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

J 2022

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

WASSERBAUER, Martin, Stepan HLAVA, Jiri DRABEK, Jan STOVICEK, Petra MINARIKOVA et. al.

Základní údaje

Originální název

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

Autoři

WASSERBAUER, Martin (203 Česká republika), Stepan HLAVA (203 Česká republika, garant), Jiri DRABEK (203 Česká republika), Jan STOVICEK (203 Česká republika), Petra MINARIKOVA (203 Česká republika), Lenka NEDBALOVA (203 Česká republika), Tomas DRASAR (203 Česká republika), Zdena ZADOROVA (203 Česká republika), Jiří DOLINA (203 Česká republika, domácí), Štefan KONEČNÝ (703 Slovensko, domácí), Vladimír KOJECKY (203 Česká republika), Jana KOZELUHOVA (203 Česká republika), Pavlina CERNIKOVA (203 Česká republika), Dita PICHLEROVA (203 Česká republika), Barbora KUCEROVA (203 Česká republika), Stepan COUFAL (203 Česká republika) a Radan KEIL (203 Česká republika)

Vydání

PLOS One, SAN FRANCISCO, PUBLIC LIBRARY SCIENCE, 2022, 1932-6203

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30219 Gastroenterology and hepatology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.700

Kód RIV

RIV/00216224:14110/22:00128066

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1371/journal.pone.0271299

UT WoS

000922632200001

Klíčová slova anglicky

adalimumab biosimilars; Crohn´s disease; ulcerative colitis

Štítky

14110213, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 24. 2. 2023 07:55, Mgr. Tereza Miškechová

Anotace

V originále

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.

Citovat

WASSERBAUER, Martin, Stepan HLAVA, Jiri DRABEK, Jan STOVICEK, Petra MINARIKOVA, Lenka NEDBALOVA, Tomas DRASAR, Zdena ZADOROVA, Jiří DOLINA, Štefan KONEČNÝ, Vladimír KOJECKY, Jana KOZELUHOVA, Pavlina CERNIKOVA, Dita PICHLEROVA, Barbora KUCEROVA, Stepan COUFAL a Radan KEIL. Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring. PLOS One. SAN FRANCISCO: PUBLIC LIBRARY SCIENCE, 2022, roč. 17, č. 8, s. 1-13. ISSN 1932-6203. Dostupné z: https://dx.doi.org/10.1371/journal.pone.0271299.

@article{2247519,
   author = {Wasserbauer, Martin and Hlava, Stepan and Drabek, Jiri and Stovicek, Jan and Minarikova, Petra and Nedbalova, Lenka and Drasar, Tomas and Zadorova, Zdena and Dolina, Jiří and Konečný, Štefan and Kojecky, Vladimír and Kozeluhova, Jana and Cernikova, Pavlina and Pichlerova, Dita and Kucerova, Barbora and Coufal, Stepan and Keil, Radan},
   article_location = {SAN FRANCISCO},
   article_number = {8},
   doi = {http://dx.doi.org/10.1371/journal.pone.0271299},
   keywords = {adalimumab biosimilars; Crohn´s disease; ulcerative colitis},
   language = {eng},
   issn = {1932-6203},
   journal = {PLOS One},
   title = {Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring},
   url = {https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0271299},
   volume = {17},
   year = {2022}
}

TY  - JOUR
ID  - 2247519
AU  - Wasserbauer, Martin - Hlava, Stepan - Drabek, Jiri - Stovicek, Jan - Minarikova, Petra - Nedbalova, Lenka - Drasar, Tomas - Zadorova, Zdena - Dolina, Jiří - Konečný, Štefan - Kojecky, Vladimír - Kozeluhova, Jana - Cernikova, Pavlina - Pichlerova, Dita - Kucerova, Barbora - Coufal, Stepan - Keil, Radan
PY  - 2022
TI  - Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring
JF  - PLOS One
VL  - 17
IS  - 8
SP  - 1-13
EP  - 1-13
PB  - PUBLIC LIBRARY SCIENCE
SN  - 19326203
KW  - adalimumab biosimilars
KW  - Crohn´s disease
KW  - ulcerative colitis
UR  - https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0271299
N2  - 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.
ER  -

WASSERBAUER, Martin, Stepan HLAVA, Jiri DRABEK, Jan STOVICEK, Petra MINARIKOVA, Lenka NEDBALOVA, Tomas DRASAR, Zdena ZADOROVA, Jiří DOLINA, Štefan KONEČNÝ, Vladimír KOJECKY, Jana KOZELUHOVA, Pavlina CERNIKOVA, Dita PICHLEROVA, Barbora KUCEROVA, Stepan COUFAL a Radan KEIL. Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring. \textit{PLOS One}. SAN FRANCISCO: PUBLIC LIBRARY SCIENCE, 2022, roč.~17, č.~8, s.~1-13. ISSN~1932-6203. Dostupné z: https://dx.doi.org/10.1371/journal.pone.0271299.

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