Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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Tursi Antonio, Mocci Giammarco, Allegretta Leonardo, Aragona Giovanni, Bianco Maria Antonia, Colucci Raffaele, Cuomo Antonio, Della Valle Nicola, Ferronato Antonio, Forti Giacomo, Gaiani Federica, Giorgetti GianMarco, Graziani Maria Giovanna, Lofano Katia, Lorenzetti Roberto, Larussa Tiziana, Penna Antonio, Pica Roberta, Pranzo Giuseppe, Rodino' Stefano, Scarcelli Antonella, Zampaletta Costantino, Bassotti Gabrio, Cazzato Alessia Immacolata, Chiri Stefania, Clemente Valeria, Cocco Andrea, De' Angelis Gianluigi, Donnarumma Laura, Faggiani Roberto, Graziosi Camilla, Le Grazie Marco, Luzza Francesco, Meucci Costantino, Monterubbianesi Rita, Pagnini Cristiano, Perazzo Patrizia, Picchio Marcello, Sacco Rodolfo, Sebkova Ladislava, Serio Mariaelena, Napolitano Daniele, Pugliese Daniela, Scaldaferri Franco, Schiavoni Elisa, Turchini Laura, Armuzzi Alessandro, Elisei Walter, Maconi Giovanni, Papa Alfredo
Аннотация
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.