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Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring
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SYSNO ASEP 0564874 Document Type J - Journal Article R&D Document Type Journal Article Subsidiary J Článek ve WOS Title Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring Author(s) Wasserbauer, M. (CZ)
Hlava, S. (CZ)
Drábek, J. (CZ)
Šťovíček, J. (CZ)
Minaříková, P. (CZ)
Nedbalová, L. (CZ)
Drasar, T. (CZ)
Zadorová, Z. (CZ)
Dolina, J. (CZ)
Konečný, S. (CZ)
Kojecky, V. (CZ)
Koželuhová, J. (CZ)
Černíková, P. (CZ)
Pichlerová, D. (CZ)
Kučerová, B. (CZ)
Coufal, Štěpán (MBU-M) ORCID, RID
Keil, R. (CZ)Article number e0271299 Source Title PLoS ONE. - : Public Library of Science - ISSN 1932-6203
Roč. 17, 8 August (2022)Number of pages 13 s. Language eng - English Country US - United States Keywords Adalimumab ; Biosimilar Pharmaceuticals ; Colitis ; Ulcerative ; Crohn Disease ; Humans ; Inflammatory Bowel Diseases ; Prospective Studies ; Remission Induction ; Treatment Outcome Subject RIV FE - Other Internal Medicine Disciplines OECD category General and internal medicine Method of publishing Open access Institutional support MBU-M - RVO:61388971 UT WOS 000922632200001 EID SCOPUS 85135547185 DOI 10.1371/journal.pone.0271299 Annotation 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 <150) was achieved in 73.5% of cases, partial response (≥70-point decrease in CDAI score from baseline) in 11.8%, no response in 11.8% and 2.9% patients discontinued therapy. In UC patients, remission (total score on partial Mayo index ≤2 points) was achieved only in 18.8% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 43.8%, no response in 25.0% and 12.5% patients discontinued therapy. There were statistically significant improvements in CDAI, MSS, haemoglobin, fecal calprotectin, albumin and CRP serum levels after 12 weeks of therapy. Seven adverse events were identified, three of which resulted in therapy being discontinued. Conclusions This prospective observational study proved the effectiveness of the adalimumab biosimilars FKB327 and GP2017 in IBD. Workplace Institute of Microbiology Contact Eliška Spurná, eliska.spurna@biomed.cas.cz, Tel.: 241 062 231 Year of Publishing 2023 Electronic address https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0271299
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