دورية أكاديمية
Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring.
| العنوان: | Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring. |
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| المؤلفون: | Martin Wasserbauer, Stepan Hlava, Jiri Drabek, Jan Stovicek, Petra Minarikova, Lenka Nedbalova, Tomas Drasar, Zdena Zadorova, Jiri Dolina, Stefan Konecny, Vladimír Kojecky, Jana Kozeluhova, Pavlina Cernikova, Dita Pichlerova, Barbora Kucerova, Stepan Coufal, Radan Keil |
| المصدر: | PLoS ONE, Vol 17, Iss 8, p e0271299 (2022) |
| بيانات النشر: | Public Library of Science (PLoS) |
| سنة النشر: | 2022 |
| المجموعة: | Directory of Open Access Journals: DOAJ Articles |
| مصطلحات موضوعية: | Medicine, Science |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 1932-6203 |
| العلاقة: | https://doi.org/10.1371/journal.pone.0271299Test; https://doaj.org/toc/1932-6203Test; https://doaj.org/article/604ec382071046c2b523a4e6e4d9cc2dTest |
| DOI: | 10.1371/journal.pone.0271299 |
| الإتاحة: | https://doi.org/10.1371/journal.pone.0271299Test https://doaj.org/article/604ec382071046c2b523a4e6e4d9cc2dTest |
| رقم الانضمام: | edsbas.C1F27749 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 19326203 |
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| DOI: | 10.1371/journal.pone.0271299 |