TY - JOUR
T1 - Replacement of Adalimumab Originator to Adalimumab Biosimilar for a Non-Medical Reason in Patients with Inflammatory Bowel Disease: A Real-life Comparison of Adalimumab Biosimilars Currently Available in Italy
AU - Tursi, Antonio
AU - Mocci, Giammarco
AU - Cuomo, Antonio
AU - Ferronato, Antonio
AU - Elisei, Walter
AU - Picchio, Marcello
AU - Maconi, Giovanni
AU - Scaldaferri, Franco
AU - Papa, Alfredo
AU - Italian group for switch of biologics, -
AU - Allegretta, Leonardo
AU - Aragona, Giovanni
AU - Bianco, Maria Antonia
AU - Colucci, Raffaele
AU - Della Valle, Nicola
AU - Faggiani, Roberto
AU - Forti, Giacomo
AU - Gaiani, Federica
AU - Giorgetti, GianMarco
AU - Graziani, Maria Giovanna
AU - Lofano, Katia
AU - Lorenzetti, Roberto
AU - Larussa, Tiziana
AU - Penna, Antonio
AU - Bassotti, Gabrio
AU - Cazzato, Alessia Immacolata
AU - Chiri, Stefania
AU - Clemente, Valeria
AU - Cocco, Andrea
AU - De’ Angelis, Gianluigi
AU - Donnarumma, Laura
AU - Graziosi, Camilla
AU - Le Grazie, Marco
AU - Luzza, Francesco
AU - Meucci, Costantino
AU - Monterubbianesi, Rita
AU - Pagnini, Cristiano
AU - Perazzo, Patrizia
AU - Pica, Roberta
AU - Pranzo, Giuseppe
AU - Rodino’, Stefano
AU - Sacco, Rodolfo
AU - Sebkova, Ladislava
AU - Scarcelli, Antonella
AU - Serio, Mariaelena
AU - Napolitano, Daniele
AU - Pugliese, Daniela
AU - Schiavoni, Elisa
AU - Turchini, Laura
AU - Armuzzi, Alessandro
AU - Zampaletta, Costantino
PY - 2022
Y1 - 2022
N2 - Background & Aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason.Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars.Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6-24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild.Conclusions: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed.
AB - Background & Aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason.Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars.Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6-24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild.Conclusions: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed.
KW - ABP501
KW - GP2017
KW - MSB11022
KW - SB5
KW - adalimumab
KW - biosimilar
KW - inflammatory bowel disease
KW - ABP501
KW - GP2017
KW - MSB11022
KW - SB5
KW - adalimumab
KW - biosimilar
KW - inflammatory bowel disease
UR - https://publicatt.unicatt.it/handle/10807/268194
UR - https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85144095856&origin=inward
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85144095856&origin=inward
U2 - 10.15403/jgld-4608
DO - 10.15403/jgld-4608
M3 - Article
SN - 1842-1121
VL - 31
SP - 411
EP - 416
JO - JOURNAL OF GASTROINTESTINAL AND LIVER DISEASES
JF - JOURNAL OF GASTROINTESTINAL AND LIVER DISEASES
IS - 4
ER -
