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

Authors

  • Antonio Tursi Territorial Gastroenterology Service, ASL BAT, Andria; Department of Medical and Surgical Sciences, School of Medicine, Catholic University, Rome, Italy
  • Giammarco Mocci Division of Gastroenterology, “Brotzu” Hospital, Cagliari, Italy
  • Antonio Cuomo Division of Gastroenterology, “Umberto I” Hospital, Nocera Inferiore (SA), Italy
  • Antonio Ferronato Digestive Endoscopy Unit, ULSS7 Pedemontana, Santorso (VI), Italy
  • Walter Elisei Division of Gastroenterology, “S. Camillo” Hospital, Rome, Italy
  • Marcello Picchio Division of General Surgery, “P. Colombo” Hospital, ASL Roma 6, Velletri (Roma), Italy
  • Giovanni Maconi Division of Gastroenterology, “L. Sacco” University Hospital, Milan, Italy
  • Franco Scaldaferri Gastroenterology Department, CEMAD, Center for Diagnosis and Treatment of Digestive Diseases, Fondazione Policlinico Gemelli, IRCCS, Rome; Catholic University, School of Medicine, Rome, Italy
  • Alfredo Papa Gastroenterology Department, CEMAD, Center for Diagnosis and Treatment of Digestive Diseases, Fondazione Policlinico Gemelli, IRCCS, Rome; Catholic University, School of Medicine, Rome, Italy
  • - Italian group for switch of biologics Italy
  • Leonardo Allegretta Division of Gastroenterology, “Santa Caterina Novella” Hospital, Galatina (LE), Italy
  • Giovanni Aragona Division of Gastroenterology, “Guglielmo da Saliceto” Hospital, Piacenza, Italy
  • Maria Antonia Bianco Division of Gastroenterology, “T. Maresca” Hospital, Torre del Greco (NA), Italy
  • Raffaele Colucci Digestive Endoscopy Unit, “San Matteo degli Infermi” Hospital, Spoleto (PG), Italy
  • Nicola Della Valle Division of Gastroenterology, “Ospedali Riuniti” Hospital, Foggia
  • Roberto Faggiani Division of Gastroenterology, “S. Camillo” Hospital, Rome, Italy
  • Giacomo Forti Digestive Endoscopy Unit, “S. Maria Goretti” Hospital, Latina, Italy
  • Federica Gaiani Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy
  • GianMarco Giorgetti Digestive Endoscopy and Nutritional Unit, “S. Eugenio” Hospital, Rome, Italy
  • Maria Giovanna Graziani Division of Gastroenterology, “S. Giovanni - Addolorata” Hospital, Rome, Italy
  • Katia Lofano Division of Gastroenterology, “S. Paolo” Hospital, Bari, Italy
  • Roberto Lorenzetti Division of Gastroenterology, “Nuovo Regina Margherita” Territorial Hospital, Rome, Italy
  • Tiziana Larussa Department of Health Science, University of Catanzaro, Catanzaro, Italy
  • Antonio Penna Territorial Gastroenterology Service, ASL BA, Bari, Italy
  • Gabrio Bassotti Gastroenterology and Hepatology Section, Department of Medicine and Surgery, University of Perugia, Perugia, Italy
  • Alessia Immacolata Cazzato Division of Gastroenterology, “Santa Caterina Novella” Hospital, Galatina (LE), Italy
  • Stefania Chiri Division of Gastroenterology, “Santa Caterina Novella” Hospital, Galatina (LE), Italy
  • Valeria Clemente Digestive Endoscopy and Nutritional Unit, “S. Eugenio” Hospital, Rome, Italy
  • Andrea Cocco Division of Gastroenterology, IBD Unit, “S. Pertini” Hospital, Rome, Italy
  • Gianluigi De’ Angelis Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy
  • Laura Donnarumma Division of Gastroenterology, “Umberto I” Hospital, Nocera Inferiore (SA), Italy
  • Camilla Graziosi Department of Health Science, University of Catanzaro, Catanzaro, Italy
  • Marco Le Grazie Gastroenterology and Endoscopy Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy
  • Francesco Luzza Department of Health Science, University of Catanzaro, Catanzaro, Italy
  • Costantino Meucci Division of Gastroenterology, “T. Maresca” Hospital, Torre del Greco (NA), Italy
  • Rita Monterubbianesi Division of Gastroenterology, “S. Camillo” Hospital, Rome, Italy
  • Cristiano Pagnini Division of Gastroenterology, “S. Giovanni - Addolorata” Hospital, Rome
  • Patrizia Perazzo Division of Gastroenterology, “Guglielmo da Saliceto” Hospital, Piacenza, Italy
  • Roberta Pica Division of Gastroenterology, IBD Unit, “S. Pertini” Hospital, Rome, Italy
  • Giuseppe Pranzo Ambulatory for IBD Treatment, “Valle D’Itria” Hospital, Martina Franca (TA), Italy
  • Stefano Rodino’ Division of Gastroenterology, “Ciaccio-Pugliese” Hospital, Catanzaro, Italy
  • Rodolfo Sacco Division of Gastroenterology, “Ospedali Riuniti” Hospital, Foggia, Italy
  • Ladislava Sebkova Division of Gastroenterology, “Ciaccio-Pugliese” Hospital, Catanzaro, Italy
  • Antonella Scarcelli Division of Gastroenterology, “San Salvatore” Hospital, Pesaro, Italy
  • Mariaelena Serio Division of Gastroenterology, “San Salvatore” Hospital, Pesaro, Italy
  • Daniele Napolitano Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario “A. Gemelli” IRCCS Foundation, Rome, Italy
  • Daniela Pugliese Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario “A. Gemelli” IRCCS Foundation, Rome, Italy
  • Elisa Schiavoni Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario “A. Gemelli” IRCCS Foundation, Rome, Italy
  • Laura Turchini Division of Internal Medicine and Gastroenterology, Department of Medical and Surgical Sciences, Policlinico Universitario “A. Gemelli” IRCCS Foundation, Rome, Italy
  • Alessandro Armuzzi IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
  • Costantino Zampaletta Division of Gastroenterology, “Belcolle” Hospital, Viterbo, Italy

DOI:

https://doi.org/10.15403/jgld-4608

Keywords:

adalimumab, biosimilar, ABP501, GP2017, MSB11022, SB5, inflammatory bowel disease

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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Published

2022-12-16

How to Cite

1.
Tursi A, Mocci G, Cuomo A, Ferronato A, Elisei W, Picchio M, Maconi G, Scaldaferri F, Papa A, Italian group for switch of biologics -, Allegretta L, Aragona G, Bianco MA, Colucci R, Della Valle N, Faggiani R, Forti G, Gaiani F, Giorgetti G, Graziani MG, Lofano K, Lorenzetti R, Larussa T, Penna A, Bassotti G, Cazzato AI, Chiri S, Clemente V, Cocco A, De’ Angelis G, Donnarumma L, Graziosi C, Le Grazie M, Luzza F, Meucci C, Monterubbianesi R, Pagnini C, Perazzo P, Pica R, Pranzo G, Rodino’ S, Sacco R, Sebkova L, Scarcelli A, Serio M, Napolitano D, Pugliese D, Schiavoni E, Turchini L, Armuzzi A, Zampaletta C. 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. JGLD [Internet]. 2022 Dec. 16 [cited 2025 Jun. 25];31(4):411-6. Available from: https://www.jgld.ro/jgld/index.php/jgld/article/view/4608

Issue

Vol. 31 No. 4: December 2022

Section

Original Article