Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring

Objective The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evalu...

Full description

Saved in:
Bibliographic Details
Published in:PloS one 2022-08, Vol.17 (8), p.e0271299-e0271299
Main Authors: Wasserbauer, Martin, Hlava, Stepan, Drabek, Jiri, Stovicek, Jan, Minarikova, Petra, Nedbalova, Lenka, Drasar, Tomas, Zadorova, Zdena, Dolina, Jiri, Konecny, Stefan, Kojecky, Vladimír, Kozeluhova, Jana, Cernikova, Pavlina, Pichlerova, Dita, Kucerova, Barbora, Coufal, Stepan, Keil, Radan
Format: Article
Language:English
Subjects:
Adverse events
Albumins
Biological products
Biology and Life Sciences
Clinical trials
Complications
Crohn's disease
Crohns disease
Drugs
Endoscopy
Fistula
Hemoglobin
Immunotherapy
Inflammatory bowel disease
Inflammatory bowel diseases
Laboratories
Laboratory tests
Medicine and Health Sciences
Monoclonal antibodies
Observational studies
Patients
Performance evaluation
Remission
Remission (Medicine)
Research and Analysis Methods
Serum levels
Statistical analysis
Therapy
TNF inhibitors
Ulcerative colitis
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Objective The adalimumab biosimilars FKB327 and GP2017 were approved for the therapy of patients with inflammatory bowel disease (IBD). Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published. The aim of this prospective observational study was to evaluate the effectiveness and safety of the biosimilar adalimumab. Material and methods Adalimumab biosimilars FKB327 (Hulio®) and GP2017 (Hyrimoz®) were indicated to 50 naive patients in terms of biological therapy with Crohn’s disease (CD) or ulcerative colitis (UC). Effectiveness of therapy was evaluated via the Crohn’s Disease Activity Index [CDAI] or the Mayo Scoring System [MSS] in patients with CD or UC, respectively, before and after 12 weeks. Additional goals were to evaluate weight changes, laboratory tests and complications or adverse events of this therapy. Results In CD patients, remission (CDAI
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0271299