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Biosimilar adalimumab FKB-327 in the treatment of inflammatory bowel disease


Authors: Lukáš M.;  Vašátko M.;  Jr Lukáš M.;  Kolář M.;  Ďuricová D.;  Machková N.;  Malíčková K.;  Hrubá V.
Authors place of work: Klinické a výzkumné centrum pro střevní záněty, Klinické centrum ISCARE a. s. a 1. LF UK v Praze
Published in the journal: Gastroent Hepatol 2020; 74(6): 553-557
Category: IDB: Original Article
doi: https://doi.org/10.48095/ccgh2020553

Summary

In 2018 year, the patent of original adalimumab expired and a new biosimilar version of adalimumab have been introduced on the Czech market. FKB-327 is one of the new biosimilar adalimumab versions and was approved for all indication of the original drug. This is the first experience with biosimilar adalimumab FKB-327 in IBD patients. Patients cohort comprised from 51 patients included 40 (82%) ones with Crohn´s disease and 9 (18%) ones with ulcerative colitis. Most of the patients (78%) have been naive for biologic therapy. A positive therapeutic effect during the median follow up time (37 weeks) was described in 47 (92%) patients. This drug was tolerated very well and none of the treated patients had to stop prematurely the drug administration due to significant side effects.

Keywords:

idiopatické střevní záněty – biologická léčba – biosimilární adalimumab FKB-327 – inflammatory bowel disease – bio logic therapy – adalimumab bio similar FKB-327


Zdroje

1. Kolář M, Ďuricová D, Bortlík M et al. Infliximab bio similar (RemsimaTM) in therapy of inflammatory bowel diseases patients: experience from one tertiary IBD centre. Dig Dis 2017; 35 (1–2): 91–100. doi: 10.1159/000453343.

2. Lukáš M, Kolář M, Bortlík M. Biosimilární léčiva v léčbě idiopatických střevních zánětů. In: Tesař V  (ed). Biosimilars. Praha: Mladá fronta 2017: 105–122.

3. Lukáš M. První generace bio logických léčiv-anti-TNFa monoklonální protilátky. In: Lukáš M (ed). Pokroky v dia gnostice a léčbě idiopatických střevních zánětů. Galén 2019: 137–164.

4. Lukáš M. Biosimilární adalimumab FKB327 (Hulio®). Gastroent Hepatol 2019; 73 (2): 177–178. doi: 10.14735/amgh2019177.

5. Puri A, Niewiarovski A, Arai Y et al. Pharmacokinetics, safety, tolerability and immunogenecity of FKB-327 a new bio similar medicine of adalimumab / /Humira, in healthy subjects. Br J Clin Pharmacol 2017; 83 (7): 1405–1415. doi: 10.1111/bcp.13245.

6. Genovese MC, Glover J, Matsunga N et al. Efficacy, safety anf immunogenecity in randomized, double blind and open-label extension studies comparing FKB327 an adalimumab bio similar, with adalimumab reference product (Humira-RP) in patients with active rheumatoid arthritis. Arthritis Rheumatol 2017; Suppl 10: 2799.

7. Lukas M, Malickova K, Kolar M et al. Switching from originator adalimumab to the bio similar SB5 in patients with inflammatory bowel disease: short-term experience from a single tertiary clinical centre. J Crohns Colitis 2020; 14 (7): 915–919. doi: 10.1093/ecco-jcc/jjaa001.

Štítky
Paediatric gastroenterology Gastroenterology and hepatology Surgery

Článok vyšiel v časopise

Gastroenterology and Hepatology

Číslo 6

2020 Číslo 6
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