Efficacy and Safety of Adalimumab Biosimilar GP2017 in Patients with Inflammatory Bowel Disease

Author:

Vernero Marta1ORCID,Bezzio Cristina234ORCID,Ribaldone Davide G.1ORCID,Costa Stefania5ORCID,Scalvini Davide2ORCID,Tribocco Elisa1,Manes Gianpiero2,Saibeni Simone2ORCID

Affiliation:

1. Department of Medical Sciences, University of Turin, 10100 Turin, Italy

2. IBD Centre, Gastroenterology Unit, Rho Hospital, ASST Rhodense, 20017 Rho, Italy

3. IBD Centre, IRCCS Humanitas, Research Hospital, 20089 Rozzano, Italy

4. Department of Biomedical Sciences, Humanitas University, 20072 Pieve Emanuele, Italy

5. Gastroenterology and Digestive Endoscopy Unit, Legnano Hospital, ASST Ovest Milanese, 20025 Legnano, Italy

Abstract

(1) Background: GP2017 is one of the biosimilar drugs of adalimumab, one of the anti-TNF agents used for inflammatory bowel disease (IBD). To date, there is little real-world data about the use of GP2017 in IBD patients. The aim of our study was to evaluate the effectiveness and safety of this biosimilar in an IBD population. (2) Methods: This is an observational retrospective study including patients that were all treated with GP2017 as a first step or as a switch from the originator or other biosimilars. The clinical activity was evaluated at baseline and after 6 and 12 months of therapy. The therapy discontinuation and side effects were also evaluated. (3) Results: a total of 72 patients were included (65 with Crohn’s disease and 7 with ulcerative colitis). Of the 29 patients starting GP2017 as a first adalimumab therapy, clinical remission was achieved in 58.6%. Of the patients starting GP2017 as a switch from the originator (33 patients) or other biosimilars (10 patients), clinical remission was maintained in 78.8% and in 70%, respectively. Regarding the safety, only 11 patients experienced non-serious side effects. During the follow-up, nine patients suspended treatment mainly due to side effects or secondary failure. (4) Conclusions: GP2017 is an effective and safe therapy for IBD patients.

Funder

Institutional Review Board (or Ethics Committee) of Città della Salute e Della Scienza di Torino

Publisher

MDPI AG

Subject

General Medicine

Reference49 articles.

1. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults;Lamb;Gut,2019

2. Recent advances in monoclonal antibody therapy in IBD: Practical issues;Tamilarasan;Frontline Gastroenterol.,2019

3. Ellis, C.R., and Azmat, C.E. (2023, October 10). Adalimumab, StatPearls, Available online: http://www.ncbi.nlm.nih.gov/books/NBK557889/.

4. Switching between reference adalimumab and biosimilars in chronic immune-mediated inflammatory diseases: A systematic literature review;Br. J. Clin. Pharmacol.,2022

5. Adalimumab: A review of side effects;Scheinfeld;Expert Opin Drug Saf.,2005

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