Počet záznamů: 1
Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring
- 1.
SYSNO ASEP 0564874 Druh ASEP J - Článek v odborném periodiku Zařazení RIV J - Článek v odborném periodiku Poddruh J Článek ve WOS Název Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring Tvůrce(i) 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)Číslo článku e0271299 Zdroj.dok. PLoS ONE. - : Public Library of Science - ISSN 1932-6203
Roč. 17, 8 August (2022)Poč.str. 13 s. Jazyk dok. eng - angličtina Země vyd. US - Spojené státy americké Klíč. slova Adalimumab ; Biosimilar Pharmaceuticals ; Colitis ; Ulcerative ; Crohn Disease ; Humans ; Inflammatory Bowel Diseases ; Prospective Studies ; Remission Induction ; Treatment Outcome Vědní obor RIV FE - Ostatní obory vnitřního lékařství Obor OECD General and internal medicine Způsob publikování Open access Institucionální podpora MBU-M - RVO:61388971 UT WOS 000922632200001 EID SCOPUS 85135547185 DOI 10.1371/journal.pone.0271299 Anotace 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. Pracoviště Mikrobiologický ústav Kontakt Eliška Spurná, eliska.spurna@biomed.cas.cz, Tel.: 241 062 231 Rok sběru 2023 Elektronická adresa https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0271299
Počet záznamů: 1