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Multicenter Study
. 2022 Dec 16;31(4):411-416.
doi: 10.15403/jgld-4608.

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

Antonio Tursi  1 , Giammarco Mocci  2 , Antonio Cuomo  3 , Antonio Ferronato  4 , Walter Elisei  5 , Marcello Picchio  6 , Giovanni Maconi  7 , Franco Scaldaferri  8 , Alfredo Papa  9 ; Italian group for switch of biologics; Leonardo Allegretta  10 , Giovanni Aragona  11 , Maria Antonia Bianco  12 , Raffaele Colucci  13 , Nicola Della Valle  14 , Roberto Faggiani  15 , Giacomo Forti  16 , Federica Gaiani  17 , GianMarco Giorgetti  18 , Maria Giovanna Graziani  19 , Katia Lofano  20 , Roberto Lorenzetti  21 , Tiziana Larussa  22 , Antonio Penna  23 , Gabrio Bassotti  24 , Alessia Immacolata Cazzato  10 , Stefania Chiri  10 , Valeria Clemente  18 , Andrea Cocco  25 , Gianluigi De' Angelis  17 , Laura Donnarumma  26 , Camilla Graziosi  22 , Marco Le Grazie  17 , Francesco Luzza  22 , Costantino Meucci  12 , Rita Monterubbianesi  15 , Cristiano Pagnini  27 , Patrizia Perazzo  11 , Roberta Pica  28 , Giuseppe Pranzo  29 , Stefano Rodino'  30 , Rodolfo Sacco  31 , Ladislava Sebkova  30 , Antonella Scarcelli  32 , Mariaelena Serio  32 , Daniele Napolitano  33 , Daniela Pugliese  33 , Elisa Schiavoni  33 , Laura Turchini  33 , Alessandro Armuzzi  34 , Costantino Zampaletta  35
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Free article
Multicenter Study

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

Antonio Tursi et al. J Gastrointestin Liver Dis. .
Free article

Abstract

Background and 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.

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