE), Italy.; Chiri S; Division of Gastroenterology, 'Santa Caterina Novella' Hospital, Galatina (LE), Italy.; Clemente V; Digestive Endoscopy and Nutritional Unit, 'S. Eugenio' Hospital, Rome, Italy.; Cocco A; Division of Gastroenterology, IBD Unit, 'S. Pertini' Hospital, Rome, Italy.; De' Angelis G; Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy.; Donnarumma L; Division of Gastroenterology, 'Umberto I' Hospital, Nocera Inferiore (SA), Italy.; Faggiani R; Division of Gastroenterology, 'S. Camillo' Hospital, Rome, Italy.; Graziosi C; Division of Gastroenterology, 'Belcolle' Hospital, Viterbo, Italy.; Le Grazie M; Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy.; Luzza F; Department of Health Science, University of Catanzaro, Catanzaro, Italy.; Meucci C; Division of Gastroenterology, 'T. Maresca' Hospital, Torre del Greco (NA), Italy.; Monterubbianesi R; Division of Gastroenterology, 'S. Camillo' Hospital, Rome, Italy.; Pagnini C; Division of Gastroenterology, 'S. Giovanni - Addolorata' Hospital, Rome, Italy.; Perazzo P; Division of Gastroenterology, 'Santa Caterina Novella' Hospital, Galatina (LE), Italy.; Picchio M; Division of General Surgery, 'P. Colombo' Hospital, ASL Roma 6, Velletri (Roma), Italy.; Sacco R; Division of Gastroenterology, 'Ospedali Riuniti' Hospital, Foggia, Italy.; Sebkova L; Division of Gastroenterology, 'Ciaccio-Pugliese' Hospital, Catanzaro, Italy.; Serio M; Division of Gastroenterology, 'Ciaccio-Pugliese' Hospital, Catanzaro, Italy.; Napolitano D; Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario 'A. Gemelli' IRCCS Foundation, Rome, Italy.; Pugliese D; Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario 'A. Gemelli' IRCCS Foundation, Rome, Italy.; Scaldaferri F; Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario 'A. Gemelli' IRCCS Foundation, Rome, Italy.; Catholic University, School of Medicine, Rome, Italy.; Schiavoni E; Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario 'A. Gemelli' IRCCS Foundation, Rome, Italy.; Turchini L; Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario 'A. Gemelli' IRCCS Foundation, Rome, Italy.; Armuzzi A; IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.; Elisei W; Division of Gastroenterology, 'S. Camillo' Hospital, Rome, Italy.; Maconi G; Division of Gastroenterology, 'L. Sacco' University Hospital, Milan, Italy.; Papa A; Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario 'A. Gemelli' IRCCS Foundation, Rome, Italy.; Catholic University, School of Medicine, Rome, Italy.
Source
Publisher: Oxford University Press Country of Publication: England NLM ID: 9508162 Publication Model: Print Cited Medium: Internet ISSN: 1536-4844 (Electronic) Linking ISSN: 10780998 NLM ISO Abbreviation: Inflamm Bowel Dis Subsets: MEDLINE
Subject
Language
English
Abstract
Background: Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce.We compare the efficacy and safety of ADA biosimilars SB5, ABP501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting.
Methods: A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars.
Results: A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint.
Conclusions: Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.
(© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
Methods: A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars.
Results: A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint.
Conclusions: Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.
(© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)